Clinical trial NCT02974998: Cape Town Young Women's Health CoOp
Official title: Expanding HIV Testing and Prevention to Reach Vulnerable Young Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: Medical Research Council, South Africa
First posted: 2016-11-29
Enrollment: 500
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Reduced Sexual Risk
timeFrame: Baseline
measure: Reduced Sexual Risk
timeFrame: 6 months after baseline
measure: Reduced Sexual Risk
timeFrame: 12 months after baseline
measure: Increased Condom Use
timeFrame: Baseline
measure: Increased Condom Use
timeFrame: 6 months after baseline
measure: Increased Condom Use
timeFrame: 12 months after baseline
measure: Reduced Alcohol and Illicit Drug Use
timeFrame: Baseline
measure: Reduced Alcohol and Illicit Drug Use
timeFrame: 6 months after baseline
measure: Reduced Alcohol and Illicit Drug Use
timeFrame: 12 months after baseline
measure: Reduced Violence and Victimization
timeFrame: Baseline
measure: Reduced Violence and Victimization
timeFrame: 6 months after baseline
measure: Reduced Violence and Victimization
timeFrame: 12 months after baseline
Secondary outcomes:
measure: Increased Access to Health Services
timeFrame: Baseline
measure: Increased Access to Health Services
timeFrame: 6 months after baseline
measure: Increased Access to Health Services
timeFrame: 12 months after baseline
measure: Increased Advancement in Education and Job Training
timeFrame: Baseline
measure: Increased Advancement in Education and Job Training
timeFrame: 6 months after baseline
measure: Increased Advancement in Education and Job Training
timeFrame: 12 months after baseline
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: The South African Medical Research Council (SAMRC),
Study officials:
affiliation: RTI International
name: Felicia Browne, ScD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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 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.
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 Town, South Africa. Int J Environ Res Public Health. 2021 Oct 29;18(21):11403. doi: 10.3390/ijerph182111403.
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/SAMJ.2020.v111i1.14520.
citation: 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.