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Drug Use in Street Sex worKers (DUSSK) study – results of a mixed methods feasibility study of a complex intervention to reduce illicit drug use in drug dependent female sex workers
ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2019-036491
Article Type: Original research
Date Submitted by the 17-Dec-2019 Author:
Complete List of Authors: Patel, Rita; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences Redmond, Niamh; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences Kesten, Joanna; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences & NIHR Health Protection Research Unit in Evaluation of Interventions Linton, Myles-Jay; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences & Health Economics Bristol Horwood, Jeremy; University Hospitals Bristol NHS Foundation Trust,
NIHR ARC West; University of Bristol, Population Health Sciences & http://bmjopen.bmj.com/ Centre for Academic Primary Care Wilcox, David ; Avon & Wiltshire Partnership NHS Trust, Acer Unit, Blackberry Hill Hospital, Manor Road, Munafo , Jessica ; Avon & Wiltshire Partnership NHS Trust, Acer Unit, Blackberry Hill Hospital, Manor Road, Coast, Joanna; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; Bristol University, Population Health Sciences & Health Economics Bristol Macleod, John; University Hospitals Bristol NHS Foundation Trust, NIHR on September 30, 2021 by guest. Protected copyright. ARC West; University of Bristol, Population Health Sciences & Centre for Academic Primary Care Jeal, N; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences
Keywords: QUALITATIVE RESEARCH, MENTAL HEALTH, HEALTH ECONOMICS
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 6 7 8 9 I, the Submitting Author has the right to grant and does grant on behalf of all authors of the Work (as defined 10 in the below author licence), an exclusive licence and/or a non-exclusive licence for contributions from authors 11 who are: i) UK Crown employees; ii) where BMJ has agreed a CC-BY licence shall apply, and/or iii) in accordance 12 with the terms applicable for US Federal Government officers or employees acting as part of their official 13 duties; on a worldwide, perpetual, irrevocable, royalty-free basis to BMJ Publishing Group Ltd (“BMJ”) its 14 licensees and where the relevant Journal is co-owned by BMJ to the co-owners of the Journal, to publish the 15 Work in this journal and any other BMJ products and to exploit all rights, as set out in our licence. 16 17 The Submitting Author accepts and understands that any supply made under these terms is made by BMJ to 18 the Submitting Author Forunless you peer are acting as review an employee on behalf only of your employer or a postgraduate 19 student of an affiliated institution which is paying any applicable article publishing charge (“APC”) for Open 20 Access articles. Where the Submitting Author wishes to make the Work available on an Open Access basis (and 21 intends to pay the relevant APC), the terms of reuse of such Open Access shall be governed by a Creative 22 Commons licence – details of these licences and which Creative Commons licence will apply to this Work are set 23 out in our licence referred to above. 24 25 Other than as permitted in any relevant BMJ Author’s Self Archiving Policies, I confirm this Work has not been 26 accepted for publication elsewhere, is not being considered for publication elsewhere and does not duplicate 27 material already published. I confirm all authors consent to publication of this Work and authorise the granting 28 of this licence. 29 30 31 32 33 34 35 36
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45 on September 30, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 Drug Use in Street Sex worKers (DUSSK) study – results of a 6 7 8 9 mixed methods feasibility study of a complex intervention to 10 11 12 reduce illicit drug use in drug dependent female sex workers 13 14 15 Authors: 16 17 1,2 1,2 1,2,3 1,2,4 18 Dr Rita Patel*, Dr NiamhFor M Redmond*,peer Drreview Joanna M Kesten, only Dr Myles-Jay Linton, Dr 19 Jeremy Horwood,1,2,6 David Wilcox,5 Jess Munafo,5 Prof Joanna Coast,1,2,4 Prof John Macleod,1,2,6 Dr 20 21 Nicola Jeal.1,2 22 23 *Joint first authors. 24 25 Author affiliations: 26 27 1 The National Institute for Health Research Applied Research Collaboration West (NIHR ARC West) 28 29 at University Hospitals Bristol NHS Foundation Trust, Whitefriars, Lewins Mead, Bristol, UK, BS1 2NT 30 31 2 Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley 32 Road, Bristol, UK, BS8 2PS 33 34 3 The National Institute for Health Research Health Protection Research Unit in Evaluation of 35 36 Interventions, University of Bristol, UK
37 http://bmjopen.bmj.com/ 4 Health Economics Bristol, Population Health Sciences, Bristol Medical School, University of Bristol, 38 39 1-5 Whiteladies Road, Bristol, UK, BS8 1NU 40 41 5 Avon & Wiltshire Partnership NHS Trust, Acer Unit, Blackberry Hill Hospital, Manor Road, Bristol, 42 43 UK, BS16 2EW 44 6 Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University
45 on September 30, 2021 by guest. Protected copyright. 46 of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS 47 48 Corresponding author: 49 50 51 Dr Nicola Jeal ([email protected]) 52 53 Word count: 54 55 Target Journal BMJ Open: Abstract: (299/300), Main: (3989/4000) 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Abstract 5 6 7 Objectives 8 9 10 The majority of female street-based sex workers (SSWs) are dependent on illicit drugs and sell sex to 11 fund their drug use. They typically face multiple traumatic experiences, starting at a young age, 12 13 which are ongoing through sex work involvement. Their trauma-related symptoms tend to increase 14 15 when drug use is reduced suggesting a trauma-focussed approach to reducing drug dependency may 16 be effective. Aims to (i) evaluate recruitment and retention of participants; (ii) examine intervention 17 18 experiences and acceptability;For peerand (iii) explore review intervention costs only using mixed methods feasibility 19 20 study. 21 22 Setting 23 24 Female SSW charity premises in a large UK inner city. 25 26 27 Participants 28 29 Females aged 18 years or older, who have sold sex on the street and used heroin and/or crack cocaine 30 31 at least once a week in the last calendar month. 32 33 Intervention 34 35 36 Female SSW-only drug treatment groups in a female SSW-only setting delivered by female staff.
37 Targeted post-traumatic stress disorder (PTSD) screening then treatment of positive diagnoses with http://bmjopen.bmj.com/ 38 39 eye movement desensitization and reprocessing (EMDR) therapy by female staff from a specialist NHS 40 41 trauma service. 42 43 Results 44
45 (i) Of 125 potential participants 11 met inclusion criteria and provided informed consent, 4 for on September 30, 2021 by guest. Protected copyright. 46 47 trauma therapy; 2 received EMDR therapy. (ii) Service providers said working in collaboration with 48 49 other services was valuable, the intervention was worthwhile and had a positive influence on 50 participants. Participants viewed recruitment as acceptable and experienced the intervention 51 52 positively. The unsettled nature of participant’s lives was a key attendance barrier. (iii) The total cost 53 54 of the intervention was £11,710, with staff costs dominating. 55 56 Conclusions 57 Recruitment rates were lower than anticipated, due to study inclusion criteria targeting those with 58 59 the most complex needs. Two participants received EMDR demonstrating that three differing agencies 60
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1 2 3 working together was feasible. Staff heavy costs highlight the important role of supporting participant BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 attendance in minimising per participant intervention cost. 6 7 Ethics approval 8 9 10 South West - Frenchay Research Ethics Committee (REC reference: 17/SW/0033; IRAS project ID: 11 220631). UK HRA approval was on 03/04/2017.The University of Bristol Research Enterprise and 12 13 Development department sponsored this study (RED reference: RG2756). 14 15 16 17 Strengths and limitations of this study 18 For peer review only 19 All aspects of the intervention were delivered by specialists 20 21 PPI formed an important part of the study and informed each stage 22 23 Recruitment over several months within a trusted agency with multiple approaches allowed 24 25 SSWs many opportunities to take part 26 This feasibility study provides only preliminary information on the intervention performance 27 28 and cost and does not examine the effectiveness 29 30 Delays are likely to have adversely influenced study recruitment and retention, and higher 31 service costs 32 33 34 35 Keywords: 36
37 http://bmjopen.bmj.com/ 38 sex workers, feasibility study, qualitative research, cost analysis, trauma treatment, drug 39 dependency 40 41 42 43 44
45 on September 30, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Introduction 5 6 7 Most female street-based sex workers (SSWs) in the UK use heroin and/or crack cocaine.1-3 Their drug 8 dependency keeps them entrenched in a “work-score-use cycle”,4 5 which contributes to the morbidity 9 10 and social instability typically seen in this group.6 11 12 13 Despite their drug treatment needs, drug dependent SSWs have poorer outcomes from drug 14 15 treatment services compared to other service users,7 8 sometimes due to stigma associated with their 16 17 street sex work.9 Previous SSW-focussed interventions aiming to reduce drug use have used 18 For peer review only educational,10 11 substitute prescribing-based12 13 and psychological14 approaches but none robustly 19 20 demonstrated a positive effect in reducing drug use.15 21 22
23 16-18 24 Poor mental health is a significant problem among SSWs. Many have experienced multiple 25 adversities in early life and during their involvement in sex work,5 16 19 which exposes women to further 26 27 risk of significant trauma.16 17 Consequently, many SSWs are affected by post-traumatic stress disorder
28 16 17 29 (PTSD). Trauma symptoms, which often recur when drug use is reduced, may motivate a return to 30 drug use.20 Individual trauma-focused therapy alongside drug treatment may provide the best 31 32 outcomes for reductions in drug use.21-23 However to date, there is no robust evidence to demonstrate 33 34 the impact of an integrated trauma-focussed treatment approach in reducing drug use amongst 35 female drug dependent SSWs. 36
37 http://bmjopen.bmj.com/ 38 39 In collaboration with SSWs and service providers we developed a novel intervention, informed by 40 existing research9 15 to address the unique and complex combination of drug use and mental health 41 42 needs of female drug-dependent SSWs. The intervention proposes an integrated care pathway 43 24 44 through an innovative multi-agency partnership. We report here the results of the DUSSK (Drug Use
45 in Street Sex worKers) feasibility study, which aimed to (i) evaluate the recruitment and retention of on September 30, 2021 by guest. Protected copyright. 46 47 SSWs to the intervention; (ii) examine the experience and acceptability of the intervention for 48 49 participants and service providers; and (iii) explore costs to service providers associated with the 50 intervention. 51 52 53 54 55 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Methods 5 6 7 Study design, setting and eligibility 8 9 10 This mixed methods feasibility study took place in a UK inner city setting. Females aged 18 years or 11 older, who sold sex on the street and used heroin and/or crack cocaine at least once a week in the last 12 13 calendar month, were eligible to participate.24 The intervention was delivered at SSW charity 14 15 premises. 16 17 18 For peer review only 19 Recruitment 20 21 Local organisations that SSWs were known to access were provided with study promotional materials. 22 23 One of three researchers (JMK, NJ, SR) attended an SSW support and advocacy charity, at least twice 24 a week, to directly approach potential participants; alternatively, interested SSWs could telephone 25 26 researchers. Eligibility screening was conducted face-to-face or via telephone. Women gave fully 27 28 informed, written consent to participate in the study at the time of recruitment and baseline data 29 30 were collected. To maintain safety and confidentiality, each participant provided details of acceptable 31 ways in which to be contacted. Screening data were retained and remained anonymised for those not 32 33 recruited. 34 35 36
37 http://bmjopen.bmj.com/ 38 Patient and Public Involvement (PPI) 39 40 Women with experience of street sex work and drug-dependency contributed to the study design, 41 42 processes, documentation and intervention development. Recommendations from PPI meetings were 43 implemented and resulted in direct changes to the study processes to support recruitment, 44
45 participation and encourage adherence (described below). on September 30, 2021 by guest. Protected copyright. 46 47 48 49 The intervention 50 51 The intervention consisted of SSW only drug treatment groups, targeted screening for PTSD and, if 52 53 positively diagnosed, one-to-one EMDR therapy, all delivered by female staff through a collaboration 54 55 between three service providers (National Health Service (NHS) trauma services, the SSW and drug 56 treatment charities). The intervention was designed so participants were initially invited to attend a 57 58 weekly ‘Getting started’ drug treatment group to reduce fear and anxiety about engaging in a group 59 60 setting and get used to the format and level of disclosure expected. Participants were to progress to
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1 2 3 a ‘Preparation for recovery’ drug treatment group which focused on peoples’ barriers to motivation BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 for change, examining pros and cons of drug use and exploring triggers for using drugs to enable 6 7 participants to achieve a level of drug use stability. When group facilitators judged participants were 8 achieving drug use stabilisation, and they had attended three sessions consecutively, they were 9 10 offered screening for PTSD by a female clinical psychologist (one-to-one clinical interview and PTSD 11 25 12 checklist- PCL5). Those experiencing PTSD symptoms were invited to attend five PTSD ‘Stabilisation’ 13 group sessions, facilitated by the same female clinical psychologist, to equip participants with the skills 14 15 to self-soothe and reorientate in preparation for the one-to-one EMDR treatment. Once all 16 17 ‘Stabilisation’ group sessions had been completed, the clinical psychologist assessed participants for 18 readiness for one-to-oneFor EMDR peer sessions andreview if eligible, participants only progressed to a course of 12 19 20 sessions with the clinical psychologist on a weekly, or fortnightly, basis. Trauma treatment (PTSD 21 22 screening, stabilisation groups and one-to-one) ran in parallel to the drug treatment groups, Figure 1 23 (red boxes) shows the planned flow of participants through the study. The intervention proceeded as 24 25 described24 with the following changes (bulleted below): 26 27 Participants were encouraged to attend all sessions with the offer of car lifts, bus tickets and taxis, 28 in addition to the planned weekly phone calls and texts, by the staff at partner agencies. 29 30 31 32 ‘Getting started’ and ‘Preparation for recovery’ drug treatment groups 33 34 35 Changes to commissioning of the drug group service provider and low numbers recruited resulted 36 in the drug groups merging into a single open drug treatment ‘Getting started’ group.
37 http://bmjopen.bmj.com/ 38 Sandwiches were supplied prior to the single drug group to support attendance from the 14th 39 40 session onwards. 41 The number of sessions continued beyond those initially planned due to delays in PTSD screening 42 43 (see below). 44 Poor attendance, the participant’s unstable behaviour and the intervention running for longer
45 on September 30, 2021 by guest. Protected copyright. 46 47 than planned affected the drug group facilitators’ ability to deliver structured content, leading to 48 the involvement of an art worker for 4 sessions. 49 50 PTSD screening was halted from the 29th session onwards, due to the limited remaining study time 51 52 to complete the intervention, meaning the drug group became closed and only included PTSD 53 screened participants. 54 55 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Screening for PTSD 5 6 Delays occurred to both the organisation of the PTSD screening and PTSD stabilisation group set 7 8 up due to lack of capacity and delays in NHS trauma service staff recruitment. Therefore, some 9 participants had long gaps between recruitment and PTSD screening and subsequent stabilisation 10 11 group sessions. 12 13 14 15 PTSD ‘Stabilisation’ group 16 17 Incentives of £10 vouchers per session were offered for attendance (mandatory sessions). 18 For peer review only 19 20 21 One-to-one EMDR therapy for PTSD 22 23 Some sessions were scheduled in a private rented room (due to availability issues) in a local 24 25 community centre and not at the SSW charity premises. 26 27 Two participants were offered weekly one-to-one extended stabilisation sessions (8 maximum) 28 with the clinical psychologist rather than EMDR therapy as this was deemed the most appropriate 29 30 treatment. 31 32 33 34 Data collection methods 35 36
37 Sample size and quantitative data collection http://bmjopen.bmj.com/ 38 39 A formal sample size calculation was not conducted as the aim was to assess feasibility.24 Self-reported 40 41 levels of illicit drug use, involvement in SSW, completion of PTSD Checklist PCL525 and demographics 42 43 were collected at the time of consent. Attendance registers were taken at the start of each group or 44 one-to-one session by the facilitator(s).
45 on September 30, 2021 by guest. Protected copyright. 46 47 48 Qualitative data collection 49 50 With participants’ verbal consent one non-participant observation of a drug group was conducted to 51 52 understand delivery, examine interactions and intervention experiences, with brief notes taken during 53 54 the group.26 55 56 In-depth semi-structured interviews were conducted with participants and service providers either 57 58 face-to-face or by telephone. Participants were interviewed after intervention completion or study 59 drop out. Consent to contact participants regarding interviews was sought at recruitment. Additional 60
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1 2 3 written or audio recorded verbal, informed consent was obtained prior to all interviews. Interviews BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 explored views and experiences of the intervention and how to improve acceptability. Participants 6 7 received a £20 high street shopping voucher for taking part. Most service provider interviews were 8 conducted at the end of the intervention period and also sought to understand operational issues, 9 10 inter-agency working and intervention delivery. 11 12 13 14 15 Economic data collection 16 17 Resource use information (2018 £GBP) was collected prospectively by the agencies. Data collection 18 focussed on four categories:For Staff peer time, Facilities, review Travel (provider only funded staff and patient transport), 19 20 and Materials. 21 22 23 24 25 Data analysis 26 27 28 Statistical analysis 29 30 Descriptive statistics were used to monitor recruitment and retention via CONSORT statement27 style 31 32 flowcharts, and to examine participant demographics, questionnaire responses and attendance. 33 34 35 36 Qualitative analysis
37 http://bmjopen.bmj.com/ 38 Interviews were conducted by JMK and NJ, and the audio files transcribed, anonymised and checked 39 40 for accuracy. QSR NVivo 10 software was used to perform inductive thematic analysis28 using constant 41 29 30 42 comparison techniques. A preliminary coding framework was developed by JMK and discussed 43 with the multidisciplinary research team JH and NJ to ensure credibility and confirmability. 44
45 on September 30, 2021 by guest. Protected copyright. 46 47 Cost analysis 48 49 Costs to the service provider were examined and summarised separately for each of the four 50 51 intervention components. Staff costs were calculated using salaries and on-costs or generated using 52 53 standard unit cost data available for health and social care professionals.31 Facility costs were 54 calculated based on similar space rental options. Total cost, total cost per eligible participant, total 55 56 cost per session held, and total cost per session per eligible participant were calculated for each 57 58 intervention component. Cost data were tabulated using principles of heat-map methodology, where 59 colour lightness is used to communicate the magnitude of different costs.32 33 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Results 5 6 7 Recruitment was from November 2017 to March 2018 with the intervention delivered until December 8 2018. 9 10 11 12 13 (i) Recruitment and attendance 14 15 Recruitment Process 16 17 18 Approximately 400 flyersFor and ninepeer posters werereview distributed. Potential only participants were spoken to by 19 three researchers at 37 three-hour ‘drop-in’ sessions at the SSW charity. Of 125 women approached 20 21 84 declined screening. Reasons for decline included being too busy (n=13), not interested (n=11) or 22 23 reporting not currently street sex working (n=10). Fourteen approaches were reported as repeat 24 approaches, with seven reporting previous recruitment and four previous screening (as the 25 26 researchers recruited on different weekdays and screening data was anonymous). Figure 1 details the 27 28 flow of screened and recruited participants through the intervention. 29 30 31 Of 41 women screened, 11 were eligible and consented to participate, three were eligible but unable 32 33 to give consent (two were too distressed and one had health issues preventing participation). Of the 34 27 ineligible women, two did not fully complete the screening questions. The main reasons for 35 36 exclusion related to ineligible frequency of drug use and/or sex work. Table 1 shows the range of days
37 http://bmjopen.bmj.com/ 38 since responders last street sex worked or had taken heroin/crack by those recruited and not 39 recruited. 40 41 42 43 Of 11 participants consenting to be invited for qualitative interviews, five were uncontactable. Seven 44 interviews were conducted with six participants (six face-to-face and one via telephone); four
45 on September 30, 2021 by guest. Protected copyright. 46 interviewed participants received all components of the intervention. Ten service provider interviews 47 48 were conducted with representatives from the drug treatment service (n=4), the trauma service (n=2), 49 and the SSW charity (n=4). Table 2 details quotes from the interviews to support the main results 50 51 described below. 52 53 54 55 Acceptability of recruitment 56 57 The recruitment process was described as acceptable by most participants and service providers. Face- 58 59 to-face recruitment was experienced as confidential, with participants reporting receiving clear 60
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1 2 3 explanations of the study. Recruitment over five months within the SSW charity enhanced the BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 recruiters’ perceived trustworthiness. Offering multiple opportunities to participate was acceptable. 6 7 Most service providers interviewed reflected that if study inclusion criteria were broadened to include 8 less regular drug use, participants with more lifestyle stability could have been recruited, and whom 9 10 may have found the intervention easier to engage with. However, some felt that creating groups with 11 12 diverse levels of drug use could have negative consequences for example, risk of relapse for those 13 who had reduced their drug use. 14 15 16 17 Group attendance 18 For peer review only 19 All 11 consented participants were invited to attend drug treatment groups. However, participants 20 21 attendance varied throughout the study, with participants sometimes arriving late or leaving early 22 23 (Table 3). Four attended 30-76% of sessions compared to 7 attenders who attended only 0-18% of 24 25 sessions. The five most frequent attenders were invited to PTSD screening of which four attended and 26 were all found to have symptoms of PTSD. All four PTSD screened participants attended 20-100% of 27 28 the stabilisation groups with the clinical psychologist. At the end of the stabilisation groups, two 29 30 participants were deemed suitable for EMDR therapy by the clinical psychologist and two were offered 31 extended stabilisation sessions. All four participants missed at least two consecutive trauma 32 33 treatment appointments with the clinical psychologist and were deemed to have withdrawn from the 34 35 sessions. Following which, all participants were referred to further mental health services and one 36 participant was also referred to mainstream drug services.
37 http://bmjopen.bmj.com/ 38 39 40 Facilitators to attendance 41 42 Service providers across all partner agencies sent reminders to participants, which were described as 43 44 helpful and appreciated by participants. One SSW charity service provider played a vital role in
45 on September 30, 2021 by guest. Protected copyright. 46 encouraging attendance through reminding participants to attend, arranging transport (taxi, bus or 47 driving participants to sessions) and also helping participants mentally prepare for the intervention. 48 49 Provision of sandwich lunches before the groups was seen by service providers and participants as 50 51 helpful for encouraging attendance, facilitated a relaxed start to groups and supported concentration. 52 Vouchers were also viewed as encouraging attendance by participants and service providers. 53 54 55 56 Barriers to attendance 57 58 59 The unsettled nature of participant’s lives was perceived as an attendance barrier and was 60 underpinned by problematic drug use, poor adherence to opioid substitution therapy, sex work,
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1 2 3 tiredness due to working nights and poor mental health. Arguments between participants, a lack of BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 readiness to confront issues with drugs and trauma and an absence of social support were described 6 7 as making attendance difficult. Delays to screening referral and trauma treatment were also reported 8 to negatively affect participants’ motivation. 9 10 11 12 (ii) Experience and acceptability of the intervention 13 14 15 Initial impressions 16 17 All participants perceived the intervention as valuable and welcome. Common reasons given by 18 For peer review only 19 participants for taking part included the opportunity for ‘change’, greater stability and valuing the 20 21 opportunity to combine mental health and drug treatment. Service providers viewed the intervention 22 as a novel opportunity for 1) SSWs to receive mental health treatment while continuing to use drugs 23 24 and 2) to address the barriers to mainstream drug treatment. Some service providers highlighted the 25 26 challenge for participants to process trauma while continuing to use drugs and potential risks of sex 27 28 working when receiving trauma treatment. 29 30 31 Service providers’ views on the intervention 32 33 34 The drug group facilitators described enjoying delivering the groups and building good relationships 35 with participants. However, they described some drug sessions as intense and difficult to manage due 36
37 to participants’ distress, accounts of trauma and chaotic behaviour. The need for appropriate support http://bmjopen.bmj.com/ 38 39 and supervision of facilitators was highlighted as a requirement to manage these challenges. 40 41 42 A clinical psychologist suggested that without the ‘re-traumatising’ effects of street sex work, the 43 44 effectiveness of the trauma processing in the trauma treatment might be enhanced. Service providers
45 also proposed extending the stabilisation work to develop the effectiveness of the trauma treatment on September 30, 2021 by guest. Protected copyright. 46 47 and recommended the intervention offer alternatives to EMDR to suit individual participants’ needs. 48 49 50 Service providers said working in partnership with other specialist services to deliver the intervention 51 52 was valuable, there was mutual respect and good communication between staff. It was suggested it 53 54 would have been useful to have collaborative, regular case-review meetings between the services to 55 assess the progress and needs of the participants and enhance the communication channels. 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Participants views on the intervention 5 6 Participants described generally positive intervention experiences. They described forming 7 8 meaningful relationships with the drug group facilitators and clinical psychologist. They liked that the 9 groups were female and sex worker-only, they knew other participants already and could speak openly 10 11 about, and relate to, one another’s experience of trauma, drug use and street sex work. Participants 12 13 also valued that the intervention was delivered at SSW charity premises, which was liked for its 14 familiarity, safety, comfort, convenience and freedom from judgement and shame. The day of the 15 16 week, time and frequency of sessions, drug group session length and group size were also acceptable 17 18 to most participants Forand service peer providers. Thesereview factors overcame only some of the barriers participants 19 highlighted to attending mainstream drug services. 20 21 22 23 Impacts of the intervention 24 25 Through the intervention, participants reflected on their need to address their trauma and drug use. 26 27 Some acknowledged that they were not ready to address their trauma but aspired to this in future, 28 29 having had positive experiences of therapy during the intervention. Participants attributed improved 30 wellbeing, coping strategies and perceptions of self-worth to the intervention. One participant was 31 32 seen less on the SSW outreach van (an indicator of sex working) and, significantly, stopped using her 33 34 working name, signifying ‘taking back ownership of who she is’. One drug group facilitator felt the 35 36 participants unstable lives and level of trauma would prevent them from complying with the rules of
37 conduct in mainstream drug services and valued the flexibility of the study intervention to address http://bmjopen.bmj.com/ 38 39 these needs. They also felt that an additional positive feature of the intervention was participants 40 41 being able to discuss their sex work, due to the female SSW only membership of the groups. 42 43 44 Participation in the intervention was described by SSW charity service providers and two participants
45 on September 30, 2021 by guest. Protected copyright. 46 as supporting and empowering the participants to engage with clinical and support services to address 47 their needs. Another participant felt she used the SSW charity services less now because she needed 48 49 less support. 50 51 52 53 (iii) Cost analysis 54 55 The total cost of the intervention was £11,710, with staff costs being the largest component (Table 4). 56 57 The most expensive component of the intervention was the ’Getting started’ sessions (which totalled 58 59 £6,842). Despite having the second to lowest sub-total cost across the intervention (£1,014), the 60
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1 2 3 stabilisation groups had the highest cost per session held (£203). Although the one-to-one sessions BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 had the lowest cost per session held (£103), the larger number of sessions at this point resulted in this 6 7 section having the highest cost per eligible participant (n=4, £724). Trauma screening had the lowest 8 cost per eligible participant (n=5, £191) 9 10 11 12 Fidelity 13 14 15 The intervention was broadly delivered as intended incorporating suggested planned changes to the 16 protocol, it was more flexible and less linear than originally planned.24 Delays in PTSD screening 17 18 meant that there wasFor only a single peer drug group, review which continued only for longer than originally planned. 19 20 21 22 Discussion 23 24 Summary of findings 25 26 This study used a mixed methods approach to investigate the feasibility and acceptability of a novel, 27 28 complex intervention to reduce illicit drug use in female drug-dependent SSWs. We demonstrated 29 that drug-dependent SSWs could maintain attendance at female SSW-only drug group sessions and 30 31 the integrated trauma-focussed treatment approach, in a trusted and supportive environment, with 32 33 intensive support from SSW charity staff. Recruitment was lower than anticipated, with four 34 participants PTSD screened and whom met criteria for PTSD. They progressed through all stages of the 35 36 intervention and All four participants were ultimately able to access mental health services and one
37 http://bmjopen.bmj.com/ 38 began the process of accessing mainstream drug services. Participants and service providers mostly 39 experienced the recruitment process, the intervention and delivery mechanisms (especially the SSW- 40 41 only environment) positively. Attendance and adherence barriers primarily related to the issues the 42 43 intervention sought to address, namely problematic drug use, sex work, and poor mental health, 44 rather than the acceptability of the intervention itself. The total cost of the intervention was £11,710,
45 on September 30, 2021 by guest. Protected copyright. 46 with staff costs dominating. 47 48 49 50 Strengths and limitations of this study 51 52 53 Strengths of our study were that recruiting researchers also conducted the interviews, which may 54 have facilitated a rapport with participants and supported more open and honest reflections. 55 56 Secondly, all aspects of the intervention were delivered by specialists which was necessary for this 57 58 high-risk group with multiple complex co-morbidities. Thirdly, PPI formed an important part of the 59 study and informed each stage. Fourth, recruitment over several months with multiple approaches 60
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1 2 3 allowed SSWs many opportunities to take part. This approach took account of the rapidly changing BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 lives of SSWs resulting in changing eligibility status as well as allowing time for them to become 6 7 familiar with the researchers. Finally, recruitment within a trusted agency may have had a positive 8 influence on recruitment. 9 10 11 12 This feasibility study provides only preliminary information on the intervention performance and cost 13 and does not examine the effectiveness or potential for reducing costs in other parts of the health 14 15 service or wider society. Delays due to changes to service provision are likely to have adversely 16 17 influenced study recruitment and retention, with delays resulting in higher service costs, but reflect 18 the real-life issues facingFor multi-agency peer work. review only 19 20 21 22 Comparison with other research 23 24 25 This feasibility study is the first, to our knowledge, to address previously highlighted barriers to 26 effective drug treatment for SSWs.15 22 23 Through incorporating female SSW-only drug groups 27 28 alongside an intervention with specialised trauma treatment, delivered in a female SSW-only setting 29 30 by female staff22 24 we showed how an integrated treatment approach in this complex vulnerable 31 group can be feasibly implemented and delivered. 32 33 34 35 This study is the first interventional study to address trauma symptoms as part of the drug treatment 36 process, identified as important for this group who have been found to have high levels of poor mental
37 http://bmjopen.bmj.com/ 38 health,16 18particularly trauma,5 16 17 which has been highlighted as contributing to poor drug treatment 39 40 outcomes.7 8 The intervention took account of SSWs frequent experience of abuse and violence,34 35
41 22 36 37 42 and recommendations for female-only trauma-focussed drug treatment interventions for 43 treatment of PTSD and long term drug use reduction. Some of the characteristics the intervention 44 sought to address presented as barriers to attendance and retention, however these are common in
45 on September 30, 2021 by guest. Protected copyright.
46 23 38 47 studies trying to effect behaviour changes within vulnerable groups. 48 49 50 Previous SSW-focussed interventions aiming to reduce drug use10-13 14 were unable to demonstrate 51 15 52 strong evidence of a positive effect suggesting the need for a novel approach with evidence of 53 efficacy assessed through a robust methodological approach. The highlighted barriers to attendance, 54 55 engagement and delivery of the intervention are in keeping with other studies15 23 38 but indicate that 56 57 further changes to the DUSSK feasibility study design are likely to be required in future studies. 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Conclusion and implications for service provision and research 5 6 The inclusion criteria were informed by PPI, clinical expertise and academic literature, and targeted 7 8 women with chaotic lives who would likely benefit the most from a trauma-based intervention. Only 9 women whom sold sex on the street and used heroin or crack cocaine, at least once a week, were 10 11 eligible to take part. Many women were sex working and using drugs but less frequently than previous 12 13 evidence indicated, and so were excluded. Both participants and service providers reported that to 14 enable greater recruitment and intervention engagement, the eligibility criteria could better target 15 16 those with more stability in their lives and hence fewer barriers to participation. However, due to the 17 18 chaotic nature of participants’For lives,peer recruitment review and retention wereonly at times challenging, highlighting 19 20 a trade-off between engaging women whom might benefit the most from trauma treatment versus 21 recruiting more stable women. Future research in this area should consider this trade-off carefully, 22 23 allowing flexibility within the research process to ensure the inclusion criteria are appropriate and 24 25 realistic. 26 27 28 All four of the screened participants met criteria for PTSD, revealing the unmet need for treatment 29 30 and the severity of trauma in SSWs’ lives. Although small in numbers, meeting PTSD criteria was 31 unsurprising as it agrees with previous research. 22 36 37 Further data to understand the extent of PTSD 32 33 symptoms in this group is therefore recommended. Overall, the experiences described by those 34 35 receiving the intervention suggest it is an acceptable approach to reducing SSWs drug use. The three 36 services were able to work together effectively despite setbacks such as changing contracts and
37 http://bmjopen.bmj.com/ 38 service pressures. 39 40 41 In order to support future interventional trials in this important field where there are relatively few 42 43 effectiveness studies we would recommend the following study refinements for consideration. 44 1. The intervention could include women with more stability in their lives to increase recruitment
45 on September 30, 2021 by guest. Protected copyright. 46 and retention. 47 48 2. Regular meetings throughout the study enabling all service providers involved in intervention 49 50 delivery to express concerns and seek to understand participants needs from the perspective of 51 different professionals so there is effective multi-agency support for individual participants where 52 53 needed. 54 55 3. Support and encouragement for participant engagement through provision of transport to and 56 refreshments prior to treatment sessions. 57 58 4. Intervention flexibility and responsiveness in offering trauma-focussed alternatives to EMDR 59 60 which may be more suitable for individual participants needs.
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1 2 3 5. An extended trauma therapy programme to accommodate the complexity of SSW needs. BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Additional information 5 6 7 Acknowledgements 8 9 10 The authors are extremely grateful to all the women who have participated in the study; all service 11 providers and all other staff whose participation made this study possible. They would like to thank 12 13 the PPI group for their time, thoughts and suggestions. We are grateful to the following organisations 14 15 and individuals who have helped with the study for their time, expertise and support: Developing 16 Health and Independence, Bristol Drugs Project, Avon & Wiltshire Mental Health Partnership NHS 17 18 Trust and One25 charity,For Katie peerWarner, Lucy review Pettler, Rosie Davies, only Maggie Telfer, Elinor Griffiths, Gill 19 20 Nowland, Sophie Ramsden, Elaine Driver, Anna Smith, Rhea Warner, Jennifer Riley, Tracey Tudor, 21 Madeline Saunders, Charlotte Hignell, Sophie Banks, Jane Bowman, Sarah Shatwell, Katrina Turner, 22 23 Hasina Downie, Jo Daniels and Louisa Chowen. 24 25 26 27 Author Contributions 28 29 NJ, NMR, JH, JMK, RP, DW, JM, JMa, MJL and JC are responsible for the study design, collection of data 30 31 and analysis. NMR, RP, NJ and JH are responsible for study management and coordination. JMK and 32 33 NJ conducted the interviews. JMK led the qualitative analysis in collaboration with NJ and JH. RP 34 conducted the quantitative analysis. MJL, RP and JC conducted the costing study. NMR, RP, JMK, MJL, 35 36 JC, NJ and JH drafted the paper. All authors read, commented on and approved the final manuscript.
37 http://bmjopen.bmj.com/ 38 39 40 Funding 41 42 The research is supported by a National Institute for Health Research (NIHR) Clinic Trials Fellowship 43 44 awarded to NJ, the National Institute for Health Research Collaboration for Leadership in Applied
45 on September 30, 2021 by guest. Protected copyright. Health Research and Care West (NIHR CLAHRC West), now recommissioned as NIHR Applied Research 46 47 Collaboration West (NIHR ARC West) and Research Capability Funding awarded by University Hospitals 48 49 Bristol NHS Foundation Trust. JMK is partly funded by NIHR Health Protection Research Unit in 50 Evaluation of Interventions. The views expressed are those of the authors and not necessarily those 51 52 of the NIHR or the Department of Health and Social Care. 53 54 55 Competing interests 56 57 None declared 58 59 Data availability statement 60
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1 2 3 All data relevant to the study are included in the article. BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 References 5 6 1. Cusick L, Martin A, May T. Vulnerability and involvement in drug use and sex work. Home Office 7 research study 268. London: Home Office, 2003. 8 2. Deering KN, Kerr T, Tyndall MW, et al. A peer-led mobile outreach program and increased 9 utilization of detoxification and residential drug treatment among female sex workers who 10 11 use drugs in a Canadian setting Drug & Alcohol Dependence 2011;113(1):46-54. 12 3. Morris D, Lemus H, Wagner K D, et al. Factors associated with pathways toward concurrent sex 13 work and injection drug use among female sex workers who inject drugs in northern Mexico. 14 Addiction 2013;108:161-70. 15 4. Jeal N, Salisbury C, Turner K. The multiplicity and interdependency of factors influencing the 16 health of street-based sex workers: a qualitative study. Sex Transm Infect 2008;84(5):381-5. 17 doi: 10.1136/sti.2008.030841 [published Online First: 2008/07/04] 18 5. Gorry J, Roen K, ReillyFor J. Selling peer your self? reviewThe psychological impactonly of street sex work and factors 19 20 affecting support seeking. Health Soc Care Community 2010;18(5):492-9. doi: 21 10.1111/j.1365-2524.2010.00925.x [published Online First: 2010/06/30] 22 6. Jeal N, Salisbury C. Health needs and service use of parlour-based prostitutes compared with 23 street-based prostitutes: a cross sectional survey. BJOG 2007;114:875-81. 24 7. Burnette M LE, Ilgen M, Frayne S, Mayo J, Weitlauf J. Prevalence and health correlates of 25 prostitution among patients entering treatment for substance use disorders. Archives of 26 General Psychiatry 2008;65(3):337 - 44. 27 8. Burnette M SR, Timko C, Ilgen M. Impact of substance-use disorder treatment on women involved 28 in prostitution: substance use, mental health and prostitution one year after treatment. 29 30 Journal of Studies on Alcohol and Drugs 2009;70:32-40. 31 9. Jeal N, Macleod J, Salisbury C, et al. Identifying possible reasons why female street sex workers 32 have poor drug treatment outcomes: a qualitative study. BMJ Open 2017;7(3):e013018. doi: 33 10.1136/bmjopen-2016-013018 [published Online First: 2017/03/25] 34 10. Sherman SG, German D, Cheng Y, et al. The evaluation of the JEWEL project: An innovative 35 economic enhancement and HIV prevention intervention study targeting drug using women 36 involved in prostitution. Aids Care-Psychological and Socio-Medical Aspects of Aids/Hiv
37 http://bmjopen.bmj.com/ 2006;18(1):1-11. doi: 10.1080/09540120500101625 38 39 11. Surratt HL, Inciardi JA. An effective HIV risk-reduction protocol for drug-using female sex 40 workers. J Prev Interv Community 2010;38(2):118-31. doi: 10.1080/10852351003640732 41 [published Online First: 2010/04/15] 42 12. Gunne LM, Gronbladh L, Petersson S. [Methadone treatment in the prevention of AIDS. Heroin- 43 dependent prostitutes are an important target]. Lakartidningen 1986;83(49):4194-6. 44 [published Online First: 1986/12/03]
45 13. Litchfield J, Maronge A, Rigg T, et al. Can a targeted GP-led clinic improve outcomes for street sex on September 30, 2021 by guest. Protected copyright. 46 workers who use heroin? The British journal of general practice : the journal of the Royal 47 College of General Practitioners 2010;60(576):514-6. doi: 10.3399/bjgp10X514774 48 49 [published Online First: 2010/07/03] 50 14. Yahne CE, Miller WR, Irvin-Vitela L, et al. Magdalena Pilot Project: motivational outreach to 51 substance abusing women street sex workers. J Subst Abuse Treat 2002;23(1):49-53. 52 [published Online First: 2002/07/20] 53 15. Jeal N, Macleod J, Turner K, et al. Systematic review of interventions to reduce illicit drug use in 54 female drug-dependent street sex workers. BMJ Open 2015;5(11):e009238. doi: 55 10.1136/bmjopen-2015-009238 [published Online First: 2015/11/20] 56 16. El-Bassel N, Schilling R, Irwin K, et al. Sex trading and psychological distress among women 57 58 recruited from the streets of Harlem. American Journal Public Health 1997;87:66-70. 59 17. Chukakov B, Ilan K, Belmaker RH, et al. The motivation and mental health of sex workers. Journal 60 of Sex & Marital Therapy 2002;.28(4):pp. doi: 10.1080/00926230290001439
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1 2 3 18. Roxburgh A, Degenhardt L, J C, et al. Drug Dependence and Associated Risks Among Female BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Street-Based Sex Workers in the Greater Sydney Area, Australia. Substance Use & Misuse 5 6 2008;43(8-9):1202-17. 7 19. Mellor R, Lovell A. The lived experience of UK street-based sex workers and the health 8 consequences: an exploratory study. Health promotion international 2012;27(3):311-22. doi: 9 10.1093/heapro/dar040 [published Online First: 2011/07/06] 10 20. Reynolds M, Mezey G, Chapman M, et al. Co-morbid post-traumatic stress disorder in a 11 substance misusing clinical population. Drug and alcohol dependence 2005;77(3):251-58. 12 doi: https://doi.org/10.1016/j.drugalcdep.2004.08.017 13 21. Cloitre M, Courtois CA, Charuvastra A, et al. Treatment of complex PTSD: Results of the ISTSS 14 expert clinician survey on best practices. Journal of Traumatic Stress 2011;24(6):615-27. doi: 15 16 10.1002/jts.20697 17 22. Roberts NP, Roberts PA, Jones N, et al. Psychological therapies for post-traumatic stress disorder 18 and comorbidFor substance peer use disorder. review Cochrane Database only Syst Rev 2016;4(4):CD010204. 19 doi: 10.1002/14651858.CD010204.pub2 [published Online First: 2016/04/05] 20 23. Bailey K, Trevillion K, Gilchrist G. What works for whom and why: A narrative systematic review 21 of interventions for reducing post-traumatic stress disorder and problematic substance use 22 among women with experiences of interpersonal violence. Journal of Substance Abuse 23 Treatment 2019;99:88-103. doi: 10.1016/j.jsat.2018.12.007 24 25 24. Jeal N, Patel R, Redmond NM, et al. Drug use in street sex workers (DUSSK) study protocol: a 26 feasibility and acceptability study of a complex intervention to reduce illicit drug use in drug- 27 dependent female street sex workers. BMJ Open 2018;8(11):e022728. doi: 28 10.1136/bmjopen-2018-022728 [published Online First: 2018/11/06] 29 25. Bovin MJ, Marx BP, Weathers FW, et al. Psychometric properties of the PTSD Checklist for 30 Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. 31 Psychol Assess 2016;28(11):1379-91. doi: 10.1037/pas0000254 [published Online First: 32 2016/11/04] 33 26. Emerson RM, Fretz RI, Shaw LL, et al. Writing ethnographic fieldnotes. Chicago and London: 34 35 University of Chicago Press 1995. 36 27. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332. doi: 10.1136/bmj.c332
37 http://bmjopen.bmj.com/ 38 [published Online First: 2010/03/25] 39 28. Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology 40 2006;3(2):77-101. 41 29. Glaser B, Strauss A. The Constant Comparative method of Qualitative Analysis. In the Discovery 42 of Grounded Theory: Strategies for Qualitative Research Chicago: Aldine 1967:101-158. 43 44 30. Charmaz K. Constructing grounded theory: a practical guide through qualitative analysis. London: Sage Publications, Inc 2006.
45 on September 30, 2021 by guest. Protected copyright. 46 31. Curtis LB, A. . Unit Costs of Health and Social Care University of Kent, Canterbury: Personal Social 47 Services Research Unit 2018. 48 32. Kirk A. Data Visualization: a successful design process: Packt Publishing Ltd 2012. 49 33. Iliinsky N, Steele J. Designing data visualizations: Representing informational Relationships: 50 O'Reilly Media, Inc. 2011. 51 34. Ulibarri MD, Hiller SP, Lozada R, et al. Prevalence and characteristics of abuse experiences and 52 53 depression symptoms among injection drug-using female sex workers in Mexico. J Environ 54 Public Health 2013;2013:631479. doi: 10.1155/2013/631479 [published Online First: 55 2013/06/06] 56 35. Monica D. Ulibarri, Steffanie A. Strathdee, Remedios Lozada, et al. Prevalence and Correlates of 57 Client-Perpetrated Abuse Among Female Sex Workers in Two Mexico–U.S. Border Cities. 58 Violence Against Women 2014;20(4):427– 45. 59 60
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1 2 3 36. Greenfield SF, Brooks AJ, Gordon SM, et al. Substance abuse treatment entry, retention, and BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 outcome in women: a review of the literature. Drug and alcohol dependence 2007;86(1):1- 5 6 21. doi: 10.1016/j.drugalcdep.2006.05.012 [published Online First: 2006/06/09] 7 37. Wiechelt SA, Shdaimah CS. Trauma and Substance Abuse Among Women in Prostitution: 8 Implications for a Specialized Diversion Program. Journal of Forensic Social Work 9 2011;1(2):159-84. doi: 10.1080/1936928x.2011.598843 10 38. Bailey K, Trevillion K, Gilchrist G. “We have to put the fire out first before we start rebuilding the 11 house”: practitioners’ experiences of supporting women with histories of substance use, 12 interpersonal abuse and symptoms of post-traumatic stress disorder. Addiction Research & 13 Theory 2019:1-9. doi: https://doi.org/10.1080/16066359.2019.1644323 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Figure 1 Flow of participants through the DUSSK study 5 6 7 8 9 10 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Table 1 Characteristics of screened women 5 6 Screened not recruited Screened and recruited 7 (N=30) (N=11) 8 9 N (%) * Median (range) N (%) * Median (range) 10 Female 27 (90) 11 (100) 11 12 Age 23 (77) 37 (26-55) 11 (100) 38 (23-53) 13 Ever sold sex on the street? 14 Yes 26 (87) 11 (100) 15 No 1 (3) - 16 How many days since last worked on 23 (77) 60 (1-2920) 11 (100) 7 (1-28) 17 18 the street? For peer review only 19 How often usually sell sex on street? 20 Daily 6 (20) 3 (27) 21 Weekly 5 (17) 8 (73) 22 Less than weekly 16 (53) - 23 Ever used street drugs 24 25 Yes 26 (87) 11 (100) 26 No 1 (3) - 27 Ever used heroin 23 (77) 9 (82) 28 Days since last used heroin 19 (63) 2 (0-731) 9 (82) 1 (0-6) 29 Ever used crack cocaine 23 (77) 11(100) 30 Days since last used crack cocaine 21 (70) 2 (0-2922) 1 (0-4) 31 32 How often use heroin and/or crack 33 cocaine? 34 Daily 11 (37) 7 (64) 35 Weekly 4 (13) 4 (36) 36 Less than weekly 9 (30) -
37 http://bmjopen.bmj.com/ Has an opioid substitute script 13 (43) 6 (55) 38 39 Script type 40 Buprenorphine/Subutex® - 1 (9) 41 Methadone 13 (43) 5 (45) 42 Used other drugs: 43 Alcohol 3 (10) 1 (9) 44 Amphetamine 1 (3) -
45 on September 30, 2021 by guest. Protected copyright. 46 Cannabis 5 (17) 5 (45) 47 Spice 2 (7) - 48 MDMA (Ecstasy) 1 (3) 49 Tramadol 1 (3) - 50 Sleeping tablets - 1 (9) 51 52 *N and % of those that provided data 53 54 55 56 57 58 59 60
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1 2 3 4 Table 2 Qualitative quotes 5 6 Theme/Sub-theme Quotes 7 Recruitment and retention 8 9 Acceptability [Face-to-face recruitment] worked well, it wasn’t intrusive, you weren’t pushy, you know you blended in within the drop-in 10 setting. So I think the women felt that if they did wanna buy into it they would, there was no pressure there. So I think that 11 was done really sensitively. Service provider 6 12 For peer review only 13 14 It [recruitment] was very sort of like confidential and actually it was quite nice ‘cause, yeah no one really knew what I was 15 doing when I was doing summut, you know what I mean, which is – like it don’t usually happen like that. Everyone knows 16
what I’m doing all the time. Participant 7 http://bmjopen.bmj.com/ 17 18 Improvements I think from a clinical point of view if you remove that criteria [sex work at least once a week in the last calendar month] 19 and then of course there’s more chance of getting people through to the finish line to be able to be ready for treatment at 20 the end. Service provider 4 21 22 23 Actively drug using? Yes, that makes sense (…). If they’ve been able to bring that down themselves maybe another service 24 would be better. Like, what this offered, it’s specialistic in this. So if you was able to manage to a level yourself, maybe you 25 don’t need [the intervention]… I’m not sure, I think that would be an interesting conversation on September 30, 2021 by guest. Protected copyright. because if they could bring it 26 down themselves, they’d probably be a lot more stable and a lot more reliable to actually get to the EMDR . Service 27 provider 7 28 29 So I think if you were to extend the period of time and say ‘Oh actually do you know if you’ve used within the last three 30 months you can participate in the study and then someone who’s three months abstinent or reducing from their street 31 32 heroin use or their crack use is then exposed to somebody who’s going no no no man I’m using up like a party every night’. 33 There’d be that ethical thing within it but it would be nice to see the study opened up to a wider cohort. Service provider 2 34 Facilitators to attendance 35 Encouragement and support I would say that I’ve been quite integral in regards to developing relationships with the women, contacting them for both 36 to attend their individual one to ones and stabilisation groups and also their Thursday DUSSK groups as well. So just keeping that 37 38 contact going if they were coming in, in our drop-in service I would see them and then sort of give them reminders, did 39 they want little welfare calls, that type of thing. Service provider 6 40 41 42 25 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
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1 2 3 Transport It was more of a focus thing where you know she [service provider 6] sort of like coached us as we went down, like you 4 5 know keeping us like sort of aware of what we’ve got to be thinking of doing and making sure that, you know, there’s 6 nothing wrong. Participant 7 7 Food provision I was turning up and I was like sort of god like hanging out for (…) that lunch. It was like, not the reason I was turning up 8 but the main reason why I could (…). There is light at the end of the tunnel, you know you’re gonna be nourished and fed.’ 9 10 You’re gonna be able to concentrate as well. Participant 7 11 Barriers to attendance 12 Unstable lifestyles My mentalFor problems, peer my drug use, everything, review just my life, it gets only in the way [of attendance]. Participant 1 13 14 Mental health They’re so low resourced, they just don’t have the distress tolerance to be able to cope with any more distress, they’re 15 already facing so much. Even things like their housing and threats of eviction. Service provider 8 16 17 http://bmjopen.bmj.com/ 18 My home life was getting a bit chaotic. My depression was getting really bad as well. So, yeah, and I was waiting for my 19 antidepressants to work but they took a while. Yeah, it was just my depression, that’s all. My anxiety. Participant 6 20 Sex work If I’ve been working the night before there’s no way I could have attended because I’m too tired, because you work all 21 22 night. Participant 4 23 Delays between treatment It took a little bit of a while and also for them to access their stabilisation groups then their one to ones. I think we may 24 stages have lost some of the interest. Service provider 6 25 on September 30, 2021 by guest. Protected copyright. Experience and acceptability of the intervention 26 27 Initial impressions There aren’t many services out there, which will offer individual, tailorised counselling and support to the women who 28 have got dual diagnosis and you know mental health, drug misuse. So this study was unique and I think that’s what we 29 were all so passionate and so behind it because it was giving the women an opportunity. Service provider 6 30 31 Reason for participating I just felt so alone and afraid and stuck and just needed to see if there was some way that I might be able to gain 32 something so – really, if I’m willing to put myself out on the street and sell myself to a complete stranger, knowing that I 33 might die, whatever, so it kind of … I felt I needed to understand why I needed to do this... So it’s about me owning my 34 35 power, and about not letting myself feel as shit about myself as I have done. Participant 5 36 37 38 39 40 41 42 26 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
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1 2 3 The post-traumatic stress [treatment] is – is a way of like sort of detoxing your brain. So, you know finding a reason why 4 5 you do these drugs (…) to like sort of be the reason for me to like say ‘Well, I’ve got to stop now.’ You know and get off it. 6 Participant 7 7 Service providers views on I guess that people thought they weren’t going to talk about their traumas [in the drug groups] but if somebody’s been 8 the intervention raped last night, they’re going to need to talk about it, so we were here dealing with that stuff on the spot and then we 9 10 didn’t have no-one to go away and talk about it. Service provider 10 11 12 It’s veryFor hard to do traumapeer processing reviewwhen women to some degree only are being traumatised and then having to self- 13 14 medicate against all of that and then you’re trying to work on quite deep attachment developmental trauma stuff from a 15 long time ago. (…) I’d say that trauma processing would be more successful with women who have maybe made a very 16 strong commitment to stop [sex] working. Service provider 8 17 http://bmjopen.bmj.com/ 18 19 I would offer it [EMDR] as part of a – as a range of things that are offered…we’d say ‘You can have EMDR, trauma focus 20 CBT [Cognitive Behavioural Therapy] or narrative exposure therapy and you’d kind of match the person to what you 21 thought they might be more suited to. Service provider 8 22 23 24 I think they had huge admiration for the workers at [SSW charity], and found them friendly and supportive, but…there 25 wasn’t a specific, I don’t know, once a month structured ‘let’s talk about the women and on September 30, 2021 by guest. Protected copyright. how they’ve been in the month. 26 27 Service provider 9 28 29 Participants views of the I enjoyed going down there. (…) We had a good laugh and learned something while we were doing it. Participant 6 30 intervention 31 With it being all woman and not mixed going to (mainstream drug treatment service provider) and doing groups where 32 men are involved is like, I didn’t really want to do it but here because it’s all women and I know most of the women that 33 come here, we’ve all been through it, hence why we all come here. So one way or another we’ve all been through 34 35 something that we can all relate to. Participant 3 36 37 Intervention characteristics It’s [SSW charity] familiar and it’s comfortable and it’s safe. Service provider 5 38 39 40 41 42 27 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
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1 2 3 The groups weren’t too big, so you sort of – I knew the people that were coming to the groups which was better, so we’d 4 5 sort of you know built up a rapport. Participant 4 6 Impacts of the intervention I’m just going to stop [drug use], I’m ready and I’m kind of already preparing for that, so it’s kind of brought me to a close, 7 and I mean that as well. Personally it’s like, I’m ready, bring it on, I’m like do you know what I’ve been raped, I’ve been 8 beaten I’ve stuck needles in myself( …) I’m done, I’m not playing this game anymore, I deserve better. Participant 5 9 10 11 It’s just made (…) me realise I’m not just a, like, drug addict, sex worker. I’m a real person and I’ve got feelings and, you 12 know,For I’ve got potential. peer You know, yeah, review they [service providers] onlybuild me up a lot. Participant 6 13 14 15 When she [participant 6] started with [name of intervention] study and she was coming to her Thursday [drug] groups, she 16 didn’t want to be associated with street sex working. So she said ‘Can you call me (own name rather than working name)?’ 17 http://bmjopen.bmj.com/ 18 I could have cried (…). She was owning her own name and taking back ownership of who she is rather than somebody who 19 was street sex working. Service provider 6 20 21 Their chaoticness. (…) To manage that in a [mainstream drug service] group setting would be difficult and I’m not sure 22 23 how they would manage that. I just know how much regularly how they’ve turned up [to the intervention drug treatment 24 groups] chaotic and they’ve turned up leaking out trauma. … I’m far from confident that they would be able to sit under 25 them [mainstream drug service] rules enough to be a part of what it is for here[research on September 30, 2021 by guest. Protected copyright. study], due to the level of 26 27 flexibility here and that they would be able to talk about what their problem is without mentioning what they do and that 28 might make them vulnerable Service provider 7 29 Fidelity I guess we were kind of thinking of it in a really linear sense, that the women would engage in the drug groups and then 30 reduce their drug use to then move on to the next group and I’m not sure that that actually happened in reality. 31 32 Service provider 5 33 34 In the beginning we went in doing the same sort of work that we would do here [mainstream drug services], and it’s 35 36 getting them to look at their behaviour, and the consequences of it and stuff, and it didn’t work with these women, it’s too 37 much, too direct. Service provider 10 38 39 40 41 42 28 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
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1 2 3 4 Table 3 Attendance and retention of participants 5 6 Open group Attended Closed group 5 mandatory One-to-one sessions Referred to 7 Getting started Trauma Getting started Stabilisation group which services: 8 9 Screening sessions 10 Eligible Attended % Eligible Attended % Attended % Eligible Attended % 11 12 Participant sessions sessions* Attended Forsessions peersessions Attended reviewsessions Attended onlyTreatment sessions** sessions* Attended 13 (1) 14 1 28 10 36 Yes 26 4 15 3 60 Ext. stabilisation 8[3] 1 13 Mental health 15 2 28 5 18 No 16 (1) 17 3 28 1 4 NA http://bmjopen.bmj.com/ 18 4 27 8 30 Yes 26 11 42 5 100 EMDR 12[3] 4 (1) $ 33 Mental health 19 20 5 25 3 12 NA 21 Mental health & 22 23 6 25 19 (5) 76 Yes 26 15 58 4 80 EMDR 12[2] 8 (4) $ 67 mainstream drug 24 7 23 0 0 NA 25 on September 30, 2021 by guest. Protected copyright. 26 8 22 0 0 NA 27 9 20 7 (2) 35 Yes 26 3 12 1 20 Ext. stabilisation 8[4] 0 0 Mental health 28 29 10 19 0 0 NA 30 11 19 0 0 NA 31 32 Total 53 4 33 13 13 33 34 *N session participant arrived late/left early indicated in superscript round brackets; **N sessions cancelled due to non-attendance in square brackets; 35 NA=Not actively invited to sessions; $ Includes one review session; Ext. stabilisation=Extended stabilisation, EMDR=Eye movement desensitization and 36 37 reprocessing therapy 38 39 40 41 42 29 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
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1 2 3 4 Table 4 Health Economics 5 6 1. Getting started 2. Trauma screening 3. Stabilisation group 4. One-to-one sessions 7 Service description 8 Session lengths - range 90 - 120 minutes 1 60 minutes 60 minutes 60 - 90 minutes 2 9 Number of sessions held - total 52 8 5 28 10 Eligible participants3 - total n = 11 n = 54 n = 4 n = 4 11 Attendees per session - range 0 - 4 1 2 - 4 1 12 Costs ForSub-total peer £ £ per ppt reviewSub-total £ £ per pptonlySub-total £ £ per ppt Sub-total £ £ per ppt 13 A. Staff 14 Service manager £1,359.76 £123.61 £95.09 £19.02 £47.54 £11.89 £266.25 £66.56 15 Drug group facilitators5 £3,000.20 £272.75 £0.00 £0.00 £0.00 £0.00 £0.00 £0.00 16
Art worker £123.98 £11.27 £0.00 £0.00 £0.00 http://bmjopen.bmj.com/ £0.00 £0.00 £0.00 17 Clinical Psychologist £0.00 £0.00 £636.00 £127.20 £600.00 £150.00 £2,040.00 £510.00 18 B. Facilities 19 20 Space rental £1,270.50 £115.50 £224.00 £44.80 £140.00 £35.00 £574.00 £143.50 21 C. Travel 22 Transporting materials £73.78 £8.44 £0.00 £0.00 £11.90 £2.98 £0.00 £0.00 23 Car lifts for service-users (petrol) £38.72 £3.52 £2.24 £0.45 £3.36 £0.84 £1.20 £0.30 24 Public transport for participants £70.20 £6.38 £0.00 £0.00 £3.90 £0.98 £3.90 £0.98 25 Taxis for participants £55.00 £5.00 £0.00 £0.00 £62.20 on September 30, 2021 by guest. Protected copyright. £15.55 £11.00 £2.75 26 D. Materials 27 Art supplies £30.00 £2.73 £0.00 £0.00 £0.00 £0.00 £0.00 £0.00 28 Stationary £0.00 £0.00 £0.00 £0.00 £5.00 £1.25 £0.00 £0.00 29 Voucher incentives £0.00 £0.00 £0.00 £0.00 £130.00 £32.50 £0.00 £0.00 30 Refreshments6 £820.00 £74.55 £0.00 £0.00 £10.00 £.2.50 £0.00 £0.00 31 Summary 32 Total cost £6,842.13 £622.01 £957.33 £191.47 £1,013.907 £253.48 £2,896.35 £724.09 33 Total cost per session £131.58 £11.96 £119.67 £23.93 £202.78 £50.70 £103.44 £25.86 34 Note: 1 = Sessions were originally were 90 minutes, however when sandwiches were provided drug group facilitators arrived 30 minutes prior to session to be with participants while they ate, 2 = 35 One-to-one EMDR sessions were 90 minutes and one-to-one Stabilisation sessions were 60 minutes, 3 = participants, 4 = Five participants were eligible for screening, however only four 36 participants were successfully screened, 5 = Getting started groups were facilitated by two drug group facilitators, and 6 = Sandwiches and biscuits, 7 = Total cost without vouchers would have 37 been £883.90 . 38 Heat map description: £0.00 £0.01 - £99.99 £100 - £499.99 £500.00 - £1999.99 £2000.00 + 39 40 41 42 30 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open Page 32 of 36
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Figure legend 5 *Numbers may include more than one approach to potential participants by different recruiters 6 7 8 9 10 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44
45 on September 30, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
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1 2 3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 6 Women spoken to at 7 Women spoken to but not screened recruiting site (n=125)* 8 (n=84) 9 10 13 Too busy 11 11 Not interested 12 10 Not currently street sex working Attempted screening 9 Too unsettled/stressed 13 9 Unwilling to be screened questionnaire (n=41)* 14 7 Woman considers herself ineligible 15 7 Previously recruited 16 4 Previously screened 17 4 Not currently taking heroin/crack 18 3 Previously approachedFor by researcher peer reviewScreened and recruitedonly 19 7 Other (n=11) 20 Screened, not eligible/consented (n=30) 21 22 1 Not street sex working (escort) 23 2 Few/no screening questions completed Invited to Getting started Screened for 24 1 Never used street drugs sessions - Open group PTSD 25 Remaining women were SSWs and took 26 street drugs: (n=11) (n=4) 27 6 Not street sex worked and not used 28 heroin/crack in last month 29 9 Heroin/crack users who had not street sex Invited to Getting started Positive for PTSD and 30 worked in last month 1 Street sex worked not used heroin/crack in sessions - Closed group invited to Stabilisation 31 last month (n=4) sessions (n=4) 32 7 Street sex worked or used heroin/crack less 33 than weekly 34 3 Eligible unable to obtain consent 35 Invited to one-to-one 36 sessions: Not actively invited to closed group
37 http://bmjopen.bmj.com/ 38 sessions (n=7) EMDR Extended 39 (n=2) stabilisation 40 5 Non-attenders (n=2) 41 2 Poor attenders 42 43 Referred to mainstream 44 drug services
45 on September 30, 2021 by guest. Protected copyright. (n=1) 46 Referred to mental health 47 services 48 (n=4) 49 50 51 52 *Numbers may include more than one approach to potential participants by different recruiters 53 54 55 56 57 58 59 60
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1 2 3 Reporting checklist for cohort study. 4 5 6 Based on the STROBE cohort guidelines. 7 8 9 Instructions to authors 10 11 Complete this checklist by entering the page numbers from your manuscript where readers will find each of the 12 items listed below. 13 14 15 Your article may not currently address all the items on the checklist. Please modify your text to include the 16 missing information. If youFor are certain peer that an item review does not apply, pleaseonly write "n/a" and provide a short 17 18 explanation. 19 20 Upload your completed checklist as an extra file when you submit to a journal. 21 22 In your methods section, say that you used the STROBE cohortreporting guidelines, and cite them as: 23 24 25 von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP. The Strengthening the 26 Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting 27 observational studies. 28 29 30 Page 31 Reporting Item Number 32
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1 Participants #13b Give reasons for non-participation at each stage 9 2 3 Participants #13c Consider use of a flow diagram 20 4 5 6 Descriptive data #14a Give characteristics of study participants (eg demographic, clinical, 9 7 social) and information on exposures and potential confounders. Give 8 9 information separately for exposed and unexposed groups if applicable. 10 11 Descriptive data #14b Indicate number of participants with missing data for each variable of 21 12 13 interest 14 15 Descriptive data #14c Summarise follow-up time (eg, average and total amount) 26 16 For peer review only 17 Outcome data #15 Report numbers of outcome events or summary measures over time. 9 18 19 Give information separately for exposed and unexposed groups if 20 applicable. 21 22 23 Main results #16a Give unadjusted estimates and, if applicable, confounder-adjusted 9-12 24 estimates and their precision (eg, 95% confidence interval). Make clear 25 26 which confounders were adjusted for and why they were included 27 28 Main results #16b Report category boundaries when continuous variables were categorized N/A 29 30 Main results #16c If relevant, consider translating estimates of relative risk into absolute N/A 31 32 risk for a meaningful time period
33 http://bmjopen.bmj.com/ 34 Other analyses #17 Report other analyses done—e.g., analyses of subgroups and 9-12 35 36 interactions, and sensitivity analyses 37 38 Discussion 39 40 Key results #18 Summarise key results with reference to study objectives 13
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Drug Use in Street Sex worKers (DUSSK) study – results of a mixed methods feasibility study of a complex intervention to reduce illicit drug use in drug dependent female sex workers
ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2019-036491.R1
Article Type: Original research
Date Submitted by the 02-Aug-2020 Author:
Complete List of Authors: Patel, Rita; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences Redmond, Niamh; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences Kesten, Joanna; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences & NIHR Health Protection Research Unit in Evaluation of Interventions Linton, Myles-Jay; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences & Health Economics Bristol Horwood, Jeremy; University Hospitals Bristol NHS Foundation Trust,
NIHR ARC West; University of Bristol, Population Health Sciences & http://bmjopen.bmj.com/ Centre for Academic Primary Care Wilcox, David ; Avon and Wiltshire Mental Health Partnership NHS Trust, Acer Unit, Blackberry Hill Hospital, Manor Road, Munafo , Jess; Avon and Wiltshire Mental Health Partnership NHS Trust, Acer Unit, Blackberry Hill Hospital, Manor Road, Coast, Joanna; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences & Health Economics Bristol Macleod, John; University Hospitals Bristol NHS Foundation Trust, NIHR on September 30, 2021 by guest. Protected copyright. ARC West; University of Bristol, Population Health Sciences & Centre for Academic Primary Care Jeal, Nicola; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences
Primary Subject Addiction Heading:
Secondary Subject Heading: Health services research, Mental health, Public health, Health economics
QUALITATIVE RESEARCH, MENTAL HEALTH, HEALTH ECONOMICS, Keywords: TRAUMA MANAGEMENT, Substance misuse < PSYCHIATRY
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 Drug Use in Street Sex worKers (DUSSK) study – results of a mixed 6 7 methods feasibility study of a complex intervention to reduce illicit 8 9 10 drug use in drug dependent female sex workers 11 12 Authors: 13 1,2 1,2 1,2,3 1,2,4 14 Dr Rita Patel*, Dr Niamh M Redmond*, Dr Joanna M Kesten, Dr Myles-Jay Linton, Dr 15 Jeremy Horwood,1,2,6 David Wilcox,5 Jess Munafo,5 Prof Joanna Coast,1,2,4 Prof John Macleod,1,2,6 Dr 16 17 Nicola Jeal.1,2,7 18 For peer review only 19 *Joint first authors. 20 21 Author affiliations: 22 23 1 The National Institute for Health Research Applied Research Collaboration West (NIHR ARC West) 24 at University Hospitals Bristol NHS Foundation Trust, Whitefriars, Lewins Mead, Bristol, UK, BS1 2NT 25 26 2 Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley 27 28 Road, Bristol, UK, BS8 2PS 29 3 The National Institute for Health Research Health Protection Research Unit in Evaluation of 30 31 Interventions, University of Bristol, UK 32 33 4 Health Economics Bristol, Population Health Sciences, Bristol Medical School, University of Bristol, 34 1-5 Whiteladies Road, Bristol, UK, BS8 1NU 35 36 5 Avon & Wiltshire Partnership NHS Trust, Acer Unit, Blackberry Hill Hospital, Manor Road, Bristol,
37 http://bmjopen.bmj.com/ 38 UK, BS16 2EW 39 6 Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University 40 41 of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS 42 43 7 Northern Devon Healthcare NHS Trust, Devon Sexual Health - North Devon, Barnstaple Health 44 Centre, Vicarage Road, Barnstaple EX32 7BH
45 on September 30, 2021 by guest. Protected copyright. 46 Corresponding author: 47 48 Dr Nicola Jeal ([email protected]) 49 50 Word count: 51 52 Target Journal BMJ Open: Abstract: (297/300), Main: (4122/4000) 53 54 55 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Abstract 5 6 Objectives 7 8 The majority of female street-based sex workers (SSWs) are dependent on illicit drugs and sell sex to 9 10 fund their drug use. They typically face multiple traumatic experiences, starting at a young age, which 11 continue through sex work involvement. Their trauma-related symptoms tend to increase when drug 12 13 use is reduced, hindering sustained reduction. Providing specialist trauma care alongside drug 14 15 treatment may improve treatment outcomes. Aims to (i) evaluate recruitment and retention of 16 participants; (ii) examine intervention experiences and acceptability; and (iii) explore intervention 17 18 costs using mixed methodsFor feasibility peer study. review only 19 20 Setting 21 22 Female SSW charity premises in a large UK inner city. 23 24 Participants 25 26 Females aged 18 years or older, who have sold sex on the street and used heroin and/or crack cocaine 27 at least once a week in the last calendar month. 28 29 Intervention 30 31 Female SSW-only drug treatment groups in a female SSW-only setting delivered by female staff. 32 33 Targeted post-traumatic stress disorder (PTSD) screening then treatment of positive diagnoses with 34 eye movement desensitization and reprocessing (EMDR) therapy by female staff from a specialist NHS 35 36 trauma service.
37 http://bmjopen.bmj.com/ 38 Results 39 40 (i) Of 125 contacts 11 met inclusion criteria and provided informed consent, 4 reached the 41 42 intervention final stage (ii) Service providers said working in collaboration with other services was 43 valuable, the intervention was worthwhile and had a positive influence on participants. Participants 44
45 viewed recruitment as acceptable and experienced the intervention positively. The unsettled nature on September 30, 2021 by guest. Protected copyright. 46 47 of participant’s lives was a key attendance barrier. (iii) The total cost of the intervention was £11,710, 48 with staff costs dominating. 49 50 Conclusions 51 52 Recruitment and retention rates reflected study inclusion criteria targeting women with the most 53 complex needs. Two participants received EMDR demonstrating that the three agencies working 54 55 together was feasible. Staff heavy costs highlight the importance of supporting participant attendance 56 57 to minimise per participant costs in a future trial. 58 59 60
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1 2 3 Ethics approval BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 South West - Frenchay Research Ethics Committee (REC reference: 17/SW/0033; IRAS project ID: 6 7 220631). UK HRA approval was on 03/04/2017.The University of Bristol Research Enterprise and 8 9 Development department sponsored this study (RED reference: RG2756). 10 11 12 Strengths and limitations of this study 13 14 The novel intervention integrates a trauma-focussed treatment approach in order to reduce 15 16 drug use in a challenging drug treatment population 17 18 The interventionFor was deliveredpeer by specialists,review reflecting only the skills and experience required to 19 appropriately manage the complex needs of the study population 20 21 PPI formed an important part of the study methodology and informed each stage 22 23 Recruitment took place over several months within an agency trusted and used daily by the 24 study population to allow familiarisation with the researchers and multiple opportunities to 25 26 participate 27 28 This feasibility study design and methodology were not able to examine intervention 29 effectiveness or cost effectiveness 30 31 32 33 Keywords: 34 35 sex workers, feasibility study, qualitative research, cost analysis, trauma treatment, drug 36 dependency
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45 on September 30, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Introduction 5 1-3 6 Most female street-based sex workers (SSWs) in the UK use heroin and/or crack cocaine. Their drug 7 dependency keeps them entrenched in a “work-score-use cycle”,4 5 which contributes to the morbidity 8 9 and social instability typically seen in this group.6 10 11 12 Despite their drug treatment needs, drug dependent SSWs have poorer outcomes from drug 13 14 treatment services compared to other service users,7 8 sometimes due to stigma associated with their 15 16 street sex work.9 Previous SSW-focussed interventions aiming to reduce drug use have used 17 educational,10 11 substitute prescribing-based12 13 and psychological14 approaches but none robustly 18 For peer review only 19 demonstrated a positive effect in reducing drug use.15 20 21 22 Poor mental health is a significant problem among SSWs.16-18 Many have experienced multiple 23 24 adversities in early life and during their involvement in sex work,5 16 19 which exposes women to further 25 26 risk of significant trauma.16 17 Consequently, many SSWs are affected by post-traumatic stress disorder
27 16 17 28 (PTSD). Trauma symptoms, which often recur when drug use is reduced, may motivate a return to 29 drug use.20 Individual trauma-focused therapy alongside drug treatment may provide the best 30 31 outcomes for reductions in drug use.21-23 However to date, there is no robust evidence to demonstrate 32 33 the impact of an integrated trauma-focussed treatment approach in reducing drug use amongst 34 female drug dependent SSWs. 35 36
37 http://bmjopen.bmj.com/ 38 In collaboration with SSWs and service providers we developed a novel intervention, informed by 39 existing research9 15 to address the unique and complex combination of drug and trauma treatment 40 41 needs of female drug-dependent SSWs. The intervention proposes an integrated care pathway 42 24 43 through an innovative multi-agency partnership. We report here the results of the DUSSK (Drug Use 44 in Street Sex worKers) feasibility study, which aimed to (i) evaluate the recruitment and retention of
45 on September 30, 2021 by guest. Protected copyright. 46 SSWs to the intervention; (ii) examine the experience and acceptability of the intervention for 47 48 participants and service providers; and (iii) explore costs to service providers associated with the 49 intervention. 50 51 52 53 54 55 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Methods 5 6 Study design, setting and eligibility 7 8 Detailed methods are described in the published protocol.24 This mixed methods feasibility study took 9 10 place in a UK inner city setting. Females aged 18 years or older, who sold sex on the street at least 11 weekly in the last calendar month and used heroin and/or crack cocaine at least once a week in the 12 13 last calendar month, were eligible to participate.24 The intervention was delivered at SSW charity
14 24 15 premises, which supplied support, health and advocacy services. 16 17 18 Recruitment For peer review only 19 20 The recruitment target for this feasibility study was 30 women.24 Local organisations that SSWs were 21 22 known to access were provided with study promotional materials. One of three researchers (JMK, NJ, 23 SR) attended an SSW support and advocacy charity, at least twice a week, to directly approach 24 25 potential participants; alternatively, interested SSWs could telephone researchers. This approach 26 27 meant that women were potentially approached and counted as contacts several times during 28 recruitment. Eligibility screening was conducted face-to-face or via telephone. Women gave fully 29 30 informed, written consent to participate in the study and baseline data were also collected at the time 31 32 of recruitment. To maintain safety and confidentiality, each participant provided details of acceptable 33 34 ways in which to be contacted. Screening data were retained and remained anonymised for those not 35 recruited. 36
37 http://bmjopen.bmj.com/ 38 39 40 Patient and Public Involvement (PPI) 41 42 Women with experience of street sex work and drug-dependency contributed to the study design, 43 processes, documentation and intervention development. Recommendations from PPI meetings were 44 implemented and resulted in direct changes to the study processes to support recruitment,
45 on September 30, 2021 by guest. Protected copyright. 46 47 participation and encourage adherence (described below). 48 49 50 The intervention 51 52 The intervention consisted of SSW only drug treatment groups, targeted screening for PTSD symptoms 53 54 (one-to-one clinical interview and PTSD checklist- PCL5)25 and, if positively diagnosed, one-to-one 55 EMDR therapy, all delivered by female staff through a collaboration between three service providers 56 57 (National Health Service (NHS) trauma services, the SSW and drug treatment charities). The 58 59 intervention was designed so participants were initially invited to attend a weekly ‘Getting started’ 60
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1 2 3 drug treatment group to reduce fear and anxiety about engaging in a group setting and get used to BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 the format and level of disclosure expected. Participants were to progress to a ‘Preparation for 6 7 recovery’ drug treatment group which focused on people’s barriers to motivation for change, 8 examining pros and cons of drug use and exploring triggers for using drugs to enable participants to 9 10 achieve a level of drug use stability. When group facilitators judged participants were achieving drug 11 12 use stabilisation, and they had attended three sessions consecutively, they were offered screening for 13 PTSD symptoms by a female clinical psychologist. Those experiencing PTSD symptoms were invited 14 15 to attend five PTSD ‘Stabilisation’ group sessions, facilitated by the same female clinical psychologist, 16 17 to equip participants with the skills to self-soothe and reorientate in preparation for the one-to-one 18 EMDR treatment. OnceFor all ‘Stabilisation’ peer group review sessions had been only completed, the clinical psychologist 19 20 assessed participants for readiness for one-to-one EMDR sessions and if eligible, participants 21 22 progressed to a course of 12 sessions with the clinical psychologist on a weekly, or fortnightly, basis. 23 Trauma treatment (PTSD screening, stabilisation groups and one-to-one) ran in parallel to the drug 24 25 treatment groups, Figure 1 (red boxes) shows the planned flow of participants through the study. 26 27 The intervention proceeded as described in the protocol paper 24 with the following changes (bulleted 28 below): 29 30 Participants were encouraged to attend all sessions with the offer of car lifts, bus tickets and taxis, 31 32 in addition to the planned weekly phone calls and texts, by the staff at partner agencies. 33 34 35 ‘Getting started’ and ‘Preparation for recovery’ drug treatment groups 36
37 Retendering resulted in a change of drug group service provider which, along with low numbers http://bmjopen.bmj.com/ 38 39 recruited, resulted in the drug groups merging into a single open drug treatment ‘Getting started’ 40 41 group. 42 Attendance at three consecutive sessions was required to move onto the next group, instead of 43 44 attendance at any four.
45 on September 30, 2021 by guest. Protected copyright. 46 Sandwiches were supplied prior to the single drug group to support attendance from the 14th 47 session onwards. 48 49 The number of sessions continued beyond those initially planned due to delays in PTSD screening 50 51 (see below). 52 53 Poor attendance, the participant’s unstable behaviour and the intervention running for longer 54 than planned (due to the retendering of drug services) affected the drug group facilitators’ ability 55 56 to deliver structured content. An art worker was included in 4 sessions to maintain participant’s 57 58 interest and engagement with sessions. 59 60
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1 2 3 PTSD screening was halted from the 29th session onwards, due to the limited remaining study time BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 to complete the intervention, meaning the drug group became closed and only included PTSD 6 7 screened participants. 8 9 10 Screening for PTSD 11 12 Delays occurred to both the organisation of the PTSD screening and PTSD stabilisation group set 13 14 up due to lack of capacity and delays in NHS trauma service staff recruitment. Therefore, some 15 participants had long gaps between recruitment and PTSD screening and subsequent stabilisation 16 17 group sessions. 18 For peer review only 19 20 21 PTSD ‘Stabilisation’ group 22 23 Incentives of £10 vouchers per session were offered for attendance (mandatory sessions). 24 25 26 One-to-one EMDR therapy for PTSD 27 28 Some sessions were scheduled in a private rented room (due to availability issues) in a local 29 30 community centre and not at the SSW charity premises. 31 Two participants were offered weekly one-to-one extended stabilisation sessions (8 maximum) 32 33 with the clinical psychologist rather than EMDR therapy as this was deemed the most appropriate 34 35 treatment. 36
37 http://bmjopen.bmj.com/ 38 Data collection methods 39 40 Sample size and quantitative data collection 41 42 A formal sample size calculation was not conducted as the aim was to assess feasibility.24 Self-reported 43 44 levels of illicit drug use, involvement in SSW, completion of PTSD Checklist PCL525 and demographics
45 on September 30, 2021 by guest. Protected copyright. 46 were collected at the time of consent. Attendance registers were taken at the start of each group or 47 one-to-one session by the facilitator(s). 48 49 50 51 Qualitative data collection 52 53 With participants’ verbal consent one non-participant observation of a drug group was conducted to 54 understand delivery, examine interactions and intervention experiences, with brief notes taken during 55 56 the group.26 57 58 In-depth semi-structured interviews were conducted with participants and service providers either 59 60 face-to-face or by telephone. Participants were interviewed after intervention completion or study
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1 2 3 drop out. Consent to contact participants regarding interviews was sought at recruitment. Additional BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 written or audio recorded verbal, informed consent was obtained prior to all interviews. Interviews 6 7 explored views and experiences of the intervention and how to improve acceptability. Participants 8 received a £20 high street shopping voucher for taking part. Most service provider interviews were 9 10 conducted at the end of the intervention period and also sought to understand operational issues, 11 12 inter-agency working and intervention delivery. 13 14 15 16 Economic data collection 17 18 Resource use informationFor (2018 peer £GBP) was reviewcollected prospectively only by the agencies. Data collection 19 focussed on four categories: Staff time, Facilities, Travel (provider funded staff and patient transport), 20 21 and Materials. 22 23 24 25 Data analysis 26 27 The integration of qualitative and quantitative data used the established ‘following a thread’ 28 29 technique 27 where key themes were traced using all data sets. 30 31 32 Statistical analysis 33 34 Descriptive statistics (using Stata version14) were used to monitor recruitment and retention via 35 CONSORT statement28 style flowcharts, and to examine participant demographics, questionnaire 36
37 responses and attendance. http://bmjopen.bmj.com/ 38 39 40 41 Qualitative analysis 42 43 Interviews were conducted by JMK and NJ, and the audio files transcribed, anonymised and checked 44 for accuracy. QSR NVivo 10 software was used to perform inductive thematic analysis29 using constant
45 on September 30, 2021 by guest. Protected copyright. 46 comparison techniques.30 31 A preliminary coding framework was developed by JMK and discussed 47 48 with the multidisciplinary research team JH and NJ to ensure credibility and confirmability. 49 50 51 52 Cost analysis 53 Costs to the service provider were examined and summarised separately for each of the four 54 55 intervention components. Staff costs were calculated using salaries and on-costs or generated using 56 32 57 standard unit cost data available for health and social care professionals. Facility costs were 58 calculated based on similar space rental options. Total cost, total cost per eligible participant, total 59 60 cost per session held, and total cost per session per eligible participant were calculated for each
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1 2 3 intervention component. Cost data were tabulated using principles of heat-map methodology, where BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 colour lightness is used to communicate the magnitude of different costs.33 34 6 7 8 9 10 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Results 5 6 Recruitment was from November 2017 to March 2018 with the intervention delivered until December 7 2018. 8 9 10 11 (i) Recruitment and retention 12 13 Recruitment Process 14 15 Approximately 400 flyers and nine posters were distributed. Potential participants were spoken to by 16 17 three researchers at 37 three-hour ‘drop-in’ sessions at the SSW charity. Of 125 contacts made with 18 women, 84 declined Forscreening. peer Reasons for review decline included beingonly too busy (n=13), not interested 19 20 (n=11) or reporting not currently street sex working (n=10). Fourteen approaches were reported as 21 22 repeat approaches, with seven reporting previous recruitment and four previous screening (as the 23 researchers recruited on different weekdays and screening data was anonymous). Figure 1 details the 24 25 flow of screened and recruited participants through the intervention. 26 27 28 Of 41 women screened, 11 were eligible and consented to participate, three were eligible but unable 29 30 to give consent (two were too distressed and one had health issues preventing participation). Of the 31 32 27 ineligible women, two did not fully complete the screening questions. The main reasons for 33 exclusion related to ineligible frequency of drug use and/or sex work. Table 1 shows the range of days 34 35 since responders last street sex worked or had taken heroin/crack by those recruited and not 36 recruited.
37 http://bmjopen.bmj.com/ 38 39 40 Of 11 participants consenting to be invited for qualitative interviews, five were uncontactable. Seven 41 42 interviews were conducted with six participants (six face-to-face and one via telephone); four 43 interviewed participants received all components of the intervention. Ten service provider interviews 44
45 were conducted with representatives from the drug treatment service (n=4), the trauma service (n=2), on September 30, 2021 by guest. Protected copyright. 46 47 and the SSW charity (n=4). Table 2 details quotes from the interviews to support the main results 48 described below. 49 50 51 52 Acceptability of recruitment 53 54 The recruitment process was described as acceptable by most participants and service providers. Face- 55 to-face recruitment was experienced as confidential, with participants reporting receiving clear 56 57 explanations of the study. Recruitment over five months within the SSW charity offered multiple 58 59 opportunities to participate and was acceptable. Most service providers interviewed reflected that if 60
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1 2 3 study inclusion criteria were broadened to include less regular drug use, participants with more BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 lifestyle stability could have been recruited, and whom may have found the intervention easier to 6 7 engage with. However, some felt that creating groups with diverse levels of drug use could have 8 negative consequences for example, risk of relapse for those who had reduced their drug use. 9 10 11 12 Group attendance 13 14 All 11 consented participants were invited to attend drug treatment groups. However, participants 15 attendance varied throughout the study, with participants sometimes arriving late or leaving early 16 17 (Table 3). Four attended 30-76% of sessions compared to 7 attenders who attended only 0-18% of 18 For peer review only 19 sessions. The five most frequent attenders were invited to PTSD screening of which four attended and 20 were all found to have symptoms of PTSD. All four PTSD screened participants attended 20-100% of 21 22 the stabilisation groups with the clinical psychologist. At the end of the stabilisation groups, two 23 24 participants were deemed suitable for EMDR therapy by the clinical psychologist and two were offered 25 extended stabilisation sessions. All four participants attended some one-to-one sessions (Table 3) but 26 27 missed at least two consecutive trauma treatment appointments with the clinical psychologist and 28 29 had to withdraw from the sessions. However, all participants were referred to further mental health 30 services and one participant was also referred to mainstream drug services. 31 32 33 34 Facilitators to attendance 35 36 Service providers across all partner agencies sent reminders to participants, which were described as
37 http://bmjopen.bmj.com/ helpful and appreciated by participants. One SSW charity service provider played a vital role in 38 39 encouraging attendance through reminding participants to attend, arranging transport (taxi, bus or 40 41 driving participants to sessions) and helping participants prepare for the intervention. Provision of 42 43 sandwich lunches before the groups was seen by service providers and participants as helpful for 44 encouraging attendance, facilitating a relaxed start to groups and supporting concentration. Vouchers
45 on September 30, 2021 by guest. Protected copyright. 46 were also viewed as encouraging attendance by participants and service providers. 47 48 49 Barriers to attendance 50 51 The unsettled nature of participant’s lives was perceived as an attendance barrier and was 52 53 underpinned by problematic drug use, poor adherence to opioid substitution therapy, sex work, 54 55 tiredness and poor mental health. Arguments between participants, a lack of readiness to confront 56 issues with drugs and trauma and an absence of social support were described as making attendance 57 58 difficult. Delays to screening referral and trauma treatment were also reported to negatively affect 59 60 participants’ motivation.
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 (ii) Experience and acceptability of the intervention 6 7 Initial impressions 8 9 All participants perceived the intervention as valuable and welcome. Common reasons given by 10 11 participants for taking part included the opportunity for ‘change’, greater stability and valuing the 12 opportunity to combine mental health and drug treatment. Service providers viewed the intervention 13 14 as a novel opportunity for 1) SSWs to receive mental health treatment while continuing to use drugs 15 16 and 2) to address the barriers to mainstream drug treatment. Some service providers highlighted the 17 challenge for participants to process trauma while continuing to use drugs and potential risks of sex 18 For peer review only 19 working when receiving trauma treatment. 20 21 22 23 Service providers’ views on the intervention 24 25 The drug group facilitators described enjoying delivering the groups and building good relationships 26 with participants. However, they described some drug sessions as intense and difficult to manage due 27 28 to participants’ distress, accounts of trauma and chaotic behaviour. The need for appropriate support 29 30 and supervision of facilitators was highlighted as a requirement to manage these challenges. 31 32 33 A clinical psychologist suggested that without the ‘re-traumatising’ effects of street sex work, the 34 35 effectiveness of the trauma processing in the trauma treatment might be enhanced. Service providers 36 also proposed extending the stabilisation work to develop the effectiveness of the trauma treatment
37 http://bmjopen.bmj.com/ 38 and recommended the intervention offer alternatives to EMDR to suit individual participants’ needs. 39 40 41 Service providers said working in partnership with other specialist services to deliver the intervention 42 43 was valuable, there was mutual respect and good communication between staff. It was suggested it 44 would have been useful to have collaborative, regular case-review meetings between the services to
45 on September 30, 2021 by guest. Protected copyright. 46 assess the progress and needs of the participants and enhance the communication channels. 47 48 49 50 Participants views on the intervention 51 52 Participants described generally positive intervention experiences. They described forming 53 meaningful relationships with the drug group facilitators and clinical psychologist. They liked that the 54 55 groups were female and sex worker-only, they knew other participants already and could speak openly 56 57 about, and relate to, one another’s experience of trauma, drug use and street sex work. Participants 58 also valued that the intervention was delivered at SSW charity premises, which was liked for its 59 60 familiarity, safety, comfort, convenience and freedom from judgement and shame. The day of the
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1 2 3 week, time and frequency of sessions, drug group session length and group size were also acceptable BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 to most participants and service providers. These factors overcame some of the barriers participants 6 7 highlighted to attending mainstream drug services. 8 9 10 Strengths of the intervention 11 12 Through the intervention, participants reflected on their need to address their trauma and drug use. 13 14 Some acknowledged that they were not ready to address their trauma but aspired to this in future, 15 having had positive experiences of therapy during the intervention. Participants attributed improved 16 17 wellbeing, coping strategies and perceptions of self-worth to the intervention. One participant was 18 For peer review only 19 seen less on the SSW outreach van (an indicator of sex working) and, significantly, stopped using her 20 working name, signifying ‘taking back ownership of who she is’. One drug group facilitator felt the 21 22 flexibility of the study intervention was able accommodate participants’ unstable lives and level of 23 24 trauma that would have prevented them from complying with the rules of conduct in mainstream 25 drug services and thus prevented them from receiving treatment to address their needs. They also felt 26 27 that an additional positive feature of the intervention was participants being able to discuss their sex 28 29 work, due to the female SSW only membership of the groups. 30 Participation in the intervention was described by SSW charity service providers and two participants 31 32 as supporting and empowering the participants to engage with clinical and support services to address 33 34 their needs. Another participant felt she used the SSW charity services less now because she needed 35 less support. 36
37 http://bmjopen.bmj.com/ 38 39 (iii) Cost analysis 40 41 The total cost of the intervention was £11,710, with staff costs being the largest component (Table 4). 42 43 The most expensive component of the intervention was the ’Getting started’ sessions (which totalled 44 £6,842). Despite having the second to lowest sub-total cost across the intervention (£1,014), the
45 on September 30, 2021 by guest. Protected copyright. 46 stabilisation groups had the highest cost per session held (£203). Although the one-to-one sessions 47 48 had the lowest cost per session held (£103), the larger number of sessions at this point resulted in this 49 section having the highest cost per eligible participant (n=4, £724). Trauma screening had the lowest 50 51 cost per eligible participant (n=5, £191) 52 53 54 55 Fidelity 56 57 The intervention was broadly delivered as intended incorporating suggested planned changes to the 58 protocol, it was more flexible and less linear than originally planned.24 Delays in PTSD screening 59 60 meant that there was only a single drug group, which continued for longer than originally planned.
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Discussion 5 Summary of findings 6 7 This study used a mixed methods approach to investigate the feasibility and acceptability of a novel, 8 9 complex intervention to reduce illicit drug use in female drug-dependent SSWs. We demonstrated 10 that drug-dependent SSWs could maintain attendance at female SSW-only drug group sessions and 11 12 the integrated trauma-focussed treatment approach, in a trusted and supportive environment, with 13 14 intensive support from SSW charity staff. Recruitment was lower than anticipated, with four 15 participants PTSD screened and whom met criteria for PTSD. They progressed through to the final 16 17 stage of the intervention, all four participants were ultimately able to access mental health services 18 For peer review only 19 and one began the process of accessing mainstream drug services. Participants and service providers 20 mostly experienced the recruitment process, the intervention and delivery mechanisms (especially 21 22 the SSW-only environment) positively. Managing SSW trauma proved challenging for participants, 23 24 drug group facilitators and the clinical psychologist and resulted in the need for intervention 25 26 refinement. Attendance and adherence barriers primarily related to the issues the intervention sought 27 to address, namely problematic drug use, sex work, and poor mental health, rather than the 28 29 acceptability of the intervention itself. The total cost of the intervention was £11,710, with staff costs 30 31 dominating. 32 33 34 Strengths and limitations of this study 35 36 Strengths of our study were that recruiting researchers also conducted the interviews, which may
37 http://bmjopen.bmj.com/ 38 have facilitated a rapport with participants and supported more open and honest reflections. 39 Secondly, all aspects of the intervention were delivered by specialists which was necessary for this 40 41 high-risk group with multiple complex co-morbidities. Thirdly, PPI formed an important part of the 42 43 study and informed each stage. Fourth, recruitment over several months with multiple approaches 44 allowed SSWs many opportunities to take part. This approach took account of the rapidly changing
45 on September 30, 2021 by guest. Protected copyright. 46 lives of SSWs resulting in changing eligibility status as well as allowing time for them to become 47 48 familiar with the researchers. Finally, recruitment within a trusted agency may have had a positive 49 influence on recruitment. 50 51 52 53 This feasibility study provides only preliminary information on the intervention performance and cost 54 55 and does not examine the effectiveness or potential for reducing costs in other parts of the health 56 service or wider society. Delays due to changes to service provision are likely to have adversely 57 58 influenced study recruitment and retention, with delays resulting in higher service costs, but reflect 59 60 the real-life issues facing multi-agency work.
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 Comparison with other research 6 7 This feasibility study is the first, to our knowledge, to address previously highlighted barriers to 8 9 effective drug treatment for SSWs.15 22 23 Through incorporating female SSW-only drug groups 10 alongside an intervention with specialised trauma treatment, delivered in a female SSW-only setting 11 12 by female staff22 24 we showed how an integrated treatment approach in this complex vulnerable 13 14 group could feasibly be implemented and delivered, with small changes to the intervention. 15 16 17 This study is the first interventional study to employ clinical staff from a specialist trauma service to 18 For peer review only 19 deliver EMDR to address trauma symptoms as part of the drug treatment process for SSWs. These
20 16 18 5 16 17 21 women have been found to have high levels of poor mental health, particularly trauma, which 22 contributes to poor drug treatment outcomes.7 8 The intervention took account of SSWs frequent 23 24 experience of abuse and violence,35 36 and recommendations for female-only trauma-focussed drug
25 22 37 38 26 treatment interventions for treatment of PTSD and long term drug use reduction. Some of the 27 characteristics the intervention sought to address presented as barriers to attendance and retention, 28 29 however these are common in studies trying to effect behaviour changes within vulnerable groups.23 30 39 31 32 33 34 Previous SSW-focussed interventions aiming to reduce drug use10-13 14 were unable to demonstrate 35 15 36 strong evidence of a positive effect suggesting the need for a novel approach with evidence of
37 efficacy assessed through a robust methodological approach. The highlighted barriers to attendance, http://bmjopen.bmj.com/ 38 39 engagement and delivery of the intervention are in keeping with other studies15 23 39 but indicate that 40 41 further changes to the DUSSK feasibility study design are likely to be required in future studies. 42 43 44 Conclusion and implications for service provision and research
45 on September 30, 2021 by guest. Protected copyright. 46 This study sought to explore the feasibility of delivering a novel complex intervention to a challenging 47 48 population with high levels of unmet need. Inclusion criteria were informed by PPI, clinical expertise 49 50 and academic literature. They targeted women who were likely to benefit the most from a trauma- 51 based intervention but whose drug dependency and chaotic lives made them challenging study 52 53 participants to recruit and retain. However, all four of the participants screened for PTSD were 54 55 diagnosed, revealing the unmet need for trauma treatment. Though unsurprising, the severity of 56 trauma disclosed by SSWs proved unexpectedly challenging for service providers.22 37 38 Further data 57 58 to understand the extent and severity of PTSD in SSWs is recommended to inform service provision. 59 60
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1 2 3 Overall, the experiences described by those receiving the intervention, suggest it is an acceptable BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 approach to reducing SSWs drug use. 6 7 8 The three services found the intervention valuable and were able to work together effectively despite 9 10 setbacks such as changing contracts and service pressures, and suggested closer working could 11 12 improve intervention delivery. 13 14 15 Intervention costs were driven up by poor participant attendance, though staff pressures and the 16 17 retendering process increased the length (and cost) of the intervention period. However, decreased 18 SSW use of health services,For the peercriminal justice review system and impacts only of criminal activity on wider society 19 20 may justify its adoption if future trials demonstrate intervention effectiveness in reducing drug use. 21 22 23 In order to support future interventional trials in this important field where there are few effectiveness 24 25 studies we recommend the following study refinements for consideration. 26 27 1. The intervention could include women with more stability in their lives to increase recruitment 28 and retention. 29 30 2. Regular meetings throughout the study enabling all service providers involved in intervention 31 32 delivery to express concerns and seek to understand participants needs from the perspective of 33 different professionals so there is effective multi-agency support for individual participants where 34 35 needed. 36 3. Training for all involved staff in managing the disclosure of trauma.
37 http://bmjopen.bmj.com/ 38 39 4. Support and encouragement for participant engagement through provision of transport to and 40 refreshments prior to treatment sessions 41 42 5. Intervention flexibility and responsiveness in offering trauma-focussed alternatives to EMDR 43 44 which may be more suitable for individual participants needs.
45 6. An extended trauma therapy programme to accommodate the complexity of SSW needs. on September 30, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Additional information 5 6 Acknowledgements 7 8 The authors are extremely grateful to all the women who have participated in the study; all service 9 providers and all other staff whose participation made this study possible. They would like to thank 10 11 the PPI group for their time, thoughts and suggestions. We are grateful to the following organisations 12 13 and individuals who have helped with the study for their time, expertise and support: Developing 14 Health and Independence, Bristol Drugs Project, Avon & Wiltshire Mental Health Partnership NHS 15 16 Trust and One25 charity, Katie Warner, Lucy Pettler, Rosie Davies, Maggie Telfer, Elinor Griffiths, Gill 17 18 Nowland, Sophie Ramsden,For Elaine peer Driver, Annareview Smith, Rhea Warner,only Jennifer Riley, Tracey Tudor, 19 Madeline Saunders, Charlotte Hignell, Sophie Banks, Jane Bowman, Sarah Shatwell, Katrina Turner, 20 21 Hasina Downie, Jo Daniels and Louisa Chowen. 22 23 24 25 Author Contributions 26 NJ, NMR, JH, JMK, RP, DW, JM, JMa, MJL and JC are responsible for the study design, collection of data 27 28 and analysis. NMR, RP, NJ and JH are responsible for study management and coordination. JMK and 29 30 NJ conducted the interviews. JMK led the qualitative analysis in collaboration with NJ and JH. RP 31 conducted the quantitative analysis. MJL, RP and JC conducted the costing study. NMR, RP, JMK, MJL, 32 33 JC, NJ and JH drafted the paper. All authors read, commented on and approved the final manuscript. 34 35 36 Funding
37 http://bmjopen.bmj.com/ 38 39 The research is supported by a National Institute for Health Research (NIHR) Clinic Trials Fellowship 40 awarded to NJ (NIHR-CTF-2016-05-07), the National Institute for Health Research Collaboration for 41 42 Leadership in Applied Health Research and Care West (NIHR CLAHRC West P324), now 43 44 recommissioned as NIHR Applied Research Collaboration West (NIHR ARC West) and Research
45 Capability Funding awarded by University Hospitals Bristol NHS Foundation Trust (RCF 2016-17-18). on September 30, 2021 by guest. Protected copyright. 46 47 JMK is partly funded by NIHR Health Protection Research Unit in Evaluation of Interventions. The views 48 49 expressed are those of the authors and not necessarily those of the NIHR or the Department of Health 50 and Social Care. 51 52 Competing interests 53 54 None declared 55 56 57 58 Data availability statement 59 All data relevant to the study are included in the article. 60
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1 2 3 References BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 1. Cusick L, Martin A, May T. Vulnerability and involvement in drug use and sex work. Home Office 6 research study 268. London: Home Office, 2003. 7 2. Deering KN, Kerr T, Tyndall MW, et al. A peer-led mobile outreach program and increased 8 9 utilization of detoxification and residential drug treatment among female sex workers who 10 use drugs in a Canadian setting Drug & Alcohol Dependence 2011;113(1):46-54. 11 3. Morris D, Lemus H, Wagner K D, et al. Factors associated with pathways toward concurrent sex 12 work and injection drug use among female sex workers who inject drugs in northern Mexico. 13 Addiction 2013;108:161-70. 14 4. Jeal N, Salisbury C, Turner K. The multiplicity and interdependency of factors influencing the 15 health of street-based sex workers: a qualitative study. Sex Transm Infect 2008;84(5):381-5. 16 doi: 10.1136/sti.2008.030841 [published Online First: 2008/07/04] 17 18 5. Gorry J, Roen K, ReillyFor J. Selling peer your self? reviewThe psychological impactonly of street sex work and factors 19 affecting support seeking. Health Soc Care Community 2010;18(5):492-9. doi: 20 10.1111/j.1365-2524.2010.00925.x [published Online First: 2010/06/30] 21 6. Jeal N, Salisbury C. Health needs and service use of parlour-based prostitutes compared with 22 street-based prostitutes: a cross sectional survey. BJOG 2007;114:875-81. 23 7. Burnette M LE, Ilgen M, Frayne S, Mayo J, Weitlauf J. Prevalence and health correlates of 24 prostitution among patients entering treatment for substance use disorders. Archives of 25 General Psychiatry 2008;65(3):337 - 44. 26 27 8. Burnette M SR, Timko C, Ilgen M. Impact of substance-use disorder treatment on women involved 28 in prostitution: substance use, mental health and prostitution one year after treatment. 29 Journal of Studies on Alcohol and Drugs 2009;70:32-40. 30 9. Jeal N, Macleod J, Salisbury C, et al. Identifying possible reasons why female street sex workers 31 have poor drug treatment outcomes: a qualitative study. BMJ Open 2017;7(3):e013018. doi: 32 10.1136/bmjopen-2016-013018 [published Online First: 2017/03/25] 33 10. Sherman SG, German D, Cheng Y, et al. The evaluation of the JEWEL project: An innovative 34 economic enhancement and HIV prevention intervention study targeting drug using women 35 involved in prostitution. Aids Care-Psychological and Socio-Medical Aspects of Aids/Hiv 36 2006;18(1):1-11. doi: 10.1080/09540120500101625
37 http://bmjopen.bmj.com/ 38 11. Surratt HL, Inciardi JA. An effective HIV risk-reduction protocol for drug-using female sex 39 workers. J Prev Interv Community 2010;38(2):118-31. doi: 10.1080/10852351003640732 40 [published Online First: 2010/04/15] 41 12. Gunne LM, Gronbladh L, Petersson S. [Methadone treatment in the prevention of AIDS. Heroin- 42 dependent prostitutes are an important target]. Lakartidningen 1986;83(49):4194-6. 43 [published Online First: 1986/12/03] 44 13. Litchfield J, Maronge A, Rigg T, et al. Can a targeted GP-led clinic improve outcomes for street sex
45 on September 30, 2021 by guest. Protected copyright. 46 workers who use heroin? The British journal of general practice : the journal of the Royal 47 College of General Practitioners 2010;60(576):514-6. doi: 10.3399/bjgp10X514774 48 [published Online First: 2010/07/03] 49 14. Yahne CE, Miller WR, Irvin-Vitela L, et al. Magdalena Pilot Project: motivational outreach to 50 substance abusing women street sex workers. J Subst Abuse Treat 2002;23(1):49-53. 51 [published Online First: 2002/07/20] 52 15. Jeal N, Macleod J, Turner K, et al. Systematic review of interventions to reduce illicit drug use in 53 female drug-dependent street sex workers. BMJ Open 2015;5(11):e009238. doi: 54 10.1136/bmjopen-2015-009238 [published Online First: 2015/11/20] 55 56 16. El-Bassel N, Schilling R, Irwin K, et al. Sex trading and psychological distress among women 57 recruited from the streets of Harlem. American Journal Public Health 1997;87:66-70. 58 17. Chukakov B, Ilan K, Belmaker RH, et al. The motivation and mental health of sex workers. Journal 59 of Sex & Marital Therapy 2002;.28(4):pp. doi: 10.1080/00926230290001439 60
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1 2 3 18. Roxburgh A, Degenhardt L, J C, et al. Drug Dependence and Associated Risks Among Female BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Street-Based Sex Workers in the Greater Sydney Area, Australia. Substance Use & Misuse 5 6 2008;43(8-9):1202-17. 7 19. Mellor R, Lovell A. The lived experience of UK street-based sex workers and the health 8 consequences: an exploratory study. Health promotion international 2012;27(3):311-22. doi: 9 10.1093/heapro/dar040 [published Online First: 2011/07/06] 10 20. Reynolds M, Mezey G, Chapman M, et al. Co-morbid post-traumatic stress disorder in a 11 substance misusing clinical population. Drug and alcohol dependence 2005;77(3):251-58. 12 doi: https://doi.org/10.1016/j.drugalcdep.2004.08.017 13 21. Cloitre M, Courtois CA, Charuvastra A, et al. Treatment of complex PTSD: Results of the ISTSS 14 expert clinician survey on best practices. Journal of Traumatic Stress 2011;24(6):615-27. doi: 15 16 10.1002/jts.20697 17 22. Roberts NP, Roberts PA, Jones N, et al. Psychological therapies for post-traumatic stress disorder 18 and comorbidFor substance peer use disorder. review Cochrane Database only Syst Rev 2016;4(4):CD010204. 19 doi: 10.1002/14651858.CD010204.pub2 [published Online First: 2016/04/05] 20 23. Bailey K, Trevillion K, Gilchrist G. What works for whom and why: A narrative systematic review 21 of interventions for reducing post-traumatic stress disorder and problematic substance use 22 among women with experiences of interpersonal violence. Journal of Substance Abuse 23 Treatment 2019;99:88-103. doi: 10.1016/j.jsat.2018.12.007 24 25 24. Jeal N, Patel R, Redmond NM, et al. Drug use in street sex workers (DUSSK) study protocol: a 26 feasibility and acceptability study of a complex intervention to reduce illicit drug use in drug- 27 dependent female street sex workers. BMJ Open 2018;8(11):e022728. doi: 28 10.1136/bmjopen-2018-022728 [published Online First: 2018/11/06] 29 25. Bovin MJ, Marx BP, Weathers FW, et al. Psychometric properties of the PTSD Checklist for 30 Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. 31 Psychol Assess 2016;28(11):1379-91. doi: 10.1037/pas0000254 [published Online First: 32 2016/11/04] 33 26. Emerson RM, Fretz RI, Shaw LL, et al. Writing ethnographic fieldnotes. Chicago and London: 34 35 University of Chicago Press 1995. 36 27. Moran-Ellis J, Alexander VD, Cronin A, et al. Triangulation and integration: processes, claims and implications. 2006;6(1):45-59. doi: 10.1177/1468794106058870
37 http://bmjopen.bmj.com/ 38 28. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for 39 reporting parallel group randomised trials. BMJ 2010;340:c332. doi: 10.1136/bmj.c332 40 [published Online First: 2010/03/25] 41 29. Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology 42 2006;3(2):77-101. 43 44 30. Glaser B, Strauss A. The Constant Comparative method of Qualitative Analysis. In the Discovery of Grounded Theory: Strategies for Qualitative Research Chicago: Aldine 1967:101-158.
45 on September 30, 2021 by guest. Protected copyright. 46 31. Charmaz K. Constructing grounded theory: a practical guide through qualitative analysis. London: 47 Sage Publications, Inc 2006. 48 32. Curtis LB, A. . Unit Costs of Health and Social Care University of Kent, Canterbury: Personal Social 49 Services Research Unit 2018. 50 33. Kirk A. Data Visualization: a successful design process: Packt Publishing Ltd 2012. 51 34. Iliinsky N, Steele J. Designing data visualizations: Representing informational Relationships: 52 53 O'Reilly Media, Inc. 2011. 54 35. Ulibarri MD, Hiller SP, Lozada R, et al. Prevalence and characteristics of abuse experiences and 55 depression symptoms among injection drug-using female sex workers in Mexico. J Environ 56 Public Health 2013;2013:631479. doi: 10.1155/2013/631479 [published Online First: 57 2013/06/06] 58 59 60
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1 2 3 36. Monica D. Ulibarri, Steffanie A. Strathdee, Remedios Lozada, et al. Prevalence and Correlates of BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Client-Perpetrated Abuse Among Female Sex Workers in Two Mexico–U.S. Border Cities. 5 6 Violence Against Women 2014;20(4):427– 45. 7 37. Greenfield SF, Brooks AJ, Gordon SM, et al. Substance abuse treatment entry, retention, and 8 outcome in women: a review of the literature. Drug and alcohol dependence 2007;86(1):1- 9 21. doi: 10.1016/j.drugalcdep.2006.05.012 [published Online First: 2006/06/09] 10 38. Wiechelt SA, Shdaimah CS. Trauma and Substance Abuse Among Women in Prostitution: 11 Implications for a Specialized Diversion Program. Journal of Forensic Social Work 12 2011;1(2):159-84. doi: 10.1080/1936928x.2011.598843 13 39. Bailey K, Trevillion K, Gilchrist G. “We have to put the fire out first before we start rebuilding the 14 house”: practitioners’ experiences of supporting women with histories of substance use, 15 16 interpersonal abuse and symptoms of post-traumatic stress disorder. Addiction Research & 17 Theory 2019:1-9. doi: https://doi.org/10.1080/16066359.2019.1644323 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
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1 2 3 Figure 1 Flow of participants through the DUSSK study BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
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1 2 3 Table 1 Characteristics of screened women BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 Screened not recruited Screened and recruited 6 (N=30) (N=11) 7 8 N (%) * Median (range) N (%) * Median (range) 9 10 Female 27 (90) 11 (100) 11 Age 23 (77) 37 (26-55) 11 (100) 38 (23-53) 12 Ever sold sex on the street? 13 Yes 26 (87) 11 (100) 14 No 1 (3) - 15 16 How many days since last worked on 23 (77) 60 (1-2920) 11 (100) 7 (1-28) 17 the street? 18 How often usually sellFor sex on street? peer review only 19 Daily 6 (20) 3 (27) 20 Weekly 5 (17) 8 (73) 21 Less than weekly 16 (53) - 22 23 Ever used street drugs 24 Yes 26 (87) 11 (100) 25 No 1 (3) - 26 Ever used heroin 23 (77) 9 (82) 27 Days since last used heroin 19 (63) 2 (0-731) 9 (82) 1 (0-6) 28 Ever used crack cocaine 23 (77) 11(100) 29 30 Days since last used crack cocaine 21 (70) 2 (0-2922) 1 (0-4) 31 How often use heroin and/or crack 32 cocaine? 33 Daily 11 (37) 7 (64) 34 Weekly 4 (13) 4 (36) 35 Less than weekly 9 (30) - 36 Has an opioid substitute script 13 (43) 6 (55)
37 http://bmjopen.bmj.com/ 38 Script type 39 Buprenorphine/Subutex® - 1 (9) 40 Methadone 13 (43) 5 (45) 41 Used other drugs: 42 Alcohol 3 (10) 1 (9) 43 44 Amphetamine 1 (3) - Cannabis 5 (17) 5 (45)
45 on September 30, 2021 by guest. Protected copyright. 46 Spice 2 (7) - 47 MDMA (Ecstasy) 1 (3) 48 Tramadol 1 (3) - 49 Sleeping tablets - 1 (9) 50 51 PCL5 score (possible range 0-80) - 10 (91) 56 (43-73) 52 *N and % of those that provided data 53 54 55 56 57 58 59 60
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1 2 3 4 Table 2 Qualitative quotes 5 Theme/Sub-theme Quotes 6 7 Recruitment and retention 8 Acceptability [Face-to-face recruitment] worked well, it wasn’t intrusive, you weren’t pushy, you know you blended in within the drop-in 9 setting. So I think the women felt that if they did wanna buy into it they would, there was no pressure there. So I think that 10 11 was done really sensitively. Service provider 6 12 For peer review only 13 It [recruitment] was very sort of like confidential and actually it was quite nice ‘cause, yeah no one really knew what I was 14 doing when I was doing summut, you know what I mean, which is – like it don’t usually happen like that. Everyone knows 15 16 what I’m doing all the time. Participant 7 17 Improvements I think from a clinical point of view if you remove that criteria [sex work at least once http://bmjopen.bmj.com/ a week in the last calendar month] 18 and then of course there’s more chance of getting people through to the finish line to be able to be ready for treatment at 19 the end. Service provider 4 20 21 22 Actively drug using? Yes, that makes sense (…). If they’ve been able to bring that down themselves maybe another service 23 would be better. Like, what this offered, it’s specialistic in this. So if you was able to manage to a level yourself, maybe you 24 don’t need [the intervention]… I’m not sure, I think that would be an interesting conversation because if they could bring it 25 down themselves, they’d probably be a lot more stable and a lot more reliable to actually on September 30, 2021 by guest. Protected copyright. get to the EMDR . Service 26 provider 7 27 28 So I think if you were to extend the period of time and say ‘Oh actually do you know if you’ve used within the last three 29 30 months you can participate in the study and then someone who’s three months abstinent or reducing from their street 31 heroin use or their crack use is then exposed to somebody who’s going no no no man I’m using up like a party every night’. 32 There’d be that ethical thing within it but it would be nice to see the study opened up to a wider cohort. Service provider 2 33 Facilitators to attendance 34 Encouragement and support I would say that I’ve been quite integral in regards to developing relationships with the women, contacting them for both 35 36 to attend their individual one to ones and stabilisation groups and also their Thursday DUSSK groups as well. So just keeping that 37 contact going if they were coming in, in our drop-in service I would see them and then sort of give them reminders, did 38 they want little welfare calls, that type of thing. Service provider 6 39 40 41 42 24 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
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1 2 3 Transport It was more of a focus thing where you know she [service provider 6] sort of like coached us as we went down, like you 4 5 know keeping us like sort of aware of what we’ve got to be thinking of doing and making sure that, you know, there’s 6 nothing wrong. Participant 7 7 Food provision I was turning up and I was like sort of god like hanging out for (…) that lunch. It was like, not the reason I was turning up 8 but the main reason why I could (…). There is light at the end of the tunnel, you know you’re gonna be nourished and fed.’ 9 10 You’re gonna be able to concentrate as well. Participant 7 11 Barriers to attendance 12 Unstable lifestyles My mentalFor problems, peer my drug use, everything, review just my life, it gets only in the way [of attendance]. Participant 1 13 14 Mental health They’re so low resourced, they just don’t have the distress tolerance to be able to cope with any more distress, they’re 15 already facing so much. Even things like their housing and threats of eviction. Service provider 8 16 17 http://bmjopen.bmj.com/ 18 My home life was getting a bit chaotic. My depression was getting really bad as well. So, yeah, and I was waiting for my 19 antidepressants to work but they took a while. Yeah, it was just my depression, that’s all. My anxiety. Participant 6 20 Sex work If I’ve been working the night before there’s no way I could have attended because I’m too tired, because you work all 21 22 night. Participant 4 23 Delays between treatment It took a little bit of a while and also for them to access their stabilisation groups then their one to ones. I think we may 24 stages have lost some of the interest. Service provider 6 25 on September 30, 2021 by guest. Protected copyright. Experience and acceptability of the intervention 26 27 Initial impressions There aren’t many services out there, which will offer individual, tailorised counselling and support to the women who 28 have got dual diagnosis and you know mental health, drug misuse. So this study was unique and I think that’s what we 29 were all so passionate and so behind it because it was giving the women an opportunity. Service provider 6 30 31 Reason for participating I just felt so alone and afraid and stuck and just needed to see if there was some way that I might be able to gain 32 something so – really, if I’m willing to put myself out on the street and sell myself to a complete stranger, knowing that I 33 might die, whatever, so it kind of … I felt I needed to understand why I needed to do this... So it’s about me owning my 34 35 power, and about not letting myself feel as shit about myself as I have done. Participant 5 36 37 38 39 40 41 42 25 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
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1 2 3 The post-traumatic stress [treatment] is – is a way of like sort of detoxing your brain. So, you know finding a reason why 4 5 you do these drugs (…) to like sort of be the reason for me to like say ‘Well, I’ve got to stop now.’ You know and get off it. 6 Participant 7 7 Service providers views on I guess that people thought they weren’t going to talk about their traumas [in the drug groups] but if somebody’s been 8 the intervention raped last night, they’re going to need to talk about it, so we were here dealing with that stuff on the spot and then we 9 10 didn’t have no-one to go away and talk about it. Service provider 10 11 12 It’s veryFor hard to do traumapeer processing reviewwhen women to some degree only are being traumatised and then having to self- 13 14 medicate against all of that and then you’re trying to work on quite deep attachment developmental trauma stuff from a 15 long time ago. (…) I’d say that trauma processing would be more successful with women who have maybe made a very 16 strong commitment to stop [sex] working. Service provider 8 17 http://bmjopen.bmj.com/ 18 19 I would offer it [EMDR] as part of a – as a range of things that are offered…we’d say ‘You can have EMDR, trauma focus 20 CBT [Cognitive Behavioural Therapy] or narrative exposure therapy and you’d kind of match the person to what you 21 thought they might be more suited to. Service provider 8 22 23 24 I think they had huge admiration for the workers at [SSW charity], and found them friendly and supportive, but…there 25 wasn’t a specific, I don’t know, once a month structured ‘let’s talk about the women and on September 30, 2021 by guest. Protected copyright. how they’ve been in the month. 26 27 Service provider 9 28 29 Participants views of the I enjoyed going down there. (…) We had a good laugh and learned something while we were doing it. Participant 6 30 intervention 31 With it being all woman and not mixed going to (mainstream drug treatment service provider) and doing groups where 32 men are involved is like, I didn’t really want to do it but here because it’s all women and I know most of the women that 33 come here, we’ve all been through it, hence why we all come here. So one way or another we’ve all been through 34 35 something that we can all relate to. Participant 3 36 37 Intervention characteristics It’s [SSW charity] familiar and it’s comfortable and it’s safe. Service provider 5 38 39 40 41 42 26 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
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1 2 3 The groups weren’t too big, so you sort of – I knew the people that were coming to the groups which was better, so we’d 4 5 sort of you know built up a rapport. Participant 4 6 Impacts of the intervention I’m just going to stop [drug use], I’m ready and I’m kind of already preparing for that, so it’s kind of brought me to a close, 7 and I mean that as well. Personally it’s like, I’m ready, bring it on, I’m like do you know what I’ve been raped, I’ve been 8 beaten I’ve stuck needles in myself( …) I’m done, I’m not playing this game anymore, I deserve better. Participant 5 9 10 11 It’s just made (…) me realise I’m not just a, like, drug addict, sex worker. I’m a real person and I’ve got feelings and, you 12 know,For I’ve got potential. peer You know, yeah, review they [service providers] onlybuild me up a lot. Participant 6 13 14 15 When she [participant 6] started with [name of intervention] study and she was coming to her Thursday [drug] groups, she 16 didn’t want to be associated with street sex working. So she said ‘Can you call me (own name rather than working name)?’ 17 http://bmjopen.bmj.com/ 18 I could have cried (…). She was owning her own name and taking back ownership of who she is rather than somebody who 19 was street sex working. Service provider 6 20 21 Their chaoticness. (…) To manage that in a [mainstream drug service] group setting would be difficult and I’m not sure 22 23 how they would manage that. I just know how much regularly how they’ve turned up [to the intervention drug treatment 24 groups] chaotic and they’ve turned up leaking out trauma. … I’m far from confident that they would be able to sit under 25 them [mainstream drug service] rules enough to be a part of what it is for here[research on September 30, 2021 by guest. Protected copyright. study], due to the level of 26 27 flexibility here and that they would be able to talk about what their problem is without mentioning what they do and that 28 might make them vulnerable Service provider 7 29 Fidelity I guess we were kind of thinking of it in a really linear sense, that the women would engage in the drug groups and then 30 reduce their drug use to then move on to the next group and I’m not sure that that actually happened in reality. 31 32 Service provider 5 33 34 In the beginning we went in doing the same sort of work that we would do here [mainstream drug services], and it’s 35 36 getting them to look at their behaviour, and the consequences of it and stuff, and it didn’t work with these women, it’s too 37 much, too direct. Service provider 10 38 39 40 41 42 27 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
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1 2 3 Table 3 Attendance and retention of participants 4 5 Open group Attended Closed group 5 mandatory One-to-one sessions Referred to 6 7 Getting started Trauma Getting started Stabilisation group which services: 8 Screening sessions 9 10 Eligible Attended % Eligible Attended % Attended % Eligible Attended % 11 Participant sessions sessions* Attended sessions sessions Attended sessions Attended Treatment sessions** sessions* Attended 12 For peer review only (1) 13 1 28 10 36 Yes 26 4 15 3 60 Ext. stabilisation 8[3] 1 13 Mental health 14 2 28 5 18 No 15 16 3 28 1 (1) 4 NA http://bmjopen.bmj.com/ 17 4 27 8 30 Yes 26 11 42 5 100 EMDR 12[3] 4 (1) $ 33 Mental health 18 19 5 25 3 12 NA 20 Mental health & 21 22 6 25 19 (5) 76 Yes 26 15 58 4 80 EMDR 12[2] 8 (4) $ 67 mainstream drug 23 7 23 0 0 NA 24 25 8 22 0 0 NA on September 30, 2021 by guest. Protected copyright. 26 9 20 7 (2) 35 Yes 26 3 12 1 20 Ext. stabilisation 8[4] 0 0 Mental health 27 28 10 19 0 0 NA 29 30 11 19 0 0 NA 31 Total 53 4 33 13 13 32 33 *N session participant arrived late/left early indicated in superscript round brackets; **N sessions cancelled due to non-attendance in square brackets; 34 NA=Not actively invited to sessions; $ Includes one review session; Ext. stabilisation=Extended stabilisation, EMDR=Eye movement desensitization and 35 36 reprocessing therapy 37 38 39 40 41 42 28 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
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1 2 3 4 Table 4 Health Economics 5 6 1. Getting started 2. Trauma screening 3. Stabilisation group 4. One-to-one sessions 7 Service description 1 2 8 Session lengths - range 90 - 120 minutes 60 minutes 60 minutes 60 - 90 minutes 9 Number of sessions held - total 52 8 5 28 3 4 10 Eligible participants - total n = 11 n = 5 n = 4 n = 4 11 Attendees per session - range 0 - 4 1 2 - 4 1 12 Costs ForSub-total peer £ £ per ppt reviewSub-total £ £ per pptonlySub-total £ £ per ppt Sub-total £ £ per ppt 13 A. Staff 14 Service manager £1,359.76 £123.61 £95.09 £19.02 £47.54 £11.89 £266.25 £66.56 15 Drug group facilitators5 £3,000.20 £272.75 £0.00 £0.00 £0.00 £0.00 £0.00 £0.00 16 Art worker £123.98 £11.27 £0.00 £0.00 £0.00 £0.00 £0.00 £0.00 17 Clinical Psychologist £0.00 £0.00 £636.00 £127.20 £600.00 http://bmjopen.bmj.com/ £150.00 £2,040.00 £510.00 18 B. Facilities 19 Space rental £1,270.50 £115.50 £224.00 £44.80 £140.00 £35.00 £574.00 £143.50 20 C. Travel 21 Transporting materials £73.78 £8.44 £0.00 £0.00 £11.90 £2.98 £0.00 £0.00 22 Car lifts for service-users (petrol) £38.72 £3.52 £2.24 £0.45 £3.36 £0.84 £1.20 £0.30 23 Public transport for participants £70.20 £6.38 £0.00 £0.00 £3.90 £0.98 £3.90 £0.98 24 Taxis for participants £55.00 £5.00 £0.00 £0.00 £62.20 £15.55 £11.00 £2.75 25 D. Materials on September 30, 2021 by guest. Protected copyright. 26 Art supplies £30.00 £2.73 £0.00 £0.00 £0.00 £0.00 £0.00 £0.00 27 Stationary £0.00 £0.00 £0.00 £0.00 £5.00 £1.25 £0.00 £0.00 28 Voucher incentives £0.00 £0.00 £0.00 £0.00 £130.00 £32.50 £0.00 £0.00 29 Refreshments6 £820.00 £74.55 £0.00 £0.00 £10.00 £.2.50 £0.00 £0.00 30 Summary 31 Total cost £6,842.13 £622.01 £957.33 £191.47 £1,013.907 £253.48 £2,896.35 £724.09 32 Total cost per session £131.58 £11.96 £119.67 £23.93 £202.78 £50.70 £103.44 £25.86 33 Note: 1 = Sessions were originally were 90 minutes, however when sandwiches were provided drug group facilitators arrived 30 minutes prior to session to be with participants while they ate, 2 = 34 One-to-one EMDR sessions were 90 minutes and one-to-one Stabilisation sessions were 60 minutes, 3 = participants, 4 = Five participants were eligible for screening, however only four 35 participants were successfully screened, 5 = Getting started groups were facilitated by two drug group facilitators, and 6 = Sandwiches and biscuits, 7 = Total cost without vouchers would have 36 been £883.90 . 37 Heat map description: £0.00 £0.01 - £99.99 £100 - £499.99 £500.00 - £1999.99 £2000.00 + 38 39 40 41 42 29 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open Page 32 of 35
1 2 3 Figure legend BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 6 Figure displaying the flow and numbers of potential and consented participants through the DUSSK 7 8 study. Numbers may include more than one approach to potential participants by different recruiters. 9 Includes reasons provided by women spoken to, but not screened, those screened but not eligible/ 10 11 not consented and consented participants who did not reach the ‘getting started’ closed group 12 13 intervention stage. 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
37 http://bmjopen.bmj.com/ 38 39 40 41 42 43 44
45 on September 30, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
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1 2 3 Figure 1: Flow of participants through the DUSSK study BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 6 7 8 Women spoken to at 9 Women spoken to but not screened recruiting site (n=125)* 10 (n=84) 11 12 13 Too busy 13 11 Not interested 14 10 Not currently street sex working Attempted screening 15 9 Too unsettled/stressed 9 Unwilling to be screened questionnaire (n=41)* 16 7 Woman considers herself ineligible 17 7 Previously recruited 18 4 Previously screened For peer review only 19 4 Not currently taking heroin/crack 20 3 Previously approached by researcher Screened and recruited 21 7 Other (n=11) 22 Screened, not eligible/consented (n=30) 23
24 1 Not street sex working (escort) 25 2 Few/no screening questions completed Invited to Getting started Screened for 26 1 Never used street drugs sessions - Open group PTSD 27 Remaining women were SSWs and took 28 street drugs: (n=11) (n=4) 29 6 Not street sex worked and not used 30 heroin/crack in last month 31 9 Heroin/crack users who had not street sex Invited to Getting started Positive for PTSD and worked in last month 32 sessions - Closed group invited to Stabilisation 33 1 Street sex worked not used heroin/crack in last month (n=4) sessions (n=4) 34 7 Street sex worked or used heroin/crack less 35 than weekly 36 3 Eligible unable to obtain consent Invited to one-to-one
37 http://bmjopen.bmj.com/ 38 sessions: 39 Not actively invited to closed group 40 sessions (n=7) EMDR Extended 41 (n=2) stabilisation 42 5 Non-attenders (n=2) 43 2 Poor attenders 44
45 on September 30, 2021 by guest. Protected copyright. Referred to mainstream 46 47 drug services (n=1) 48 *Women could be approached Referred to mental health 49 multiple times throughout the services 50 recruitment period. (n=4) 51 52 53 54 55 56 57 58 59 60
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1 2 3 Reporting checklist for cohort study. 4 5 6 Based on the STROBE cohort guidelines. 7 8 9 Instructions to authors 10 11 Complete this checklist by entering the page numbers from your manuscript where readers will find 12 each of the items listed below. 13 14 15 Your article may not currently address all the items on the checklist. Please modify your text to 16 include the missing information.For Ifpeer you are certain review that an item onlydoes not apply, please write "n/a" and 17 18 provide a short explanation. 19 20 Upload your completed checklist as an extra file when you submit to a journal. 21 22 In your methods section, say that you used the STROBE cohortreporting guidelines, and cite them 23 24 as: 25 26 von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP. The Strengthening 27 the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for 28 29 reporting observational studies. 30 31 Page 32
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1 Study design #4 Present key elements of study design early in the paper 5 2 3 Setting #5 Describe the setting, locations, and relevant dates, including 5 4 5 periods of recruitment, exposure, follow-up, and data 6 collection 7 8 9 Eligibility criteria #6a Give the eligibility criteria, and the sources and methods of 5 10 selection of participants. Describe methods of follow-up. 11 12 13 Eligibility criteria #6b For matched studies, give matching criteria and number of N/A 14 exposed and unexposed 15 16 Variables #7 ForClearly peer define all reviewoutcomes, exposures, only predictors, potential 8 17 18 confounders, and effect modifiers. Give diagnostic criteria, if 19 applicable 20 21 22 Data sources / #8 For each variable of interest give sources of data and details 7 23 measurement of methods of assessment (measurement). Describe 24 25 comparability of assessment methods if there is more than 26 one group. Give information separately for for exposed and 27 28 unexposed groups if applicable. 29 30 Bias #9 Describe any efforts to address potential sources of bias N/A 31 32 Study size #10 Explain how the study size was arrived at 7
33 http://bmjopen.bmj.com/ 34 35 Quantitative #11 Explain how quantitative variables were handled in the 7 36 variables analyses. If applicable, describe which groupings were 37 38 chosen, and why 39 40 Statistical #12a Describe all statistical methods, including those used to 8
41 on September 30, 2021 by guest. Protected copyright. 42 methods control for confounding 43 44 Statistical #12b Describe any methods used to examine subgroups and N/A 45 methods interactions 46 47 48 Statistical #12c Explain how missing data were addressed N/A 49 methods 50 51 Statistical #12d If applicable, explain how loss to follow-up was addressed N/A 52 53 methods 54 55 Statistical #12e Describe any sensitivity analyses N/A 56 57 methods 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 36 of 35 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
1 Results 2 3 Participants #13a Report numbers of individuals at each stage of study—eg 20 4 5 numbers potentially eligible, examined for eligibility, 6 confirmed eligible, included in the study, completing follow- 7 8 up, and analysed. Give information separately for for 9 exposed and unexposed groups if applicable. 10 11 12 Participants #13b Give reasons for non-participation at each stage 9 13 14 Participants #13c Consider use of a flow diagram 20 15 16 Descriptive data #14aForGive characteristicspeer review of study participants only (eg demographic, 9 17 18 clinical, social) and information on exposures and potential 19 confounders. Give information separately for exposed and 20 21 unexposed groups if applicable. 22 23 Descriptive data #14b Indicate number of participants with missing data for each 21 24 25 variable of interest 26 27 Descriptive data #14c Summarise follow-up time (eg, average and total amount) 26 28 29 Outcome data #15 Report numbers of outcome events or summary measures 9 30 31 over time. Give information separately for exposed and 32 unexposed groups if applicable.
33 http://bmjopen.bmj.com/ 34 35 Main results #16a Give unadjusted estimates and, if applicable, confounder- 9-12 36 adjusted estimates and their precision (eg, 95% confidence 37 38 interval). Make clear which confounders were adjusted for 39 and why they were included 40
41 on September 30, 2021 by guest. Protected copyright. 42 Main results #16b Report category boundaries when continuous variables were N/A 43 categorized 44 45 Main results #16c If relevant, consider translating estimates of relative risk into N/A 46 47 absolute risk for a meaningful time period 48 49 Other analyses #17 Report other analyses done—e.g., analyses of subgroups 9-12 50 51 and interactions, and sensitivity analyses 52 53 Discussion 54 55 Key results #18 Summarise key results with reference to study objectives 13 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 37 of 35 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
1 Limitations #19 Discuss limitations of the study, taking into account sources 13 2 3 of potential bias or imprecision. Discuss both direction and 4 magnitude of any potential bias. 5 6 Interpretation #20 Give a cautious overall interpretation considering objectives, 15 7 8 limitations, multiplicity of analyses, results from similar 9 studies, and other relevant evidence. 10 11 12 Generalisability #21 Discuss the generalisability (external validity) of the study N/A 13 results 14 15 16 Other For peer review only 17 Information 18 19 Funding #22 Give the source of funding and the role of the funders for the 16 20 21 present study and, if applicable, for the original study on 22 which the present article is based 23 24 25 The STROBE checklist is distributed under the terms of the Creative Commons Attribution License 26 CC-BY. This checklist was completed on 16. December 2019 using https://www.goodreports.org/, a 27 28 tool made by the EQUATOR Network in collaboration with Penelope.ai 29 30 31 32
33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40
41 on September 30, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
Drug Use in Street Sex worKers (DUSSK) study – results of a mixed methods feasibility study of a complex intervention to reduce illicit drug use in drug dependent female sex workers
ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2019-036491.R2
Article Type: Original research
Date Submitted by the 13-Oct-2020 Author:
Complete List of Authors: Patel, Rita; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences Redmond, Niamh; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences Kesten, Joanna; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences & NIHR Health Protection Research Unit in Evaluation of Interventions Linton, Myles-Jay; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences & Health Economics Bristol Horwood, Jeremy; University Hospitals Bristol NHS Foundation Trust,
NIHR ARC West; University of Bristol, Population Health Sciences & http://bmjopen.bmj.com/ Centre for Academic Primary Care Wilcox, David ; Avon and Wiltshire Mental Health Partnership NHS Trust, Acer Unit, Blackberry Hill Hospital, Manor Road, Munafo , Jess; Avon and Wiltshire Mental Health Partnership NHS Trust, Acer Unit, Blackberry Hill Hospital, Manor Road, Coast, Joanna; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences & Health Economics Bristol Macleod, John; University Hospitals Bristol NHS Foundation Trust, NIHR on September 30, 2021 by guest. Protected copyright. ARC West; University of Bristol, Population Health Sciences & Centre for Academic Primary Care Jeal, Nicola; University Hospitals Bristol NHS Foundation Trust, NIHR ARC West; University of Bristol, Population Health Sciences
Primary Subject Addiction Heading:
Secondary Subject Heading: Health services research, Mental health, Public health, Health economics
QUALITATIVE RESEARCH, MENTAL HEALTH, HEALTH ECONOMICS, Keywords: TRAUMA MANAGEMENT, Substance misuse < PSYCHIATRY
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45 on September 30, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 Drug Use in Street Sex worKers (DUSSK) study – results of a 6 7 8 9 mixed methods feasibility study of a complex intervention to 10 11 12 reduce illicit drug use in drug dependent female sex workers 13 14 15 Authors: 16 17 1,2 1,2 1,2,3 1,2,4 18 Dr Rita Patel*, Dr NiamhFor M Redmond*,peer Drreview Joanna M Kesten, only Dr Myles-Jay Linton, Dr 19 Jeremy Horwood,1,2,6 David Wilcox,5 Jess Munafo,5 Prof Joanna Coast,1,2,4 Prof John Macleod,1,2,6 Dr 20 21 Nicola Jeal.1,2,7 22 23 *Joint first authors. 24 25 Author affiliations: 26 27 1 The National Institute for Health Research Applied Research Collaboration West (NIHR ARC West) 28 29 at University Hospitals Bristol NHS Foundation Trust, Whitefriars, Lewins Mead, Bristol, UK, BS1 2NT 30 31 2 Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley 32 Road, Bristol, UK, BS8 2PS 33 34 3 The National Institute for Health Research Health Protection Research Unit in Evaluation of 35 36 Interventions, University of Bristol, UK
37 http://bmjopen.bmj.com/ 4 Health Economics Bristol, Population Health Sciences, Bristol Medical School, University of Bristol, 38 39 1-5 Whiteladies Road, Bristol, UK, BS8 1NU 40 41 5 Avon & Wiltshire Partnership NHS Trust, Acer Unit, Blackberry Hill Hospital, Manor Road, Bristol, 42 43 UK, BS16 2EW 44 6 Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University
45 on September 30, 2021 by guest. Protected copyright. 46 of Bristol, Canynge Hall, 39 Whatley Road, Bristol BS8 2PS 47 48 7 Northern Devon Healthcare NHS Trust, Devon Sexual Health - North Devon, Barnstaple Health 49 Centre, Vicarage Road, Barnstaple EX32 7BH 50 51 52 Corresponding author: 53 54 Dr Nicola Jeal ([email protected]) 55 56 Word count: 57 58 59 Target Journal BMJ Open: Abstract: (304/300), Main: (4320/4000) 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Abstract 5 6 7 Objectives 8 9 10 The majority of female street-based sex workers (SSWs) are dependent on illicit drugs and sell sex to 11 fund their drug use. They typically face multiple traumatic experiences, starting at a young age, which 12 13 continue through sex work involvement. Their trauma-related symptoms tend to increase when drug 14 15 use is reduced, hindering sustained reduction. Providing specialist trauma care to address post- 16 traumatic stress disorder (PTSD) alongside drug treatment may therefore improve treatment 17 18 outcomes. Aims to (i)For evaluate peer recruitment review and retention of participants;only (ii) examine intervention 19 20 experiences and acceptability; and (iii) explore intervention costs using mixed methods feasibility 21 study. 22 23 24 Setting 25 26 Female SSW charity premises in a large UK inner city. 27 28 29 Participants 30 31 Females aged 18 years or older, who have sold sex on the street and used heroin and/or crack cocaine 32 33 at least once a week in the last calendar month. 34 35 Intervention 36
37 Female SSW-only drug treatment groups in a female SSW-only setting delivered by female staff. http://bmjopen.bmj.com/ 38 39 Targeted post-traumatic stress disorder (PTSD) screening then treatment of positive diagnoses with 40 41 eye movement desensitization and reprocessing (EMDR) therapy by female staff from a specialist NHS 42 trauma service. 43 44 Results
45 on September 30, 2021 by guest. Protected copyright. 46 47 (i) Of 125 contacts 11 met inclusion criteria and provided informed consent, 4 reached the 48 49 intervention final stage (ii) Service providers said working in collaboration with other services was 50 valuable, the intervention was worthwhile and had a positive influence on participants. Participants 51 52 viewed recruitment as acceptable and experienced the intervention positively. The unsettled nature 53 54 of participant’s lives was a key attendance barrier. (iii) The total cost of the intervention was £11,710, 55 with staff costs dominating. 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Conclusions 5 Recruitment and retention rates reflected study inclusion criteria targeting women with the most 6 7 complex needs. Two participants received EMDR demonstrating that the three agencies working 8 9 together was feasible. Staff heavy costs highlight the importance of supporting participant attendance 10 to minimise per participant costs in a future trial. 11 12 13 Ethics approval 14 15 South West - Frenchay Research Ethics Committee (REC reference: 17/SW/0033; IRAS project ID: 16 17 220631). UK HRA approval was on 03/04/2017.The University of Bristol Research Enterprise and 18 Development departmentFor sponsored peer this study review (RED reference: only RG2756). 19 20 21 22 Strengths and limitations of this study 23 24 25 The novel intervention integrates a trauma-focussed treatment approach in order to reduce 26 drug use in a challenging drug treatment population 27 28 The intervention was delivered by specialists, reflecting the skills and experience required to 29 30 appropriately manage the complex needs of the study population 31 PPI formed an important part of the study methodology and informed each stage 32 33 Recruitment took place over several months within an agency trusted and used daily by the 34 35 study population to allow familiarisation with the researchers and multiple opportunities to 36 participate
37 http://bmjopen.bmj.com/ 38 This feasibility study design and methodology were not able to examine intervention 39 40 effectiveness or cost effectiveness 41 42 43 44 Keywords:
45 on September 30, 2021 by guest. Protected copyright. 46 sex workers, feasibility study, qualitative research, cost analysis, trauma treatment, drug 47 48 dependency 49 50 51 52 53 54 55 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Introduction 5 6 7 Most female street-based sex workers (SSWs) in the UK use heroin and/or crack cocaine.1-3 Their drug 8 dependency keeps them entrenched in a “work-score-use cycle”,4 5 which contributes to the morbidity 9 10 and social instability typically seen in this group.6 11 12 13 Despite their drug treatment needs, drug dependent SSWs have poorer outcomes from drug 14 15 treatment services compared to other service users,7 8 sometimes due to stigma associated with their 16 17 street sex work.9 Previous SSW-focussed interventions aiming to reduce drug use have used 18 For peer review only educational,10 11 substitute prescribing-based12 13 and psychological14 approaches but none robustly 19 20 demonstrated a positive effect in reducing drug use.15 21 22
23 16-18 24 Poor mental health is a significant problem among SSWs. Many have experienced multiple 25 adversities in early life and during their involvement in sex work,5 16 19 which exposes women to further 26 27 risk of significant trauma.16 17 Consequently, many SSWs are affected by post-traumatic stress disorder
28 16 17 29 (PTSD). Trauma symptoms, which often recur when drug use is reduced, may motivate a return to 30 drug use.20 Individual trauma-focused therapy alongside drug treatment may provide the best 31 32 outcomes for reductions in drug use.21-23 However to date, there is no robust evidence to demonstrate 33 34 the impact of an integrated trauma-focussed treatment approach in reducing drug use amongst 35 female drug dependent SSWs. 36
37 http://bmjopen.bmj.com/ 38 9 15 39 In collaboration with SSWs and service providers, and informed by existing research we developed 40 a novel intervention, to simultaneously address the unique and complex combination of drug use and 41 42 PTSD in female drug-dependent SSWs. The intervention proposes an integrated care pathway through 43 24 44 an innovative multi-agency partnership. We report here the results of the DUSSK (Drug Use in Street
45 Sex worKers) feasibility study, which aimed to (i) evaluate the recruitment and retention of SSWs to on September 30, 2021 by guest. Protected copyright. 46 47 the intervention; (ii) examine the experience and acceptability of the intervention for participants and 48 49 service providers; and (iii) explore costs to service providers associated with the intervention. 50 51 52 53 54 55 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Methods 5 6 7 Study design, setting and eligibility 8 9 10 Detailed methods are described in the published protocol.24 This mixed methods feasibility study took 11 place in a UK inner city setting. Females aged 18 years or older, who sold sex on the street at least 12 13 weekly in the last calendar month and used heroin and/or crack cocaine at least once a week in the 14 15 last calendar month, were eligible to participate.24 The intervention was delivered at SSW charity 16 premises, which supplied support, health and advocacy services.24 17 18 For peer review only 19 20 21 Recruitment 22 23 The recruitment target for this feasibility study was 30 women.24 Local organisations that SSWs were 24 known to access were provided with study promotional materials. One of three researchers (JMK, NJ, 25 26 SR) attended an SSW support and advocacy charity, at least twice a week, to directly approach 27 28 potential participants; alternatively, interested SSWs could telephone researchers. This approach 29 30 meant that women were potentially approached and counted as contacts several times during 31 recruitment. Eligibility screening was conducted face-to-face or via telephone. Women gave fully 32 33 informed, written consent to participate in the study and baseline data were also collected at the time 34 35 of recruitment. To maintain safety and confidentiality, each participant provided details of acceptable 36 ways in which to be contacted. Screening data were retained and remained anonymised for those not
37 http://bmjopen.bmj.com/ 38 recruited. 39 40 41 42 43 Patient and Public Involvement (PPI) 44
45 Women with experience of street sex work and drug-dependency took part in focus groups and one- on September 30, 2021 by guest. Protected copyright. 46 47 to-one discussions with NJ to inform study design, processes, documentation and intervention 48 development. On commencement of the study, a group of women who were ineligible for recruitment 49 50 were approached for involvement in PPI. They addressed challenges with recruitment, participation 51 52 and adherence issues (described below) and suggested solutions, which were implemented. For 53 54 example, they recommended changes such as provision of sandwiches to improve attendance. 55 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 The intervention 5 6 The intervention consisted of SSW only drug treatment groups, targeted screening for PTSD symptoms 7 8 (one-to-one clinical interview and PTSD checklist- PCL5)25 and, if positively diagnosed, one-to-one 9 EMDR therapy, all delivered by female staff through a collaboration between three service providers 10 11 (National Health Service (NHS) trauma services, the SSW and drug treatment charities). The 12 13 intervention was designed so participants were initially invited to attend a weekly ‘Getting started’ 14 drug treatment group to reduce fear and anxiety about engaging in a group setting and get used to 15 16 the format and level of disclosure expected. Participants were to progress to a ‘Preparation for 17 18 recovery’ drug treatmentFor group peer which focused review on people’s only barriers to motivation for change, 19 20 examining pros and cons of drug use and exploring triggers for using drugs to enable participants to 21 achieve a level of drug use stability. As stated in the protocol24 and in line with provider’s usual care, 22 23 participants were perceived as demonstrating drug use stability by exhibiting evidence of life/drug use 24 25 stability such as engagement and functioning in the group, positive interaction with group facilitators 26 and regular opioid substitution therapy (OST) by the group facilitators. When group facilitators judged 27 28 participants were achieving drug use stabilisation, and they had attended three sessions 29 30 consecutively, they were offered screening for PTSD symptoms by a female clinical psychologist. 31 Those experiencing PTSD symptoms were invited to attend five PTSD ‘Stabilisation’ group sessions, 32 33 facilitated by the same female clinical psychologist, to equip participants with the skills to self-soothe 34 35 and reorientate in preparation for the one-to-one EMDR treatment. Once all ‘Stabilisation’ group 36 sessions had been completed, the clinical psychologist assessed participants for readiness for one-to-
37 http://bmjopen.bmj.com/ 38 one EMDR sessions and if eligible, participants progressed to a course of 12 sessions with the clinical 39 40 psychologist on a weekly, or fortnightly, basis. Trauma treatment (PTSD screening, stabilisation groups 41 and one-to-one) ran in parallel to the drug treatment groups, Figure 1 (red boxes) shows the planned 42 43 flow of participants through the study. 44 The intervention proceeded as described in the protocol paper 24 with the following changes (bulleted
45 on September 30, 2021 by guest. Protected copyright. 46 below): 47 48 Participants were encouraged to attend all sessions with the offer of car lifts, bus tickets and taxis, 49 50 in addition to the planned weekly phone calls and texts, by the staff at partner agencies. 51 52 53 54 ‘Getting started’ and ‘Preparation for recovery’ drug treatment groups 55 56 Retendering resulted in a change of drug group service provider which, along with low numbers 57 58 recruited, resulted in the drug groups merging into a single open drug treatment ‘Getting started’ 59 group. 60
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1 2 3 Attendance at three consecutive sessions was required to move onto the next group, instead of BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 attendance at any four. 6 th 7 Sandwiches were supplied prior to the single drug group to support attendance from the 14 8 session onwards. 9 10 The number of sessions continued beyond those initially planned due to delays in PTSD screening 11 12 (see below). 13 14 Poor attendance, the participant’s unstable behaviour and the intervention running for longer 15 than planned (due to the retendering of drug services) affected the drug group facilitators’ ability 16 17 to deliver structured content. An art worker was included in 4 sessions to maintain participant’s 18 For peer review only 19 interest and engagement with sessions. 20 PTSD screening was halted from the 29th session onwards, due to the limited remaining study time 21 22 to complete the intervention, meaning the drug group became closed and only included PTSD 23 24 screened participants. 25 26 27 28 Screening for PTSD 29 30 Delays occurred to both the organisation of the PTSD screening and PTSD stabilisation group set 31 32 up due to lack of capacity and delays in NHS trauma service staff recruitment. Therefore, some 33 participants had long gaps between recruitment and PTSD screening and subsequent stabilisation 34 35 group sessions. 36
37 http://bmjopen.bmj.com/ 38 39 PTSD ‘Stabilisation’ group 40 41 Incentives of £10 vouchers per session were offered for attendance (mandatory sessions). 42 43 44
45 One-to-one EMDR therapy for PTSD on September 30, 2021 by guest. Protected copyright. 46 47 Some sessions were scheduled in a private rented room (due to availability issues) in a local 48 49 community centre and not at the SSW charity premises. 50 51 Two participants were offered weekly one-to-one extended stabilisation sessions (8 maximum) 52 with the clinical psychologist rather than EMDR therapy as this was deemed the most appropriate 53 54 treatment. 55 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Data collection methods 5 6 7 Sample size and quantitative data collection 8 9 A formal sample size calculation was not conducted as the aim was to assess feasibility.24 Self-reported
10 25 11 levels of illicit drug use, involvement in SSW, completion of PTSD Checklist PCL5 and demographics 12 were collected at the time of consent. Attendance registers were taken at the start of each group or 13 14 one-to-one session by the facilitator(s). 15 16 17 18 Qualitative data collectionFor peer review only 19 20 With participants’ verbal consent one non-participant observation of a drug group was conducted to 21 22 understand delivery, examine interactions and intervention experiences, with brief notes taken during 23 the group.26 24 25 26 In-depth semi-structured interviews were conducted with participants and service providers either 27 face-to-face or by telephone. Participants were interviewed after intervention completion or study 28 29 drop out. Consent to contact participants regarding interviews was sought at recruitment. Additional 30 31 written or audio recorded verbal, informed consent was obtained prior to all interviews. Interviews 32 explored views and experiences of the intervention and how to improve acceptability. Participants 33 34 received a £20 high street shopping voucher for taking part. Most service provider interviews were 35 36 conducted at the end of the intervention period and also sought to understand operational issues,
37 http://bmjopen.bmj.com/ inter-agency working and intervention delivery. 38 39 40 41 42 Economic data collection 43 44 Resource use information (2018 £GBP) was collected prospectively by the agencies. Data collection
45 on September 30, 2021 by guest. Protected copyright. 46 focussed on four categories: Staff time, Facilities, Travel (provider funded staff and patient transport), 47 48 and Materials. 49 Non-attendance was dealt with as follows; if no participants arrived after 45 minutes for a ‘getting 50 51 started’ session, staff left and were only costed for the time that they spent waiting. Staff delivering 52 53 ‘trauma screening’, ‘1-1s’ and ‘stabilisation groups’ were costed for all sessions booked, regardless of 54 non-attendances. 55 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Data analysis 5 6 The integration of qualitative and quantitative data used the established ‘following a thread’ 7 8 technique 27 where key themes were traced using all data sets. 9 10 11 Statistical analysis 12 13 Descriptive statistics (using Stata version14) were used to monitor recruitment and retention via 14 15 CONSORT statement28 style flowcharts, and to examine participant demographics, questionnaire 16 17 responses and attendance. 18 For peer review only 19 20 21 Qualitative analysis 22 23 Interviews were conducted by JMK and NJ, and the audio files transcribed, anonymised and checked 24 25 for accuracy. QSR NVivo 10 software was used to perform inductive thematic analysis29 using constant 26 30 31 27 comparison techniques. A preliminary coding framework was developed by JMK and discussed 28 with the multidisciplinary research team JH and NJ to ensure credibility and confirmability. 29 30 31 32 Cost analysis 33 34 35 Costs to the service provider were examined and summarised separately for each of the four 36 intervention components. Staff costs were calculated using salaries and on-costs or generated using
37 http://bmjopen.bmj.com/ 38 standard unit cost data available for health and social care professionals.32 Facility costs were 39 40 calculated based on similar space rental options. Total cost, total cost per eligible participant, total 41 cost per session held, and total cost per session per eligible participant were calculated for each 42 43 intervention component. Cost data were tabulated using principles of heat-map methodology, where 44 colour lightness is used to communicate the magnitude of different costs.33 34
45 on September 30, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Results 5 6 7 Recruitment was from November 2017 to March 2018 with the intervention delivered until December 8 2018. 9 10 11 12 13 (i) Recruitment and retention 14 15 Recruitment Process 16 17 18 Approximately 400 flyersFor and ninepeer posters werereview distributed. Potential only participants were spoken to by 19 three researchers at 37 three-hour ‘drop-in’ sessions at the SSW charity. Of 125 contacts made with 20 21 women, 84 declined screening. Reasons for decline included being too busy (n=13), not interested 22 23 (n=11) or reporting not currently street sex working (n=10). Fourteen approaches were reported as 24 repeat approaches, with seven reporting previous recruitment and four previous screening (as the 25 26 researchers recruited on different weekdays and screening data was anonymous). Figure 1 details the 27 28 flow of screened and recruited participants through the intervention. 29 30 31 Of 41 women screened, 11 were eligible and consented to participate, three were eligible but unable 32 33 to give consent (two were too distressed and one had health issues preventing participation). Of the 34 27 ineligible women, two did not fully complete the screening questions. The main reasons for 35 36 exclusion related to ineligible frequency of drug use and/or sex work. Table 1 shows the range of days
37 http://bmjopen.bmj.com/ 38 since responders last street sex worked or had taken heroin/crack by those recruited and not 39 recruited. 40 41 42 43 Of 11 participants consenting to be invited for qualitative interviews, five were uncontactable. Seven 44 interviews were conducted with six participants (six face-to-face and one via telephone); four
45 on September 30, 2021 by guest. Protected copyright. 46 interviewed participants received all components of the intervention. Ten service provider interviews 47 48 were conducted with representatives from the drug treatment service (n=4), the trauma service (n=2), 49 and the SSW charity (n=4). Table 2 details quotes from the interviews to support the main results 50 51 described below. 52 53 54 55 Acceptability of recruitment 56 57 The recruitment process was described as acceptable by most participants and service providers. Face- 58 59 to-face recruitment was experienced as confidential, with participants reporting receiving clear 60
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1 2 3 explanations of the study. Recruitment over five months within the SSW charity offered multiple BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 opportunities to participate and was acceptable. Most service providers interviewed reflected that if 6 7 study inclusion criteria were broadened to include less regular drug use, participants with more 8 lifestyle stability could have been recruited, and whom may have found the intervention easier to 9 10 engage with. However, some felt that creating groups with diverse levels of drug use could have 11 12 negative consequences for example, risk of relapse for those who had reduced their drug use. 13 14 15 16 Group attendance 17 18 All 11 consented participantsFor werepeer invited toreview attend drug treatment only groups. However, participants 19 attendance varied throughout the study, with participants sometimes arriving late or leaving early 20 21 (Table 3). Four attended 30-76% of sessions compared to 7 attenders who attended only 0-18% of 22 23 sessions. The five most frequent attenders were invited to PTSD screening of which four attended and 24 25 were all found to have symptoms of PTSD. All four PTSD screened participants attended 20-100% of 26 the stabilisation groups with the clinical psychologist. At the end of the stabilisation groups, two 27 28 participants were deemed suitable for EMDR therapy by the clinical psychologist and two were offered 29 30 extended stabilisation sessions. All four participants attended some one-to-one sessions (Table 3) but 31 missed at least two consecutive trauma treatment appointments with the clinical psychologist and 32 33 had to withdraw from the sessions. However, all participants were referred to further mental health 34 35 services and one participant was also referred to mainstream drug services. 36
37 http://bmjopen.bmj.com/ 38 39 Facilitators to attendance 40 41 Service providers across all partner agencies sent reminders to participants, which were described as 42 helpful and appreciated by participants. One SSW charity service provider played a vital role in 43 44 encouraging attendance through reminding participants to attend, arranging transport (taxi, bus or
45 on September 30, 2021 by guest. Protected copyright. 46 driving participants to sessions) and helping participants prepare for the intervention. Provision of 47 sandwich lunches before the groups was seen by service providers and participants as helpful for 48 49 encouraging attendance, facilitating a relaxed start to groups and supporting concentration. Vouchers 50 51 were also viewed as encouraging attendance by participants and service providers. 52 53 54 55 Barriers to attendance 56 57 The unsettled nature of participant’s lives was perceived as an attendance barrier and was 58 59 underpinned by problematic drug use, poor adherence to OST, sex work, tiredness and poor mental 60 health. Arguments between participants, a lack of readiness to confront issues with drugs and trauma
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1 2 3 and an absence of social support were described as making attendance difficult. Delays to screening BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 referral and trauma treatment were also reported to negatively affect participants’ motivation. 6 7 8 9 (ii) Experience and acceptability of the intervention 10 11 12 Initial impressions 13 14 All participants perceived the intervention as valuable and welcome. Common reasons given by 15 16 participants for taking part included the opportunity for ‘change’, greater stability and valuing the 17 opportunity to combine mental health and drug treatment. Service providers viewed the intervention 18 For peer review only 19 as a novel opportunity for 1) SSWs to receive mental health treatment while continuing to use drugs 20 21 and 2) to address the barriers to mainstream drug treatment. Some service providers highlighted the 22 challenge for participants to process trauma while continuing to use drugs and potential risks of sex 23 24 working when receiving trauma treatment. 25 26 27 28 Service providers’ views on the intervention 29 30 The drug group facilitators described enjoying delivering the groups and building good relationships 31 32 with participants. However, they described some drug sessions as intense and difficult to manage due 33 34 to participants’ distress, accounts of trauma and chaotic behaviour. The need for appropriate support 35 and supervision of facilitators was highlighted as a requirement to manage these challenges. 36
37 http://bmjopen.bmj.com/ 38 39 A clinical psychologist suggested that without the ‘re-traumatising’ effects of street sex work, the 40 effectiveness of the trauma processing in the trauma treatment might be enhanced. Service providers 41 42 also proposed extending the stabilisation work to develop the effectiveness of the trauma treatment 43 44 and recommended the intervention offer alternatives to EMDR to suit individual participants’ needs.
45 on September 30, 2021 by guest. Protected copyright. 46 47 Service providers said working in partnership with other specialist services to deliver the intervention 48 49 was valuable, there was mutual respect and good communication between staff. It was suggested it 50 would have been useful to have collaborative, regular case-review meetings between the services to 51 52 assess the progress and needs of the participants and enhance the communication channels. 53 54 55 56 Participants views on the intervention 57 58 Participants described generally positive intervention experiences. They described forming 59 60 meaningful relationships with the drug group facilitators and clinical psychologist. They liked that the
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1 2 3 groups were female and sex worker-only, they knew other participants already and could speak openly BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 about, and relate to, one another’s experience of trauma, drug use and street sex work. Participants 6 7 also valued that the intervention was delivered at SSW charity premises, which was liked for its 8 familiarity, safety, comfort, convenience and freedom from judgement and shame. The day of the 9 10 week, time and frequency of sessions, drug group session length and group size were also acceptable 11 12 to most participants and service providers. These factors overcame some of the barriers participants 13 highlighted to attending mainstream drug services. 14 15 16 17 Strengths of the intervention 18 For peer review only 19 Through the intervention, participants reflected on their need to address their trauma and drug use. 20 21 Some acknowledged that they were not ready to address their trauma but aspired to this in future, 22 23 having had positive experiences of therapy during the intervention. Participants attributed improved 24 25 wellbeing, coping strategies and perceptions of self-worth to the intervention. One participant was 26 seen less on the SSW outreach van (an indicator of sex working) and, significantly, stopped using her 27 28 working name, signifying ‘taking back ownership of who she is’. One drug group facilitator felt the 29 30 flexibility of the study intervention was able accommodate participants’ unstable lives and level of 31 trauma that would have prevented them from complying with the rules of conduct in mainstream 32 33 drug services and thus prevented them from receiving treatment to address their needs. They also felt 34 35 that an additional positive feature of the intervention was participants being able to discuss their sex 36 work, due to the female SSW only membership of the groups.
37 http://bmjopen.bmj.com/ 38 Participation in the intervention was described by SSW charity service providers and two participants 39 40 as supporting and empowering the participants to engage with clinical and support services to address 41 their needs. Another participant felt she used the SSW charity services less now because she needed 42 43 less support. 44
45 on September 30, 2021 by guest. Protected copyright. 46 47 (iii) Cost analysis 48 49 The total cost of the intervention was £11,710, with staff costs being the largest component (Table 4). 50 51 The most expensive component of the intervention was the ’Getting started’ sessions (which totalled 52 53 £6,842). Despite having the second to lowest sub-total cost across the intervention (£1,014), the 54 stabilisation groups had the highest cost per session held (£203). Although the one-to-one sessions 55 56 had the lowest cost per session held (£103), the larger number of sessions at this point resulted in this 57 58 section having the highest cost per eligible participant (n=4, £724). Trauma screening had the lowest 59 cost per eligible participant (n=5, £191) 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 6 Fidelity 7 8 The intervention was broadly delivered as intended incorporating suggested planned changes to the 9 24 10 protocol, it was more flexible and less linear than originally planned. Delays in PTSD screening 11 meant that there was only a single drug group, which continued for longer than originally planned. 12 13 14 15 Discussion 16 17 Summary of findings 18 For peer review only 19 This study used a mixed methods approach to investigate the feasibility and acceptability of a novel, 20 21 complex intervention to reduce illicit drug use in female drug-dependent SSWs. We demonstrated 22 23 that drug-dependent SSWs could maintain attendance at female SSW-only drug group sessions and 24 the integrated trauma-focussed treatment approach, in a trusted and supportive environment, with 25 26 intensive support from SSW charity staff. Recruitment was lower than anticipated, with four 27 28 participants PTSD screened and whom met criteria for PTSD. They progressed through to the final 29 stage of the intervention, all four participants were ultimately able to access mental health services 30 31 and one began the process of accessing mainstream drug services. Participants and service providers 32 33 mostly experienced the recruitment process, the intervention and delivery mechanisms (especially 34 the SSW-only environment) positively. Managing SSW trauma disclosure proved challenging for drug 35 36 group facilitators and non-clinical staff and resulted in the recommendation that there is additional
37 http://bmjopen.bmj.com/ 38 training and support for staff in future studies. The need for intervention refinement, for example, 39 extending drug stabilisation sessions, were suggested to provide additional support prior to trauma 40 41 treatment. Attendance and adherence barriers primarily related to the issues the intervention sought 42 43 to address, namely problematic drug use, sex work, and poor mental health, rather than the 44 acceptability of the intervention itself. The total cost of the intervention was £11,710, with staff costs
45 on September 30, 2021 by guest. Protected copyright. 46 dominating. 47 48 49 50 Strengths and limitations of this study 51 52 53 Strengths of our study were that recruiting researchers also conducted the interviews, which may 54 have facilitated a rapport with participants and supported more open and honest reflections. 55 56 Secondly, all aspects of the intervention were delivered by specialists which was necessary for this 57 58 high-risk group with multiple complex co-morbidities. Thirdly, PPI formed an important part of the 59 study and informed each stage. Fourth, recruitment over several months with multiple approaches 60
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1 2 3 allowed SSWs many opportunities to take part. This approach took account of the rapidly changing BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 lives of SSWs resulting in changing eligibility status as well as allowing time for them to become 6 7 familiar with the researchers. Finally, recruitment within a trusted agency may have had a positive 8 influence on recruitment. 9 10 11 12 This feasibility study provides only preliminary information on the intervention performance and cost 13 and does not examine the effectiveness or potential for reducing costs in other parts of the health 14 15 service or wider society. Delays due to changes to service provision are likely to have adversely 16 17 influenced study recruitment and retention, with delays resulting in higher service costs, but reflect 18 the real-life issues facingFor multi-agency peer work. review only 19 20 21 22 Comparison with other research 23 24 25 This feasibility study is the first, to our knowledge, to address previously highlighted barriers to 26 effective drug treatment for SSWs.15 22 23 Through incorporating female SSW-only drug groups 27 28 alongside an intervention with specialised trauma treatment, delivered in a female SSW-only setting 29 30 by female staff22 24 we showed how an integrated treatment approach in this complex vulnerable 31 group could feasibly be implemented and delivered, with changes to the intervention, albeit at a 32 33 higher than expected cost, mostly due to the delays incurred due to service retendering. 34 35 36 This study is the first interventional study to employ clinical staff from a specialist trauma service to
37 http://bmjopen.bmj.com/ 38 deliver EMDR to address trauma symptoms as part of the drug treatment process for SSWs. These 39 40 women have been found to have high levels of poor mental health,16 18 particularly trauma,5 16 17 which
41 7 8 42 contributes to poor drug treatment outcomes. The intervention took account of SSWs frequent 43 experience of abuse and violence,35 36 and recommendations for female-only trauma-focussed drug 44 treatment interventions22 37 38 for treatment of PTSD and long term drug use reduction. Some of the
45 on September 30, 2021 by guest. Protected copyright. 46 47 characteristics the intervention sought to address presented as barriers to attendance and retention, 48 however these are common in studies trying to effect behaviour changes within vulnerable groups.23 49 50 39 51 52 53 Previous SSW-focussed interventions aiming to reduce drug use10-13 14 were unable to demonstrate 54 55 strong evidence of a positive effect15 suggesting the need for a novel approach with evidence of 56 57 efficacy assessed through a robust methodological approach. The highlighted barriers to attendance, 58 engagement and delivery of the intervention are in keeping with other studies15 23 39 but indicate that 59 60 further changes to the DUSSK feasibility study design are likely to be required in future studies.
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 6 Conclusion and implications for service provision and research 7 8 This study sought to explore the feasibility of delivering a novel complex intervention to a very 9 10 challenging population with high levels of unmet need. Inclusion criteria were informed by PPI, clinical 11 expertise and academic literature. They targeted women who were likely to benefit the most from a 12 13 trauma-based intervention but whose drug dependency and chaotic lives made them challenging 14 15 study participants to recruit and retain. However, all four of the participants screened for PTSD were 16 diagnosed, revealing the unmet need for trauma treatment. Though unsurprising, the severity of 17 18 trauma disclosed by ForSSWs proved peer unexpectedly review challenging for only service providers.22 37 38 Further data 19 20 to understand the extent and severity of PTSD in SSWs is recommended to inform service provision. 21 Overall, the experiences described by those receiving the intervention, suggest it is an acceptable 22 23 approach to reducing SSWs drug use. 24 25 26 The three services found the intervention valuable and were able to work together effectively despite 27 28 setbacks such as changing contracts and service pressures. They also suggested more staff support for 29 30 managing trauma disclosure, extended stabilisation sessions and closer working could improve 31 intervention delivery. 32 33 34 35 Intervention costs were driven up by poor participant attendance, though staff pressures and the 36 retendering process increased the length (and cost) of the intervention period. However, decreased
37 http://bmjopen.bmj.com/ 38 SSW use of health services, the criminal justice system and impacts of criminal activity on wider society 39 40 may justify its adoption if future trials demonstrate intervention effectiveness in reducing drug use. 41 42 43 In order to support future interventional trials in this important field where there are few effectiveness 44 studies we recommend the following study refinements for consideration.
45 on September 30, 2021 by guest. Protected copyright. 46 47 1. The intervention could also include women with more stability in their lives to increase 48 recruitment and retention. 49 50 2. Regular meetings throughout the study enabling all service providers involved in intervention 51 52 delivery to express concerns and seek to understand participants needs from the perspective of 53 different professionals so there is effective multi-agency support for individual participants where 54 55 needed. 56 57 3. Training for all involved staff in managing the disclosure of trauma. 58 4. Support and encouragement for participant engagement through provision of transport to and 59 60 refreshments prior to treatment sessions
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1 2 3 5. Intervention flexibility and responsiveness in offering trauma-focussed alternatives to EMDR BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 which may be more suitable for individual participants needs. 6 7 6. An extended trauma therapy programme, including extended stabilisation therapy prior to trauma 8 treatment, to accommodate the complexity of SSW needs. 9 10 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Additional information 5 6 7 Acknowledgements 8 9 10 The authors are extremely grateful to all the women who have participated in the study; all service 11 providers and all other staff whose participation made this study possible. They would like to thank 12 13 the PPI group for their time, thoughts and suggestions. We are grateful to the following organisations 14 15 and individuals who have helped with the study for their time, expertise and support: Developing 16 Health and Independence, Bristol Drugs Project, Avon & Wiltshire Mental Health Partnership NHS 17 18 Trust and One25 charity,For Katie peerWarner, Lucy review Pettler, Rosie Davies, only Maggie Telfer, Elinor Griffiths, Gill 19 20 Nowland, Sophie Ramsden, Elaine Driver, Anna Smith, Rhea Warner, Jennifer Riley, Tracey Tudor, 21 Madeline Saunders, Charlotte Hignell, Sophie Banks, Jane Bowman, Sarah Shatwell, Katrina Turner, 22 23 Hasina Downie, Jo Daniels and Louisa Chowen. 24 25 26 27 Author Contributions 28 29 NJ, NMR, JH, JMK, RP, DW, JM, JMa, MJL and JC are responsible for the study design, collection of data 30 31 and analysis. NMR, RP, NJ and JH are responsible for study management and coordination. JMK and 32 33 NJ conducted the interviews. JMK led the qualitative analysis in collaboration with NJ and JH. RP 34 conducted the quantitative analysis. MJL, RP and JC conducted the costing study. NMR, RP, JMK, MJL, 35 36 JC, NJ and JH drafted the paper. All authors read, commented on and approved the final manuscript.
37 http://bmjopen.bmj.com/ 38 39 40 Funding 41 42 The research is supported by a National Institute for Health Research (NIHR) Clinic Trials Fellowship 43 44 awarded to NJ (NIHR-CTF-2016-05-07), the National Institute for Health Research Collaboration for
45 on September 30, 2021 by guest. Protected copyright. Leadership in Applied Health Research and Care West (NIHR CLAHRC West P324), now 46 47 recommissioned as NIHR Applied Research Collaboration West (NIHR ARC West) and Research 48 49 Capability Funding awarded by University Hospitals Bristol NHS Foundation Trust (RCF 2016-17-18). 50 JMK is partly funded by NIHR Health Protection Research Unit in Evaluation of Interventions. The views 51 52 expressed are those of the authors and not necessarily those of the NIHR or the Department of Health 53 54 and Social Care. 55 56 Competing interests 57 58 59 None declared 60
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Data availability statement 5 6 All data relevant to the study are included in the article. 7 8 9 10 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 References 5 6 1. Cusick L, Martin A, May T. Vulnerability and involvement in drug use and sex work. Home Office 7 research study 268. London: Home Office, 2003. 8 2. Deering KN, Kerr T, Tyndall MW, et al. A peer-led mobile outreach program and increased 9 utilization of detoxification and residential drug treatment among female sex workers who 10 11 use drugs in a Canadian setting Drug & Alcohol Dependence 2011;113(1):46-54. 12 3. Morris D, Lemus H, Wagner K D, et al. Factors associated with pathways toward concurrent sex 13 work and injection drug use among female sex workers who inject drugs in northern Mexico. 14 Addiction 2013;108:161-70. 15 4. Jeal N, Salisbury C, Turner K. The multiplicity and interdependency of factors influencing the 16 health of street-based sex workers: a qualitative study. Sex Transm Infect 2008;84(5):381-5. 17 doi: 10.1136/sti.2008.030841 [published Online First: 2008/07/04] 18 5. Gorry J, Roen K, ReillyFor J. Selling peer your self? reviewThe psychological impactonly of street sex work and factors 19 20 affecting support seeking. Health Soc Care Community 2010;18(5):492-9. doi: 21 10.1111/j.1365-2524.2010.00925.x [published Online First: 2010/06/30] 22 6. Jeal N, Salisbury C. Health needs and service use of parlour-based prostitutes compared with 23 street-based prostitutes: a cross sectional survey. BJOG 2007;114:875-81. 24 7. Burnette M LE, Ilgen M, Frayne S, Mayo J, Weitlauf J. Prevalence and health correlates of 25 prostitution among patients entering treatment for substance use disorders. Archives of 26 General Psychiatry 2008;65(3):337 - 44. 27 8. Burnette M SR, Timko C, Ilgen M. Impact of substance-use disorder treatment on women involved 28 in prostitution: substance use, mental health and prostitution one year after treatment. 29 30 Journal of Studies on Alcohol and Drugs 2009;70:32-40. 31 9. Jeal N, Macleod J, Salisbury C, et al. Identifying possible reasons why female street sex workers 32 have poor drug treatment outcomes: a qualitative study. BMJ Open 2017;7(3):e013018. doi: 33 10.1136/bmjopen-2016-013018 [published Online First: 2017/03/25] 34 10. Sherman SG, German D, Cheng Y, et al. The evaluation of the JEWEL project: An innovative 35 economic enhancement and HIV prevention intervention study targeting drug using women 36 involved in prostitution. Aids Care-Psychological and Socio-Medical Aspects of Aids/Hiv
37 http://bmjopen.bmj.com/ 2006;18(1):1-11. doi: 10.1080/09540120500101625 38 39 11. Surratt HL, Inciardi JA. An effective HIV risk-reduction protocol for drug-using female sex 40 workers. J Prev Interv Community 2010;38(2):118-31. doi: 10.1080/10852351003640732 41 [published Online First: 2010/04/15] 42 12. Gunne LM, Gronbladh L, Petersson S. [Methadone treatment in the prevention of AIDS. Heroin- 43 dependent prostitutes are an important target]. Lakartidningen 1986;83(49):4194-6. 44 [published Online First: 1986/12/03]
45 13. Litchfield J, Maronge A, Rigg T, et al. Can a targeted GP-led clinic improve outcomes for street sex on September 30, 2021 by guest. Protected copyright. 46 workers who use heroin? The British journal of general practice : the journal of the Royal 47 College of General Practitioners 2010;60(576):514-6. doi: 10.3399/bjgp10X514774 48 49 [published Online First: 2010/07/03] 50 14. Yahne CE, Miller WR, Irvin-Vitela L, et al. Magdalena Pilot Project: motivational outreach to 51 substance abusing women street sex workers. J Subst Abuse Treat 2002;23(1):49-53. 52 [published Online First: 2002/07/20] 53 15. Jeal N, Macleod J, Turner K, et al. Systematic review of interventions to reduce illicit drug use in 54 female drug-dependent street sex workers. BMJ Open 2015;5(11):e009238. doi: 55 10.1136/bmjopen-2015-009238 [published Online First: 2015/11/20] 56 16. El-Bassel N, Schilling R, Irwin K, et al. Sex trading and psychological distress among women 57 58 recruited from the streets of Harlem. American Journal Public Health 1997;87:66-70. 59 17. Chukakov B, Ilan K, Belmaker RH, et al. The motivation and mental health of sex workers. Journal 60 of Sex & Marital Therapy 2002;.28(4):pp. doi: 10.1080/00926230290001439
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1 2 3 18. Roxburgh A, Degenhardt L, J C, et al. Drug Dependence and Associated Risks Among Female BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Street-Based Sex Workers in the Greater Sydney Area, Australia. Substance Use & Misuse 5 6 2008;43(8-9):1202-17. 7 19. Mellor R, Lovell A. The lived experience of UK street-based sex workers and the health 8 consequences: an exploratory study. Health promotion international 2012;27(3):311-22. doi: 9 10.1093/heapro/dar040 [published Online First: 2011/07/06] 10 20. Reynolds M, Mezey G, Chapman M, et al. Co-morbid post-traumatic stress disorder in a 11 substance misusing clinical population. Drug and alcohol dependence 2005;77(3):251-58. 12 doi: https://doi.org/10.1016/j.drugalcdep.2004.08.017 13 21. Cloitre M, Courtois CA, Charuvastra A, et al. Treatment of complex PTSD: Results of the ISTSS 14 expert clinician survey on best practices. Journal of Traumatic Stress 2011;24(6):615-27. doi: 15 16 10.1002/jts.20697 17 22. Roberts NP, Roberts PA, Jones N, et al. Psychological therapies for post-traumatic stress disorder 18 and comorbidFor substance peer use disorder. review Cochrane Database only Syst Rev 2016;4(4):CD010204. 19 doi: 10.1002/14651858.CD010204.pub2 [published Online First: 2016/04/05] 20 23. Bailey K, Trevillion K, Gilchrist G. What works for whom and why: A narrative systematic review 21 of interventions for reducing post-traumatic stress disorder and problematic substance use 22 among women with experiences of interpersonal violence. Journal of Substance Abuse 23 Treatment 2019;99:88-103. doi: 10.1016/j.jsat.2018.12.007 24 25 24. Jeal N, Patel R, Redmond NM, et al. Drug use in street sex workers (DUSSK) study protocol: a 26 feasibility and acceptability study of a complex intervention to reduce illicit drug use in drug- 27 dependent female street sex workers. BMJ Open 2018;8(11):e022728. doi: 28 10.1136/bmjopen-2018-022728 [published Online First: 2018/11/06] 29 25. Bovin MJ, Marx BP, Weathers FW, et al. Psychometric properties of the PTSD Checklist for 30 Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. 31 Psychol Assess 2016;28(11):1379-91. doi: 10.1037/pas0000254 [published Online First: 32 2016/11/04] 33 26. Emerson RM, Fretz RI, Shaw LL, et al. Writing ethnographic fieldnotes. Chicago and London: 34 35 University of Chicago Press 1995. 36 27. Moran-Ellis J, Alexander VD, Cronin A, et al. Triangulation and integration: processes, claims and implications. 2006;6(1):45-59. doi: 10.1177/1468794106058870
37 http://bmjopen.bmj.com/ 38 28. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for 39 reporting parallel group randomised trials. BMJ 2010;340:c332. doi: 10.1136/bmj.c332 40 [published Online First: 2010/03/25] 41 29. Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology 42 2006;3(2):77-101. 43 44 30. Glaser B, Strauss A. The Constant Comparative method of Qualitative Analysis. In the Discovery of Grounded Theory: Strategies for Qualitative Research Chicago: Aldine 1967:101-158.
45 on September 30, 2021 by guest. Protected copyright. 46 31. Charmaz K. Constructing grounded theory: a practical guide through qualitative analysis. London: 47 Sage Publications, Inc 2006. 48 32. Curtis LB, A. . Unit Costs of Health and Social Care University of Kent, Canterbury: Personal Social 49 Services Research Unit 2018. 50 33. Kirk A. Data Visualization: a successful design process: Packt Publishing Ltd 2012. 51 34. Iliinsky N, Steele J. Designing data visualizations: Representing informational Relationships: 52 53 O'Reilly Media, Inc. 2011. 54 35. Ulibarri MD, Hiller SP, Lozada R, et al. Prevalence and characteristics of abuse experiences and 55 depression symptoms among injection drug-using female sex workers in Mexico. J Environ 56 Public Health 2013;2013:631479. doi: 10.1155/2013/631479 [published Online First: 57 2013/06/06] 58 59 60
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1 2 3 36. Monica D. Ulibarri, Steffanie A. Strathdee, Remedios Lozada, et al. Prevalence and Correlates of BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Client-Perpetrated Abuse Among Female Sex Workers in Two Mexico–U.S. Border Cities. 5 6 Violence Against Women 2014;20(4):427– 45. 7 37. Greenfield SF, Brooks AJ, Gordon SM, et al. Substance abuse treatment entry, retention, and 8 outcome in women: a review of the literature. Drug and alcohol dependence 2007;86(1):1- 9 21. doi: 10.1016/j.drugalcdep.2006.05.012 [published Online First: 2006/06/09] 10 38. Wiechelt SA, Shdaimah CS. Trauma and Substance Abuse Among Women in Prostitution: 11 Implications for a Specialized Diversion Program. Journal of Forensic Social Work 12 2011;1(2):159-84. doi: 10.1080/1936928x.2011.598843 13 39. Bailey K, Trevillion K, Gilchrist G. “We have to put the fire out first before we start rebuilding the 14 house”: practitioners’ experiences of supporting women with histories of substance use, 15 16 interpersonal abuse and symptoms of post-traumatic stress disorder. Addiction Research & 17 Theory 2019:1-9. doi: https://doi.org/10.1080/16066359.2019.1644323 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Figure 1 Flow of participants through the DUSSK study 5 6 7 8 9 10 11 12 13 14 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Table 1 Characteristics of screened women 5 6 Screened not recruited Screened and recruited 7 (N=30) (N=11) 8 9 N (%) * Median (range) N (%) * Median (range) 10 Female 27 (90) 11 (100) 11 12 Age 23 (77) 37 (26-55) 11 (100) 38 (23-53) 13 Ever sold sex on the street? 14 Yes 26 (87) 11 (100) 15 No 1 (3) - 16 How many days since last worked on 23 (77) 60 (1-2920) 11 (100) 7 (1-28) 17 18 the street? For peer review only 19 How often usually sell sex on street? 20 Daily 6 (20) 3 (27) 21 Weekly 5 (17) 8 (73) 22 Less than weekly 16 (53) - 23 Ever used street drugs 24 25 Yes 26 (87) 11 (100) 26 No 1 (3) - 27 Ever used heroin 23 (77) 9 (82) 28 Days since last used heroin 19 (63) 2 (0-731) 9 (82) 1 (0-6) 29 Ever used crack cocaine 23 (77) 11(100) 30 Days since last used crack cocaine 21 (70) 2 (0-2922) 1 (0-4) 31 32 How often use heroin and/or crack 33 cocaine? 34 Daily 11 (37) 7 (64) 35 Weekly 4 (13) 4 (36) 36 Less than weekly 9 (30) -
37 http://bmjopen.bmj.com/ Has an opioid substitute script 13 (43) 6 (55) 38 39 Script type 40 Buprenorphine/Subutex® - 1 (9) 41 Methadone 13 (43) 5 (45) 42 Used other drugs: 43 Alcohol 3 (10) 1 (9) 44 Amphetamine 1 (3) -
45 on September 30, 2021 by guest. Protected copyright. 46 Cannabis 5 (17) 5 (45) 47 Spice 2 (7) - 48 MDMA (Ecstasy) 1 (3) 49 Tramadol 1 (3) - 50 Sleeping tablets - 1 (9) 51 PCL5 score (possible range 0-80) - 10 (91) 56 (43-73) 52 53 *N and % of those that provided data 54 55 56 57 58 59 60
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1 2 3 4 Table 2 Qualitative quotes 5 6 Theme/Sub-theme Quotes 7 Recruitment and retention 8 9 Acceptability [Face-to-face recruitment] worked well, it wasn’t intrusive, you weren’t pushy, you know you blended in within the drop-in 10 setting. So I think the women felt that if they did wanna buy into it they would, there was no pressure there. So I think that 11 was done really sensitively. Service provider 6 12 For peer review only 13 14 It [recruitment] was very sort of like confidential and actually it was quite nice ‘cause, yeah no one really knew what I was 15 doing when I was doing summut, you know what I mean, which is – like it don’t usually happen like that. Everyone knows 16
what I’m doing all the time. Participant 7 http://bmjopen.bmj.com/ 17 18 Improvements I think from a clinical point of view if you remove that criteria [sex work at least once a week in the last calendar month] 19 and then of course there’s more chance of getting people through to the finish line to be able to be ready for treatment at 20 the end. Service provider 4 21 22 23 Actively drug using? Yes, that makes sense (…). If they’ve been able to bring that down themselves maybe another service 24 would be better. Like, what this offered, it’s specialistic in this. So if you was able to manage to a level yourself, maybe you 25 don’t need [the intervention]… I’m not sure, I think that would be an interesting conversation on September 30, 2021 by guest. Protected copyright. because if they could bring it 26 down themselves, they’d probably be a lot more stable and a lot more reliable to actually get to the EMDR . Service 27 provider 7 28 29 So I think if you were to extend the period of time and say ‘Oh actually do you know if you’ve used within the last three 30 months you can participate in the study and then someone who’s three months abstinent or reducing from their street 31 32 heroin use or their crack use is then exposed to somebody who’s going no no no man I’m using up like a party every night’. 33 There’d be that ethical thing within it but it would be nice to see the study opened up to a wider cohort. Service provider 2 34 Facilitators to attendance 35 Encouragement and support I would say that I’ve been quite integral in regards to developing relationships with the women, contacting them for both 36 to attend their individual one to ones and stabilisation groups and also their Thursday DUSSK groups as well. So just keeping that 37 38 contact going if they were coming in, in our drop-in service I would see them and then sort of give them reminders, did 39 they want little welfare calls, that type of thing. Service provider 6 40 41 42 25 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
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1 2 3 Transport It was more of a focus thing where you know she [service provider 6] sort of like coached us as we went down, like you 4 5 know keeping us like sort of aware of what we’ve got to be thinking of doing and making sure that, you know, there’s 6 nothing wrong. Participant 7 7 Food provision I was turning up and I was like sort of god like hanging out for (…) that lunch. It was like, not the reason I was turning up 8 but the main reason why I could (…). There is light at the end of the tunnel, you know you’re gonna be nourished and fed.’ 9 10 You’re gonna be able to concentrate as well. Participant 7 11 Barriers to attendance 12 Unstable lifestyles My mentalFor problems, peer my drug use, everything, review just my life, it gets only in the way [of attendance]. Participant 1 13 14 Mental health They’re so low resourced, they just don’t have the distress tolerance to be able to cope with any more distress, they’re 15 already facing so much. Even things like their housing and threats of eviction. Service provider 8 16 17 http://bmjopen.bmj.com/ 18 My home life was getting a bit chaotic. My depression was getting really bad as well. So, yeah, and I was waiting for my 19 antidepressants to work but they took a while. Yeah, it was just my depression, that’s all. My anxiety. Participant 6 20 Sex work If I’ve been working the night before there’s no way I could have attended because I’m too tired, because you work all 21 22 night. Participant 4 23 Delays between treatment It took a little bit of a while and also for them to access their stabilisation groups then their one to ones. I think we may 24 stages have lost some of the interest. Service provider 6 25 on September 30, 2021 by guest. Protected copyright. Experience and acceptability of the intervention 26 27 Initial impressions There aren’t many services out there, which will offer individual, tailorised counselling and support to the women who 28 have got dual diagnosis and you know mental health, drug misuse. So this study was unique and I think that’s what we 29 were all so passionate and so behind it because it was giving the women an opportunity. Service provider 6 30 31 Reason for participating I just felt so alone and afraid and stuck and just needed to see if there was some way that I might be able to gain 32 something so – really, if I’m willing to put myself out on the street and sell myself to a complete stranger, knowing that I 33 might die, whatever, so it kind of … I felt I needed to understand why I needed to do this... So it’s about me owning my 34 35 power, and about not letting myself feel as shit about myself as I have done. Participant 5 36 37 38 39 40 41 42 26 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
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1 2 3 The post-traumatic stress [treatment] is – is a way of like sort of detoxing your brain. So, you know finding a reason why 4 5 you do these drugs (…) to like sort of be the reason for me to like say ‘Well, I’ve got to stop now.’ You know and get off it. 6 Participant 7 7 Service providers views on I guess that people thought they weren’t going to talk about their traumas [in the drug groups] but if somebody’s been 8 the intervention raped last night, they’re going to need to talk about it, so we were here dealing with that stuff on the spot and then we 9 10 didn’t have no-one to go away and talk about it. Service provider 10 11 12 It’s veryFor hard to do traumapeer processing reviewwhen women to some degree only are being traumatised and then having to self- 13 14 medicate against all of that and then you’re trying to work on quite deep attachment developmental trauma stuff from a 15 long time ago. (…) I’d say that trauma processing would be more successful with women who have maybe made a very 16 strong commitment to stop [sex] working. Service provider 8 17 http://bmjopen.bmj.com/ 18 19 I would offer it [EMDR] as part of a – as a range of things that are offered…we’d say ‘You can have EMDR, trauma focus 20 CBT [Cognitive Behavioural Therapy] or narrative exposure therapy and you’d kind of match the person to what you 21 thought they might be more suited to. Service provider 8 22 23 24 I think they had huge admiration for the workers at [SSW charity], and found them friendly and supportive, but…there 25 wasn’t a specific, I don’t know, once a month structured ‘let’s talk about the women and on September 30, 2021 by guest. Protected copyright. how they’ve been in the month. 26 27 Service provider 9 28 29 Participants views of the I enjoyed going down there. (…) We had a good laugh and learned something while we were doing it. Participant 6 30 intervention 31 With it being all woman and not mixed going to (mainstream drug treatment service provider) and doing groups where 32 men are involved is like, I didn’t really want to do it but here because it’s all women and I know most of the women that 33 come here, we’ve all been through it, hence why we all come here. So one way or another we’ve all been through 34 35 something that we can all relate to. Participant 3 36 37 Intervention characteristics It’s [SSW charity] familiar and it’s comfortable and it’s safe. Service provider 5 38 39 40 41 42 27 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
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1 2 3 The groups weren’t too big, so you sort of – I knew the people that were coming to the groups which was better, so we’d 4 5 sort of you know built up a rapport. Participant 4 6 Impacts of the intervention I’m just going to stop [drug use], I’m ready and I’m kind of already preparing for that, so it’s kind of brought me to a close, 7 and I mean that as well. Personally it’s like, I’m ready, bring it on, I’m like do you know what I’ve been raped, I’ve been 8 beaten I’ve stuck needles in myself( …) I’m done, I’m not playing this game anymore, I deserve better. Participant 5 9 10 11 It’s just made (…) me realise I’m not just a, like, drug addict, sex worker. I’m a real person and I’ve got feelings and, you 12 know,For I’ve got potential. peer You know, yeah, review they [service providers] onlybuild me up a lot. Participant 6 13 14 15 When she [participant 6] started with [name of intervention] study and she was coming to her Thursday [drug] groups, she 16 didn’t want to be associated with street sex working. So she said ‘Can you call me (own name rather than working name)?’ 17 http://bmjopen.bmj.com/ 18 I could have cried (…). She was owning her own name and taking back ownership of who she is rather than somebody who 19 was street sex working. Service provider 6 20 21 Their chaoticness. (…) To manage that in a [mainstream drug service] group setting would be difficult and I’m not sure 22 23 how they would manage that. I just know how much regularly how they’ve turned up [to the intervention drug treatment 24 groups] chaotic and they’ve turned up leaking out trauma. … I’m far from confident that they would be able to sit under 25 them [mainstream drug service] rules enough to be a part of what it is for here[research on September 30, 2021 by guest. Protected copyright. study], due to the level of 26 27 flexibility here and that they would be able to talk about what their problem is without mentioning what they do and that 28 might make them vulnerable Service provider 7 29 Fidelity I guess we were kind of thinking of it in a really linear sense, that the women would engage in the drug groups and then 30 reduce their drug use to then move on to the next group and I’m not sure that that actually happened in reality. 31 32 Service provider 5 33 34 In the beginning we went in doing the same sort of work that we would do here [mainstream drug services], and it’s 35 36 getting them to look at their behaviour, and the consequences of it and stuff, and it didn’t work with these women, it’s too 37 much, too direct. Service provider 10 38 39 40 41 42 28 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
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1 2 3 4 Table 3 Attendance and retention of participants (top four rows – those that attended trauma screening) 5 6 Open group Attended Closed group 5 mandatory One-to-one sessions Referred to 7 Getting started Trauma Getting started Stabilisation group which services: 8 9 Screening sessions 10 Eligible Attended % Eligible Attended % Attended % Eligible Attended % 11 12 Participant sessions sessions* Attended Forsessions peersessions Attended reviewsessions Attended onlyTreatment sessions** sessions* Attended 13 (1) 14 1 28 10 36 Yes 26 4 15 3 60 Ext. stabilisation 8[3] 1 13 Mental health 15 2 27 8 30 Yes 26 11 42 5 100 EMDR 12[3] 4 (1) $ 33 Mental health 16 (2) 17 3 20 7 35 Yes 26 3 12 1 20 Ext. stabilisation 8[4]http://bmjopen.bmj.com/ 0 0 Mental health 18 Mental health & 19 4 25 19 (5) 76 Yes 26 15 58 4 80 EMDR 12[2] 8 (4) $ 67 20 mainstream drug 21 5 28 5 18 No 22 23 6 28 1 (1) 4 NA 24
7 25 3 12 NA on September 30, 2021 by guest. Protected copyright. 25 26 8 23 0 0 NA 27 9 22 0 0 NA 28 29 10 19 0 0 NA 30 31 11 19 0 0 NA 32 Total 53 4 33 13 13 33 34 *N session participant arrived late/left early indicated in superscript round brackets; **N sessions cancelled due to non-attendance in square brackets; 35 36 NA=Not actively invited to sessions; $ Includes one review session; Ext. stabilisation=Extended stabilisation, EMDR=Eye movement desensitization and 37 reprocessing therapy 38 39 40 41 42 29 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
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1 2 3 4 Table 4 Health Economics 5 6 1. Getting started 2. Trauma screening 3. Stabilisation group 4. One-to-one sessions 7 Service description 8 Session lengths - range 90 - 120 minutes 1 60 minutes 60 minutes 60 - 90 minutes 2 9 Number of sessions held - total 52 8 5 28 10 Eligible participants3 - total n = 11 n = 54 n = 4 n = 4 11 Attendees per session - range 0 - 4 1 2 - 4 1 12 Costs ForSub-total peer £ £ per ppt reviewSub-total £ £ per pptonlySub-total £ £ per ppt Sub-total £ £ per ppt 13 A. Staff 14 Service manager £1,359.76 £123.61 £95.09 £19.02 £47.54 £11.89 £266.25 £66.56 15 Drug group facilitators5 £3,000.20 £272.75 £0.00 £0.00 £0.00 £0.00 £0.00 £0.00 16
Art worker £123.98 £11.27 £0.00 £0.00 £0.00 http://bmjopen.bmj.com/ £0.00 £0.00 £0.00 17 Clinical Psychologist £0.00 £0.00 £636.00 £127.20 £600.00 £150.00 £2,040.00 £510.00 18 B. Facilities 19 20 Space rental £1,270.50 £115.50 £224.00 £44.80 £140.00 £35.00 £574.00 £143.50 21 C. Travel 22 Transporting materials £73.78 £8.44 £0.00 £0.00 £11.90 £2.98 £0.00 £0.00 23 Car lifts for service-users (petrol) £38.72 £3.52 £2.24 £0.45 £3.36 £0.84 £1.20 £0.30 24 Public transport for participants £70.20 £6.38 £0.00 £0.00 £3.90 £0.98 £3.90 £0.98 25 Taxis for participants £55.00 £5.00 £0.00 £0.00 £62.20 on September 30, 2021 by guest. Protected copyright. £15.55 £11.00 £2.75 26 D. Materials 27 Art supplies £30.00 £2.73 £0.00 £0.00 £0.00 £0.00 £0.00 £0.00 28 Stationary £0.00 £0.00 £0.00 £0.00 £5.00 £1.25 £0.00 £0.00 29 Voucher incentives £0.00 £0.00 £0.00 £0.00 £130.00 £32.50 £0.00 £0.00 30 Refreshments6 £820.00 £74.55 £0.00 £0.00 £10.00 £.2.50 £0.00 £0.00 31 Summary 32 Total cost £6,842.13 £622.01 £957.33 £191.47 £1,013.907 £253.48 £2,896.35 £724.09 33 Total cost per session £131.58 £11.96 £119.67 £23.93 £202.78 £50.70 £103.44 £25.86 34 Note: 1 = Sessions were originally were 90 minutes, however when sandwiches were provided drug group facilitators arrived 30 minutes prior to session to be with participants while they ate, 2 = 35 One-to-one EMDR sessions were 90 minutes and one-to-one Stabilisation sessions were 60 minutes, 3 = participants, 4 = Five participants were eligible for screening, however only four 36 participants were successfully screened, 5 = Getting started groups were facilitated by two drug group facilitators, and 6 = Sandwiches and biscuits, 7 = Total cost without vouchers would have 37 been £883.90 . 38 Heat map description: £0.00 £0.01 - £99.99 £100 - £499.99 £500.00 - £1999.99 £2000.00 + 39 40 41 42 30 43 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 Page 33 of 36 BMJ Open
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3 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 Figure legend 5 6 7 Figure displaying the flow and numbers of potential and consented participants through the DUSSK 8 9 study. Numbers may include more than one approach to potential participants by different recruiters. 10 Includes reasons provided by women spoken to, but not screened, those screened but not eligible/ 11 12 not consented and consented participants who did not reach the ‘getting started’ closed group 13 14 intervention stage. 15 16 17 18 For peer review only 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36
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45 on September 30, 2021 by guest. Protected copyright. 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
31 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 34 of 36
1 2 3 Figure 1: Flow of participants through the DUSSK study BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from 4 5 6 7 8 Women spoken to at 9 Women spoken to but not screened recruiting site (n=125)* 10 (n=84) 11 12 13 Too busy 13 11 Not interested 14 10 Not currently street sex working Attempted screening 15 9 Too unsettled/stressed 9 Unwilling to be screened questionnaire (n=41)* 16 7 Woman considers herself ineligible 17 7 Previously recruited 18 4 Previously screened For peer review only 19 4 Not currently taking heroin/crack 20 3 Previously approached by researcher Screened and recruited 21 7 Other (n=11) 22 Screened, not eligible/consented (n=30) 23
24 1 Not street sex working (escort) 25 2 Few/no screening questions completed Invited to Getting started Screened for 26 1 Never used street drugs sessions - Open group PTSD 27 Remaining women were SSWs and took 28 street drugs: (n=11) (n=4) 29 6 Not street sex worked and not used 30 heroin/crack in last month 31 9 Heroin/crack users who had not street sex Invited to Getting started Positive for PTSD and worked in last month 32 sessions - Closed group invited to Stabilisation 33 1 Street sex worked not used heroin/crack in last month (n=4) sessions (n=4) 34 7 Street sex worked or used heroin/crack less 35 than weekly 36 3 Eligible unable to obtain consent Invited to one-to-one
37 http://bmjopen.bmj.com/ 38 sessions: 39 Not actively invited to closed group 40 sessions (n=7) EMDR Extended 41 (n=2) stabilisation 42 5 Non-attenders (n=2) 43 2 Poor attenders 44
45 on September 30, 2021 by guest. Protected copyright. Referred to mainstream 46 47 drug services (n=1) 48 *Women could be approached Referred to mental health 49 multiple times throughout the services 50 recruitment period. (n=4) 51 52 53 54 55 56 57 58 59 60
For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 35 of 36 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
1 2 3 Reporting checklist for cohort study. 4 5 6 Based on the STROBE cohort guidelines. 7 8 9 Instructions to authors 10 11 Complete this checklist by entering the page numbers from your manuscript where readers will find 12 each of the items listed below. 13 14 15 Your article may not currently address all the items on the checklist. Please modify your text to 16 include the missing information.For Ifpeer you are certain review that an item onlydoes not apply, please write "n/a" and 17 18 provide a short explanation. 19 20 Upload your completed checklist as an extra file when you submit to a journal. 21 22 In your methods section, say that you used the STROBE cohortreporting guidelines, and cite them 23 24 as: 25 26 von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP. The Strengthening 27 the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for 28 29 reporting observational studies. 30 31 Page 32
33 Reporting Item Number http://bmjopen.bmj.com/ 34 35 Title and 36 37 abstract 38 39 Title #1a Indicate the study’s design with a commonly used term in the 1 40 title or the abstract
41 on September 30, 2021 by guest. Protected copyright. 42 43 Abstract #1b Provide in the abstract an informative and balanced summary 2 44 of what was done and what was found 45 46 47 Introduction 48 49 Background / #2 Explain the scientific background and rationale for the 4 50 rationale investigation being reported 51 52 53 Objectives #3 State specific objectives, including any prespecified 4 54 hypotheses 55 56 57 Methods 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 36 of 36 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
1 Study design #4 Present key elements of study design early in the paper 5 2 3 Setting #5 Describe the setting, locations, and relevant dates, including 5 4 5 periods of recruitment, exposure, follow-up, and data 6 collection 7 8 9 Eligibility criteria #6a Give the eligibility criteria, and the sources and methods of 5 10 selection of participants. Describe methods of follow-up. 11 12 13 Eligibility criteria #6b For matched studies, give matching criteria and number of N/A 14 exposed and unexposed 15 16 Variables #7 ForClearly peer define all reviewoutcomes, exposures, only predictors, potential 8 17 18 confounders, and effect modifiers. Give diagnostic criteria, if 19 applicable 20 21 22 Data sources / #8 For each variable of interest give sources of data and details 7 23 measurement of methods of assessment (measurement). Describe 24 25 comparability of assessment methods if there is more than 26 one group. Give information separately for for exposed and 27 28 unexposed groups if applicable. 29 30 Bias #9 Describe any efforts to address potential sources of bias N/A 31 32 Study size #10 Explain how the study size was arrived at 7
33 http://bmjopen.bmj.com/ 34 35 Quantitative #11 Explain how quantitative variables were handled in the 7 36 variables analyses. If applicable, describe which groupings were 37 38 chosen, and why 39 40 Statistical #12a Describe all statistical methods, including those used to 8
41 on September 30, 2021 by guest. Protected copyright. 42 methods control for confounding 43 44 Statistical #12b Describe any methods used to examine subgroups and N/A 45 methods interactions 46 47 48 Statistical #12c Explain how missing data were addressed N/A 49 methods 50 51 Statistical #12d If applicable, explain how loss to follow-up was addressed N/A 52 53 methods 54 55 Statistical #12e Describe any sensitivity analyses N/A 56 57 methods 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 37 of 36 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
1 Results 2 3 Participants #13a Report numbers of individuals at each stage of study—eg 20 4 5 numbers potentially eligible, examined for eligibility, 6 confirmed eligible, included in the study, completing follow- 7 8 up, and analysed. Give information separately for for 9 exposed and unexposed groups if applicable. 10 11 12 Participants #13b Give reasons for non-participation at each stage 9 13 14 Participants #13c Consider use of a flow diagram 20 15 16 Descriptive data #14aForGive characteristicspeer review of study participants only (eg demographic, 9 17 18 clinical, social) and information on exposures and potential 19 confounders. Give information separately for exposed and 20 21 unexposed groups if applicable. 22 23 Descriptive data #14b Indicate number of participants with missing data for each 21 24 25 variable of interest 26 27 Descriptive data #14c Summarise follow-up time (eg, average and total amount) 26 28 29 Outcome data #15 Report numbers of outcome events or summary measures 9 30 31 over time. Give information separately for exposed and 32 unexposed groups if applicable.
33 http://bmjopen.bmj.com/ 34 35 Main results #16a Give unadjusted estimates and, if applicable, confounder- 9-12 36 adjusted estimates and their precision (eg, 95% confidence 37 38 interval). Make clear which confounders were adjusted for 39 and why they were included 40
41 on September 30, 2021 by guest. Protected copyright. 42 Main results #16b Report category boundaries when continuous variables were N/A 43 categorized 44 45 Main results #16c If relevant, consider translating estimates of relative risk into N/A 46 47 absolute risk for a meaningful time period 48 49 Other analyses #17 Report other analyses done—e.g., analyses of subgroups 9-12 50 51 and interactions, and sensitivity analyses 52 53 Discussion 54 55 Key results #18 Summarise key results with reference to study objectives 13 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 38 of 36 BMJ Open: first published as 10.1136/bmjopen-2019-036491 on 15 December 2020. Downloaded from
1 Limitations #19 Discuss limitations of the study, taking into account sources 13 2 3 of potential bias or imprecision. Discuss both direction and 4 magnitude of any potential bias. 5 6 Interpretation #20 Give a cautious overall interpretation considering objectives, 15 7 8 limitations, multiplicity of analyses, results from similar 9 studies, and other relevant evidence. 10 11 12 Generalisability #21 Discuss the generalisability (external validity) of the study N/A 13 results 14 15 16 Other For peer review only 17 Information 18 19 Funding #22 Give the source of funding and the role of the funders for the 16 20 21 present study and, if applicable, for the original study on 22 which the present article is based 23 24 25 The STROBE checklist is distributed under the terms of the Creative Commons Attribution License 26 CC-BY. This checklist was completed on 16. December 2019 using https://www.goodreports.org/, a 27 28 tool made by the EQUATOR Network in collaboration with Penelope.ai 29 30 31 32
33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40
41 on September 30, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml