Young Women's Health CoOp (Cooperative) in Cape Town (YWHC)
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|ClinicalTrials.gov Identifier: NCT02677025|
Recruitment Status : Completed
First Posted : February 9, 2016
Last Update Posted : June 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV Substance Abuse||Behavioral: Young Women's Health CoOp (YWHC) Behavioral: HIV Counseling/Testing||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Seek, Test, Treat, & Retain Pilot for Out of School Teens at Risk in Cape Town|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Experimental: 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.
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.
Active Comparator: HIV Counseling/Testing
Provide age and gender appropriate standard HIV counseling and testing.
Behavioral: HIV Counseling/Testing
Participants will be tested for HIV and if positive will receive counseling in accordance with national standards.
- Unprotected intercourse among women [ Time Frame: One month post-intervention ]Percentages of condom use at last sex
- Alcohol use [ Time Frame: One month post-intervention ]Frequency of alcohol use in past 30 days measured by RRBA (Revised Risk Behavior Assessment) and breath test
- Alcohol use [ Time Frame: One month post-intervention ]Frequency of alcohol use in past 30 days measured by breath test
- Substance use [ Time Frame: One month post-intervention ]Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by PRBA (Pretoria Risk Behavior Assessment)
- Substance use [ Time Frame: One month post-intervention ]Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by self-report
- Victimization [ Time Frame: One month post-intervention ]Percentages of young women who report being beaten in the previous 30 days
- Victimization [ Time Frame: One month post-intervention ]Percentages of young women who report being attacked with a weapon in the previous 30 days
- Victimization [ Time Frame: One month post-intervention ]Percentages of young women who report being forced to have sex in the previous 30 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677025
|United States, North Carolina|
|Research Triangle Park, North Carolina, United States, 27709|
|Principal Investigator:||Wendee M Wechsberg, PhD||Director of RTI Global Gender Center, Senior Director of SATEI|