- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02677025
Young Women's Health CoOp (Cooperative) in Cape Town (YWHC)
Seek, Test, Treat, & Retain Pilot for Out of School Teens at Risk in Cape Town
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Research Triangle Park, North Carolina, United States, 27709
- RTI International
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
Participants will be tested for HIV and if positive will receive counseling in accordance with national standards.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unprotected intercourse among women
Time Frame: One month post-intervention
|
Percentages of condom use at last sex
|
One month post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
One month post-intervention
|
Alcohol use
Time Frame: One month post-intervention
|
Frequency of alcohol use in past 30 days measured by breath test
|
One month post-intervention
|
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)
|
One month post-intervention
|
Substance use
Time Frame: One month post-intervention
|
Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by self-report
|
One month post-intervention
|
Victimization
Time Frame: One month post-intervention
|
Percentages of young women who report being beaten in the previous 30 days
|
One month post-intervention
|
Victimization
Time Frame: One month post-intervention
|
Percentages of young women who report being attacked with a weapon in the previous 30 days
|
One month post-intervention
|
Victimization
Time Frame: One month post-intervention
|
Percentages of young women who report being forced to have sex in the previous 30 days
|
One month post-intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wendee M Wechsberg, PhD, Director of RTI Global Gender Center, Senior Director of SATEI
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA032061 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV
-
University of Alabama at BirminghamMobile County Health Deparment; Alabama Department of Public HealthNot yet recruitingHIV | HIV Testing | HIV Linkage to Care | HIV TreatmentUnited States
-
ANRS, Emerging Infectious DiseasesHopital Universitaire Robert-Debre; Institut de Recherche pour le Developpement and other collaboratorsUnknownHIV | HIV-uninfected Children | Children Exposed to HIVCameroon
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS FoundationCompletedPartner HIV Testing | Couple HIV Counseling | Couple Communication | HIV IncidenceCameroon, Dominican Republic, Georgia, India
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
CDC FoundationGilead SciencesUnknownHIV Preexposure Prophylaxis | HIV ChemoprophylaxisUnited States
-
Africa Health Research InstituteLondon School of Hygiene and Tropical Medicine; University College, London; University... and other collaboratorsRecruiting
-
Massachusetts General HospitalNational Institute of Mental Health (NIMH); Fenway Community Health; Tuberculosis...CompletedHIV/STI Risk | HIV/STI IncidenceUnited States, India
-
Erasmus Medical CenterNot yet recruitingHIV Infections | Hiv | HIV-1-infection | HIV I InfectionNetherlands
-
Hospital Clinic of BarcelonaCompletedIntegrase Inhibitors, HIV; HIV PROTEASE INHIBSpain
-
University of WashingtonNational Institute of Mental Health (NIMH)RecruitingHIV Prevention | HIV Preexposure Prophylaxis | ImplementationKenya
Clinical Trials on Young Women's Health CoOp (YWHC)
-
RTI InternationalMedical Research Council, South AfricaCompletedHuman Immunodeficiency Virus (HIV) | Condomless Sex | Alcohol and Drug Use | Sexually Transmitted Infections (STIs) | Violence and Victimization | Access and Linkage to Healthcare | Education AdvancementSouth Africa
-
RTI InternationalSetshaba Research CentreCompletedHIV PreventionSouth Africa
-
RTI InternationalDurham County Department of Public Health; Guilford County Department of Public... and other collaboratorsTerminatedHuman Immunodeficiency Virus (HIV) | Condomless Sex | Alcohol and Drug Use | Sexually Transmitted Infection (STI)United States
-
Eunice Kennedy Shriver National Institute of Child...Medical Research Council, South AfricaCompletedHIV | Substance Abuse | ViolenceSouth Africa
-
RTI InternationalNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Medical Research...Completed
-
RTI InternationalCenters for Disease Control and PreventionCompletedSexually Transmitted Diseases | HIV | Substance Abuse | Violence | Victimization | Sexual RiskUnited States
-
RTI InternationalKheth'ImpiloCompletedHIV | Substance AbuseUnited States, South Africa
-
Brown UniversityNational Institute of Mental Health (NIMH)CompletedSexual Assault | Unsafe Sex | Physical Violence | Sexual AbuseUnited States
-
RTI InternationalUniversity of North Carolina, Chapel HillCompletedSexually Transmitted Diseases | HIV | Substance Abuse | Violence | Victimization | Sexual RiskUnited States, South Africa
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA)Completed