NCT02677025

Brief Summary

This supplement study is an adaptation of the larger NIH-funded parent study, the Women's Health CoOp+, which tests a combination biobehavioral HIV prevention approach to enhance standard HIV testing practices for alcohol and drug (AOD)-using women across the city of Pretoria, South Africa. The current supplemental study seeks to reach AOD-using female adolescents who experience the greatest burden of new HIV infections and are currently underserved by HIV and drug-treatment programs in Cape Town, South Africa and test the validation of both the instrument and adapted intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable hiv

Timeline
Completed

Started May 2014

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

May 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

January 8, 2025

Status Verified

January 1, 2025

Enrollment Period

1.9 years

First QC Date

January 19, 2016

Last Update Submit

January 6, 2025

Conditions

Keywords

HIVSexual RiskSexually Transmitted DiseasesSubstance AbuseViolence and Victimization

Outcome Measures

Primary Outcomes (1)

  • Unprotected intercourse among women

    Percentages of condom use at last sex

    One month post-intervention

Secondary Outcomes (7)

  • Alcohol use

    One month post-intervention

  • Alcohol use

    One month post-intervention

  • Substance use

    One month post-intervention

  • Substance use

    One month post-intervention

  • Victimization

    One month post-intervention

  • +2 more secondary outcomes

Study Arms (2)

Young Women's Health CoOp (YWHC)

EXPERIMENTAL

This is an adapted behavioral intervention for young women in Cape Town South Africa who dropped out of school, who use alcohol and other drugs and are at risk for HIV.

Behavioral: Young Women's Health CoOp (YWHC)

HIV Counseling/Testing

ACTIVE COMPARATOR

Provide age and gender appropriate standard HIV counseling and testing.

Behavioral: HIV Counseling/Testing

Interventions

Participants in this group will participate in two workshops of the young woman-focused intervention about HIV/STIs (sexually transmitted infections), sexual behaviors, alcohol and other drug use, violence, communication skills, and other issues. Participants will develop personalized risk reduction action plans at the end of each workshop session.

Young Women's Health CoOp (YWHC)

Participants will be tested for HIV and if positive will receive counseling in accordance with national standards.

HIV Counseling/Testing

Eligibility Criteria

Age16 Years - 21 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Female, 16 to 21 years of age
  • Dropped out of school for at least 6 months
  • Currently dropped out of school
  • Have not completed matric or N 3 certificate
  • Have used at least one drug (which can include alcohol) at least weekly in the past 90 days
  • Report unprotected sex with a male partner in the last 90 days
  • Able to provide informed assent to participate or informed consent if at least 18 years old
  • Live in a targeted community Delft, Khayelitsha, or Mfuleni

You may not qualify if:

  • Have been a part of formative activities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RTI International

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (1)

  • Carney T, Browne FA, Myers B, Kline TL, Howard B, Wechsberg WM. Adolescent female school dropouts who use drugs and engage in risky sex: effects of a brief pilot intervention in Cape Town, South Africa. AIDS Care. 2019 Jan;31(1):77-84. doi: 10.1080/09540121.2018.1500008. Epub 2018 Jul 18.

MeSH Terms

Conditions

Substance-Related DisordersSexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

January 19, 2016

First Posted

February 9, 2016

Study Start

May 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

January 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

After the main findings are published, we welcome other researchers who want to analyze the data in other ways. Before this time, however, we anticipate establishing a publication plan that involves other researchers and institutions. Analytic data sets will be prepared in accordance with the "Privacy Rule" of the Health Insurance Portability and Accountability Act (HIPAA; http://www.hhs.gov/ocr/) as "limited data sets" in which names and other personal health identifiers are removed, birthdays have been converted to age at intake, and other dates have been changed to be days before or after the date of intake.

Locations