BackgroundIn 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.MethodsIn 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.ResultsOf 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.ConclusionsPersonal 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.

Our findings indicate that men facilitated contraceptive use for their partners. Although the IMB model does not fully explain our findings, our results show that the intervention's content and its training in communication skills are essential mechanisms for successfully enabling men to help couples use a contraceptive.

Research suggests that spousal communication and male involvement in decision making can positively influence family-planning use and continuation. However, few existing studies explore the dynamics of this communication and how they factor into family-planning decision making. Building upon a recent evaluation of a theory-based male-involvement intervention in Malawi, this study aimed to fill this gap by examining the role of communication in the intervention's success, through semi-structured in-depth interviews with male participants and female partners of study participants. Results support the idea that communication is an integral component of successful interventions to increase male involvement in family planning. Participants reported improvements in spousal communication, increased frequency of communication, and an increase in shared decision making as a result of the study, which directly contributed to their family-planning use. This effect was often mediated through increased knowledge or reduced male opposition to family planning. Further analysis of communication and decision-making dynamics revealed shifts in gendered communication norms, leading to improvements in spousal relationships in addition to contraceptive uptake. This study shows that interventions can and should encourage spousal communication and shared decision making, and it provides an effective model for involving men in family-planning use.

Objectives In VOICE, a phase IIB trial of daily oral and vaginal tenofovir for HIV prevention, ≥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 (PK) results, explored adherence challenges during VOICE. Methods We systematically recruited participants with PK data (median 6 plasma samples), categorized as low (0%, N=79), inconsistent (1%-74%, N=28), or high (≥75%; N=20) based on frequency of tenofovir detection. Following disclosure of PK results, reactions were captured and adherence challenges systematically elicited; IDIs and FGDs were audio-recorded, transcribed, coded, and thematically analyzed. Results We interviewed 127 participants from South Africa, Uganda, and Zimbabwe. The most common reactions to PK results included surprise (41%; low PK), acceptance (39%; inconsistent PK), and happiness (65%; high PK). Based on participants’ explanations, we developed a typology of adherence patterns: noninitiation, discontinuation, misimplementation (resulting from visit-driven use, variable taking, modified dosing or regimen), and adherence. Fear of product side effects/harm was a frequent concern, fueled by stories shared among participants. Although women with high PK levels reported similar concerns, several described strategies to overcome challenges. Women at all PK levels suggested real-time drug monitoring and feedback to improve adherence and reporting. Conclusions Retrospective provision of PK results seemingly promoted candid discussions around nonadherence and study participation. The effect of real-time drug monitoring and feedback on adherence and accuracy of reporting should be evaluated in trials.

IntroductionAntiretroviral (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.MethodsVOICE-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.ResultsThe 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.ConclusionsVOICE 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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IntroductionExisting biomedical HIV prevention options, though highly effective, present substantial adherence challenges. End‐user input on early‐stage design of new HIV prevention approaches is critical to yielding products that achieve high uptake and adherence. The iPrevent Study examined youths’ preferences for key attributes of long‐acting Pre‐Exposure Prophylaxis (PrEP), with a focus on characteristics pertinent to product delivery alongside key modifiable product attributes.MethodsA discrete choice experiment was conducted with female and male youth aged 18 to 24 in two high‐density communities in Cape Town, South Africa during the period July 2017 to January 2019. Sexually active, PrEP‐naïve youth were recruited using population‐based sampling; targeted sampling was used to enrol men who have sex with men (MSM). In a series of nine questions, participants were asked to choose between two hypothetical products composed of five attributes (form, dosing frequency, access, pain, insertion site). We used a random‐parameters logit model to estimate preference weights and trade‐offs among product alternatives. We examined differences across three subgroups: females, men who have sex with only women (MSW) and MSM.ResultsA total of 807 participants (401 female) were enrolled with a median age of 21 years. Males included 190 MSM. Most youth had tested for HIV (95%) and reported being HIV‐negative (91%). Across all groups, duration of effectiveness was the most important attribute, with strong preference for less frequent dosing. Injections were favoured over implants, though these preferences were strongest for females and MSM. Females preferred a product offered at a health clinic and disliked pharmacy access; all groups preferred the arm as the insertion site. Youth were willing to trade their preferred product form for longer duration.ConclusionsYouth indicated strong preferences for longer duration products. Each attribute nonetheless influenced preferences, offering insight into trade‐offs that inform long‐acting PrEP development.

Hazardous drinking is an important contributing factor to intimate partner violence (IPV) occurrence. However, only a limited number of community-based alcohol reduction interventions have been tested in low- and middle-income countries (LMICs) for their efficacy in reducing IPV. This pilot intervention study tested a 1-month combined behavioral economics and cognitive behavioral therapy intervention to reduce hazardous alcohol use and IPV in Bengaluru, India. Sixty couples were randomized to one of three study arms to test the effect of incentives-only and incentives plus counseling interventions compared with a control condition. Alcohol use among male participants was assessed using breathalyzer tests. Violence experienced by female participants was measured using the Indian Family Violence and Control Scale. Couples in the counseling arm participated in four weekly counseling sessions. Male participants in the incentive arms earned a reward for sobriety (breath alcohol concentration [BrAC] <0.01 g/dl). Results showed that while incentives reduced alcohol use, there was a greater proportion of negative BrAC samples among participants in the counseling arm compared with the control group (0.96 vs. 0.76, p = .03). Violence also decreased in both intervention arms. The estimated mean violence score for the counseling arm was 10.8 points lower than the control arm at 4-month follow-up visit ( p = .02). This study contributes important evidence to the field of alcohol reduction and IPV prevention approaches in LMIC settings and adds to the growing evidence that alcohol reduction is a modifiable means of addressing IPV.