Social Context of Adherence in an Open-Label 1% Tenofovir Gel Trial: Gender Dynamics and Disclosure in KwaZulu-Natal, South Africa.

Kathleen M Macqueen,Brian Perry,Diantha Pillay,Chitra Singh,Quarraisha Abdool Karim,Sarah Dlamini,Steve Sortijas,Salim Abdool Karim,Sharon Watson,Alesha Majors,Sonja Jerome,Eunice Okumu,Leila E Mansoor

doi:10.1007/s10461-016-1339-4

Kathleen M Macqueen, Brian Perry + Show 11 more

Open Access

https://doi.org/10.1007/s10461-016-1339-4

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Abstract

CAPRISA 008, an open-label extension study of tenofovir gel with coitally-related dosing, provided an opportunity to explore the relationship between product adherence and gender dynamics in a context where women knew they were receiving an active product with evidence of HIV prevention effectiveness. Interviews with 63 CAPRISA 008 participants and 13 male partners in KwaZulu-Natal, South Africa, highlighted that the process of negotiating gel use was determined in part by relationship dynamics including the duration of the relationship, the living situation, an evaluation of the relationship (e.g., partner intimacy and relationship expectations) and culturally-defined steps for formalizing the relationship. While disclosure facilitated adherence for many, others reported using the gel effectively with no disclosure, and in some situations disclosure was a barrier to adherence. Women should be supported in their choice about what to disclose and have opportunity to use this and similar products without their partners’ knowledge or acquiescence.

Highlights

An increasingly broad range of HIV prevention products containing antiretrovirals (ARVs) are being evaluated in clinical trials including pills, vaginal and rectal gels, vaginal rings, and long-acting injectables
The four main themes explored in this analysis were discussed in each of the in-depth interview (IDI) from both research sites
In this study we sought to gain a nuanced understanding of product use in the context of an open-label implementation trial (CAPRISA 008) of an ARV-based microbicide with some evidence of effectiveness

Summary

Introduction

An increasingly broad range of HIV prevention products containing antiretrovirals (ARVs) are being evaluated in clinical trials including pills, vaginal and rectal gels, vaginal rings, and long-acting injectables. One of the most consistent findings from HIV prevention trials of products requiring behavioral adherence is that product adherence by women may be undermined or supported as a result of gender dynamics including norms surrounding sexual negotiation, culturally defined gender roles, gender-based violence, and economic vulnerability [1]. There are limited data on the extent to which findings about product disclosure to male partners and adherence by AIDS Behav (2016) 20:2682–2691 women during a randomized, blinded clinical trial is generalizable beyond the trial context [2]. Two trials of tenofovir gel in KwaZulu-Natal, South Africa—one a randomized, blinded, placebo-controlled trial (CAPRISA 004) [4] and the other an open-label implementation trial (CAPRISA 008) [5]—provided an opportunity to explore gender dynamics and disclosure in more depth

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