Adolescent Girls and Young Women's Experiences with Disclosing Oral PrEP or Dapivirine Vaginal Ring Use: a Multi-Country Qualitative Analysis.

Effective use of oral pre-exposure prophylaxis (PrEP) has been low among adolescent girls and young women (AGYW) in Eastern and Southern Africa, partly due to stigma and opposition from key influencers. Understanding AGYW's experiences of disclosure of different PrEP modalities to key influencers may inform strategies to motivate uptake and adherence. We analyzed qualitative in-depth interviews and focus group discussions data from 119 participants in the MTN-034/REACH (Reversing the Epidemic in Africa with Choices in HIV Prevention) study of oral PrEP and the dapivirine vaginal ring (ring) to explore AGYW's disclosure experiences. We found that AGYW disclosure experiences varied across influencers and product type. The ring was disclosed less often to most influencers, except partners, because it was discreet. Oral PrEP was disclosed more often, because pills were more common and to avoid HIV stigma given that oral PrEP resembled HIV treatment. Ultimately, disclosure typically led most key influencers to support product use through reminders and encouragement. While disclosure yielded positive support from influencers, further community awareness of both PrEP products is essential to reduce potential opposition and perceived stigma.Clinical Trial Number: NCT03593655.

Changes in relationships, HIV risk, and feelings towards PrEP: findings from a qualitative explanatory study among participants in the CHARISMA intervention trial.

BACKGROUND: Intimate partner violence (IPV) and other relationship-based challenges have been demonstrated to reduce women's ability to use pre-exposure prophylaxis (PrEP) effectively for HIV prevention. The Community Health Clinical Model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA) intervention was designed to mitigate these challenges and increase South African women's agency to use PrEP. The CHARISMA randomized controlled trial did not identify statistically significant differences in PrEP adherence or relationship dynamics between the intervention and control arms. As such, the aim of this explanatory qualitative sub-study was to understand women's experiences with the CHARISMA trial and explore reasons for the null results. METHODS: Twelve CHARISMA trial participants were purposively selected to participate in serial in-depth interviews, which took place at the trial end and 3 months later. Participants represented individuals who had received each of the three counselling modules, 1) healthy communication counselling, 2) PrEP disclosure counselling, or 3) IPV counselling, as well as those in the control arm who received IPV standard-of-care counselling. RESULTS: A thematic case analysis revealed numerous positive relationship outcomes among intervention participants, including identifying and ending unhealthy relationships, gaining a sense of personal empowerment, and enacting more positive behaviors and HIV risk reduction strategies in subsequent relationships. These positive shifts were occasionally described as contributing to decisions to discontinue PrEP use, which may partly explain the limited impact of the intervention on PrEP adherence. CONCLUSIONS: Future investigations of counselling interventions addressing relationship-based barriers to PrEP use should account for changing risk dynamics and need for PrEP.

Ring-ing in the Future: Participant and Male Partner Perspectives Regarding Future Use of the Dapivirine Vaginal Ring for HIV Prevention.

Women account for a disproportionate percentage of new HIV infections in sub-Saharan Africa indicating a need for female-initiated HIV prevention options congruent with their lifestyles. The dapivirine vaginal ring for HIV prevention is one such option. We explored the interest of women, who used this ring during the Microbicide Trials Network's ASPIRE and HOPE studies, in using the ring post-licensure and what they perceived as important considerations for future use. We also explored perspectives of HOPE participants' male partners on their involvement in their partners' future ring use. Women appeared keen to use the ring in the future and expressed desires for easy access, support for both ongoing and new users and intense community engagement. In parallel, male partners indicated high levels of interest in supporting their partners' ring use and being involved in ring use decision making. These data offer important insights for ring rollout planning and engagement activities.

Men's Sexual Experiences with the Dapivirine Vaginal Ring in Malawi, South Africa, Uganda and Zimbabwe.

The dapivirine vaginal ring has been well-tolerated and shown to prevent HIV in clinical trials. The ring is female initiated, yet endorsement for use is sought from male partners in many relationships. In clinical studies, participants have expressed worries about men detecting rings during vaginal sex, which introduces concerns about product use disclosure, sexual pleasure, penile harm, inter-partner dynamics, and ring removals. This study reports African men's firsthand sexual experiences with the ring. Qualitative data were captured through 11 focus group discussions and one in-depth interview with 54 male partners of ring-users at six research sites in Malawi, South Africa, Uganda and Zimbabwe. Following a semi-structured guide, and using demonstration rings, vulva and penis models, men were asked to discuss the ring's impact on sex and views on male engagement and ring use. Interviews were facilitated by local male social scientists, audio-recorded, translated into English, and analyzed thematically. 22 (41%) of the male partners reported feeling the ring during sex, often attributed to perceived incorrect insertion. Many men described the ring as "scratching" the tip of their penises, and sensations of "prodding" something that "blocked" the vagina and prohibited "full entry". In most cases, feelings dissipated with time or when sexual fluids increased. Less common descriptions included perceiving the vaginal texture, wetness and size as different, which increased pleasure for some, and decreased for others. Over half (59%) never noticed the ring; some attempting and failing to feel it during intercourse. A majority of men reported that the ring did not lead to changes in sexual positions, feelings, frequency or experience of sex, although some were initially afraid that the ring was a "magic snake" or "potion". Male partners expressed strong opinions that ring use was a shared prevention responsibility that men should be engaged in, especially for maintaining trust and open communication in relationships. The ring was noticed by many male partners, particularly during women's initial stages of ring use, although this led to few sexual problems or changes. Nevertheless, results suggest that risk of ring discovery should be discussed with women to mitigate any potential negative reactions or social harm. Strategies to increase male partner engagement will enhance support of this prevention method for women.

The relationship between vaginal ring use and intimate partner violence and social harms: formative research outcomes from the CHARISMA study in Johannesburg, South Africa.

Despite being designed for autonomous use, research suggests partner approval is often in women's microbicide use. Microbicide study participants have described many ways product use affects relationships, from improving sexual pleasure to increasing harm, including exacerbating intimate partner violence (IPV). As the dapivirine ring proceeds closer to licensure, supporting women's agency to use microbicides safely is a priority. We conducted 42 in-depth interviews with former participants of the Microbicide Trials Network (MTN)-020 trial of the dapivirine vaginal ring and their male partners in Johannesburg, South Africa, to explore how ring use and partnership dynamics interacted. We sampled women who reported harms or partner non-support and women with supportive partners. Male and female narratives revealed high background levels of IPV. Women described how study participation/ring use exacerbated violence, and for a few couples served as a rationale for additional abuse. In response, women described feeling powerless and fearful of conflict, resulting in product nonuse. For one participant violence was reduced, and for several others, empowerment was sparked. These findings suggest future providers have the opportunity to shift more women from a place of fear/violence to one of safety/empowerment through the integration of IPV screening and relationship counselling.

The impact of COVID-19 on sexual behavior, HIV prevention interest, general healthcare access, and other HIV risk factors among trial participants in Malawi, South Africa, Uganda, and Zimbabwe.

Introduction: The COVID-19 pandemic greatly impacted HIV prevention and care globally. The pandemic also had disproportionate impacts on the financial, emotional, and physical wellbeing of women and girls in East and Southern Africa, who were already at increased HIV vulnerability. This study aimed to understand how the COVID-19 pandemic and its response efforts impacted the sexual behavior, HIV prevention interest, general healthcare access, and other HIV risk factors of women and girls in HIV prevention studies. Methods: Using the socio-ecological model (SEM), an explanatory sequential mixed-methods analysis was performed with data from four Microbicide Trial Network (MTN) studies on different populations-adolescent girls and young women (AGYW), pregnant persons, breastfeeding persons, and couples-in Malawi, South Africa, Uganda, and Zimbabwe. Descriptive statistics for outcomes of interest were calculated within each study separately and Chi-squared tests of independence were performed to evaluate associations between study population and outcomes. Excerpts from study qualitative interviews were stratified into code reports which were then summarized into memos with key themes and considerations of the SEM framework to provide context to quantitative findings. Results: Few participants (8/731) had known or suspected COVID-19 infection. Sexual frequency and alcohol use decreased most often among AGYW compared to pregnant or breastfeeding women and couples (p-value < 0.001). The pandemic had little impact on changes in reported HIV prevention interest or access to HIV prevention study products. Healthcare access was impacted for everyone, with couples most likely to report decreases in access (p-value < 0.001). From qualitative interviews, economic instability, adverse mental health, and increased violence due to COVID-19 caused increased strain on other factors related to HIV vulnerability. Conclusions: While interest in HIV prevention did not change and a few HIV risks decreased for most women and girls, other vulnerabilities to HIV increased due to the COVID-19 pandemic, highlighting the importance of continued access to HIV prevention for women and girls. More research is needed to better understand the long-term impact of COVID-19 on HIV prevention and vulnerability in community populations.

Development of a relationship counselling website to identify and mitigate risk of intimate partner violence in the context of women's PrEP use.

Discreet, accessible interventions are urgently needed to mitigate the risk of intimate-partner violence (IPV) and other relationship barriers that women encounter to using HIV prevention methods such as pre-exposure prophylaxis (PrEP). We adapted a counsellor-administered intervention, CHARISMA, into a mobile-optimized website to enhance accessibility and reduce human resources required for HIV prevention and relationship counseling. Using human-centered design and participatory methods, CHARISMA was adapted through workshops with former CHARISMA in-person intervention participants (n = 14; ages 18-45) and web development 'sprints' combined with cognitive interviews (n = 24). 'CHARISMA mobile' was then beta-tested with 81 women naïve to the in-person intervention. In beta-testing, participants used a 'think aloud' process to provide feedback on ease of use and rated design, functionality, comprehension, confidentiality, safety, and usefulness on a scale of 1 to 5 via a survey. Data were conducted in four rounds, interspersed with rapid assessment according to go/no-go criteria, and website adaptations. The updated website was pilot tested for 'real-world' feasibility and acceptability among 159 women using their own smartphones at a location of their choice. Feedback was measured via surveys and website analytics. Workshops and cognitive interviews generated insights on technology use, contextual adaptations, and confidentiality, which were integrated into the beta version. The beta version met all 'go' criteria and was further adapted for pilot testing. In pilot testing, users found the website was useful (mean rating 4.54 out of 5), safe (4.5 out of 5), and had few concerns about confidentiality (1.75, representing low concern). On average, users rated the website more than 4 stars out of 5. Beta and pilot-testing suggested the smartphone-optimized website was well-accepted, relevant, engaging, feasible to administer, discreet and safe. Results contributed to a refined website, suitable for adaptations to other contexts and further evaluation where outcomes related to PrEP use and relationships should be assessed.

''Ask the way from those who have walked it before"-Grandmothers' roles in health-related decision making and HIV pre-exposure prophylaxis use among pregnant and breastfeeding women in sub-Saharan Africa.

HIV acquisition among pregnant and breastfeeding women in sub-Saharan Africa and vertical transmission rates remain high despite established strategies for HIV prevention. During the MTN-041/MAMMA study, we explored the influence of grandmothers (mothers and mothers-in-law of pregnant and breastfeeding women) in eastern and southern Africa on the health-related decisions of pregnant and breastfeeding women and their potential to support use of HIV prevention products. To do this we used structured questionnaires and focus group discussions with three stakeholder groups: 1) grandmothers, 2) HIV-uninfected currently or recently pregnant or breastfeeding women and 3) male partners of currently or recently pregnant or breastfeeding women. A total of 23 focus group discussions comprising 68 grandmothers, 65 pregnant or breastfeeding women and 63 male partners were completed across four study sites. Grandmothers were described as important sources of information during pregnancy and breastfeeding playing both supportive and influencer roles due to personal maternal experience and generational knowledge. While pregnant and breastfeeding women were not keen to involve grandmothers in HIV prevention decision making, they were accepting of grandmothers' involvement in a supportive role. Grandmothers expressed willingness to support pre-exposure prophylaxis use and agreed with the other two stakeholder groups that this decision should be made by women themselves or together with partners. These novel data indicate potential for grandmothers' health related supportive roles to be extended to support decision-making and adherence to biomedical HIV prevention options, and possibly contribute to the decline in HIV acquisition among pregnant and breastfeeding women in these communities.

Evidence for use of a healthy relationships assessment tool in the CHARISMA pilot study.

INTRODUCTION: The CHARISMA intervention, nested within the MTN-025/HOPE vaginal ring trial in Johannesburg, South Africa, seeks to facilitate women's use of HIV prevention products by promoting partner dialogue and mitigating intimate partner violence (IPV). We developed "HEART", a lay counselor-administered relationship assessment tool, for the CHARISMA pilot. The five-scale tool assesses participants' endorsement of Traditional Values (TV), her HIV Prevention Readiness (HPR) and levels of partner support (PS), abuse and control (PAC), and resistance to HIV prevention (PR), guiding decisions about which of three counselling modules to offer (partner communication/A; ring disclosure/B; and IPV prevention/C). METHODS: We correlated baseline scores on HEART subscales with a) independent measures of relationship stability, disclosure and IPV to assess construct validity, and b) with specific modules offered to determine how HEART was used in the pilot. We examined changes in HEART scores at three and six months. Finally, we ran separate growth models for each subscale to examine changes in scores, accounting for partnership changes and counseling module(s) received. RESULTS: Baseline HEART scores correlated as predicted among subscales and with other measures. Reliabilities for four subscales were 0.75 or higher. Women who disclosed study participation and ring use scored higher on PS and lower on PR. Women experiencing IPV scored lower on PS, and higher on PAC and PR. During the pilot, 82% of women received one and 17% received two or more modules; over half received the IPV module. Women with higher PAC and PR scores were more likely to receive the IPV than the communication or disclosure modules. Over time, the TV, PAC and PR scores decreased, and PS score increased. Receiving the IPV module was associated with a decreased PAC score. CONCLUSIONS: These data offer preliminary evidence for HEART construct and predictive validity and support its further evaluation to guide implementation and monitor the impact of the CHARISMA intervention in a randomized controlled evaluation.

Online socializing among men who have sex with men and transgender people in Nairobi and Johannesburg and implications for public health-related research and health promotion: an analysis of qualitative and respondent-driven sampling survey data.

INTRODUCTION: There is little published literature about gay, bisexual and other men who have sex with men and transgender individuals (MSM and TG)'s use of social media in sub-Saharan Africa, despite repressive social and/or criminalizing contexts that limit access to physical HIV prevention. We sought to describe MSM and TG's online socializing in Nairobi and Johannesburg, identifying the characteristics of those socializing online and those not, in order to inform the development of research and health promotion in online environments. METHODS: Respondent-driven sampling surveys were conducted in 2017 in Nairobi (n = 618) and Johannesburg (n = 301) with those reporting current male gender identity or male sex assigned at birth and sex with a man in the last 12 months. Online socializing patterns, sociodemographic, sexual behaviour and HIV-testing data were collected. We examined associations between social media use and sociodemographic characteristics and sexual behaviours among all, and only those HIV-uninfected, using logistic regression. Analyses were RDS-II weighted. Thirty qualitative interviews were conducted with MSM and TG in each city, which examined the broader context of and motivations for social media use. RESULTS: Most MSM and TG had used social media to socialize with MSM in the last month (60% Johannesburg, 71% Nairobi), mostly using generic platforms (e.g. Facebook), but also gay-specific (e.g. Grindr). HIV-uninfected MSM and TG reporting riskier recent sexual behaviours had raised odds of social media use in Nairobi, including receptive anal intercourse (adjusted OR = 2.15, p = 0.006), buying (aOR = 2.24, p = 0.015) and selling sex with men (aOR = 2.17, p = 0.004). Evidence for these associations was weaker in Johannesburg, though socializing online was associated with condomless anal intercourse (aOR = 3.67, p = 0.003) and active syphilis (aOR = 13.50, p = 0.016). Qualitative findings indicated that while online socializing can limit risk of harm inherent in face-to-face interactions, novel challenges were introduced, including context collapse and a fear of blackmail. CONCLUSIONS: Most MSM and TG in these cities socialize online regularly. Users reported HIV acquisition risk behaviours, yet this space is not fully utilized for sexual health promotion and research engagement. Effective, safe and acceptable means of using online channels to engage with MSM/TG that account for MSM and TG's strategies and concerns for managing online security should now be explored, as complements or alternatives to existing outreach.

Development and initial validation of a simple tool to screen for partner support or opposition to HIV prevention product use.

In HIV prevention trials, male partners have influenced women's ability to adhere to investigational products, including antiretroviral (ARV) containing vaginal rings. Validated scales can be useful tools to systematically measure complex constructs, such as those related to male partner engagement. Although multiple scales exist to assess physical, psychological and sexual violence within intimate relationships, fewer scales focus on supportive behaviors within these relationships. Our intervention involved development of a Healthy Relationship Assessment Tool (HEART) that assessed both positive and negative aspects of male partner involvement in women's HIV prevention. We identified and refined 127 potential items, representing intimate partner violence, agency and social support. A structured survey, including potential items and other sociodemographic and behavioral variables was administered to former microbicide trial and non-trial participants. We conducted an exploratory factor analysis (EFA) to identify a reduced set of constructs and items to screen women who might experience social harms or benefits from vaginal ring use. We examined associations between constructs and with other survey variables to assess content and construct validity. In a subset of 10 women who participated in the survey and qualitative interviews, we used qualitative data to predict survey scores. We retained five constructs with theoretical relevance and good-to-strong reliability for the tool, including: Traditional Values; Partner Support; Partner Abuse & Control; Partner Resistance to HIV Prevention; and HIV Prevention Readiness. Predicted associations between HEART constructs, and correspondence between participants' qualitative data and HEART scores were generally correct, while those between constructs and other sociodemographic variables were more mixed. Initial validation of the HEART tool was promising. The tool will be used during the CHARISMA pilot study at the Johannesburg MTN 025/HOPE site and validated as part of a randomized controlled trial of CHARISMA within a PrEP demonstration project. Beyond clinical trial settings, HEART could assist PrEP or antiretroviral treatment (ART) providers with an easy-to-administer tool to identify risk and tailor risk reduction, empowerment and adherence counseling for microbicides, PrEP or ART related services.

HIV testing, care and viral suppression among men who have sex with men and transgender individuals in Johannesburg, South Africa.

INTRODUCTION: Men who have sex with men and transgender individuals (MSM/TG) carry a disproportionately high burden of HIV, including in South Africa. However, there are few empirical population-representative estimates of viral suppression and the HIV care cascade including HIV testing among this population, nor of factors associated with these outcomes. METHODS: We conducted a respondent driven sampling (RDS) survey among 301 MSM/TG in Johannesburg in 2017. Participants gave blood samples for HIV testing and viral load. Participants self-completed a survey including sociodemographics, HIV testing history, and engagement in care. We calculated RDS-II weighted estimates of the percentage of HIV-negative MSM/TG reporting HIV testing in the previous 6 months, their testing experience and preferences. Among those HIV-positive, we estimated the percentage status-aware, on ART, and virally suppressed (<50 viral copies/ml plasma). We conducted RDS-weighted robust Poisson regression to obtain weighted prevalence ratios of factors associated with 1) HIV testing among those HIV-negative; and 2) viral suppression among those HIV-positive. RESULTS: There were 118/300 HIV-positive MSM/TG, (37.5%). Of the HIV-negative MSM/TG, 61.5% reported that they had tested for HIV in the previous 6 months, which was associated with selling sex to men (Prevalence Ratio = 1.67, 95% CI 1.36-2.05). There were 76/118 HIV-positive MSM/TG (56.5%) who reported having previously tested positive for HIV and 39/118 (30.0%) who reported current ART. There were 58/118 HIV-positive MSM/TG with viral loads <50 copies/ml plasma (46.9%). Viral suppression was associated with older age (adjusted PR = 1.03, 95% CI 1.00-1.06 for each year), neighbourhood, and having bought sex from men (adjusted PR = 1.53, 95% CI 1.12-2.08). CONCLUSIONS: HIV prevalence was very high. Viral suppression among those HIV-positive was similar to the general male population in South Africa, but remains far short of national and international targets. A majority of HIV-negative MSM/TG had HIV tested in the previous 6 months, though there is room for improvement.