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This protocol presents a multilevel cluster randomized study in 24 communities in Cape Town, South Africa. The study comprises four specific aims. Aim 1, conducted during the formative phase, was to modify the original Couples Health CoOp (CHC) intervention to include antiretroviral therapy/pre-exposure prophylaxis (ART/PrEP), called the Couples Health CoOp Plus (CHC+), with review from our Community Collaborative Board and a Peer Advisory Board. Aim 1 has been completed for staging the trial. Aim 2 is to evaluate the impact of a stigma awareness and education workshop on community members' attitudes and behaviors toward young women and men who use AODs and people in their community seeking HIV services (testing/ART/PrEP) and other health services in their local clinics. Aim 3 is to test the efficacy of the CHC+ to increase both partners' PrEP/ART initiation and adherence (at 3 and 6 months) and to reduce alcohol and other drug use, sexual risk and gender-based violence, and to enhance positive gender norms and communication relative to HIV testing services (n = 480 couples). Aim 4 seeks to examine through mixed methods the interaction of the stigma awareness workshop and the CHC+ on increased PrEP and ART initiation, retention, and adherence among young women and their primary partners. Ongoing collaborations with community peer leaders and local outreach staff from these communities are essential for reaching the project's aims. Additionally, a manualized field protocol with regular training, fidelity checks, and quality assurance are critical components of this multilevel community trial for successful ongoing data collection. Trial registration. Clinicaltrials.gov Registration Number: NCT05310773. Pan African Trials: pactr.samrc.ac.za/ Registration Number: PACTR202205640398485., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Wechsberg et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Adolescent girls and young women (AGYW) in South Africa experience contextual barriers to HIV risk reduction including incomplete schooling, unintended pregnancy, substance use, and gender-based violence. A cluster randomised trial in Cape Town allocated 24 Black and Coloured communities to a gender-focused HIV risk-reduction intervention or HIV testing, with 500 AGYW total enrolled. We evaluated intervention efficacy by comparing mean differences overall, by community population group (Black and Coloured) and among those with structural barriers based on neighbourhood, education, and employment (n = 406). Both arms reported reductions in alcohol, cannabis, and condomless sex, with no intervention efficacy overall. Among AGYW with barriers, intervention participants reported fewer days of methamphetamine use at 6 months (t(210) = 2·08, p  = ·04). In population group analysis, we found intervention effects on alcohol and sexual communication. Intervention participants in Black communities had fewer days of alcohol use at 12 months (t(136) = 2·10, p  = ·04). Sexual discussion (t(147) = -2·47, p  = ·02) and condom negotiation (t(146) = -2·51, p  = ·01) increased for intervention participants at 12 months in Coloured communities. Gender-focused interventions must address population group differences and intersecting barriers to decrease substance use and increase education, skills, and sexual health protection.

Background: Globally, an urgent need exists to expand access to HIV prevention among adolescent girls and young women (AGYW), but the need is particularly acute in sub-Saharan Africa. Oral pre-exposure prophylaxis (PrEP) offers an effective HIV prevention method. In many countries, however, accessing PrEP necessitates that AGYW visit their local health clinic, where they may face access challenges. Some countries have implemented youth-friendly services to reduce certain challenges in local health clinics, but barriers to access persist, including clinic stigma. However, evidence of clinic stigma toward AGYW, particularly with respect to PrEP service delivery, is still limited. This mixed methods study explores stigma toward AGYW seeking clinic services, in particular PrEP, from the perspective of both clinic staff (clinical and nonclinical) and AGYW who seek services at clinic sites in Tshwane province, South Africa., Methods: Six focus group discussions were conducted with AGYW (43 total participants) and four with clinic staff (42 total participants) and triangulated with survey data with AGYW (n = 449) and clinic staff (n = 130). Thematic analysis was applied to the qualitative data and descriptive statistics were conducted with the survey data., Results: Four common themes emerged across the qualitative and quantitative data and with both AGYW and clinic staff, although with varying degrees of resonance between these two groups. These themes included (1) clinic manifestations of stigma toward AGYW, (2) concerns about providing PrEP services for AGYW, (3) healthcare providers' identity as mothers, and (4) privacy and breaches of confidentiality. An additional theme identified mainly in the AGYW data pertained to stigma and access to healthcare., Conclusion: Evidence is needed to inform strategies for addressing clinic stigma toward AGYW, with the goal of removing barriers to PrEP services for this group. While awareness has increased and progress has been achieved around the provision of comprehensive, youth-friendly sexual and reproductive health services, these programs need to be adapted for the specific concerns of young people seeking PrEP services. Our findings point to the four key areas noted above where programs seeking to address stigma toward AGYW in clinics can tailor their programming., (© 2022. The Author(s).)

Women in South Africa living with HIV who use alcohol may not adhere to ART, affecting the country's 90-90-90 targets. The Women's Health CoOp (WHC), a woman-focused HIV intervention, has shown efficacy in numerous trials with key populations of women in South Africa who use alcohol and drugs. In a hybrid implementation effectiveness study, the WHC was implemented in usual care clinics by healthcare providers in a modified stepped-wedge design. We present the outcomes of alcohol use and ART adherence with 480 women, with a 95% 6-month follow-up rate across 4 implementation cycles. Compared with the first cycle, women in the fourth cycle were significantly less likely (OR = 0.10 [95% CI 0.04, 0.24]) to report alcohol use disorder risk and were 4 times more likely (OR = 4.16 [95% CI 1.05, 16.51]) to report ART adherence at 6-month follow-up. Overall, acceptability and satisfaction were extremely high. The WHC intervention was successful in reaching key populations of women to reduce alcohol use and increase ART adherence, which is essential for South Africa to reach the 90-90-90 goals., (© 2021. The Author(s).)

This brief report emphasizes the need to focus on women with HIV who are pregnant who use alcohol or other drugs. A recently completed implementation science study tested a gender-focused behavioral intervention, the Women's Health CoOp (WHC), to improve antiretroviral therapy (ART) adherence and reduce alcohol use among women with HIV. The study identified 33 participants who had a positive pregnancy test result at the baseline assessment, of whom five participants remained pregnant during the 6-month duration of the study. Of the 33 pregnant participants at the baseline assessment, 55% reported past-month alcohol use, with 27% reporting a history of physical abuse and 12% reporting a history of sexual abuse. The five women who remained pregnant at 6 months showed improved ART adherence and reduced prenatal alcohol use. The gender-focused WHC intervention shows promise as a cost-effective, sustainable, behavioral intervention to address these intersecting syndemic issues. Future research should focus on identifying the needs of women with HIV who are pregnant who use alcohol or other drugs and developing tailored evidence-based behavioral interventions such as the WHC for preventing FASD in addition to improving ART adherence in this key population of women and reducing the economic burden on society.

Background: HIV prevalence has increased among South African women who use alcohol and other drugs (AOD). However, HIV prevention and treatment efforts have not focused on this population. This study presents the efficacy of the Women's Health CoOp Plus (WHC+) in a cluster-randomized trial to reduce AOD use, gender-based violence, and sexual risk and to increase linkage to HIV care among women who use AODs, compared with HIV counseling and testing alone., Methods: Black African women (N = 641) were recruited from 14 geographic clusters in Pretoria, South Africa, and underwent either an evidence-based gender-focused HIV prevention intervention that included HIV counseling and testing (WHC+) or HIV counseling and testing alone. Participants were assessed at baseline, 6-months, and 12-months post enrollment., Results: At 6-month follow-up, the WHC+ arm (vs. HCT) reported more condom use with a main partner and sexual negotiation, less physical and sexual abuse by a boyfriend, and less frequent heavy drinking (ps < 0.05). At 12-month follow-up, the WHC+ arm reported less emotional abuse (p < 0.05). Among a subsample of women, the WHC+ arm was significantly more likely to have a non-detectable viral load (measured by dried blood spots; p = 0.01)., Conclusion: The findings demonstrate the WHC+'s efficacy to reduce HIV risk among women who use AODs in South Africa. Substance abuse rehabilitation centers and health centers that serve women may be ideal settings to address issues of gender-based violence and sexual risk as women engage in substance use treatment, HIV testing, or HIV care., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Female adolescents from socioeconomically underserved communities in Cape Town, South Africa, who have dropped out of school, use substances, and engage in risky sex behaviour are at risk of HIV. Tailored gender-focused HIV behavioural interventions for this key population are needed to mitigate these risk factors. A pilot trial of a woman-focused risk-reduction intervention for adolescents was conducted (N = 100), with a one-month follow-up appointment. Participants in the intervention group attended two group workshops. Data were examined for significant differences within and between the groups. At baseline, 94% of participants tested positive for cannabis, 17% were HIV-positive and 11% were pregnant. Ninety-two participants returned for 1-month follow-up. At follow-up, the proportion who tested positive for cannabis use decreased significantly in both the intervention (p = 0.07) and control groups (p = 0.04). Impaired sex with any partner (p = 0.02), or with main partner (p = 0.06) decreased among the intervention group. Impaired sex with a main partner was less likely in the intervention group (p = 0.07) in the regression model. In conclusion, findings indicate a need for HIV prevention interventions among out-of-school female adolescents. Intervention acceptability was high, and there were some decreases in sexual risk behaviour among intervention participants which is promising. Future intervention research with this key population involving larger sample sizes and longer follow-up periods will help to determine intervention efficacy.

Background: Women have generally been found to be the victims of violence, but scant attention has been paid to the characteristics of women who perpetrate aggression and violence. In South Africa, violence is a prevalent societal issue, especially in the Western Cape., Method: This study aimed at identifying factors that were associated with aggression among a sample of 720 substance-using women. We conducted multivariate logistic regression to identify factors that are significantly associated with these behaviours., Results: Ethnicity (Wald Χ 2  = 17.07(2), p < 0.01) and heavy drinking (Wald Χ 2  = 6.60 (2), p = 0.01) were significantly related to verbal aggression, methamphetamine use was significantly related to physical (Wald Χ 2  = 2.73 (2), p = 0.01) and weapon aggression (Wald Χ 2  = 7.94 (2), p < 0.01) and intimate partner violence was significantly related to verbal (Wald Χ 2  = 12.43 (2), p < 0.01) and physical aggression (Wald Χ 2  = 25.92 (2), p < 0.01)., Conclusions: The findings show high levels of aggression among this sample, and highlight the need for interventions that address methamphetamine, heavy drinking and intimate partner violence among vulnerable substance-using women.

Objectives: HIV testing and disclosure of results to partners is an important strategy in HIV prevention but is under-researched within heterosexual partnerships. To address this gap, we describe patterns of HIV testing, discrepancies between beliefs and biologically confirmed HIV status of each partner, and characteristics of mutually correct knowledge of HIV status among heterosexual couples in a high-prevalence community., Methods: The study recruited 290 high-risk heterosexual couples in stable relationships from a township in Cape Town, South Africa. Male patrons of shebeens (drinking establishments) were approached to participate with their main partner in an intervention designed to reduce substance use, violence and unsafe sex. All participants were tested for HIV at baseline and asked about their partner's past HIV testing and current status. Using the couple as the unit of analysis, we conducted logistic regression to identify partnership and individual characteristics associated with having mutually correct knowledge of partner's HIV status., Results: Half (52%) of women and 41% of men correctly knew whether their partner had ever been tested for HIV. 38% of women, 28% of men and in 17% of couples, both members reported mutually correct knowledge of their partner's HIV status. Correlates of correct knowledge included married/cohabitating (aOR 2.69, 95% CI 1.35 to 5.40), both partners HIV-negative (aOR 3.32 (1.38 to 8.00)), women's acceptance of traditional gender roles (aOR 1.17 (1.01 to 1.40)) and men's relationship satisfaction (aOR 2.22 (1.01 to 4.44))., Conclusions: Findings highlight the need to improve HIV testing uptake among men and to improve HIV disclosure among women in heterosexual partnerships., Trial Registration Number: ClinicalTrials.gov registration NCT01121692., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background: South Africa has 6.4 million adults over the age of 15 living with HIV. Gender inequality issues continue to drive the HIV epidemic in South Africa, where Black African women bear the greatest HIV burden. Limited access to services; little capacity to negotiate sex and condom use; and other legal, social, and economic inequities make women highly vulnerable to HIV infection. Behavioral interventions have been shown to decrease risk behaviors, but they have been less successful in reducing HIV incidence. Conversely, biomedical prevention strategies have proven to be successful in reducing HIV incidence, but require behavioral interventions to increase uptake and adherence. Consequently, there is a need for integrated approaches that combine biomedical and behavioral interventions. Effective combination prevention efforts should comprise biomedical, behavioral, and structural programming proven in randomized trials that focuses on the driving forces and key populations at higher risk of HIV infection and transmission., Methods/design: This prospective, geographically clustered randomized field experiment is enrolling participants into two arms: a control arm that receives standard HIV testing and referral for treatment; and an intervention arm that receives an evidence-based, woman-focused behavioral intervention that emphasizes risk reduction and retention, the Women's Health CoOp. We divided the city of Pretoria into 14 mutually exclusive geographic zones and randomized these zones into either the control arm or the intervention arm. Outreach workers are recruiting drug-using women from each zone. At baseline, eligible participants complete a questionnaire and biological testing for HIV, recent drug use, and pregnancy. Follow-up interviews are completed at 6 and 12 months., Discussion: The biobehavioral intervention in this study merges an efficacious behavioral HIV prevention intervention for women with biomedical prevention through HIV treatment as prevention using a Seek, Test, Treat and Retain strategy. This combination biobehavioral intervention is designed to (1) improve the quality of life and reduce HIV infectiousness among women who are HIV positive, and (2) reduce HIV risk behaviors among women regardless of their HIV status. If efficacious, this intervention could help control the HIV epidemic in South Africa., Trial Registration: Trial registration no: NCT01497405.

Background: This study was conducted in a large Black African township outside of Cape Town, South Africa, where HIV infection has been endemic at extremely high levels for years. Problems associated with high HIV prevalence are compounded by gender inequality and high rates of gender-based violence exacerbated by heavy alcohol use and increasing methamphetamine use., Methods: Informal drinking establishments (known as shebeens) were geocoded and mapped. Based on visual examination, we identified 36 neighbourhoods, each of which contained between three to seven drinking venues clustered together. Neighbourhoods were separated from each other by at least 200m. We randomly selected 30 of the 36 neighbourhoods. Outreach workers screened males in shebeens and screened their female partners. This analysis includes 580 study participants recruited from 30 neighbourhoods between 2010 and 2012. All participants completed a baseline questionnaire that included individual-level, couple-level, and neighbourhood-level measures of alcohol and other drug use, HIV infection, and HIV risk behaviours. Multilevel fixed effects regression analyses stratified by gender were conducted to examine correlates of HIV infection., Results: Women were twice as likely as men to be HIV infected, yet they reported fewer sex partners. Neighbourhood prevalence of HIV was correlated with greater likelihood of HIV infection among women, but not men. Neighbourhood methamphetamine use was marginally associated with HIV among women but not among men. At the individual level, heavy alcohol use was marginally associated with HIV infection among men but not among women. Having an HIV positive partner was the strongest correlate of being HIV positive among both men and women., Conclusion: Findings from this study underscore the need for policy makers to direct scarce resources to the communities, places within communities, and populations, especially vulnerable women, where the impact on HIV prevention and onward transmission will be greatest., (Copyright © 2014 Elsevier B.V. All rights reserved.)

Background: Alcohol and other drug (AOD) use among poor Black African and Coloured women in South Africa compounds their sexual risk for HIV. Given South Africa's history of ethnic disparities, ethnic differences in sex risk profiles may exist that should be taken into account when planning HIV risk reduction interventions. This paper aims to describe ethnic differences in AOD use and AOD-related sexual risks for HIV among vulnerable women from Cape Town, South Africa., Method: Cross-sectional data on 720 AOD-using women (324 Black African; 396 Coloured) recruited from poor communities in Cape Town were examined for ethnic differences in AOD use and AOD-related sexual risk behavior., Results: Ethnic differences in patterns of AOD use were found; with self-reported drug problems, heavy episodic drinking and methamphetamine use being most prevalent among Coloured women and cannabis use being most likely among Black African women. However, more than half of Black African women reported drug-related problems and more than a third tested positive for recent methamphetamine use. More than a third of women reported being AOD-impaired and having unprotected sex during their last sexual encounter. Coloured women had four-fold greater odds of reporting that their last sexual episode was AOD-impaired and unprotected than Black African women. In addition, close to one in two women reported that their sexual partner was AOD-impaired at last sex, with Coloured women having three-fold greater odds of reporting that their partner was AOD-impaired at last sex than Black African women., Conclusions: Findings support the need to develop and test AOD risk reduction interventions for women from both ethnic groups. In addition, findings point to the need for tailored interventions that target the distinct profiles of AOD use and AOD-related sex risks for HIV among Black African and Coloured women.