Cape Town Young Women's Health CoOp

Human Immunodeficiency Virus (HIV) Clinical Trial

Official title:

Expanding HIV Testing and Prevention to Reach Vulnerable Young Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974998
• Other study ID #: R01DA041227
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: November 26, 2019

Study information

• Verified date: November 2023
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Access and Linkage to Healthcare
• Acquired Immunodeficiency Syndrome
• Alcohol and Drug Use
• Condomless Sex
• Education Advancement
• HIV Infections
• Human Immunodeficiency Virus (HIV)
• Immunologic Deficiency Syndromes
• Sexually Transmitted Diseases
• Sexually Transmitted Infections (STIs)
• Violence and Victimization

Intervention

Behavioral:
• Young Women's Health CoOp (YWHC)
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.
• Standard HTC
Participants received the standard HTC available in South Africa for this population.

Locations

Country	Name	City	State
South Africa	The South African Medical Research Council (SAMRC),	Cape Town

Sponsors (2)

Lead Sponsor	Collaborator
RTI International	Medical Research Council, South Africa

Country where clinical trial is conducted

South Africa, 

References & Publications (5)

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 — View Citation

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/SA — View Citation

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 wome — View Citation

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 Tow — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline
Primary	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	6 months after baseline
Primary	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	12 months after baseline
Primary	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)	Baseline
Primary	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)	6 months after baseline
Primary	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)	12 months after baseline
Primary	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.	Baseline
Primary	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.	6 months after baseline
Primary	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.	12 months after baseline
Primary	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).	Baseline
Primary	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).	6 months after baseline
Primary	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).	12 months after baseline
Secondary	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.	Baseline
Secondary	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.	6 months after baseline
Secondary	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.	12 months after baseline
Secondary	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.	Baseline
Secondary	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.	6 months after baseline
Secondary	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.	12 months after baseline

External Links

•   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