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Pre-exposure prophylaxis (PrEP) is highly effective, although PrEP adherence and persistence has been variable during real world implementation. Little is known about missed opportunities to enhance PrEP adherence among individuals who later HIV seroconverted after using PrEP. The goal of this analysis was to identify all HIV infections among individuals who had accessed PrEP in an integrated health system in San Francisco, and to identify potentially intervenable factors that could have prevented HIV infection through in-depth interviews with people who HIV seroconverted after using PrEP.We identified individuals who initiated PrEP in an integrated safety-net public health system and performed in-depth chart review to determine person-time on and after stopping PrEP over six years. We identified all PrEP seroconversions using the Centers for Disease Control and Prevention's Enhanced HIV/AIDS Reporting System and then calculated HIV incidence while using PrEP and during gaps in use. We then performed in-depth interviews with those who seroconverted.Overall, 986 initiated PrEP across the San Francisco Department of Public Health from July 2012 to November 2018. Data were gathered from 895 person-years on PrEP and 953 after stopping PrEP. The HIV incidence was 7.5-fold higher after stopping PrEP compared to while on PrEP (95% CI 1 to 336). Of the eight individuals who HIV seroconverted; only one was taking PrEP at the time of seroconversion but was using on-demand PrEP inconsistently. All eight agreed to qualitative interviews. Major barriers to PrEP persistence included substance use, mental health and housing loss; difficulty accessing PrEP due to cost, insurance, and the cost and time of medical visits; difficulty weighing PrEP's benefit versus self-perceived risk; and entering a primary partnership. The individual who developed HIV using on-demand PrEP reported confusion about the dosing regimen and which sexual encounters required accompanying PrEP dosing.HIV incidence during gaps in PrEP use was nearly eight-fold higher than while on PrEP in this large cohort in San Francisco. Many individuals who stop PrEP remain at risk of HIV, and participants reported that proactive outreach could potentially have prevented HIV infections. Individuals using non-daily PrEP may require additional education and support in the United States.

OBJECTIVE(S): MTN-020/ASPIRE and IPM-027/Ring Study recently proved the dapivirine vaginal ring was safe and effective with consistent use. To optimize the ring’s impact, the barriers and facilitators to ring adherence must be understood and addressed. METHODS: Former ASPIRE participants were stratified by age group (18–21; 22–45) and randomly selected at seven sites in Malawi, South Africa, Uganda and Zimbabwe, 12–17 months after trial exit. Using in-depth interviews or focus group discussions, ring use barriers were explored using structured guides and visual tools including individual-level depictions of dapivirine levels detected in plasma and returned rings. RESULTS: 187 were enrolled; 37% were 18–21 when they began ASPIRE. Most (75%) had drug-level results suggesting inconsistent ring use throughout ASPIRE. Participants viewed themselves as adherent, while simultaneously describing regular instances and reasons for ring removal (e.g. for sex or menses). Less adherent women reported fears that partners would oppose the ring or feel it during sex. High adherers expressed altruistic motivations for ring use. Women of all ages attributed young women’s non-adherence to their tendency to be less “serious” about the future, HIV prevention and the study; motivated predominantly by benefits; more fearful of fertility-related consequences; and to having less relationship control. CONCLUSIONS: When presented with objective adherence data, participants provided reasons for intermittent ring use, while simultaneously portraying themselves as consistent ring users. Further research is needed to understand how women could use the ring in a way that fits into the context of their relationships and their lives while still conferring adequate HIV prophylaxis.

OBJECTIVES 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. METHODS We systematically recruited participants with pharmacokinetic data (median six plasma samples), categorized as low (0%, N = 79), inconsistent (1-74%, N = 28) or high (≥75%; N = 20) on the basis of frequency of tenofovir detection. Following disclosure of pharmacokinetic results, reactions were captured and adherence challenges systematically elicited; IDIs and FGDs were audio-recorded, transcribed, coded and thematically analysed. RESULTS We interviewed 127 participants from South Africa, Uganda and Zimbabwe. The most common reactions to pharmacokinetic results included surprise (41%; low pharmacokinetic), acceptance (39%; inconsistent pharmacokinetic) and happiness (65%; high pharmacokinetic). On the basis of 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, fuelled by stories shared among participants. Although women with high pharmacokinetic levels reported similar concerns, several described strategies to overcome challenges. Women at all pharmacokinetic levels suggested real-time drug monitoring and feedback to improve adherence and reporting. CONCLUSION Retrospective provision of pharmacokinetic 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.

The MTN-020/ASPIRE trial evaluated the safety and effectiveness of the dapivirine vaginal ring for prevention of HIV-1 infection among African women. A nested qualitative component was conducted at six of 15 study sites in Uganda, Malawi, Zimbabwe and South Africa to evaluate acceptability of and adherence to the ring.Qualitative study participants (n = 214) were interviewed with one of three modalities: single in-depth interview, up to three serial interviews or an exit Focus Group Discussion. Using semistructured guides administered in local languages, 280 interviews were audio-recorded, transcribed, translated, coded and analyzed.We identified three key findings: first, despite initial fears about the ring's appearance and potential side effects, participants grew to like it and developed a sense of ownership of the ring once they had used it. Second, uptake and sustained adherence challenges were generally overcome with staff and peer support. Participants developed gradual familiarity with ring use through trial progression, and most reported that it was easy to use and integrate into their lives. Using the ring in ASPIRE was akin to joining a team and contributing to a broader, communal good. Third, the actual or perceived dynamics of participants' male partner relationship(s) were the most consistently described influence (which ranged from positive to negative) on participants' acceptability and use of the ring.It is critical that demonstration projects address challenges during the early adoption stages of ring diffusion to help achieve its potential public health impact as an effective, long-acting, female-initiated HIV prevention option addressing women's disproportionate HIV burden.

Romantic relationships play a central role in young people's social development and sexual health. This paper examines romantic relationship ideals valued by urban Latino youth in San Francisco and their experiences in achieving their ideals in their current relationship. We draw on in-depth interviews with 33 young men and women aged 16-22 years in San Francisco, California. In spite of, or perhaps related to, the prevailing perception that their peers were unfaithful in their relationships, young people in this study identified trust as one of the most important characteristics of a romantic relationship. Trust was related not only to fidelity, but also vulnerability and emotional intimacy. Understanding valued relationship ideals and factors that facilitate and impede their attainment is critical in promoting healthy relationships.

While much attention has been paid to women's drinking during pregnancy, few studies address a woman's drinking once she has given birth, which presents potential dangers to herself and her child. This time of transition can be extremely stressful, potentially leading to problem drinking. On the other hand, this new role and change in lifestyle may be protective against alcohol use and abuse. We used the California Women's Health Survey (CWHS), a randomized sample of adult women in California, to compare new mothers' drinking behaviors to other women. In order to obtain a large enough sample to observe trends in subpopulations, we combined CWHS data from years 1997–2008 (n = 28,537 women aged 18–48). We used logistic regression to determine the individual-level characteristics that best predicted the outcomes postpartum and to compare new mothers (those with a child in the household

Female-initiated methods of HIV prevention are needed to address barriers to HIV prevention rooted in gender inequalities. Understanding the socio-cultural context of pre-exposure prophylaxis (PrEP) trials, including gender-based violence, is thus critical. MTN-003C (VOICE-C), a qualitative sub-study of the larger MTN-003 (VOICE) trial, examined socio-cultural barriers and facilitators to PrEP amongst women in Johannesburg. We conducted focus group discussions, in-depth interviews, and ethnographic interviews with 102 trial participants, 22 male partners, 17 community advisory board members, and 23 community stakeholders. We analysed how discussions of rape are emblematic of the gendered context in which HIV risk occurs. Rape emerged spontaneously in half of discussions with community advisory board members, two-thirds with stakeholders and among one-fifth of interviews/discussions with trial participants. Rape was used to reframe HIV risk as external to women’s or partner’s behaviour and to justify the importance of PrEP. Our research illustrates how women, in contexts of high levels of sexual violence, may use existing gender inequalities to negotiate PrEP use. This suggests that future interventions should simultaneously address harmful gender attitudes, as well as equip women with alternative means to negotiate product use, in order to more effectively empower women to protect themselves from HIV.

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. Keywords: HIV prevention; antiretroviral; pre-exposure prophylaxis; microbicides; adherence; South Africa; qualitative methods; HIV stigma. (Published: 8 September 2014) Citation: van der Straten A et al. Journal of the International AIDS Society 2014, 17 (Suppl 2):19146 http://www.jiasociety.org/index.php/jias/article/view/19146 | http://dx.doi.org/10.7448/IAS.17.3.19146

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.