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

NCT ID: NCT02677025

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-04-30

Brief Summary

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.

Detailed 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.

Conditions

HIV; Substance Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Young Women's Health CoOp (YWHC)

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.

Group Type: EXPERIMENTAL

Young Women's Health CoOp (YWHC)

Intervention Type: BEHAVIORAL

Participants in this group will participate in two workshops of the young woman-focused intervention about HIV/STIs (sexually transmitted infections), sexual behaviors, alcohol and other drug use, violence, communication skills, and other issues. Participants will develop personalized risk reduction action plans at the end of each workshop session.

HIV Counseling/Testing

Provide age and gender appropriate standard HIV counseling and testing.

Group Type: ACTIVE_COMPARATOR

HIV Counseling/Testing

Intervention Type: BEHAVIORAL

Participants will be tested for HIV and if positive will receive counseling in accordance with national standards.

Interventions

Young Women's Health CoOp (YWHC)

Participants in this group will participate in two workshops of the young woman-focused intervention about HIV/STIs (sexually transmitted infections), sexual behaviors, alcohol and other drug use, violence, communication skills, and other issues. Participants will develop personalized risk reduction action plans at the end of each workshop session.

Intervention Type: BEHAVIORAL

HIV Counseling/Testing

Participants will be tested for HIV and if positive will receive counseling in accordance with national standards.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical Research Council, South Africa

OTHER

Sponsor Role: collaborator

RTI International

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Felicia Browne, ScD

Role: PRINCIPAL_INVESTIGATOR

RTI International

Locations

RTI International

Research Triangle Park, North Carolina, United States

Countries

United States

References

Carney T, Browne FA, Myers B, Kline TL, Howard B, Wechsberg WM. Adolescent female school dropouts who use drugs and engage in risky sex: effects of a brief pilot intervention in Cape Town, South Africa. AIDS Care. 2019 Jan;31(1):77-84. doi: 10.1080/09540121.2018.1500008. Epub 2018 Jul 18.

Reference Type: DERIVED

PMID: 30021470 (View on PubMed)

Other Identifiers

R01DA032061

Identifier Type: NIH

Identifier Source: org_study_id

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