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Cape Town Young Women's Health CoOp

Primary Purpose

Condomless Sex, Human Immunodeficiency Virus (HIV), Sexually Transmitted Infections (STIs)

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Young Women's Health CoOp (YWHC)
Standard HTC
Sponsored by
RTI International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Condomless Sex focused on measuring Human Immunodeficiency Virus (HIV), HIV Testing and Counseling (HTC), Sexually Transmitted Infections (STIs), Substance Abuse, Gender Based Violence, Gang Violence, Victimization, Linkage to Care, Sexual Risk, Out-of-school Adolescents, Young Women

Eligibility Criteria

16 Years - 19 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • The South African Medical Research Council (SAMRC),

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Young Women's Health CoOp (YWHC)/ HTC

Standard HTC

Arm Description

Participants received an enhanced gender-focused HTC intervention.

Participants received the standard HTC available in South Africa for this population.

Outcomes

Primary Outcome Measures

Reduced Sexual Risk
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)
Reduced Sexual Risk
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
Reduced Sexual Risk
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
Increased Condom Use
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)
Increased Condom Use
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)
Increased Condom Use
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)
Reduced Alcohol and Illicit Drug Use
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.
Reduced Alcohol and Illicit Drug Use
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.
Reduced Alcohol and Illicit Drug Use
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.
Reduced Violence and Victimization
Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
Reduced Violence and Victimization
Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
Reduced Violence and Victimization
Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).

Secondary Outcome Measures

Increased Access to Health Services
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.
Increased Access to Health Services
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.
Increased Access to Health Services
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.
Increased Advancement in Education and Job Training
Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.
Increased Advancement in Education and Job Training
Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.
Increased Advancement in Education and Job Training
Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.

Full Information

First Posted
November 23, 2016
Last Updated
May 23, 2023
Sponsor
RTI International
Collaborators
Medical Research Council, South Africa
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1. Study Identification

Unique Protocol Identification Number
NCT02974998
Brief Title
Cape Town Young Women's Health CoOp
Official Title
Expanding HIV Testing and Prevention to Reach Vulnerable Young Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 26, 2019 (Actual)
Study Completion Date
November 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RTI International
Collaborators
Medical Research Council, South Africa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Condomless Sex, Human Immunodeficiency Virus (HIV), Sexually Transmitted Infections (STIs), Alcohol and Drug Use, Violence and Victimization, Access and Linkage to Healthcare, Education Advancement
Keywords
Human Immunodeficiency Virus (HIV), HIV Testing and Counseling (HTC), Sexually Transmitted Infections (STIs), Substance Abuse, Gender Based Violence, Gang Violence, Victimization, Linkage to Care, Sexual Risk, Out-of-school Adolescents, Young Women

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Young Women's Health CoOp (YWHC)/ HTC
Arm Type
Experimental
Arm Description
Participants received an enhanced gender-focused HTC intervention.
Arm Title
Standard HTC
Arm Type
Active Comparator
Arm Description
Participants received the standard HTC available in South Africa for this population.
Intervention Type
Behavioral
Intervention Name(s)
Young Women's Health CoOp (YWHC)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard HTC
Intervention Description
Participants received the standard HTC available in South Africa for this population.
Primary Outcome Measure Information:
Title
Reduced Sexual Risk
Description
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)
Time Frame
Baseline
Title
Reduced Sexual Risk
Description
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
Time Frame
6 months after baseline
Title
Reduced Sexual Risk
Description
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
Time Frame
12 months after baseline
Title
Increased Condom Use
Description
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)
Time Frame
Baseline
Title
Increased Condom Use
Description
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)
Time Frame
6 months after baseline
Title
Increased Condom Use
Description
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)
Time Frame
12 months after baseline
Title
Reduced Alcohol and Illicit Drug Use
Description
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.
Time Frame
Baseline
Title
Reduced Alcohol and Illicit Drug Use
Description
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.
Time Frame
6 months after baseline
Title
Reduced Alcohol and Illicit Drug Use
Description
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.
Time Frame
12 months after baseline
Title
Reduced Violence and Victimization
Description
Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
Time Frame
Baseline
Title
Reduced Violence and Victimization
Description
Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
Time Frame
6 months after baseline
Title
Reduced Violence and Victimization
Description
Self-reported recent emotional, physical, and sexual abuse in the past 6 months measured by the RRBA (WHC Revised Risk Behavior Assessment).
Time Frame
12 months after baseline
Secondary Outcome Measure Information:
Title
Increased Access to Health Services
Description
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.
Time Frame
Baseline
Title
Increased Access to Health Services
Description
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.
Time Frame
6 months after baseline
Title
Increased Access to Health Services
Description
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.
Time Frame
12 months after baseline
Title
Increased Advancement in Education and Job Training
Description
Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.
Time Frame
Baseline
Title
Increased Advancement in Education and Job Training
Description
Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.
Time Frame
6 months after baseline
Title
Increased Advancement in Education and Job Training
Description
Enrollment in training certifications; self-reported motivation and perception regarding learning; self-reported knowledge regarding strategies to improve educational outcomes.
Time Frame
12 months after baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendee Wechsberg, PhD
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
The South African Medical Research Council (SAMRC),
City
Cape Town
ZIP/Postal Code
7501
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
29996792
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6042235/
Description
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

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Cape Town Young Women's Health CoOp

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