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

HIV Clinical Trial

— YWHC  

Official title:

Seek, Test, Treat, & Retain Pilot for Out of School Teens at Risk in Cape Town

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677025
• Other study ID #: R01DA032061
• Status: Completed
• Phase: N/A
• First received: January 19, 2016
• Last updated: June 7, 2016
• Start date: May 2014
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medical Research CouncilUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Substance Abuse

Intervention

Behavioral:
• 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.
• HIV Counseling/Testing
Participants will be tested for HIV and if positive will receive counseling in accordance with national standards.

Locations

Country	Name	City	State
United States	RTI International	Research Triangle Park	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
RTI International	Medical Research Council, South Africa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unprotected intercourse among women	Percentages of condom use at last sex	One month post-intervention	No
Secondary	Alcohol use	Frequency of alcohol use in past 30 days measured by RRBA (Revised Risk Behavior Assessment) and breath test	One month post-intervention	No
Secondary	Alcohol use	Frequency of alcohol use in past 30 days measured by breath test	One month post-intervention	No
Secondary	Substance use	Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by PRBA (Pretoria Risk Behavior Assessment)	One month post-intervention	No
Secondary	Substance use	Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by self-report	One month post-intervention	No
Secondary	Victimization	Percentages of young women who report being beaten in the previous 30 days	One month post-intervention	No
Secondary	Victimization	Percentages of young women who report being attacked with a weapon in the previous 30 days	One month post-intervention	No
Secondary	Victimization	Percentages of young women who report being forced to have sex in the previous 30 days	One month post-intervention	No