The development of a conceptual framework on PrEP stigma among adolescent girls and young women in sub-Saharan Africa.

INTRODUCTION: Stigma is a well-known barrier to HIV testing and treatment and is an emerging barrier to pre-exposure prophylaxis (PrEP) use. To guide future research, measurement and interventions, we developed a conceptual framework for PrEP stigma among adolescent girls and young women (AGYW) in sub-Saharan Africa, a priority population for PrEP. METHODS: A literature review, expert consultations and focus group discussions (FGDs) were conducted to adapt the Health Stigma and Discrimination Framework, describing the stigmatization process nested within the socio-ecological framework. We reviewed all articles on PrEP stigma and on HIV, contraceptive or sexuality stigma among AGYW from 2009 to 2019. Expert consultations were conducted with 10 stigma or PrEP researchers and two Kenyan youth advisory boards to revise the framework. Finally, FGDs were conducted with AGYW PrEP users (4 FGDs; n = 20) and key influencers (14 FGDs; n = 72) in Kenya with the help of a Youth Research Team who aided in FGD conduct and results interpretation. Results from each phase were reviewed and the framework was updated to incorporate new and divergent findings. This was validated against an updated literature search from 2020 to 2023. RESULTS: The conceptual framework identifies potential drivers, facilitators and manifestations of PrEP stigma, its outcomes and health impacts, and relevant intersecting stigmas. The main findings include: (1) PrEP stigma is driven by HIV, gender and sexuality stigmas, and low PrEP community awareness. (2) Stigma is facilitated by factors at multiple levels: policy (e.g. targeting of PrEP to high-risk populations), health systems (e.g. youth-friendly service availability), community (e.g. social capital) and individual (e.g. empowerment). (3) Similar to other stigmas, manifestations include labelling, violence and shame. (4) PrEP stigma results in decreased access to and acceptability of PrEP, limited social support and community resistance, which can impact mental health and decrease PrEP uptake and adherence. (5) Stigma may engender resilience by motivating AGYW to think of PrEP as an exercise in personal agency. CONCLUSIONS: Our PrEP stigma conceptual framework highlights potential intervention targets at multiple levels in the stigmatization process. Its adoption would enable researchers to develop standardized measures and compare stigma across timepoints and populations as well as design and evaluate interventions.

Breaking down relationship barriers to increase PrEP uptake and adherence among adolescent girls and young women in Kenya: safety and preliminary effectiveness results from a pilot cluster-randomized trial.

INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) has the potential to reduce HIV acquisition among adolescent girls and young women (AGYW) in sub-Saharan Africa, a priority population for epidemic control. However, intimate partner violence (IPV) and low relationship power can create significant challenges to PrEP use. The Tu'Washindi intervention aimed to increase PrEP use by addressing relationship- and violence-related barriers among AGYW enrolled in the DREAMS Initiative in Siaya County, Kenya. METHODS: Our multi-level, community-based intervention was piloted in a cluster-randomized controlled trial conducted at six DREAMS sites from April to December 2019 (NCT03938818). Three intervention components were delivered over 6 months: an eight-session empowerment-based support club, community sensitization targeted towards male partners and a couples' PrEP education event. Participants were ages 17-24, HIV negative and either eligible for, or already taking, PrEP. Over 6 months of follow-up, we assessed IPV (months 3 and 6) and PrEP uptake and continuation (month 6) through interviewer-administered questionnaires; PrEP adherence was assessed with Wisepill electronic monitoring devices. These outcomes were compared using adjusted Poisson and negative binomial regression models. RESULTS: We enrolled 103 AGYW with median age of 22 years (IQR 20-23); one-third were currently taking PrEP and 45% reported IPV in the past 3 months. Retention was 97% at month 6. Compared to the control arm, intervention arm participants were more likely to initiate PrEP, if not already using it at enrolment (52% vs. 24%, aRR 2.28, 95% CI 1.19-4.38, p = 0.01), and those taking PrEP had more days with device openings (25% of days vs. 13%, aRR 1.94, 95% CI 1.16-3.25, p = 0.01). Twenty percent of participants reported IPV during follow-up. There were trends towards fewer IPV events (aIRR 0.66, 95% CI 0.27-1.62, p = 0.37) and fewer events resulting in injury (aIRR 0.21, 95% CI 0.04-1.02, p = 0.05) in the intervention versus control arm. CONCLUSIONS: Tu'Washindi shows promise in promoting PrEP uptake and adherence among AGYW without concomitant increases in IPV; however, adherence was still suboptimal. Further research is needed to determine whether these gains translate to increases in the proportion of AGYW with protective levels of PrEP adherence and to evaluate the potential for the intervention to reduce IPV risk.

Family influences on oral PrEP use among adolescent girls and young women in Kenya and South Africa.

INTRODUCTION: Effective use of oral HIV pre-exposure prophylaxis (PrEP) has been lower among African adolescent girls and young women (AGYW) than among older women, young men who have sex with men, and serodiscordant heterosexual couples in the region. Efforts to build PrEP support have centered around peers and male partners, but the family may also play an important role. This qualitative study aimed to describe family influence on PrEP use among AGYW in in three African cities. METHODS: POWER (Prevention Options for Women Evaluation Research) was a PrEP demonstration project among 2550 AGYW (16-25 years old) in Johannesburg and Cape Town, South Africa and Kisumu, Kenya conducted from 2017 to 2020. In-depth interviews and focus group discussions were conducted with 136 AGYW participants to explore their PrEP views and experiences, including awareness and interest in PrEP; barriers and facilitators to uptake and use; the influence of family, peers, intimate partners, and community; and the key types of support for their PrEP use. Transcripts were coded and analysed thematically. RESULTS: The decision to initiate PrEP was associated with fear and anxiety linked to anticipated stigma from family members, and with family's lived HIV experience. Family disclosure, especially to mothers, was important to participants, as most lived with their families and considered it essential for them to obtain their mother's approval to use PrEP. Most family members, particularly mothers, provided instrumental, emotional, informational and appraisal support to participants using PrEP, including reminders, encouragement, and problem-solving. Participants reported that family members with insufficient information about PrEP safety and efficacy and who voiced concerns were a substantial barrier to their use. However, they often became supportive after receiving more PrEP information. CONCLUSION: Families, particularly mothers, can play an important role in supporting PrEP use. PrEP programmes should leverage family support to help with PrEP persistence by providing basic information to families about PrEP safety and efficacy. AGYW using PrEP should be encouraged to selectively disclose PrEP use to build support and counseled on how to disclose and address family concerns.

How a menu of adherence support strategies facilitated high adherence to HIV prevention products among adolescent girls and young women in sub-Saharan Africa: a mixed methods analysis.

INTRODUCTION: Effective use of pre-exposure prophylaxis (PrEP) has been low among adolescent girls and young women (AGYW) in sub-Saharan Africa. The MTN-034/REACH trial offered AGYW a menu of adherence support strategies and achieved high adherence to both daily oral PrEP and the monthly dapivirine vaginal ring. Understanding how these strategies promoted product use could inform the design of adherence support systems in programmatic settings. METHODS: REACH was a randomized crossover trial evaluating the safety of and adherence to the ring and oral PrEP among 247 HIV-negative AGYW (ages 16-21) in South Africa, Uganda and Zimbabwe from January 2019 to September 2021 (NCT03593655). Adherence support included monthly counselling sessions with drug-level feedback (DLF) plus optional daily short message service (SMS) reminders, weekly phone or SMS check-ins, peer support clubs, "peer buddies" and additional counselling. Counsellors documented adherence support choices and counselling content on standardized forms. Through focus groups, serial in-depth interviews (IDIs) and single IDIs (n = 119 total), we explored participants' experiences with adherence support and how it encouraged product use. RESULTS: Participants received counselling at nearly all visits. DLF was provided at 54.3% of sessions and, across sites, 49%-68% received results showing high adherence for oral PrEP, and 73%-89% for the ring. The most popular support strategies were in-person clubs and weekly calls, followed by online clubs, additional counselling and SMS. Preferences differed across sites but were similar for both products. Qualitative results demonstrated that the REACH strategies supported adherence by providing information about HIV and PrEP, continually motivating participants, and supporting the development of behavioural skills and self-efficacy, aligning with the Information, Motivation, and Behavioural Skills (IMB) model. Effectiveness was supported by three foundational pillars: strong interpersonal relationships with counsellors; ongoing, easily accessible support and resources; and establishing trust in the counsellors and study products through counsellor relationships, peer-to-peer exchange and DLF. CONCLUSIONS: Implementation programmes could support effective PrEP use by offering a small menu of counsellor- and peer-based support options that are youth-friendly and developmentally appropriate. The same menu options can support both ring and oral PrEP users, though content should be tailored to the individual products.

Measuring Effects of Counseling to Increase Pre-Exposure Prophylaxis Adherence and Partner Support in South Africa Using the Healthy Relationship Assessment Tool.

INTRODUCTION: In response to the diverse roles and strong influence that male partners may have in women's decisions and ability to use HIV prevention products, we previously developed the counselor-administered Healthy Relationship Assessment Tool (HEART). This tool helps counselors tailor pre-exposure prophylaxis (PrEP) adherence support counseling to women's relationship dynamics with their sexual partners, suggesting modules for counselors to deliver. In this study, we examined the extent to which counselors used the HEART to guide the delivery of intervention modules and whether changes in subsequent HEART scores reflected the counseling module(s) received. METHODS: We conducted this study during a randomized controlled trial of the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence (CHARISMA) counseling intervention in Johannesburg, South Africa. Trained lay counselors administered the HEART to intervention group participants at enrollment (n=203) and at 3- and 6-month follow-up visits between October 2018 and April 2021. The HEART auto-calculated participants' response scores to recommend relevant counseling modules. We compared the mean scores for the 5 HEART scales across groups receiving different counseling modules. We also assessed changes in scale scores over time by the counseling module received. RESULTS: Although counselors could override HEART counseling module recommendations based on additional knowledge of participants' cases, they consistently agreed with the HEART recommendations. The HEART also triggered the sorting of women into counseling modules that they were positioned to successfully leverage. Additionally, participants' HEART scores changed over time in predictable ways based on the type of counseling module received. CONCLUSION: Overall, the tool performed as predicted and was consistent with past validation efforts of the HEART, indicating that the HEART may provide an efficient means to tailor women's counseling to address relationship-related challenges to PrEP adherence.

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.

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.

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.

Association of sexual relationship power with PrEP persistence and other sexual health outcomes among adolescent and young women in Kenya and South Africa.

Introduction: Gendered power inequalities impact adolescent girls' and young women's (AGYW) sexual and reproductive health (SRH) outcomes. We investigated the influence of sexual relationship power on AGYW's SRH outcomes, including HIV pre-exposure prophylaxis (PrEP) persistence. Methods: The POWER study in Kisumu, Kenya, and Cape Town and Johannesburg, South Africa provided PrEP to 2,550 AGYW (aged 16-25). AGYW's perceived power in their primary sexual relationship was measured among the first 596 participants enrolled using the Sexual Relationship Power Scale's (SRPS) relationship control sub-scale. Multivariable regression was used to test for (1) key sociodemographic and relationship characteristics associated with relationship power; and (2) the association of relationship power with SRH outcomes including PrEP persistence. Results: In this cohort, the mean SRPS score was 2.56 (0.49), 542 (90.9%) initiated PrEP; 192 (35.4%) persisted with PrEP at 1 month of which 46 (24.0% of 192) persisted at 6 months. SRPS were significantly lower among AGYW who cohabited with their sex partner (-0.14, 95% CI: -0.24 to -0.04, p = 0.01), or had ≥1 sex partner (-0.10, 95% CI: -0.19 to -0.00, p = 0.05). AGYW with lower SRPS were more likely to not know their partner's HIV status (aOR 2.05, 95% CI: 1.27 to 3.33, p < 0.01), but SRPS was not associated with PrEP persistence, STI infection, condom, or hormonal contraception use. Discussion: AGYW's reasons for initiating PrEP and reasons for continuously using PrEP may be different. While low relationship power was associated with perceived HIV vulnerability, AGYW's PrEP persistence may be influenced by more than relationship power.

Baseline preferences for oral pre-exposure prophylaxis (PrEP) or dapivirine intravaginal ring for HIV prevention among adolescent girls and young women in South Africa, Uganda and Zimbabwe (MTN-034/IPM-045 study).

INTRODUCTION: Adolescent girls and young women (AGYW) in sub-Saharan Africa are disproportionately affected by the HIV epidemic and face an array of challenges using proven behavioral and biomedical prevention methods. To address the urgent need for expanding prevention options, we evaluated the baseline preferences of HIV prevention methods among participants enrolled in the MTN-034/REACH crossover trial along with their stated product preference prior to product initiation. METHODS: AGYW aged 16-21 years were enrolled at 4 study sites: Cape Town and Johannesburg, South Africa; Kampala, Uganda; and Harare, Zimbabwe and randomly assigned to the sequence of using oral PrEP and the dapivirine ring for 6 months each, followed by a choice period in which they could choose either product (or neither) for an additional six months. Eligible AGYW were HIV-negative, not pregnant and using effective contraception for at least two months prior to enrollment. Descriptive statistics were used to summarize demographic and behavioral data while multinomial analysis was used to determine predictors of stated product preference (ring or oral PrEP). RESULTS: Of the 247 AGYW enrolled in REACH, 34% were aged 16-17 and 89% had a primary partner.The median age of sexual debut was 16 years and 40% had ever been pregnant. At screening, 35% of participants were diagnosed with a sexually transmitted infection (STI), 39% had an AUDIT-C score associated with harmful drinking and 11% reported intimate partner violence in the past 6 months. Overall, 28% of participants, had CESD-10 scores suggestive of depressive symptoms (≥12) in the past week. At baseline, similar proportions stated a preference for the ring and oral PrEP (38.1% and 40.5% respectively), with 19% of participants stating they preferred both products equally. Only study site was significantly associated with product preference (P<0.05) with AGYW from Johannesburg having higher odds of preferring the ring and those from Kampala having higher odds of preferring both options equally. CONCLUSIONS: We successfully enrolled African AGYW with a clear unmet need for HIV prevention. The balanced preference between the two products suggests that multiple biomedical prevention options may be appealing to this age group and could address their prevention needs.

Integrating Adolescent Mental Health into HIV Prevention and Treatment Programs: Can Implementation Science Pave the Path Forward?

Adolescent mental health (AMH) is a critical driver of HIV outcomes, but is often overlooked in HIV research and programming. The implementation science Exploration, Preparation, Implementation, Sustainment (EPIS) framework informed development of a questionnaire that was sent to a global alliance of adolescent HIV researchers, providers, and implementors working in sub-Saharan Africa with the aim to (1) describe current AMH outcomes incorporated into HIV research within the alliance; (2) identify determinants (barriers/gaps) of integrating AMH into HIV research and care; and (3) describe current AMH screening and referral systems in adolescent HIV programs in sub-Saharan Africa. Respondents reported on fourteen named studies that included AMH outcomes in HIV research. Barriers to AMH integration in HIV research and care programs were explored with suggested implementation science strategies to achieve the goal of integrated and sustained mental health services within adolescent HIV programs.

Examining Associations Between Mental Health, IPV Exposure, HIV Risk Behaviors, and PrEP Use in South African Women: An Analysis of Data from the Charisma Study.

Intimate partner violence (IPV) has been associated with poorer mental health outcomes and increased human immunodeficiency virus (HIV) risk behaviors. We examine the relations between IPV, mental health symptomology (defined as psychological distress and alcohol misuse), and engagement in HIV risk behaviors among a sample of South African women who participated in a randomized controlled trial of CHARISMA, an intervention to increase women's agency to use oral pre-exposure prophylaxis (PrEP) safely and consistently as well as mitigate relationship challenges. We also examined the impact of trial participation on women's mental health, as well as the impact of psychological distress on the effectiveness of the CHARISMA intervention. Mental health symptomology and IPV exposure were prevalent and associated with some HIV risk and protective behaviors. Trial participation reduced psychological distress. There was no evidence for mental health symptomology impacting the effectiveness of the CHARISMA intervention.

Assessing Engagement of Adolescents and Young Adults (AYA) in HIV Research: A Multi-method Analysis of a Crowdsourcing Open Call and Typology of AYA Engagement in Sub-Saharan Africa.

Engagement of adolescents and young adults (AYA) in HIV research is increasing in many settings. We organized a crowdsourcing open call to solicit examples of how AYA have been engaged in HIV research in Africa and to develop an engagement typology. We formed a steering committee, promoted the open call, organized judging and recognized finalists. We used a multi-methods approach to identify emerging themes and measure engagement. We received 95 entries from individuals in 15 countries; 74 met the eligibility criteria. More than three-quarters of entries were from AYA (55/74, 74%). Four themes characterized AYA engagement: (1) AYA were co-creators in the HIV research process. (2) AYA were involved in community-level capacity building. (3) AYA were co-leaders in minor risk research. (4) AYA used digital methods to enhance engagement. Our open call identified diverse methods of AYA engagement, which can enhance strategies used to reach AYA in African HIV studies.

Intimate Partner Violence and Engagement in the HIV Care Continuum among Women in Sub-Saharan Africa: A Prospective Cohort Study.

Research suggests that women's experience of intimate partner violence (IPV) is associated with poor engagement in HIV care and treatment. However, most studies have been cross-sectional and conducted in North America. We examined the association between physical IPV and HIV care outcomes in a prospective cohort study of women living with HIV (WLHIV) in Malawi, South Africa, Uganda, and Zimbabwe. At enrollment, 15% of the 351 participants self-reported physical IPV. IPV experience was not associated with time to first engagement in HIV care or the proportion virally suppressed after 6 months on ART. Women reporting physical IPV were less likely to initiate ART within 6 months of becoming eligible (adjusted RR 0.74, 95% CI 0.53-1.03). IPV screening is critical to identify survivors and link them to appropriate services. However, addressing IPV may not increase engagement in HIV care or viral load suppression among WLHIV in sub-Saharan Africa.

Integrating Gender-Based Violence Screening and Support into the Research Clinic Setting: Experiences from an HIV Prevention Open-Label Extension Trial in Sub-Saharan Africa.

HIV and gender-based violence (GBV) are syndemic in sub-Saharan Africa and provision of support for participants who disclose GBV constitutes part of comprehensive care. Consequently, a process was undertaken to develop, implement, and evaluate standard operating procedures (SOPs) in MTN-025/HOPE, a study of the dapivirine vaginal ring for HIV prevention. The SOP was developed using needs assessment surveys in addition to World Health Organization (WHO) guidelines and other literature. Sites tailored and implemented the SOP through HOPE implementation. At study end, staff reported increased training 32/35 (91.43%); improved confidence (18/26; 69.23%); and improved vicarious trauma prevention onsite (17/28; 60.71%). Leadership reported increased staff competence in GBV response. Obstacles included limited referral organizations and time for follow-up, continued training needs, and cultural norms. Development and implementation of an SOP is a feasible strategy to build a GBV response to improve health systems and support sustained effective use of HIV prevention products.

Health worker perceptions of stigma towards Zambian adolescent girls and young women: a qualitative study.

BACKGROUND: The high prevalence of HIV among adolescent girls and young women aged 15-24 in Eastern and Southern Africa indicates a substantial need for accessible HIV prevention and treatment services in this population. Amidst this need, Zambia has yet to meet global testing and treatment targets among adolescent girls and young women living with HIV. Increasing access to timely, high-quality HIV services in this population requires addressing the intensified anticipated and experienced stigma that adolescent girls and young women often face when seeking HIV care, particularly stigma in the health facility setting. To better understand the multi-level drivers and manifestations of health facility stigma, we explored health workers' perceptions of clinic- and community-level stigma against adolescent girls and young women seeking sexual and reproductive health, including HIV, services in Lusaka, Zambia. METHODS: We conducted 18 in-depth interviews in August 2020 with clinical and non-clinical health workers across six health facilities in urban and peri-urban Lusaka. Data were coded in Dedoose and thematically analyzed. RESULTS: Health workers reported observing manifestations of stigma driven by attitudes, awareness, and institutional environment. Clinic-level stigma often mirrored community-level stigma. Health workers clearly described the negative impacts of stigma for adolescent girls and young women and seemed to generally express a desire to avoid stigmatization. Despite this lack of intent to stigmatize, results suggest that community influence perpetuates a lingering presence of stigma, although often unrecognized and unintended, in health workers and clinics. CONCLUSIONS: These findings demonstrate the overlap in health workers' clinic and community roles and suggest the need for multi-level stigma-reduction approaches that address the influence of community norms on health facility stigma. Stigma-reduction interventions should aim to move beyond fostering basic knowledge about stigma to encouraging critical thinking about internal beliefs and community influence and how these may manifest, often unconsciously, in service delivery to adolescent girls and young women.

"I didn't support PrEP because I didn't know what it was": Inadequate information undermines male partner support for young women's pre-exposure prophylaxis use in western Kenya.

The HIV infection rate is higher among adolescent girls and young women (AGYW) in Africa than men in the same age range. Pre-exposure prophylaxis (PrEP) can be used by women discreetly; however, for most AGYW, male partner approval is desired. We explored PrEP use in the context of relationship violence and power dynamics through focus group discussions and support club sessions with AGYW, in-depth interviews and male sensitisation sessions with male partners of AGYW, and joint sessions with AGYW and their male partners. Many male partners reported hesitancy in supporting partner's PrEP use without sufficient information; most of these became supportive following their engagement in study activities; and most preferred participation in decisions around PrEP use. For AGYW, male involvement minimised partner violence around their PrEP use. The findings support the need for correct PrEP information to be provided to male partners of AGYW and to involve them early on, in decision-making about PrEP use. This is likely to improve uptake of and adherence to PrEP.

The CHARISMA Randomized Controlled Trial: A Relationship-Focused Counseling Intervention Integrated Within Oral PrEP Delivery for HIV Prevention Among Women in Johannesburg, South Africa.

BACKGROUND: Consistent use of oral pre-exposure prophylaxis (PrEP) has been a challenge among women, particularly when in relationships with lack of partner support or intimate partner violence (IPV). METHODS: We conducted a randomized controlled trial (RCT) of an empowerment counseling intervention called "CHARISMA" delivered to women within a PrEP demonstration project in Johannesburg, South Africa. The trial tested the effectiveness of CHARISMA to increase PrEP adherence; decrease social harms and IPV; and improve partnership dynamics (eg, communication, disclosure and support) compared with those who received the standard of care counselling support and referrals. Four hundred seven HIV-seronegative, nonpregnant women aged 18-45 years were enrolled for 6 months of PrEP use, with 203 randomized (1:1) to the intervention. All participants reporting IPV received counseling and referrals that followed the WHO five-step Listen, Inquire, Validate, Enhance Safety, and Support approach. RESULTS: This RCT did not identify statistically significant differences between study arms for PrEP adherence or relationship dynamics, with the exception of an increase in PrEP disclosure among intervention arm women. In our study, we cannot determine whether the lack of detectable findings may have been because of lack of intervention effect, strength of standard of care services, low risk in the study population, or other factors. CONCLUSIONS: Addressing IPV and relationship dynamics remain important factors influencing HIV risk, and addressing these within the context of PrEP delivery is an important synergistic opportunity. CHARISMA was highly acceptable to participants, and further adaptation and testing of the intervention to other populations and settings will augment the evidence base.

Acceptability and Preference for 3-Month Versus 1-Month Vaginal Rings for HIV-1 Risk Reduction Among Participants in a Phase 1 Trial.

Background: The monthly dapivirine vaginal ring provides partial protection against HIV, and a longer duration ring may reduce user burden and improve adherence. We examined acceptability and preference for 3-month versus 1-month rings for HIV-1 risk reduction in a phase 1 clinical trial. Materials and Methods: In Microbicide Trials Network-036/International Partnership for Microbicides 047, 49 HIV-negative participants aged 18-45 were randomized to one of two 3-month rings or the 1-month ring. Acceptability ratings were collected at enrollment, week 4, and study exit (week 13). At exit, ring preference was assessed quantitatively among all participants and a randomly selected subset of 24 participants completed in-depth interviews. Quantitative and qualitative findings were integrated to explore factors influencing acceptability and preference. Results: Acceptability of each ring was initially moderate and increased during the trial. Ratings were lower in the 3-month ring arms than the 1-month arm at each time point, including baseline. Most participants (34/47; 72%) preferred a 3-month ring at exit; however, this proportion was significantly lower within some subgroups characterized by site, education, race/ethnicity, and experiences with ring use. Qualitative interviews revealed reservations about hygiene and safety of the 3-month ring, including discomfort with use during menses, but these were usually outweighed by its increased convenience. Conclusions: Both ring durations were highly acceptable at study exit. Although most participants preferred a 3-month ring, preference was more divided in certain subgroups, highlighting the benefit of offering different duration options. Providing additional support to address concerns about hygiene and safety may improve acceptability of a 3-month vaginal ring.