Likely clinical depression and HIV-related decline in antiretroviral therapy untreated women who seroconverted during participation in microbicide trials in sub-Saharan Africa

Depression worsens HIV outcomes in populations treated with antiretroviral therapy (ART) medications. Data are limited on the relationship between depression and HIV in untreated populations in sub-Saharan Africa. We aimed to identify associations between likely clinical depression, alcohol use, social support by partners, and HIV viral load (VL) among ART untreated women who recently became HIV positive and enrolled in the Microbicide Trials Network (MTN)-015 study. Analyses used cross-sectional data collected at baseline in MTN-015. Participants in this analysis (N = 190) enrolled from other MTN trials were not receiving ART and provided data on their HIV disclosure status to their husband or male partner and alcohol use behavior. The dependent variable, VL, was categorized as: low (≤400 RNA copies/mL; 9.1% of participants), medium (401-20,000 RNA copies/mL; 48.8%), and high (>20,000 RNA copies/mL; 42.0%). Depression was assessed using eight items from Hopkins Symptom Checklist; a cutoff of ≥1.75 indicated likely clinical depression. Independent variables with a significance of p ≤ 0.05 in unadjusted regressions were included in a regression adjusted for age, education, and time since seroconversion. Depressive symptoms were positively associated with high VL, in the adjusted regression (OR = 1.80; 95% CI = 1.07-3.01). Results suggest that likely having clinical depression may have a biological relationship with HIV disease progression

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

Oral abstracts of the 21st International AIDS Conference 18-22 July 2016, Durban, South Africa

The rate at which HIV-1 infected individuals progress to AIDS is highly variable and impacted by T cell immunity. CD8 T cell inhibitory molecules are up-regulated in HIV-1 infection and associate with immune dysfunction. We evaluated participants (n=122) recruited to the SPARTAC randomised clinical trial to determine whether CD8 T cell exhaustion markers PD-1, Lag-3 and Tim-3 were associated with immune activation and disease progression.Expression of PD-1, Tim-3, Lag-3 and CD38 on CD8 T cells from the closest pre-therapy time-point to seroconversion was measured by flow cytometry, and correlated with surrogate markers of HIV-1 disease (HIV-1 plasma viral load (pVL) and CD4 T cell count) and the trial endpoint (time to CD4 count <350 cells/μl or initiation of antiretroviral therapy). To explore the functional significance of these markers, co-expression of Eomes, T-bet and CD39 was assessed.Expression of PD-1 on CD8 and CD38 CD8 T cells correlated with pVL and CD4 count at baseline, and predicted time to the trial endpoint. Lag-3 expression was associated with pVL but not CD4 count. For all exhaustion markers, expression of CD38 on CD8 T cells increased the strength of associations. In Cox models, progression to the trial endpoint was most marked for PD-1/CD38 co-expressing cells, with evidence for a stronger effect within 12 weeks from confirmed diagnosis of PHI. The effect of PD-1 and Lag-3 expression on CD8 T cells retained statistical significance in Cox proportional hazards models including antiretroviral therapy and CD4 count, but not pVL as co-variants.Expression of ‘exhaustion’ or ‘immune checkpoint’ markers in early HIV-1 infection is associated with clinical progression and is impacted by immune activation and the duration of infection. New markers to identify exhausted T cells and novel interventions to reverse exhaustion may inform the development of novel immunotherapeutic approaches

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 ( 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.</p

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. </jats:sec

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

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 &amp; 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.</jats:p

The “Ideal Man”: How Gender Norms and Expectations Shape South African Men’s Masculinity, Sexual Identities, and Well-Being

Dominant gender norms among South African males promote ideals of masculinity characterized by control, emotional stoicism, and power, which can impact overall health. This study explores South African men’s perceptions of the “ideal” man, societal expectations, and how sexual identities intersect with masculinity, health-seeking behaviors, and HIV prevention. We conducted 40 interviews with men who have sex with women and men who have sex with men, aged 18–35 years who resided in Johannesburg or Cape Town municipal areas. Participants described their idea of the “ideal man” as a provider, protector, and role model, though these ideals varied across contexts. High family and community expectations created both stress and motivation. Barriers to sexual healthcare included resistance from male-dominated communities and stigma towards non-heteronormative sexual identities, particularly among men who have sex with men. Addressing these challenges requires promoting more inclusive understandings of masculinity and improving healthcare access by challenging gender norms