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Biomedical, female-initiated HIV prevention methods can help reduce disproportionately high HIV rates among women in sub-Saharan Africa, but male partner resistance and intimate partner violence (IPV) may impact ability to ensure effective use. To support consistent use of the dapivirine vaginal ring (VR), we pilot-tested the impact of the CHARISMA relationship counseling intervention ("CHARISMA") with women enrolled in the multi-site open-label Microbicide Trials Network (MTN) 025/HOPE trial at the Wits Reproductive Health and HIV Research Institute (Wits RHI) site in Johannesburg, South Africa. Lay counselors used a 42-item tool with five subscales to assess relationships and IPV and provide tailored counseling at enrolment, followed by a booster counselling session at Month 1 and follow-up checks at Months 3 and 6. We evaluated potential impact by examining self-reported ring disclosure to partners, partner clinic attendance, self-reported incident social harms (SH) and IPV, and biomarkers of ring adherence at Wits RHI. We subsequently compared these outcomes at three comparator HOPE study sites using multivariable regression models. Comparator study sites were purposively selected as those most similar to Wits RHI for baseline characteristics identified a priori. At Wits RHI, 95 of 96 (99%) HOPE participants enrolled into the CHARISMA pilot study. Mean age was 30, 36.8% lived with a partner, and 85.3% received their partner's financial support. During the six months of pilot study follow-up, participants reported: ring use disclosure to partners at 72.7% visits; 4.3% partners attending the research clinic; one partner-related SH; and 9.5% experienced incident IPV. The mean level of dapivirine released from returned used rings was 3.4 mg (SD 1.56), suggesting moderate adherence. Participants in the CHARISMA pilot had high background prevalence and incidence of IPV but were nevertheless able to adhere to ring use, and some male partners came to the research clinic. In adjusted regression models, compared to Wits RHI, partner clinic attendance was lower at all comparator sites; and significantly so at Site A (aRR 0.12, 95% CI 0.00-0.98). Sites B and C had lower levels of dapivirine released (suggesting lower adherence), but this difference was not significant. Site B women were more likely to report ring disclosure to partners at FU visits (aRR 1.12, 95% CI 1.00-1.25). IPV reported during follow-up was significantly lower at Site B (aRR 0.20, 95% CI 0.04-0.98, p = 0.047). CHARISMA taught women skills to decide on levels of ring-use disclosure to partners or others; therefore it is difficult to interpret differences in ring disclosure to partners with other sites. Similarly, CHARISMA heightened participants' awareness of abuse, possibly increasing IPV reports. Testing CHARISMA under fully-powered controlled conditions will improve understanding of its impact on women's relationships and ability to use female-initiated HIV prevention methods.

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.

Adherence to care and antiretroviral therapy is challenging, especially for people living with HIV (PLWH) with additional co-occurring risk factors. Case management interventions, including motivational interviewing (MI), show promise to improve HIV treatment adherence, but few studies have examined how such interventions are delivered to or experienced by PLWH who have been reengaged in care. We conducted qualitative interviews with six case managers and 110 PLWH exiting from a randomized study (HPTN 078) who received a MI-based case management intervention in addition to standard patient-navigation services, or standard services only. Our study provided greater insight into the main findings from HPTN 078, including an in-depth description of the multiple barriers to adherence faced by this largely “out-of-care” population, as well as a more nuanced understanding of the benefits and challenges of implementing MI. A blend of MI plus more intensive interventions may be needed for PLWH facing multiple structural barriers.

HPTN 065 utilized financial incentives to promote viral suppression among HIV-positive participants. Exit interviews were conducted in a sub-study of participants in Washington, DC and Bronx, NY. The present analyses explored lived experiences of social ties and stigma as individuals navigated the HIV care continuum, including gender differences in lived experiences. Using viral load data and informed by stages-of-change theory, participants were categorized into "Low-Adherers (n = 13)", "Action (n = 29)" and "Maintenance (n = 31)" stages. Secondary analyses of qualitative data were informed by grounded theory, and instances of social ties and stigma discussed by participants were quantified with descriptive statistics. Participants (N = 73) were mostly male (64%), African American (58%), with yearly income under $10,000 (52%). Low-adherers identified fewer, and sometimes more combative social ties than those in other adherence stages. Maintainers identified supportive ties as motivation for medication adherence (68%) but relied less on them for motivation than individuals in other adherence stages. Low-adherers described current experiences of stigma related to being diagnosed with HIV more than other adherence stages (23%). Individuals in Action reported stigma related to disclosing their HIV status to others (52%), while individuals in Maintenance mostly stigmatized others engaging in "risky" behaviors (32%). Findings suggest that women may perceive greater HIV stigma than men, perceive less supportive social ties, and were the majority of Low-adherers. Gender-informed approaches can facilitate community de-stigmatization of HIV, as African American women may be at greater risk of negative HIV health outcomes.

The stages of change (SOC) theory suggests individuals adapt incrementally to behaviors like adherence, requiring different strategies over the behavior change continuum. Offering financial incentives (FIs) is one strategy to motivate adherence. This qualitative sub-study examined adherence barriers and the role of FIs to increase viral suppression (VS) among HIV Prevention Trials Network (HPTN) 065 study participants categorized into SOC-related adherence stages based on changes from baseline to follow-up viral load tests. Of 73 participants, most were in Maintenance stage (n = 31), defined as having achieved VS throughout HPTN 065, or in Action stage (n = 29), defined as moving from virally unsuppressed to suppressed in 50% or more of tests. Only 13 were Low Adherers, having achieved VS in fewer than 50% of tests. The latter group faced substantial social and structural adherence barriers. Participants in the Action stage made positive changes to adherence routines to achieve VS. Those in Maintenance were less incentivized by FIs, as they were already committed. Results from this sub-study suggest FI effectiveness may vary across the SOC continuum, with greatest impact for those initiating antiretroviral or without explicit adherence routines. FIs may be insufficient to overcome strong social or structural barriers, and unnecessary for those intrinsically committed to remaining adherent.

HIV prevention trials typically randomize thousands of participants to active or control intervention arms, with regular (e.g. monthly) clinic visits over one or more years of follow-up. Because HIV infection rates are often lower than 3 per 100 person-years even in high prevalence settings, tens of thousands of clinic visits may take place before the number of infections required to achieve adequate study power has been observed. In addition to clinical outcomes, the multitude of study visits provides an opportunity to assess adherence and related participant behaviors in great detail. These data may be used to refine counseling messages, gain insight into patterns of behavior, and perform supporting analyses in an attempt to obtain more precise estimates of treatment efficacy. Exploratory analyses were performed to assess how our understanding of participant behaviors and their relationships to biological outcomes in two recent prevention trials might have been impacted had the frequency of routine behavioral data collection been reduced from monthly to just months 1, 3, 6, 9, and 12. Results were comparably informative in the reduced case, suggesting that unnecessarily extensive amounts of routine behavioral data may be collected in these trials.

The concept of acceptability involves a complex set of individual, couple and socio-cultural factors. Within a specific focus on microbicides, this article sets forth the relevant behavioral issues demanding attention as scientists and product developers strive to identify microbicides that will be used in a sustained, long-term fashion to prevent HIV/AIDS. The paper re-conceptualizes long-term acceptability within the ARRM framework, reviews the basic issues and research related to microbicide acceptability, discusses couple relationships (especially the nature of intimate relationships), and identifies related gender and power factors. The importance of the cultural context within various international settings pervades all of these issues. Finally, a set of challenges is discussed for those contemplating such research.

The inconclusive results of past trials and recent findings of partial protection of Tenofovir 1% gel underscore the need to better understand product adherence in microbicide trials. This study aimed to identify factors predicting couples’ ability to sustain topical gel and condom use during clinical trial participation. We enrolled 100 Indian participants of a randomized, controlled safety trial of Tenofovir 1% gel (CT cohort) and 100 similar women who were ineligible or declined trial participation (NCT cohort). Compared to the NCT cohort, CT women reported higher baseline condom use, more positive attitudes towards condoms and higher levels of protection efficacy. While NCT condom use remained low, CT condom use increased dramatically during the study. Reported gel consistency was higher than condom consistency. Individual and couple-related factors predicted condom consistency and interest in future gel use, but not gel consistency. Findings could inform trial recruitment strategies and product introduction.