This article was downloaded by: [5.249.37.136] On: 03 March 2015, At: 01:47 Publisher: Routledge Informa Ltd Registered in England and Wales Registered Number: 1072954 Registered office: Mortimer House, 37-41 Mortimer Street, London W1T 3JH, UK AIDS Care: Psychological and Socio-medical Aspects of AIDS/HIV Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/caic20 Trial participation disclosure and gel use behavior in the CAPRISA 004 tenofovir gel trial Stacey M. Succopa, Kathleen M. MacQueena, Francois van Loggerenbergb, Nelisile Majolab, Quarraisha Abdool Karimb & Salim S. Abdool Karimb a Social and Behavioral Health Sciences, FHI 360, Durham, NC, USA b Centre for the AIDS Program of Research in South Africa (CAPRISA), Durban, South Africa Published online: 06 Oct 2014. Click for updates To cite this article: Stacey M. Succop, Kathleen M. MacQueen, Francois van Loggerenberg, Nelisile Majola, Quarraisha Abdool Karim & Salim S. Abdool Karim (2014) Trial participation disclosure and gel use behavior in the CAPRISA 004 tenofovir gel trial, AIDS Care: Psychological and Socio-medical Aspects of AIDS/HIV, 26:12, 1521-1525, DOI: 10.1080/09540121.2014.938014 To link to this article: http://dx.doi.org/10.1080/09540121.2014.938014 PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. 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This article may be used for research, teaching, and private study purposes. Terms & Conditions of access and use can be found at http://www.tandfonline.com/page/terms-and-conditions It is essential that you check the license status of any given Open and Open Select article to confirm conditions of access and use. AIDS Care, 2014 Vol. 26, No. 12, 1521–1525, http://dx.doi.org/10.1080/09540121.2014.938014 Trial participation disclosure and gel use behavior in the CAPRISA 004 tenofovir gel trial Stacey M. Succopa*, Kathleen M. MacQueena, Francois van Loggerenbergb, Nelisile Majolab, Quarraisha Abdool Karimb and Salim S. Abdool Karimb aSocial and Behavioral Health Sciences, FHI 360, Durham, NC, USA; bCentre for the AIDS Program of Research in South Africa (CAPRISA), Durban, South Africa (Received 14 November 2013; accepted 20 June 2014) Disclosure, or open communication, by female microbicide trial participants of their trial participation and use of an investigational HIV prevention drug to a sexual partner may affect participants’ trial product usage behavior and contribute to poor adherence. With mixed results from recent microbicide clinical trials being linked to differing participant adherence, insights into the communication dynamics between trial participants and their sexual partners are particularly important. We examined the quantitative association between (1) communication of trial participation to a partner and participant adherence to gel and (2) communication of trial participation to a partner and participant HIV status. An in-depth adherence and product acceptability assessment was administered to the women participating in the CAPRISA 004 trial. Additionally, we collected qualitative data related to communication of trial participation and gel use. Qualitatively, among 165 women who had reported that they had discussed trial participation with others, most (68%) stated that they communicated participation to their sexual partner. Most of the women who had communicated study participation with their partners had received a positive/neutral response from their partner. Some of these women stated that gel use was easy; only a small number said that gel use was difficult. Among women who did not communicate their study participation to their partners, difficulty with gel use was more common and some women stated that they feared communicating their participation. Quantitatively, there was no statistically significant difference in the proportions of women who had communicated study participation to a partner across different adherence levels or HIV status. A deeper knowledge of the dynamics surrounding trial participation communication to male partners will be critical to understanding the spectrum of trial product usage behavior, and ultimately to designing tailored strategies to assist trial participants with product adherence. Keywords: vaginal microbicide; HIV prevention; disclosure; adherence; covert use; partner dynamics Introduction Study product adherence has been cited as an import- Previous microbicide, diaphragm, and condom studies and ant factor in the mixed results seen in recent antiretroviral clinical trials have explored barriers women face in (ARV)-based microbicide and HIV prevention trials. The disclosing, or openly communicating, study or trial parti- 2010 CAPRISA 004 tenofovir gel microbicide trial in cipation to sexual partners including fear of violating trust South Africa demonstrated a 39% reduction in HIV ’ infections; in secondary analyses, infections were reduced Downloaded by [5.249.37.136] at 01:47 03 March 2015 or relationship norms, partners refusal of study product use, and physical violence (Gafos et al., 2012; Montgomery by 54% among women with high adherence to the study et al., 2008;Montgomery,Gafosetal.,2010; Montgomery, product (Abdool Karim et al., 2010). Similar dose– Cheng et al., 2010;Morrowetal.,2003; Sahin-Hodoglugil responseeffectshavebeenobservedinotherHIVpreven- et al., 2006; Sahin-Hodoglugil et al., 2011; Woodsong & tion trials including iPrEx (Grant et al., 2010), Partner- Alleman, 2008; Woodsong et al., 2013). Studies have also sPrep (Baeten et al., 2012), and TDF2 (Thigpen et al., explored linkages between communication of participation 2011). In contrast, two studies with evidence of poor and study product adherence and found more consistent adherence were unable to demonstrate product effective- usage among women whose partners knew of their ness (Marrazzo, Ramjee, & Nair, 2013;VanDamme participation (Greene et al., 2010; Montgomery et al., 2008; Montgomery, Gafos et al., 2010; Montgomery, et al., 2012). Cheng et al., 2010; Pistorius et al., 2004; van der Straten We used a mixed methods approach to explore the et al., 2008; Woodsong & Alleman, 2008). One study relationships between communication of participation showed product adherence was more difficult for women in the CAPRISA 004 microbicide trial to male sexual whose partners were not aware of their participation and partners, participant HIV status, and use of study product use (Sahin-Hodoglugil et al., 2006). product. *Corresponding author. Email: [email protected] This material is published by permission of the U.S. Agency for International Development (USAID) for the US Department of Energy under Contract No. [GHO‑A‑00‑09‑00016-00]. The US Government retains for itself, and others acting on its behalf, a paid-up, non-exclusive, and irrevocable worldwide license in said article to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, by or on behalf of the Government. This is an Open Access article. Non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly attributed, cited, and is not altered, transformed, or built upon in any way, is permitted. The moral rights of the named author(s) have been asserted. 1522 S.M. Succop et al. Methods participants’ HIV status. However, 10 participants (with positive HIV test results) divulged their HIV test results The study was approved by FHI 360’s Protection of during the interview. Human Subjects Committee in Durham, NC, USA and the University of KwaZulu-Natal Biomedical Research Ethics Committee in Durban, South Africa. Data analysis Logistic regression was used to assess the association between communication of trial participation to a partner Study population and (1) participant adherence to gel and (2) participant This study was conducted simultaneously with the HIV status. CAPRISA 004 microbicide gel clinical trial in KwaZulu- Qualitative data were coded using a team-based, Natal, South Africa. Participants (n = 277) were recruited data-driven, thematic approach and implemented with from the CAPRISA 004 study population (n =889).All AnSWR qualitative data analysis software. Two coders trial participants with a positive HIV test result at their separately coded 20% of transcripts