Young Women's Health CoOp (Cooperative) in Cape Town (YWHC)

RTI International

Status: Completed

Conditions: HIV; Substance Abuse

Treatments: Behavioral: Young Women's Health CoOp (YWHC); Behavioral: HIV Counseling/Testing

Study type: Interventional

Funder types: Other

Identifiers

NCT02677025

R01DA032061

Details and patient eligibility

About

This supplement study is an adaptation of the larger NIH-funded parent study, the Women's Health CoOp+, which tests a combination biobehavioral HIV prevention approach to enhance standard HIV testing practices for alcohol and drug (AOD)-using women across the city of Pretoria, South Africa. The current supplemental study seeks to reach AOD-using female adolescents who experience the greatest burden of new HIV infections and are currently underserved by HIV and drug-treatment programs in Cape Town, South Africa and test the validation of both the instrument and adapted intervention.

Full description

This study is testing and validating both the revised instrument and adapted intervention through a small pilot trial where a cluster randomized design is used to recruit 100 participants through snowball sampling by community to either the YWHC condition or standard HIV Counseling and Testing (HCT); collect biological specimens to screen for recent drug use, pregnancy and HIV infection and provide referrals for care to resources; conduct process evaluation measures for satisfaction and a 1-month follow-up post-intervention interview assessing the feasibility and preliminary efficacy of conducting this intervention among vulnerable young women and linking them to care.

Young women from disadvantaged communities in Cape Town who have dropped out of school and who use AODs are highly vulnerable to physical victimization (violence and sexual victimization) from any perpetrator, including main sexual partners and drug-related sexual risks for HIV. Yet these vulnerable young women remain underserved by current HIV and drug treatment programs in the region, even though they are experiencing the greatest burden of new HIV infections in the country. The adapted Young Women's Health CoOp (YWHC) intervention has a high likelihood of wider implementation, sustainability, and a significant public health impact by reducing the exceedingly high HIV incidence amongst the most vulnerable populations in South Africa.

Enrollment: 100 patients

Sex: Female

Ages: 16 to 21 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female, 16 to 21 years of age
• Dropped out of school for at least 6 months
• Currently dropped out of school
• Have not completed matric or N 3 certificate
• Have used at least one drug (which can include alcohol) at least weekly in the past 90 days
• Report unprotected sex with a male partner in the last 90 days
• Able to provide informed assent to participate or informed consent if at least 18 years old
• Live in a targeted community Delft, Khayelitsha, or Mfuleni

Exclusion criteria

• Have been a part of formative activities

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Young Women's Health CoOp (YWHC)

Experimental group

Description:

This is an adapted behavioral intervention for young women in Cape Town South Africa who dropped out of school, who use alcohol and other drugs and are at risk for HIV.

Treatment:

Behavioral: Young Women's Health CoOp (YWHC)

HIV Counseling/Testing

Active Comparator group

Description:

Provide age and gender appropriate standard HIV counseling and testing.

Treatment:

Behavioral: HIV Counseling/Testing