Cape Town Young Women's Health CoOp

Study Overview
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Brief Summary
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This two-arm cluster randomized trial tested a gender-focused comprehensive HIV testing and counselling (HTC) program, the Young Women's Health CoOp (YWHC) with a standard HTC program and targeted female adolescents (aged 16-19) who use substances and have dropped out of school. To evaluate the process, the study examined the feasibility of using peer role models as recruiters and co-facilitators of the intervention and monitored fidelity to the intervention. Efficacy of the intervention on behavioral and biological outcomes, and on linkages to health services, through follow-up visits conducted 6- and 12-months post-enrollment was also assessed.

Detailed Description
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The purpose of this study was to test a gender-focused comprehensive HIV testing and counselling (HTC) program, the Young Women's Health CoOp (YWHC) with a standard HTC program in 24 disadvantaged communities in Cape Town, South Africa. The researchers conducted community-level randomization across the 24 communities with balanced recruitment from predominantly Black African and predominantly Coloured communities. The aims of the study were: Aim 1. To train and evaluate adolescent peer role models to conduct community outreach with established outreach workers to recruit 500 out-of-school, substance-using female adolescents aged 16 to 19 for HIV testing and counseling (HTC) and to co-facilitate a gender-focused comprehensive HTC program. Aim 2. To test the efficacy of a young women's gender-focused comprehensive HTC program for reducing substance use, victimization, and sexual risk behavior (primary outcomes) and improving access to effective treatment and support services through linkages to care (substance abuse treatment, HIV, sexually transmitted infections [STIs], antenatal and reproductive health as secondary outcomes) relative to standard HTC for adolescent females. The Young Women's Health CoOp has been adapted from the South African Women's Health CoOp (WHC) and the North Carolina Young Women's CoOp (YWC) which was found acceptable in focus groups and maintained all the core elements of the evidence-based intervention. For this study, the intervention was co-facilitated by trained staff from the local communities. The intervention consisted of two 1.5-hour group workshops (sessions), each having several modules that are usually administered a week apart: Workshop 1: Developmental Issues and Alcohol and Other Drugs; Gender, Problem-Solving and Conflict Negotiation, Violence and Values and Becoming a Powerful Young Woman: and Workshop 2: STIs, HIV/AIDS, Prevention, Condoms and Role-play. After each session, each participant developed a risk-reduction personalized action plan (PAP). To maintain PAP goals and reduce decay of intervention effects over time, the staff conducted case management to help participants attain these personal goals. Participants completed baseline, 6-month follow-up and 12-month follow-up assessments, which included a survey and biological testing for substance use, pregnancy and HIV.

Official Title
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Expanding HIV Testing and Prevention to Reach Vulnerable Young Women

Conditions
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Condomless Sex, Human Immunodeficiency Virus (HIV), Sexually Transmitted Infections (STIs), Alcohol and Drug Use, Violence and Victimization, Access and Linkage to Healthcare, Education Advancement

Intervention / Treatment
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* Behavioral: Young Women's Health CoOp (YWHC)
* Behavioral: Standard HTC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Self-identify as living in one of the 24 targeted disadvantaged communities Between 16 and 19 years old Has dropped out of school for at least 6 months Is currently dropped out of school Has not completed matric (high school diploma) or have an N3 Certificate (South Africa National Technical Certificate) Reports consuming 2-3 alcoholic drinks at least once in the last 30 days or using illicit drugs at least once a week. Reports unprotected sex with a male partner in the last 90 days Is able to provide informed assent to participate or informed consent if emancipated or 18 years old Has lived in targeted community for at least 6 months and plans to reside in the target community for the next year and provide verifiable locator information Exclusion Criteria: Participant must be able to pass a cognitive test

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Young Women's Health CoOp (YWHC)/ HTC<br>Participants received an enhanced gender-focused HTC intervention. | Behavioral: Young Women's Health CoOp (YWHC)<br>* Participants received HTC and engaged in a two-session gender-focused intervention. The intervention included information addressing the intersection of substance use, sexual risk, and violence through skill building, role-play, and rehearsal. The intervention also encouraged positive goal-seeking to access linkages to health care within the larger social ecological framework of where the young women live.<br>|
| Active Comparator: Standard HTC<br>Participants received the standard HTC available in South Africa for this population. | Behavioral: Standard HTC<br>* Participants received the standard HTC available in South Africa for this population.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced Sexual Risk | Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment) | Baseline | 
| Reduced Sexual Risk | Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment | 6 months after baseline | 
| Reduced Sexual Risk | Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment | 12 months after baseline | 
| Increased Condom Use | Reduced number of unprotected anal and vaginal sex acts in the past 90 days. Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment) | Baseline | 
| Increased Condom Use | Reduced number of unprotected anal and vaginal sex acts in the past 90 days. Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment) | 6 months after baseline | 
| Increased Condom Use | Reduced number of unprotected anal and vaginal sex acts in the past 90 days. Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment) | 12 months after baseline | 
| Reduced Alcohol and Illicit Drug Use | Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA. Biological measures of drug use through urine drug tests and breathalyzer tests. | Baseline | 
| Reduced Alcohol and Illicit Drug Use | Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA. Biological measures of drug use through urine drug tests and breathalyzer tests. | 6 months after baseline | 
| Reduced Alcohol and Illicit Drug Use | Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA. Biological measures of drug use through urine drug tests and breathalyzer tests. | 12 months after baseline | 
| Reduced Violence and Victimization | Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment). | Baseline | 
| Reduced Violence and Victimization | Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment). | 6 months after baseline | 
| Reduced Violence and Victimization | Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment). | 12 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased Access to Health Services | Self-reported use of sexual reproductive health and HIV & STI testing services; linkage to HIV treatment and care services, staging and antiretroviral therapy (ART) initiation. | Baseline | 
| Increased Access to Health Services | Self-reported use of sexual reproductive health and HIV & STI testing services; linkage to HIV treatment and care services, staging and antiretroviral therapy (ART) initiation. | 6 months after baseline | 
| Increased Access to Health Services | Self-reported use of sexual reproductive health and HIV & STI testing services; linkage to HIV treatment and care services, staging and antiretroviral therapy (ART) initiation. | 12 months after baseline | 
| Increased Advancement in Education and Job Training | Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes. | Baseline | 
| Increased Advancement in Education and Job Training | Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes. | 6 months after baseline | 
| Increased Advancement in Education and Job Training | Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes. | 12 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Substance Abuse, Sexual Risk, Out-of-school Adolescents, Young Women, Human Immunodeficiency Virus (HIV), HIV Testing and Counseling (HTC), Sexually Transmitted Infections (STIs), Gender Based Violence, Gang Violence, Victimization, Linkage to Care