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      Women’s Experiences with Oral and Vaginal Pre-Exposure Prophylaxis: The VOICE-C Qualitative Study in Johannesburg, South Africa

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          Abstract

          Background

          In VOICE, a multisite HIV pre-exposure prophylaxis (PrEP) trial, plasma drug levels pointed to widespread product nonuse, despite high adherence estimated by self-reports and clinic product counts. Using a socio-ecological framework (SEF), we explored socio-cultural and contextual factors that influenced participants’ experience of daily vaginal gel and oral tablet regimens in VOICE.

          Methods

          In Johannesburg, a qualitative ancillary study was concurrently conducted among randomly selected VOICE participants assigned to in-depth interviews (n = 41), serial ethnographic interviews (n = 21), or focus group discussions (n = 40). Audiotaped interviews were transcribed, translated, and coded thematically for analysis.

          Results

          Of the 102 participants, the mean age was 27 years, and 96% had a primary sex partner with whom 43% cohabitated. Few women reported lasting nonuse, which they typically attributed to missed visits, lack of product replenishments, and family-related travel or work. Women acknowledged occasionally skipping or mistiming doses because they forgot, were busy, felt lazy or bored, feared or experienced side effects. However, nearly all knew or heard of other study participants who did not use products daily. Three overarching themes emerged from further analyses: ambivalence toward research, preserving a healthy status, and managing social relationships. These themes highlighted the profound and complex meanings associated with participating in a blinded HIV PrEP trial and taking antiretroviral-based products. The unknown efficacy of products, their connection with HIV infection, challenges with daily regimen given social risks, lack of support–from partners and significant others–and the relationship tradeoffs entailed by using the products appear to discourage adequate product use.

          Conclusions

          Personal acknowledgment of product nonuse was challenging. This qualitative inquiry highlighted key influences at all SEF levels that shaped women’s perceptions of trial participation and experiences with investigational products. Whether these impacted women’s behaviors and may have contributed to ineffective trial results warrants further investigation.

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          Most cited references 23

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          Unraveling the divergent results of pre-exposure prophylaxis trials for HIV prevention.

          Although the balance of recent evidence supports the efficacy of antiretroviral (ARV)-based pre-exposure prophylaxis (PrEP) against HIV-1 infection, recent negative trial results are perplexing. Of seven trials with available HIV endpoints, three different products have been tested: tenofovir 1% vaginal gel, oral tenofovir disoproxil fumarate (TDF) tablets, and TDF/emtricitabine tablets. Six of these trials were conducted exclusively in sub-Saharan Africa; all found the products to be well tolerated, and four demonstrated effectiveness. Furthermore, the HIV Prevention Trial Network (HPTN) 052 trial recently confirmed that antiretroviral treatment leads to 96% reduction in transmission to HIV-negative partners in HIV-serodiscordant couples. These results, along with human and animal data, provide substantial evidence for the efficacy of antiretroviral-based HIV prevention. Yet assessment of oral TDF/emtricitabine in the FEM-PrEP study and of oral and vaginal tenofovir in the Microbicide Trial Network (MTN)-003 trial (VOICE) was stopped for futility. How do we make sense of these discrepant results? We believe that adherence is a key factor, although it cannot be the only factor. Expanding upon a recent editorial in the Lancet, we discuss the impact of suboptimal product adherence on PrEP efficacy in the context of variable drug concentration at the exposure site, integrity of the vaginal epithelium, and the role of acute infection.
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            The role of partnership dynamics in determining the acceptability of condoms and microbicides.

            Microbicides are a class of substances under development that could reduce the sexual transmission of HIV and other sexually transmitted diseases when applied locally to genital mucosal surfaces. Microbicide acceptability research has largely focused on product characteristics, rather than processes of negotiation within relationships about use. Gender relations, decision-making power and communication within sexual relationships are recognised as important determinants of condom and contraceptive use, and are likely to determine microbicide use also. As part of social science research linked to the Microbicides Development Programme (MDP) we combine relationship-based theories with anthropological work conducted with women and men using a placebo gel. We explore communication and decision-making in gel and condom use, including constructions of risk and trust. During the MDP301 Phase III pilot study, in-depth interviews were conducted at sites in South Africa, Tanzania, Uganda and Zambia. Following four weeks of placebo gel use, women and their partners were asked about gel use and acceptability, partner involvement, sexual practices and condom use. Data from 45 couples at five sites were analysed using a grounded theory approach in NVivo. Participation in the study did not require women to inform their partners, yet our data shows women seeking permission from their partners, negotiating disclosure, exchanging information and persuading or motivating for gel use. Although gel was supposedly 'woman-controlled', men exercised considerable influence in determining whether and how it was used. Despite this, negotiations around use were largely successful, since the gel increased sexual pleasure and provided opportunities for intimate communication and the building of trust. Decisions about condom and microbicide use are made in a dyadic context and involve a complex negotiation of risk and trust. Whilst preferences relating to product characteristics are largely individual, use itself is dependent on partnership dynamics and the broader social context in which sexual risk management occurs.
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              Conditional economic incentives to improve HIV treatment adherence: literature review and theoretical considerations.

              We present selected theoretical issues regarding conditional economic incentives (CEI) for HIV treatment adherence. High HIV treatment adherence is essential not only to improve individual health for persons living with HIV, but also to reduce transmission. The incentives literature spans several decades and various disciplines, thus we selectively point out useful concepts from economics, psychology and HIV clinical practice to elucidate the complex interaction between socio-economic issues, psychological perspectives and optimal treatment adherence. Appropriately-implemented CEI can help patients improve their adherence to HIV treatment in the short-term, while the incentives are in place. However, more research is needed to uncover mechanisms that can increase habit formation or maintenance effects in the longer-term. We suggest some potentially fruitful avenues for future research in this area, including the use of concepts from self-determination theory. This general framework may have implications for related research among disadvantaged communities with high rates of HIV/AIDS infection.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                1932-6203
                2014
                21 February 2014
                : 9
                : 2
                Affiliations
                [1 ]Women’s Global Health Imperative, RTI International, San Francisco, California, United States of America
                [2 ]Center for AIDS Prevention Studies, Department of Medicine, UCSF, San Francisco, California, United States of America
                [3 ]Wits Reproductive Health and HIV Institute, School of Clinical Medicine, University of the Witwatersrand, Johannesburg, South Africa
                [4 ]FHI 360, Research Triangle Park, North Carolina, United States of America
                [5 ]Division of AIDS, National Institute of Allergy and Infectious Diseases/National Institutes of Health, Bethesda, Maryland, United States of America
                Commissariat a l′Energie Atomique(cea), France
                Author notes

                Competing Interests: MTN-003C complies with all National Institutes of Health (NIH) data sharing policies. This does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials.

                Conceived and designed the experiments: AVDS JS ETM. Performed the experiments: JS BM FM KS. Analyzed the data: AVDS JS ETM BM FM MH NL. Contributed reagents/materials/analysis tools: AVDS JS ETM BM MH NL KS. Wrote the paper: AVDS JS ETM BM FM MH NL KS LST.

                Article
                PONE-D-13-46165
                10.1371/journal.pone.0089118
                3931679
                a0115407-2a97-4325-9747-a101816d22be

                This is an open-access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.

                Page count
                Pages: 12
                Funding
                This study was funded by the Microbicide Trials Network (MTN) grant, an HIV/AIDS clinical trials network funded by the National Institute of Allergy and Infectious Diseases with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health (NIH) (5UM1AI068633). This cooperative agreement involved the active collaboration of the sponsor, NIH, with the grant recipients within the MTN. One NIH employee is co-author on this paper. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Research Article
                Medicine
                Clinical research design
                Qualitative studies
                Survey research
                Infectious diseases
                Viral diseases
                HIV
                HIV prevention
                Non-clinical medicine
                Communication in health care
                Public health
                Behavioral and social aspects of health
                Women's health

                Uncategorized

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