Cape Town Young Women's Health CoOp

RTI International

Status: Completed

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

Treatments: Behavioral: Young Women's Health CoOp (YWHC); Behavioral: Standard HTC

Study type: Interventional

Funder types: Other

Identifiers

NCT02974998

R01DA041227

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 patients

Sex: Female

Ages: 16 to 19 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Young Women's Health CoOp (YWHC)/ HTC

Experimental group

Description:

Participants received an enhanced gender-focused HTC intervention.

Treatment:

Behavioral: Young Women's Health CoOp (YWHC)

Standard HTC

Active Comparator group

Description:

Participants received the standard HTC available in South Africa for this population.

Treatment:

Behavioral: Standard HTC