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      Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women.

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          Abstract

          The incidence of human immunodeficiency virus (HIV) infection remains high among women in sub-Saharan Africa. We evaluated the safety and efficacy of extended use of a vaginal ring containing dapivirine for the prevention of HIV infection in 1959 healthy, sexually active women, 18 to 45 years of age, from seven communities in South Africa and Uganda.

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          Most cited references 8

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

          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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            Adherence to Preexposure Prophylaxis: Current, Emerging, and Anticipated Bases of Evidence

            Despite considerable discussion and debate about adherence to preexposure prophylaxis (PrEP) for human immunodeficiency virus (HIV), scant data are available that characterize patterns of adherence to open-label PrEP. The current evidence base is instead dominated by research on adherence to placebo-controlled investigational drug by way of drug detection in active-arm participants of large randomized controlled trials (RCTs). Important differences between the context of blinded RCTs and open-label use suggest caution when generalizing from study product adherence to real-world PrEP use. Evidence specific to open-label PrEP adherence is presently sparse but will expand rapidly over the next few years as roll-out, demonstration projects, and more rigorous research collect and present findings. The current evidence bases established cannot yet predict uptake, adherence, or persistence with open-label effective PrEP. Emerging evidence suggests that some cohorts could execute better adherence in open-label use vs placebo-controlled research. Uptake of PrEP is presently slow in the United States; whether this changes as grassroots and community efforts increase awareness of PrEP as an effective HIV prevention option remains to be determined. As recommended by multiple guidelines for PrEP use, all current demonstration projects offer PrEP education and/or counseling. PrEP support approaches generally fall into community-based, technology, monitoring, and integrated sexual health promotion approaches. Developing and implementing research that moves beyond simple correlates of either study product use or open-label PrEP adherence toward more comprehensive models of sociobehavioral and socioecological adherence determinants would greatly accelerate progress. Intervention research is needed to identify effective models of support for open-label PrEP adherence.
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              Disclosure of pharmacokinetic drug results to understand nonadherence.

              In VOICE, a phase IIB trial of daily oral and vaginal tenofovir for HIV prevention, at least 50% of women receiving active products had undetectable tenofovir in all plasma samples tested. MTN-003D, an ancillary study using in-depth interviews (IDIs) and focus group discussions (FGDs), together with retrospective disclosure of plasma tenofovir pharmacokinetic results, explored adherence challenges during VOICE.
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                Author and article information

                Journal
                N. Engl. J. Med.
                The New England journal of medicine
                New England Journal of Medicine (NEJM/MMS)
                1533-4406
                0028-4793
                December 01 2016
                : 375
                : 22
                Affiliations
                [1 ] From International Partnership for Microbicides, Silver Spring, MD (A.N., N.N., H.C., B.D., M.I., M.M., W.M., J.N., M.R., S.N., M.S., L.S., P.S., J.S., K.W., Z.R.); London School of Hygiene and Tropical Medicine, London (S. Kapiga); Mwanza Intervention Trials Unit, Mwanza, Tanzania (S. Kapiga); Desmond Tutu HIV Centre, University of Cape Town, Cape Town (L.-G.B., K.G.), Maternal, Adolescent, and Child Health Research, Edendale (C.G., Z.M.), Qhakaza Mbokodo Research Clinic, Ladysmith (P.K.), Prevention for HIV and AIDS Project, Pinetown (N.M.), Madibeng Centre for Research, Brits, the Department of Family Medicine, Faculty of Health Sciences, University of Pretoria, Pretoria (C.L.), and Ndlovu Care Group, Elandsdoorn (H.T.) - all in South Africa; Medical Research Council-Uganda Virus Research Institute Research Unit on AIDS, Entebbe, Uganda (A.K., S. Kusemererwa); and SGS Life Science Services-Biometrics, Mechelen (M.B., S.R.), and Janssen Research and Development, Beerse (J.V.R., W.P., T.V., B.V.B.) - both in Belgium.
                Article
                10.1056/NEJMoa1602046
                27959766

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