- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02974998
Cape Town Young Women's Health CoOp
November 10, 2023 updated by: RTI International
Expanding HIV Testing and Prevention to Reach Vulnerable Young Women
This two-arm cluster randomized trial tested a gender-focused comprehensive HIV testing and counselling (HTC) program, the Young Women's Health CoOp (YWHC) with a standard HTC program and targeted female adolescents (aged 16-19) who use substances and have dropped out of school.
To evaluate the process, the study examined the feasibility of using peer role models as recruiters and co-facilitators of the intervention and monitored fidelity to the intervention.
Efficacy of the intervention on behavioral and biological outcomes, and on linkages to health services, through follow-up visits conducted 6- and 12-months post-enrollment was also assessed.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study was to test a gender-focused comprehensive HIV testing and counselling (HTC) program, the Young Women's Health CoOp (YWHC) with a standard HTC program in 24 disadvantaged communities in Cape Town, South Africa.
The researchers conducted community-level randomization across the 24 communities with balanced recruitment from predominantly Black African and predominantly Coloured communities.
The aims of the study were: Aim 1.
To train and evaluate adolescent peer role models to conduct community outreach with established outreach workers to recruit 500 out-of-school, substance-using female adolescents aged 16 to 19 for HIV testing and counseling (HTC) and to co-facilitate a gender-focused comprehensive HTC program.
Aim 2. To test the efficacy of a young women's gender-focused comprehensive HTC program for reducing substance use, victimization, and sexual risk behavior (primary outcomes) and improving access to effective treatment and support services through linkages to care (substance abuse treatment, HIV, sexually transmitted infections [STIs], antenatal and reproductive health as secondary outcomes) relative to standard HTC for adolescent females.
The Young Women's Health CoOp has been adapted from the South African Women's Health CoOp (WHC) and the North Carolina Young Women's CoOp (YWC) which was found acceptable in focus groups and maintained all the core elements of the evidence-based intervention.
For this study, the intervention was co-facilitated by trained staff from the local communities.
The intervention consisted of two 1.5-hour group workshops (sessions), each having several modules that are usually administered a week apart: Workshop 1: Developmental Issues and Alcohol and Other Drugs; Gender, Problem-Solving and Conflict Negotiation, Violence and Values and Becoming a Powerful Young Woman: and Workshop 2: STIs, HIV/AIDS, Prevention, Condoms and Role-play.
After each session, each participant developed a risk-reduction personalized action plan (PAP).
To maintain PAP goals and reduce decay of intervention effects over time, the staff conducted case management to help participants attain these personal goals.
Participants completed baseline, 6-month follow-up and 12-month follow-up assessments, which included a survey and biological testing for substance use, pregnancy and HIV.
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cape Town, South Africa, 7501
- The South African Medical Research Council (SAMRC),
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Female
- Self-identify as living in one of the 24 targeted disadvantaged communities
- Between 16 and 19 years old
- Has dropped out of school for at least 6 months
- Is currently dropped out of school
- Has not completed matric (high school diploma) or have an N3 Certificate (South Africa National Technical Certificate)
- Reports consuming 2-3 alcoholic drinks at least once in the last 30 days or using illicit drugs at least once a week.
- Reports unprotected sex with a male partner in the last 90 days
- Is able to provide informed assent to participate or informed consent if emancipated or 18 years old
- Has lived in targeted community for at least 6 months and plans to reside in the target community for the next year and provide verifiable locator information
Exclusion Criteria:
- Participant must be able to pass a cognitive test
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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)/ HTC
Participants received an enhanced gender-focused HTC intervention.
|
Participants received HTC and engaged in a two-session gender-focused intervention.
The intervention included information addressing the intersection of substance use, sexual risk, and violence through skill building, role-play, and rehearsal.
The intervention also encouraged positive goal-seeking to access linkages to health care within the larger social ecological framework of where the young women live.
|
Active Comparator: Standard HTC
Participants received the standard HTC available in South Africa for this population.
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Participants received the standard HTC available in South Africa for this population.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduced Sexual Risk
Time Frame: Baseline
|
Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment)
|
Baseline
|
Reduced Sexual Risk
Time Frame: 6 months after baseline
|
Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment
|
6 months after baseline
|
Reduced Sexual Risk
Time Frame: 12 months after baseline
|
Reduced drug or alcohol use prior to sex (impairment), self-reported number of casual partners, sex trading, and concurrent partners (defined ≥ 2 partners in past 90 days) measured by the PRBA (WHC Pretoria Risk Behavior Assessment
|
12 months after baseline
|
Increased Condom Use
Time Frame: Baseline
|
Reduced number of unprotected anal and vaginal sex acts in the past 90 days.
Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment)
|
Baseline
|
Increased Condom Use
Time Frame: 6 months after baseline
|
Reduced number of unprotected anal and vaginal sex acts in the past 90 days.
Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment)
|
6 months after baseline
|
Increased Condom Use
Time Frame: 12 months after baseline
|
Reduced number of unprotected anal and vaginal sex acts in the past 90 days.
Increased skillful condom communication as measured by the 3-item Condom Negotiation scale measured by the YRBA (Youth revised Risk Behavior Assessment)
|
12 months after baseline
|
Reduced Alcohol and Illicit Drug Use
Time Frame: Baseline
|
Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA.
Biological measures of drug use through urine drug tests and breathalyzer tests.
|
Baseline
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Reduced Alcohol and Illicit Drug Use
Time Frame: 6 months after baseline
|
Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA.
Biological measures of drug use through urine drug tests and breathalyzer tests.
|
6 months after baseline
|
Reduced Alcohol and Illicit Drug Use
Time Frame: 12 months after baseline
|
Self-reported frequency of alcohol and illicit drug use the past 30 days as measured by PRBA.
Biological measures of drug use through urine drug tests and breathalyzer tests.
|
12 months after baseline
|
Reduced Violence and Victimization
Time Frame: Baseline
|
Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
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Baseline
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Reduced Violence and Victimization
Time Frame: 6 months after baseline
|
Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
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6 months after baseline
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Reduced Violence and Victimization
Time Frame: 12 months after baseline
|
Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
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12 months after baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Increased Access to Health Services
Time Frame: Baseline
|
Self-reported use of sexual reproductive health and HIV & STI testing services; linkage to HIV treatment and care services, staging and antiretroviral therapy (ART) initiation.
|
Baseline
|
Increased Access to Health Services
Time Frame: 6 months after baseline
|
Self-reported use of sexual reproductive health and HIV & STI testing services; linkage to HIV treatment and care services, staging and antiretroviral therapy (ART) initiation.
|
6 months after baseline
|
Increased Access to Health Services
Time Frame: 12 months after baseline
|
Self-reported use of sexual reproductive health and HIV & STI testing services; linkage to HIV treatment and care services, staging and antiretroviral therapy (ART) initiation.
|
12 months after baseline
|
Increased Advancement in Education and Job Training
Time Frame: Baseline
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Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.
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Baseline
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Increased Advancement in Education and Job Training
Time Frame: 6 months after baseline
|
Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.
|
6 months after baseline
|
Increased Advancement in Education and Job Training
Time Frame: 12 months after baseline
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Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.
|
12 months after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Wendee Wechsberg, PhD, RTI International
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wechsberg WM, Browne FA, Carney T, Myers B, Minnis A, MacDonald R, Ndirangu JW, Turner LB, Howard BN, Rodman N. The Young Women's Health CoOp in Cape Town, South Africa: Study protocol for a cluster-randomised trial for adolescent women at risk for HIV. BMC Public Health. 2018 Jul 11;18(1):859. doi: 10.1186/s12889-018-5665-5.
- Bonner CP, Fisher CB, Carney T, Browne FA, Gichane MW, Howard BN, Turner L, Wechsberg WM. "Because all mothers is not the same": The development and implementation of an in loco parentis informed consent procedure to enroll adolescent girls and young women to participate in HIV research. J Adolesc. 2021 Dec;93:234-244. doi: 10.1016/j.adolescence.2021.11.001. Epub 2021 Dec 9.
- Myers B, Browne FA, Carney T, Kline T, Bonner CP, Wechsberg WM. The Association of Recurrent and Multiple Types of Abuse with Adverse Mental Health, Substance Use, and Sexual Health Outcomes among Out-of-School Adolescent Girls and Young Women in Cape Town, South Africa. Int J Environ Res Public Health. 2021 Oct 29;18(21):11403. doi: 10.3390/ijerph182111403.
- Bonner CP, Carney T, Browne FA, Ndirangu JW, Howard BN, Wechsberg WM. Substance use and depressive and anxiety symptoms among out-of-school adolescent girls and young women in Cape Town, South Africa. S Afr Med J. 2020 Dec 14;111(1):40-45. doi: 10.7196/SAMJ.2020.v111i1.14520.
- Bonner CP, Browne FA, Carney T, Shangase N, Ndirangu JW, Myers B, Wechsberg WM. Mandrax use, sexual risk, and opportunities for pre-exposure prophylaxis among out-of-school adolescent girls and young women in Cape Town, South Africa. S Afr Med J. 2022 Apr 29;112(5):341-346.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
November 26, 2019
Study Completion (Actual)
November 26, 2019
Study Registration Dates
First Submitted
November 23, 2016
First Submitted That Met QC Criteria
November 23, 2016
First Posted (Estimated)
November 29, 2016
Study Record Updates
Last Update Posted (Actual)
November 14, 2023
Last Update Submitted That Met QC Criteria
November 10, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Disease Attributes
- Slow Virus Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Sexually Transmitted Diseases
Other Study ID Numbers
- R01DA041227 (U.S. NIH Grant/Contract)
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.
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