Clinical trial NCT02677025: Young Women's Health CoOp (Cooperative) in Cape Town
Official title: Seek, Test, Treat, & Retain Pilot for Out of School Teens at Risk in Cape Town
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Substance Abuse
Keywords: HIV
Sexual Risk
Sexually Transmitted Diseases
Substance Abuse
Violence and Victimization
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: Medical Research Council, South Africa
First posted: 2016-02-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Unprotected intercourse among women
timeFrame: One month post-intervention
Secondary outcomes:
measure: Alcohol use
timeFrame: One month post-intervention
measure: Alcohol use
timeFrame: One month post-intervention
measure: Substance use
timeFrame: One month post-intervention
measure: Substance use
timeFrame: One month post-intervention
measure: Victimization
timeFrame: One month post-intervention
measure: Victimization
timeFrame: One month post-intervention
measure: Victimization
timeFrame: One month post-intervention
Other outcomes:
Locations:
city: Research Triangle Park
country: United States
facility: RTI International
state: North Carolina
Study officials:
affiliation: RTI International
name: Felicia Browne, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.