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

Study Overview
=================
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.

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

Conditions
-----------------
HIV, Substance Abuse

Intervention / Treatment
-----------------
* Behavioral: Young Women's Health CoOp (YWHC)
* Behavioral: HIV Counseling/Testing


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Young Women's Health CoOp (YWHC)<br>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. | Behavioral: Young Women's Health CoOp (YWHC)<br>* 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.<br>|
| Active Comparator: HIV Counseling/Testing<br>Provide age and gender appropriate standard HIV counseling and testing. | Behavioral: HIV Counseling/Testing<br>* Participants will be tested for HIV and if positive will receive counseling in accordance with national standards.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unprotected intercourse among women | Percentages of condom use at last sex | One month post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol use | Frequency of alcohol use in past 30 days measured by RRBA (Revised Risk Behavior Assessment) and breath test | One month post-intervention | 
| Alcohol use | Frequency of alcohol use in past 30 days measured by breath test | One month post-intervention | 
| 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 | 
| Substance use | Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by self-report | One month post-intervention | 
| Victimization | Percentages of young women who report being beaten in the previous 30 days | One month post-intervention | 
| Victimization | Percentages of young women who report being attacked with a weapon in the previous 30 days | One month post-intervention | 
| Victimization | Percentages of young women who report being forced to have sex in the previous 30 days | One month post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence and Victimization