Stigma, Discrimination and Other Social-Structural Factors Associated with Barriers to Counselling or Therapy among Women Living with HIV Who have Experienced Violence in Metro Vancouver, Canada.

Women living with HIV face high social and structural inequities that place them at heightened risk for gender-based violence and mental health conditions, alongside health services access inequities, with almost no research done to better understand access to mental health services. This study therefore examined social and structural factors associated with barriers to counselling or therapy amongst women living with HIV who experienced lifetime physical and/or sexual violence in Metro Vancouver, Canada. Bivariate and multivariable logistic regression using generalized estimating equations (GEE) were used and adjusted odds ratios (AOR) and 95% Confidence Intervals ([95%CIs] are reported). From Sept/15-Aug/21, 1695 observations were collected among 279 participants. In multivariable analysis, with all variables measured in the last six months, experiencing any barriers to counselling or therapy was significantly associated with having thoughts or attempts of suicide (AOR:1.64 [1.02-2.66]), lacking coverage for health care (AOR:1.60 [1.17-2.18]), and everyday discrimination (AOR:1.02 [1.00-1.04]) and anticipated (AOR:1.57 [1.04-2.36]), enacted (AOR:1.48 [1.02-2.16]) or internalized (AOR:1.53 [1.07-2.20]) HIV stigma. Access to interdisciplinary mental health care services should be improved. Social and structural interventions to reduce HIV stigma and discrimination are urgently needed.

Social Determinants of Alcohol and Other Drug Misuse Among Women Living with HIV in Economically Underserved Communities in Cape Town, South Africa: A Cross-Sectional Study.

This study aimed to understand how social determinants-the economic and social factors that affect health and well-being-are associated with self-reported and biological alcohol and other drug misuse in South Africa among women living with HIV. Logistic regression analyses were performed using baseline data from an implementation science trial conducted from 2015 to 2018 with 480 Black and Coloured women who were living with HIV and reported recent alcohol or other drug misuse. Educational attainment, type of housing, access to running water, food insecurity, and housing instability were examined. Women with higher education had reduced odds of any drug misuse-both biological (aOR: 0.53; 95% CI: 0.33-0.84) and self-reported (aOR: 0.37; 95% CI: 0.22-0.64). Women living in formal housing had increased odds of a positive alcohol screening test (aOR: 1.92; 95% CI: 1.16-3.18) and women with housing instability had increased odds of self-reported alcohol misuse-daily (aOR: 1.99; 95% CI: 1.18-3.35) and weekly (aOR:1.91; 95% CI: 1.19-3.07). Food insecurity was associated with reduced odds of self-reported alcohol misuse (aOR: 0.40; 95% CI: 0.25-0.64) and increased odds of self-reported drug misuse (aOR: 2.05; 95% CI: 1.16-3.61). These findings indicate the complexity of the relationship between social determinants and alcohol and other drug misuse, and may have implications for addressing social and structural determinants as part of multilevel interventions focused on reducing alcohol and other drug misuse among key populations of women in South Africa.

The Importance of the Individual in PrEP Uptake: Multilevel Correlates of PrEP Uptake Among Adolescent Girls and Young Women in Tshwane, South Africa.

Adolescent girls and young women (AGYW) account for 25% of new HIV infections in South Africa. Pre-exposure prophylaxis (PrEP) is approved by the South African Government, but the factors that promote PrEP uptake among AGYW are not well understood. This study examines multilevel factors associated with PrEP uptake among AGYW in six clinic catchment areas in Tshwane (Pretoria), South Africa. After consent/assent, PrEP-eligible AGYW (n = 448) completed a questionnaire assessing factors at the individual, network/interpersonal, and community levels and were prescribed PrEP in study clinics, if interested. A multivariable model, adjusting for clustering, assessed factors associated with PrEP uptake over a 9-month period. At the individual level, multiple partners in the past 3 months (OR = 0.47), perceived risk of HIV (OR = 0.71), and PrEP-related shame (OR = 0.63) were correlated with lower odds of PrEP uptake (ps ≤ 0.05). The findings highlight modifiable factors that should be addressed to support PrEP uptake efforts.

Binge drinking and condom negotiation behaviours among adolescent girls and young women living in Cape Town, South Africa: sexual control and perceived personal power.

BACKGROUND: Condom use among young people in South Africa has declined in recent years and adolescent girls and young women continue to bear the highest incidence of HIV in the country. Young women who have dropped out of school may be more at risk because of traditional gender norms that create substantial power imbalances and a lack of power to negotiate condom use with their male partners, especially when using alcohol and other drugs. METHODS: This study presents an analysis of baseline data provided by 500 adolescent girls and young women (AGYW) from Cape Town communities between November 2016 and November 2018 who were reached for a cluster-randomised trial conducted to assess the efficacy of an evidence-based, young woman-focused intervention seeking to reduce HIV risk and substance use behaviours. The analysis focuses on associations between binge drinking, condom use, and sexual negotiation, including impaired sex (any substance use at last sex). RESULTS: AGYW who reported frequent condom negotiation with their partners were 8.92 times (95% CI: [4.36, 18.24]) as likely to use a condom when alcohol or other drugs were not used at last sex and 5.50 times (95% CI: [2.06, 14.72]) as likely when alcohol or other drugs were used at last sex (p < 0.05). AGYW who reported frequent binge drinking in the past month (n = 177) had significantly reduced odds of condom use at last sex, irrespective of whether the sex was impaired (OR 0.60, 95% CI: [0.49, 0.73]) or not impaired (OR 0.69, 95% CI: [0.60, 0.81]). DISCUSSION: The findings highlight the need for interventions that reach AGYW in South Africa by specifically aiming to educate AGYW about the effect of binge drinking on negotiating power in their relationships, thus providing them with the knowledge and skills to increase agency regarding condom use. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02974998 (recruitment completed). 29/11/2016.

'We have goals but [it is difficult]'. Barriers to antiretroviral therapy adherence among women using alcohol and other drugs living with HIV in South Africa.

BACKGROUND: Women living with HIV who misuse alcohol and live in economically disadvantaged settings in South Africa experience a multitude of contextual barriers as they navigate the HIV care continuum. The Women's Health CoOp (WHC), a brief, woman-focused, behavioural, evidence-based intervention, has been shown to be effective in reducing heavy drinking and improving HIV-related outcomes among this key population. However, these women face other broader socioecological barriers to antiretroviral therapy (ART) adherence. METHODS: The WHC was implemented in a modified, stepped-wedge implementation science trial in public health clinics and substance use treatment programmes in Cape Town, South Africa. A qualitative substudy was conducted to explore barriers to HIV treatment adherence among women enrolled in this trial. Eight focus group discussions were conducted with 69 participants 6 months after completion of the WHC workshops. Focus groups were audio-recorded (with consent), transcribed verbatim and analysed using a thematic approach. RESULTS: The mean age of the participants was 33 years and the mean self-reported number of drinks per day was 13. The main contextual factors influencing participants' ART adherence were intrapersonal-level factors (substance use, financial constraints, food insecurity; community-level factors (anticipated and enacted stigma, community violence) and institutional-level factors (patient-provider relationships, health facility barriers, environmental stigma). CONCLUSION: Comprehensive interventions addressing the contextual barriers and unique challenges faced by women who misuse alcohol in low-resource settings that intersect with HIV treatment nonadherence should be implemented in tandem with successful biobehavioural HIV interventions for long-term effectiveness and sustainability. PATIENT OR PUBLIC CONTRIBUTION: Our South African community collaborative board has been involved throughout this study; participants and clinic staff voices have been essential in our interpretation of these findings.

Stigma in the health clinic and implications for PrEP access and use by adolescent girls and young women: conflicting perspectives in South Africa.

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.

A Scoping Review of Computer-Based and Telecommunication Technology Interventions to Address Drug and Alcohol Misuse and Smoking in Women.

BACKGROUND: Computer-based and telecommunication technology has become increasingly common to address addiction among women. This review assessed the effect of technology-based interventions on substance misuse, alcohol use, and smoking outcomes among women. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping reviews (PRISMA-ScR) guideline was used to conduct the scoping review. Four databases (PubMed, Web of Science, PsycINFO, and Scopus) were used to search for peer-reviewed articles published in English on computer-based and telecommunication technology use to address substance misuse, alcohol use, and smoking among women. RESULTS: A total of 30 articles were selected after the final full-text review from the U.S., England, Japan, and the Netherlands. The types of technology used in the interventions included computer software (standalone or web-based), mobile applications, video calling, phone, and text messaging. Intervention outcomes included alcohol and other substance misuse reduction as polysubstance misuse (n = 5), smoking cessation (n = 10), substance misuse reduction only (n = 6), and alcohol use reduction only (n = 9). The populations reached included women who were pregnant (n = 13), postpartum (n = 4), or non-pregnant (n = 14) ranging from adolescent to adulthood. Interventions that targeted polysubstance misuse showed statistically significant reductions (p < .05). CONCLUSION: Although effective in reducing alcohol and other substance misuse, mixed findings were identified for other outcomes targeting a single substance. Technology-based interventions might maximize their effects by targeting polysubstance misuse and addressing associated contextual issues in the form of a computer-delivered module(s).

Current Interventions for People Living with HIV Who Use Alcohol: Why Gender Matters.

PURPOSE OF REVIEW: Alcohol is the most misused substance in the world. For people living with HIV (PLWH), alcohol misuse may impact ART adherence and viral suppression. This review of the most recently published alcohol intervention studies with PLWH examines how these studies considered gender in the samples, design, and analyses. RECENT FINDINGS: Three searches were conducted initially, and 13 intervention studies fit our criteria with alcohol outcomes. In general, most studies did not consider gender and had used small samples, and few demonstrated significant efficacy/effectiveness outcomes. Five studies considered gender in their samples or analyses and/or were woman-focused with larger samples and demonstrated significant outcomes. It is essential for women who misuse alcohol to not only be well represented in alcohol and HIV research but also for studies to consider the barriers to reaching them and their contextual demands and/or co-occurring issues that may affect participation and outcomes in intervention research.

Outcomes of Implementing in the Real World the Women's Health CoOp Intervention in Cape Town, South Africa.

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.

Sustainability of a gender-focused HIV and alcohol risk-reduction intervention in usual care settings in South Africa: a mixed methods analysis.

Intervention sustainability is a critical yet understudied aspect of implementation science research. To address this gap, we examined the sustainability of the Women's Health CoOp (WHC), a gender-focused, evidence-based, HIV and alcohol risk-reduction intervention, after an implementation trial. We used a mixed methods design consisting of questionnaires (n = 12), 3 focus groups (n = 11), and a semistructured interview conducted with interventionists implementing the WHC in clinics and substance use treatment programs in Cape Town, South Africa. Five out of 8 facilities implemented the WHC beyond the 6-month implementation period, and 4 were still implementing the WHC as of October 2019. Sustainability ranged from approximately 8 months to more than 3 years. At the most recent assessment, interventionists delivered the intervention to 0-20 participants in the past month. Qualitative findings indicate that long-term sustainability would require support from upper management, staff dedicated to the WHC, and booster trainings. The WHC was sustained postimplementation. Integrating the program into usual care would be feasible; however, human resources, financial, and institutional support would be needed for sustainability. To move implementation science forward, it is essential to determine sustainability beyond the presence and involvement of researchers.

"Because all mothers is not the same": The development and implementation of an in loco parentis informed consent procedure to enroll adolescent girls and young women to participate in HIV research.

INTRODUCTION: South Africa has one of the highest incidences of HIV among adolescent girls and young women (AGW), ages 15-24, and recent research has focused on developing interventions for HIV prevention. However, the South African National Health Act requires those under 18 years of age to obtain a guardian's permission to participate in research. Limiting research enrolment to AGYW who can obtain guardian consent may lead to non-representative findings. Therefore, innovative, inclusive consent approaches that protect AGYW from the risks of research are needed. METHODS: This report details the development and implementation of an approach called the in loco parentis (in place of parent) consent procedure. In loco parentis consent provides a vehicle for adolescent participation that protects adolescents from potential social harms. The in loco parentis consent procedure does not seek to obtain independent minor consent but seeks to obtain permission for the minor to participate in research from a trusted adult who is not a minor's parent or legal guardian. This report also qualitatively explores the experiences of 31 AGYW who were recruited into a behavioral HIV prevention study using this method. RESULTS: Findings suggest that the in loco parentis consent procedure is a feasible and acceptable method to inclusively AGYW in HIV research. CONCLUSIONS: The in loco parentis procedure may provide a more inclusive strategy to recruit AGYW for HIV research to increase the generalizability of findings.

Individual and Relationship Predictors of Couple-Level Sexual Concurrency in Heterosexual South African Couples.

One of the major goals of couple-based HIV prevention programs in sub-Saharan Africa is to reduce outside sex partners, known as sexual concurrency. This cross-sectional study examined sexual concurrency at the couple-level and differentiated couples based on whether neither, one, or both partners engaged in sexual concurrency over the past 6 months. Individual predictors (alcohol use and lifetime history of physical or sexual trauma) and relationship predictors (mistrust, relationship inequity, relationship satisfaction, and sexual satisfaction) were used as predictors of couple-level sexual concurrency. A quantitative investigation using path analysis was carried out with data collected from 286 South African heterosexual couples. Results showed that alcohol use for both sexes, relationship dissatisfaction for women, and mistrust among women were predictive of different types of sexual concurrency. Findings suggest that consideration of the experiences and behavior of both partners may be useful in understanding different reasons for engagement in sexual concurrency.

The PrEPARE Pretoria Project: protocol for a cluster-randomized factorial-design trial to prevent HIV with PrEP among adolescent girls and young women in Tshwane, South Africa.

BACKGROUND: Despite increased prevention efforts, HIV remains the leading cause of death among adolescent girls and young women in South Africa. Although research indicates important determinants of HIV acquisition at the individual and interpersonal levels, structural-level stigma and discrimination continue to be critical barriers to reaching and retaining this key population for HIV prevention and sexual and reproductive health services. Innovative and multilevel interventions are needed that can address the intersectional structural and gender issues that young women face, including stigma, alcohol and drug use, gender-based violence, and other risk factors when seeking health services. Oral pre-exposure prophylaxis (PrEP) taken daily has been found to be an effective biomedical HIV prevention tool. Testing a comprehensive gender-focused biobehavioral HIV prevention intervention that is inclusive of social ecological determinants, such as stigma and discrimination reduction in clinics, is critical for reducing HIV among adolescent girls and young women. METHODS: This project involves both a Community Collaborative Board and a Youth Advisory Board in helping to adapt the Young Women's Health CoOp intervention and the Health Policy Project (HPP) Stigma and Discrimination (S&D) reduction training curriculum to the setting and population. This study uses a two-by-two factorial design with stratified randomization of 12 clinics, each with distinct catchment areas. The Young Women's Health CoOp addresses substance use, sexual risk, violence prevention and sexual negotiation, condom demonstration, and problem solving with the following additions: knowledge of PrEP, the importance of PrEP adherence, and sexual and reproductive health. Adolescent girls and young women will be assessed with behavioral and biological measures at baseline, 3-, 6- and 9-month follow-up. The S&D reduction training is provided for all staff in the clinics randomized to this condition. Clinic staff will be surveyed at baseline, 4- and 8-month follow-up. We will recruit 900 AGYW from communities in the 12 clinic catchment areas. DISCUSSION: The study findings, if efficacious across the outcomes, will be incorporated into the gender-focused HIV prevention intervention toolkit and disseminated to inform multilevel prevention approaches. TRIAL REGISTRATION: ClinicalTrials.gov. Identifier: NCT04048551 (Recruiting). Registered: August 7, 2019 (Retrospectively registered).

Measuring Relationship Functioning in South African Couples: A Strategy for Improving HIV Prevention Efforts.

Over the past decade there has been increased focus on targeting couples in HIV prevention efforts, particularly in sub-Saharan Africa where HIV transmission primarily occurs through heterosexual contact, in the context of intersecting alcohol use and intimate partner violence (IPV). However, little is known about couples' general relationship functioning. This understanding is needed to augment couple-based HIV prevention programs and address risk for IPV. This paper presents data on domains of relationship functioning with 300 South African couples who were recruited for an HIV prevention study. Exploratory and confirmatory factor analyses were conducted to determine the relevance of 17 individual items, as well as the overall factor structure of the questions. Results revealed three independent factors of relationship functioning: relationship satisfaction, arguing, and open communication; an overarching construct of relationship functioning for these three domains was not observed in the data. Results provide insight into the structure of relationship functioning questions and subscales that can be used to assess South African adult romantic relationships. This may allow for a greater focus on aspects of relationships within couple-based HIV prevention programs going forward.

Adolescent female school dropouts who use drugs and engage in risky sex: effects of a brief pilot intervention in Cape Town, South Africa.

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.

Exploring the associations between physical and sexual gender-based violence and HIV among women who use substances in South Africa: the role of agency and alcohol.

Objective: South Africa has the highest prevalence of HIV among women, the highest prevalence of gender-based violence (GBV), and the highest rates of per capita alcohol consumption in the world. The nuanced associations between GBV, alcohol misuse, and HIV must be explored and protective factors identified. This study examines the associations between physical and sexual GBV and HIV infection and explores how alcohol misuse and sexual agency may mediate the GBV-HIV association. Method: Participants were 361 Black African women (Mean age = 28.39, SD = 7.92) who reported using alcohol and/or drugs weekly in the past 3 months, engaging in condomless sex, and having a boyfriend. Women were recruited from disadvantaged communities in Pretoria, South Africa. Individuals who met the eligibility criteria and enrolled in the study consented and completed a computer-assisted personal interview assessing GBV, alcohol misuse, and sexual agency and underwent HIV testing (i.e., blood test). Results: The indirect effect of physical assault on HIV status at enrollment through alcohol misuse was significant (log odds = 0.23, SE = 0.12, 95% CI [0.0151, 0.4998]). Conclusions: HIV prevention efforts focusing on reducing alcohol misuse may be more effective, which might reduce the HIV burden among this group of vulnerable South African women.

Accuracy and Utility of the AUDIT-C with Adolescent Girls and Young Women (AGYW) Who Engage in HIV Risk Behaviors in South Africa.

Hazardous drinking is a risk factor associated with sexual risk, gender-based violence, and HIV transmission in South Africa. Consequently, sound and appropriate measurement of drinking behavior is critical to determining what constitutes hazardous drinking. Many research studies use internal consistency estimates as the determining factor in psychometric assessment; however, deeper assessments are needed to best define a measurement tool. Rasch methodology was used to evaluate a shorter version of the Alcohol Use Disorders Identification Test, the AUDIT-C, in a sample of adolescent girls and young women (AGYW) who use alcohol and other drugs in South Africa (n =100). Investigations of operational response range, item fit, sensitivity, and response option usage provide a richer picture of AUDIT-C functioning than internal consistency alone in women who are vulnerable to hazardous drinking and therefore at risk of HIV. Analyses indicate that the AUDIT-C does not adequately measure this specialized population, and that more validation is needed to determine if the AUDIT-C should continue to be used in HIV prevention intervention studies focused on vulnerable adolescent girls and young women.

Condom Use, Multiple Rounds of Sex, and Alcohol Use Among South African Women Who Use Alcohol and Other Drugs: An Event-Level Analysis.

BACKGROUND: High rates of alcohol and other drug use contribute to the ongoing generalized human immunodeficiency virus epidemic in South Africa. Despite the general link between alcohol use and condomless sex, findings from event-level studies of the relationship between alcohol use and condomless sex during the same encounter have been inconsistent. METHODS: We conducted event-level analyses of the most recent sexual encounter reported by 636 women who use substances in Pretoria. Data were collected via a questionnaire that included questions about the number of rounds of vaginal and anal sex and condom use during each round. We used multiple logistic regression analyses to model the associations between alcohol use by both partners and having multiple rounds of sex, and alcohol use and condom use during all rounds of sex. RESULTS: Over 50% of encounters involved multiple rounds of vaginal or anal sex. Encounters that involved multiple rounds of sex were associated with inconsistent condom use. Encounters in which both partners drank alcohol were more likely to involve condomless sex, as compared with encounters in which one or neither partner drank alcohol. CONCLUSIONS: These findings raise the possibility that prior event-level studies, which do not ask about multiple rounds of sex, may underestimate the prevalence of condomless sex. The association between alcohol use by both partners and condomless sex may partially explain inconsistent associations between alcohol use and condom use in event-level studies that did not assess the number of partners drinking.

The Young Women's Health CoOp in Cape Town, South Africa: Study protocol for a cluster-randomised trial for adolescent women at risk for HIV.

BACKGROUND: South Africa remains the global epicentre of HIV infection, and adolescent women have the highest incidence of HIV in the country. South Africa also has high rates of alcohol and other drug (AOD) use, violence, and gender inequality. Violence converges with AOD use, gender inequities and other disparities, such as poverty, to increase sexual risk and poor educational attainment for adolescent women. This study seeks to test the efficacy of peer recruitment and cofacilitation of the Young Women's Health CoOp (YWHC), a comprehensive gender-focused intervention to reduce HIV risk behaviours and increase the uptake of HIV counselling and testing (HCT) among out-of-school, adolescent women who use AODs. The YWHC is facilitated by local research staff and supported by peers. METHODS: This cluster-randomised trial is enrolling participants into two arms: a control arm that receives standard HCT, and an intervention arm that receives the YWHC. Participants are enrolled from 24 economically disadvantaged communities in Cape Town, South Africa. These geographically distinct communities serve as clusters that are the units of randomisation. This study uses adolescent peer role models and research field staff to recruit marginalised adolescent women. At baseline, participants complete a questionnaire and biological testing for HIV, recent AOD use, and pregnancy. The core intervention is delivered in the month following enrollment, with linkages to health services and educational programmes available to participants throughout the follow-up period. Follow-up interviews and biological testing are conducted at 6 and 12 months post enrollment. DISCUSSION: The study findings will increase knowledge of the efficacy of a comprehensive HCT, gender-focused programme in reducing AOD use, victimisation, and sexual risk behaviour and increase uptake services for out-of-school, adolescent women who use AODs. The trial results could lead to wider implementation of the YWHC for vulnerable adolescent women, a key population often neglected in health services. TRIAL REGISTRATION: Trial registration no: NCT02974998 , November 29, 2016.

mHealth versus face-to-face: study protocol for a randomized trial to test a gender-focused intervention for young African American women at risk for HIV in North Carolina.

BACKGROUND: Disparities in the prevalence of HIV persist in the southern United States, and young African American women have a disproportionate burden of HIV as compared with young women of other racial/ethnic backgrounds. As a result, engaging young African American women in the HIV care continuum through HIV testing is imperative. This study is designed to reach this key population at risk for HIV. The study seeks to test the efficacy of two formats of a gender-focused, evidence-based, HIV-risk reduction intervention-the Young Women's CoOp (YWC)-relative to HIV counseling and testing (HCT) among young African American women between the ages of 18 and 25 who use substances and have not recently been tested for HIV. METHODS: Using a seek-and-test framework, this three-arm cross-over randomized trial is being conducted in three county health departments in North Carolina. Each county is assigned to one of three study arms in each cycle: in-person (face-to-face) YWC, mobile Health (mHealth) YWC, or HCT. At study enrollment, participants complete a risk behavior survey via audio computer-assisted self-interview, and drug, alcohol, and pregnancy screening tests, and are then referred to HIV, gonorrhea, and chlamydia testing through their respective health departments. Participants in either of the YWC arms are asked to return approximately 1 week later to either begin the first of two in-person individual intervention sessions or to pick up the mHealth intervention preloaded on a tablet after a brief introduction to using the app. Participants in all arms are asked to return for a 6-month follow-up and 12-month follow-up, and repeat the survey and biological testing from baseline. DISCUSSION: The findings from this study will demonstrate which delivery format (mHealth or face-to-face) is efficacious in reducing substance use and sexual risk behaviors. If found to be efficacious, the intervention has potential for wider dissemination and reach. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02965014 . Registered November 16, 2016.