NCT02974998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 29, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2019

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

3.1 years

First QC Date

November 23, 2016

Last Update Submit

January 6, 2025

Conditions

Condomless SexHuman Immunodeficiency Virus (HIV)Sexually Transmitted Infections (STIs)Alcohol and Drug UseViolence and VictimizationAccess and Linkage to HealthcareEducation Advancement

Keywords

Human Immunodeficiency Virus (HIV)HIV Testing and Counseling (HTC)Sexually Transmitted Infections (STIs)Substance AbuseGender Based ViolenceGang ViolenceVictimizationLinkage to CareSexual RiskOut-of-school AdolescentsYoung Women

Outcome Measures

Primary Outcomes (12)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

  • Increased Access to Health Services

    Baseline

  • Increased Access to Health Services

    6 months after baseline

  • Increased Access to Health Services

    12 months after baseline

  • Increased Advancement in Education and Job Training

    Baseline

  • Increased Advancement in Education and Job Training

    6 months after baseline

  • +1 more secondary outcomes

Study Arms (2)

Young Women's Health CoOp (YWHC)/ HTC

EXPERIMENTAL

Participants received an enhanced gender-focused HTC intervention.

Behavioral: Young Women's Health CoOp (YWHC)

Standard HTC

ACTIVE COMPARATOR

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

Behavioral: Standard HTC

Interventions

Young Women's Health CoOp (YWHC)BEHAVIORAL

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.

Young Women's Health CoOp (YWHC)/ HTC
Standard HTCBEHAVIORAL

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

Standard HTC

Eligibility Criteria

Age16 Years - 19 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Participant must be able to pass a cognitive test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The South African Medical Research Council (SAMRC),

Cape Town, 7501, South Africa

Location

Related Publications (7)

  • 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.

    PMID: 29996792BACKGROUND

  • 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.

    PMID: 34896961RESULT

  • 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.

    PMID: 34769920RESULT

  • 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.

    PMID: 33404004RESULT

  • 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.

    PMID: 35587247RESULT

  • Wechsberg WM, Browne FA, Carney T, Kline TL, Howard BN, Russell SE, van der Drift I, Myers B, Minnis AM, Bonner CP, Ndirangu JW. Outcomes of substance use and sexual power among adolescent girls and young women in Cape Town: Implications for structural and cultural differences. Glob Public Health. 2024 Jan;19(1):2340500. doi: 10.1080/17441692.2024.2340500. Epub 2024 Apr 16.

    PMID: 38628080DERIVED

  • Singer SE, Wechsberg WM, Kline T, Browne FA, Howard BN, Carney T, Myers B, Bonner CP, Chin-Quee D. Binge drinking and condom negotiation behaviours among adolescent girls and young women living in Cape Town, South Africa: sexual control and perceived personal power. BMC Public Health. 2023 Nov 18;23(1):2282. doi: 10.1186/s12889-023-17188-0.

    PMID: 37980472DERIVED

Related Links

MeSH Terms

Conditions

Unsafe SexAcquired Immunodeficiency SyndromeSexually Transmitted DiseasesSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental Disorders

Study Officials

  • Felicia Browne, ScD

    RTI International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2016

First Posted

November 29, 2016

Study Start

November 1, 2016

Primary Completion

November 26, 2019

Study Completion

November 26, 2019

Last Updated

January 8, 2025

Record last verified: 2025-01

Locations

ZA(1)