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Young Women's Health CoOp (Cooperative) in Cape Town (YWHC)

Primary Purpose

HIV, Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Young Women's Health CoOp (YWHC)
HIV Counseling/Testing
Sponsored by
RTI International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence and Victimization

Eligibility Criteria

16 Years - 21 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

• Have been a part of formative activities

Sites / Locations

  • RTI International

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Young Women's Health CoOp (YWHC)

HIV Counseling/Testing

Arm Description

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.

Provide age and gender appropriate standard HIV counseling and testing.

Outcomes

Primary Outcome Measures

Unprotected intercourse among women
Percentages of condom use at last sex

Secondary Outcome Measures

Alcohol use
Frequency of alcohol use in past 30 days measured by RRBA (Revised Risk Behavior Assessment) and breath test
Alcohol use
Frequency of alcohol use in past 30 days measured by breath test
Substance use
Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by PRBA (Pretoria Risk Behavior Assessment)
Substance use
Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by self-report
Victimization
Percentages of young women who report being beaten in the previous 30 days
Victimization
Percentages of young women who report being attacked with a weapon in the previous 30 days
Victimization
Percentages of young women who report being forced to have sex in the previous 30 days

Full Information

First Posted
January 19, 2016
Last Updated
June 7, 2016
Sponsor
RTI International
Collaborators
Medical Research Council, South Africa
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1. Study Identification

Unique Protocol Identification Number
NCT02677025
Brief Title
Young Women's Health CoOp (Cooperative) in Cape Town
Acronym
YWHC
Official Title
Seek, Test, Treat, & Retain Pilot for Out of School Teens at Risk in Cape Town
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (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 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.
Detailed Description
This study is testing and validating both the revised instrument and adapted intervention through a small pilot trial where a cluster randomized design is used to recruit 100 participants through snowball sampling by community to either the YWHC condition or standard HIV Counseling and Testing (HCT); collect biological specimens to screen for recent drug use, pregnancy and HIV infection and provide referrals for care to resources; conduct process evaluation measures for satisfaction and a 1-month follow-up post-intervention interview assessing the feasibility and preliminary efficacy of conducting this intervention among vulnerable young women and linking them to care. Young women from disadvantaged communities in Cape Town who have dropped out of school and who use AODs are highly vulnerable to physical victimization (violence and sexual victimization) from any perpetrator, including main sexual partners and drug-related sexual risks for HIV. Yet these vulnerable young women remain underserved by current HIV and drug treatment programs in the region, even though they are experiencing the greatest burden of new HIV infections in the country. The adapted Young Women's Health CoOp (YWHC) intervention has a high likelihood of wider implementation, sustainability, and a significant public health impact by reducing the exceedingly high HIV incidence amongst the most vulnerable populations in South Africa.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Substance Abuse
Keywords
HIV, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence and Victimization

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Young Women's Health CoOp (YWHC)
Arm Type
Experimental
Arm Description
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.
Arm Title
HIV Counseling/Testing
Arm Type
Active Comparator
Arm Description
Provide age and gender appropriate standard HIV counseling and testing.
Intervention Type
Behavioral
Intervention Name(s)
Young Women's Health CoOp (YWHC)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HIV Counseling/Testing
Intervention Description
Participants will be tested for HIV and if positive will receive counseling in accordance with national standards.
Primary Outcome Measure Information:
Title
Unprotected intercourse among women
Description
Percentages of condom use at last sex
Time Frame
One month post-intervention
Secondary Outcome Measure Information:
Title
Alcohol use
Description
Frequency of alcohol use in past 30 days measured by RRBA (Revised Risk Behavior Assessment) and breath test
Time Frame
One month post-intervention
Title
Alcohol use
Description
Frequency of alcohol use in past 30 days measured by breath test
Time Frame
One month post-intervention
Title
Substance use
Description
Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by PRBA (Pretoria Risk Behavior Assessment)
Time Frame
One month post-intervention
Title
Substance use
Description
Use of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax as determined by self-report
Time Frame
One month post-intervention
Title
Victimization
Description
Percentages of young women who report being beaten in the previous 30 days
Time Frame
One month post-intervention
Title
Victimization
Description
Percentages of young women who report being attacked with a weapon in the previous 30 days
Time Frame
One month post-intervention
Title
Victimization
Description
Percentages of young women who report being forced to have sex in the previous 30 days
Time Frame
One month post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: • Have been a part of formative activities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendee M Wechsberg, PhD
Organizational Affiliation
Director of RTI Global Gender Center, Senior Director of SATEI
Official's Role
Principal Investigator
Facility Information:
Facility Name
RTI International
City
Research Triangle Park
State/Province
North Carolina
ZIP/Postal Code
27709
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
Citations:
PubMed Identifier
30021470
Citation
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.
Results Reference
derived

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Young Women's Health CoOp (Cooperative) in Cape Town

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