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

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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.

Resumen

CAPRISA 008, un estudio de etiqueta abierta de extensión del gel de tenofovir con la dosificación relacionada al coito, que brindó la oportunidad de explorar la relación entre la adherencia del producto y la dinámica de género en un contexto donde las mujeres sabían que estaban recibiendo un producto activo con eficacia evidenciada en la prevención del VIH. Las entrevistas con las participantes de 63 CAPRISA 008 y 13 parejas masculinas en KwaZulu-Natal, Sudáfrica, resaltaron que el proceso de negociación de la utilización del gel fue determinado en parte por la dinámica de la relación, incluyendo la duración de la relación, la situación de vivienda, una evaluación de la relación (por ejemplo, la intimidad de la pareja y las expectativas de la relación) y pasos definidos culturalmente para formalizar la relación. Si bien la divulgación del uso del producto facilitó la adherencia para muchas, otras informaron que usaron el gel efectivamente sin importar la divulgación del uso, y en algunas situaciones divulgación de datos fue una barrera a la adherencia. Las mujeres deben ser apoyadas en su decisión sobre divulgación y tener la oportunidad de utilizar este y otros productos similares sin el consentimiento de su pareja.

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Most cited references 10

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Perspectives on use of oral and vaginal antiretrovirals for HIV prevention: the VOICE-C qualitative study in Johannesburg, South Africa

Ariane van der Straten, Jonathan Stadler, Ellen Luecke … (2014)

Introduction Antiretroviral (ARV)-based pre-exposure prophylaxis (PrEP) is a promising new HIV prevention strategy. However, variable levels of adherence have yielded mixed results across several PrEP trials and populations. It is not clear how taking ARV – traditionally used for HIV treatment – is perceived and how that perception may affect the use of these products as preventives. We explored the views and experiences of VOICE participants, their male partners and community members regarding the use of ARV as PrEP in the VOICE trial and the implications of these shared meanings for adherence. Methods VOICE-C was a qualitative ancillary study conducted at the Johannesburg site of VOICE, a multisite, double-blind, placebo-controlled randomised trial testing tenofovir gel, oral tenofovir and oral Truvada® for HIV PrEP. We interviewed 102 randomly selected female VOICE participants, 22 male partners and 40 community members through in-depth interviews, serial ethnography, or focus group discussions. All interviews were audiotaped, transcribed, translated and coded thematically for analysis. Results The concept of ARV for prevention was understood to varying degrees across all study groups. A majority of VOICE participants understood that the products contained ARV, more so for the tablets than for the gel. Although participants knew they were HIV negative, ARV was associated with illness. Male partners and community members echoed these sentiments, highlighting confusion between treatment and prevention. Concerned that they would be mistakenly identified as HIV positive, VOICE participants often concealed use of or hid their study products. This occasionally led to relationship conflicts or early trial termination. HIV stigma and its association with ARV, especially the tablets, was articulated in rumour and gossip in the community, the workplace and the household. Although ARV were recognised as potent and beneficial medications, transforming the AIDS body from sickness to health, they were regarded as potentially harmful for those uninfected. Conclusions VOICE participants and others in the trial community struggled to conceptualise the idea of using ARV for prevention. This possibly influenced willingness to adopt ARV-based prevention in the VOICE clinical trial. Greater investments should be made to increase community understanding of ARV for prevention and to mitigate pervasive HIV stigma.

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Microbicide clinical trial adherence: insights for introduction

Cynthia Woodsong, Kathleen M. MacQueen, K Rivet Amico … (2013)

After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

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Engaging male partners in women's microbicide use: evidence from clinical trials and implications for future research and microbicide introduction

Michele Lanham, Rose Wilcher, Elizabeth T. Montgomery … (2014)

Introduction Constructively engaging male partners in women-centred health programs such as family planning and prevention of mother-to-child HIV transmission has resulted in both improved health outcomes and stronger relationships. Concerted efforts to engage men in microbicide use could make it easier for women to access and use microbicides in the future. This paper synthesizes findings from studies that investigated men's role in their partners’ microbicide use during clinical trials to inform recommendations for male engagement in women's microbicide use. Methods We conducted primary and secondary analyses of data from six qualitative studies implemented in conjunction with microbicide clinical trials in South Africa, Kenya, and Tanzania. The analyses included data from 535 interviews and 107 focus groups with trial participants, male partners, and community members to answer research questions on partner communication about microbicides, men's role in women's microbicide use, and potential strategies for engaging men in future microbicide introduction. We synthesized the findings across the studies and developed recommendations. Results The majority of women in steady partnerships wanted agreement from their partners to use microbicides. Women used various strategies to obtain their agreement, including using the product for a while before telling their partners, giving men information gradually, and continuing to bring up microbicides until resistant partners acquiesced. Among men who were aware their partners were participating in a trial and using microbicides, involvement ranged from opposition to agreement/non-interference to active support. Both men and women expressed a desire for men to have access to information about microbicides and to be able to talk with a healthcare provider about microbicides. Conclusions We recommend counselling women on whether and how to involve their partners including strategies for gaining partner approval; providing couples’ counselling on microbicides so men have the opportunity to talk with providers; and targeting men with community education and mass media to increase their awareness and acceptance of microbicides. These strategies should be tested in microbicide trials, open-label studies, and demonstration projects to identify effective male engagement approaches to include in eventual microbicide introduction. Efforts to engage men must take care not to diminish women's agency to decide whether to use the product and inform their partners.

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Author and article information

Contributors

Kathleen M. MacQueen: 919-544-7040 , kmacqueen@fhi360.org

Journal

Journal ID (nlm-ta): AIDS Behav

Journal ID (iso-abbrev): AIDS Behav

Title: AIDS and Behavior

Publisher: Springer US (New York )

ISSN (Print): 1090-7165

ISSN (Electronic): 1573-3254

Publication date (Electronic): 5 March 2016

Publication date PMC-release: 5 March 2016

Publication date (Print): 2016

Volume: 20

Issue: 11

Pages: 2682-2691

Affiliations

[1 ]Global Health Research, FHI 360, 359 Blackwell Street, Suite 200, Durham, NC 27701 USA

[2 ]CAPRISA, University of KwaZulu-Natal, Durban, South Africa

Article

Publisher ID: 1339

DOI: 10.1007/s10461-016-1339-4

PMC ID: 5069327

PubMed ID: 26945585

SO-VID: 6554535c-2a14-4b1c-be44-9940fa42cfe7

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.