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BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-011595 on 26 September 2016. Downloaded from Treatment And Prevention for female Sex workers in South Africa: protocol for the TAPS Demonstration Project ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2016-011595 Article Type: Protocol Date Submitted by the Author: 19-Feb-2016 Complete List of Authors: Gomez, Gabriela; Amsterdam Institute for Global Health and Development, Eakle, Robyn; University of the Witwatersrand, Wits RHI; London School of Hygiene and Tropical Medicine Mbogua, Judie; University of the Witwatersrand, Wits RHI Akpomiemie, Godspower; University of the Witwatersrand, Wits RHI Venter, WD Francois; University of the Witwatersrand, Wits RHI Rees, Helen; University of the Witwatersrand, Wits RHI <b>Primary Subject HIV/AIDS Heading</b>: Secondary Subject Heading: Public health, Health services research, Health economics HIV Prevention, pre-exposure prophylaxis (PrEP), key populations, Keywords: implementation science, Immediate Treatment http://bmjopen.bmj.com/ on September 26, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 18 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-011595 on 26 September 2016. Downloaded from 1 2 3 Treatment And Prevention for female Sex workers in South Africa: protocol for the TAPS 4 Demonstration Project 5 6 7 Author Institution Email 8 Gabriela B Gomez‡ Department of Global Health and g.gomez@aighd.org 9 Amsterdam Institute for Global 10 Health and Development, 11 Academic Medical Center, 12 University of Amsterdam, The 13 Netherlands and Department of 14 Global Health and Development, 15 For peerLondon School review of Hygiene and only 16 Tropical Medicine, UK 17 18 Robyn Eakle*‡ Wits Reproductive Health and HIV reakle@wrhi.ac.za 19 Institute, London School of Hygiene 20 and Tropical Medicine, UK 21 Godspower Akpomiemie Wits Reproductive Health and HIV gakpomiemie@wrhi.ac.za 22 Institute 23 Judie Mbogua Wits Reproductive Health and HIV jmbogua@wrhi.ac.za 24 Institute 25 W D Francois Venter Wits Reproductive Health and HIV fventer@wrhi.ac.za 26 Institute 27 Helen Rees Wits Reproductive Health and HIV hrees@wrhi.ac.za 28 29 Institute 30 31 ‡ Contributed equally 32 *Corresponding author: 33 Robyn Eakle 34 http://bmjopen.bmj.com/ 35 Wits Reproductive Health & HIV Institute 36 University of the Witwatersrand, 37 Hillbrow Health Precinct, 22 Esselen Street, Hillbrow, 2001, Johannesburg, South Africa 38 t: +27 11 358 5350; e: reakle@wrhi.ac.za 39 40 41 Word count: abstract – 300 (max 300 words); text – 4575 excluding tables/figures (max 42 recommended: 4000 words) on September 26, 2021 by guest. Protected copyright. 43 Number of tables: 3; Number of figures: 0 (max figures and tables: 5) 44 45 46 47 Key words: HIV prevention, pre-exposure prophylaxis (PrEP), key populations, implementation 48 science, Immediate Treatment. 49 50 51 52 53 54 55 56 57 58 59 60 1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 18 BMJ Open: first published as 10.1136/bmjopen-2016-011595 on 26 September 2016. Downloaded from 1 2 3 ABSTRACT 4 Introduction 5 Updated guidelines have been recently published by the World Health Organisation recommending 6 7 antiretroviral treatment for adults with HIV at any CD4 count and daily oral pre-exposure prophylaxis 8 (PrEP) as an additional prevention strategy for people at substantial risk of HIV infection. However, 9 implementation challenges relating to health service capacity, acceptability, financing and resource 10 allocation may hinder the ability of programmes to translate these recommendations into successful 11 12 practice. This demonstration project is the first to integrate PrEP (for HIV-negative) and Immediate 13 Treatment (ITx; for those testing HIV-positive, with a higher CD4 count above national guidelines) for 14 female sex workers (FSWs) in South Africa with the overall aim to answer operational research 15 questions. For peer review only 16 17 18 Methods and Analysis 19 This is a prospective cohort study where the main outcome is retention at 12 months. The study 20 population includes FSWs in two urban sites in South Africa recruited into two arms: 1) PrEP arm 21 22 allowing women to cycle on and off of the medication (n=400); and 2) ITx arm (n=300). We will 23 systematically investigate process and other health indicators. A qualitative research component will 24 aim to better understand the motivations and barriers to uptake and use of PrEP and ITx for both 25 participants and providers. Finally, an economic evaluation will inform a cost-effectiveness analysis 26 27 combined with estimates of impact through epidemiological modelling. 28 29 Ethics and Dissemination 30 The TAPS Project was designed as an implementation study, however, when it was conceived the 31 32 indication for use of the Truvada combination as PrEP was not yet approved in South Africa. 33 Therefore, the requirements for ethical and Medicines Control Council approvals at clinical trial level 34 regulations were followed. At completion, results will be disseminated sequentially: to TAPS http://bmjopen.bmj.com/ 35 participants, local health officials and stakeholders, and other partners. We will aim to disseminate 36 further study results in peer-reviewed journals and conferences. 37 38 39 40 Strengths and Limitations 41 The strengths of this study exist within the design, incorporating a multidisciplinary evaluation within 42 an implementation science paradigm focused on service delivery. We will be able to measure the on September 26, 2021 by guest. Protected copyright. 43 44 success of the study using several outcomes, enabling us to triangulate data to explain findings. The 45 study has also been designed for flexibility so that changes in elements such as CD4 count threshold 46 in current ART guidelines and providers delivering the services can be accommodated as clinical 47 standards shift within South Africa. In this way, we aim to provide data which are relevant and 48 49 supportive of new policy and planning. 50 51 As with any study, there are limitations. As this is an implementation study, there is no comparison 52 arm so we will not be able to measure the effectiveness of any service delivery model, only its 53 54 acceptability and feasibility within current service delivery. Substantial efforts have been made to 55 include the evaluation within a service delivery that is as close to real world as possible. This has 56 meant that data collection points have been reduced to the minimum to avoid interference in 57 service delivery. Finally, we are testing new interventions for a stigmatised population where access 58 59 60 2 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 18 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-011595 on 26 September 2016. Downloaded from 1 2 3 to services is limited. Our resulting sample size is small and might not be representative of the 4 national population of female sex workers. Nevertheless, this study is the first and only ongoing 5 study testing simultaneously the expansion of ARV-related service (ie immediate treatment and 6 7 PrEP) for FSWs in South Africa. 8 9 10 11 12 13 14 15 For peer review only 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 http://bmjopen.bmj.com/ 35 36 37 38 39 40 41 42 43 on September 26, 2021 by guest. Protected copyright. 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 3 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 18 BMJ Open: first published as 10.1136/bmjopen-2016-011595 on 26 September 2016. Downloaded from 1 2 3 INTRODUCTION 4 Globally, UNAIDS data have shown a significant and continuous decline (35%) in the number of new 5 HIV infections since 2000 (1). In sub-Saharan Africa, this trend is even more pronounced with a 41% 6 7 decline. However, in this region of the world, where women make up for more than half of all 8 people living with HIV, incidence rates remain high (1). In particular, the HIV epidemic in South Africa 9 continues to be the largest in the world (2). 10 11 12 The South African National Strategic Plan on HIV, STIs, and TB (NSP) for 2012-2016 prioritizes 13 interventions with the aim to reduce new infections on a national level by 50% using combination 14 prevention while scaling up treatment to cover at least 80% of the population. The NSP also 15 identifies key Forpopulations aspeer a major focus ofreview the strategy, which calls only for a multi-faceted approach 16 17 to ending the epidemic. Sex workers are among the key populations identified in the past and 18 current NSP. Globally, female sex workers (FSWs) are 13.5 times more likely to be living with HIV 19 than women in the general population (3). The 2013 South African Key Populations Report estimates 20 that HIV prevalence among FSWs is between 44 and 69% (4–7), with 19.8% of all new infections 21 22 being attributed to sex work, including infections among clients and partners of clients (8). A study 23 conducted in 2008 in a cohort of high risk women in KwaZulu-Natal Province, estimated incidence to 24 be as high as 7.2/100 person-years (7). More recently, an HIV and syphilis prevalence study 25 conducted among populations of sex workers found a 72% prevalence with low treatment uptake in 26 27 Gauteng Province (9). This high vulnerability is rooted in the many structural drivers of HIV risk 28 affecting this population including: restricted access to healthcare, criminalization and lack of legal 29 protection, unsafe working conditions, stigma, and economic hardship (8).