Young Women's CoOp Study (YWC)

January 6, 2025 updated by: RTI International

Adapting the Women's CoOp for At-Risk Teens

The purpose of this study is to test the efficacy of a cultural-, age- and gender-focused Human Immunodeficiency Virus (HIV) prevention intervention in reducing risk behaviors among African-American young women relative to general health intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study completed an extensive formative phase to adapt the Women's CoOp intervention to specifically address the needs of young out-of-school adolescent African-American females with regard to knowledge about sexually transmitted infections (STIs), HIV and sexuality, health consequences of substance abuse, relationships with males, condom communication and social support, and HIV risk-reduction and violence prevention methods. During this phase, in-depth interviews, focus groups, pretesting and pilot testing were conducted to adapt and refine the intervention for the clinical trial.

The aim of this trial is to:

• Evaluate the efficacy of the cultural-, age-, and gender-focused intervention (Young Women's CoOp) relative to an equal attention control nutrition intervention in terms of changes in behaviors (e.g., condom use, substance use, violence prevention).

At study enrollment/baseline, participants completed a questionnaire and baseline drug and pregnancy testing, and were randomized into one of two programs: Young Women's CoOp or Staying Healthy and Eating Well (Nutrition)-both which included 3 individual intervention sessions and 1 group activity. Follow-ups were conducted 3-months post-intervention and 6-months post-intervention and included a questionnaire and drug testing.

The study has since been completed and analysis and manuscript preparation is underway. Two abstracts have been accepted to American Public Health Association conferences in 2012 and 2013. The five papers in progress or published include:

  1. Efficacy of the Young Women's Coop - analysis complete, manuscript being drafted
  2. Summary of qualitative findings from interviews and focus groups - published September 2013
  3. Homelessness and abuse- in final preparation
  4. Correlates of gang affiliation - manuscript complete, CDC clearance obtained, under review.
  5. Post intervention social determinants - re-analyses and re-write

Study Type

Interventional

Enrollment (Actual)

237

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27703
        • RTI International; Substance Abuse Treatment Evaluations and Interventions (SATEI) Community-Based Field Site - Durham
      • Research Triangle Park, North Carolina, United States, 27709
        • RTI International - Headquarters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female
  • Black/African-American
  • 16-19 years of age
  • Have dropped out of school at least once or are having problems that they have considered dropping out of school, and have not yet completed high school or GED program
  • Have not graduated from a high school or alternative school, or completed a General Education Development (GED) program
  • Have had vaginal sex at least once in the past 90 days with a male partner
  • Have used one of the following at least once in the past 90 days--alcohol, marijuana, cocaine/crack, heroin, ecstasy, methamphetamine, any prescription drugs not prescribed to them, or any other illicit substance.
  • Will be in the area for the next 8 months
  • Has not participated in previous formative activities of the study (e.g., interviews, focus groups, pretesting and pilot testing),

Exclusion Criteria:

  • Not interested in coming to a health behavior study
  • Not able to attend 4 sessions and 2 follow ups

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nutrition
Participants in this group will participate in three individual sessions and one group session of the nutrition intervention about healthy eating, physical activity and general wellness.
Behavioral: Staying Healthy and Eating Well
Participants in this group will participate in three individual sessions and one group session of the nutrition intervention about healthy eating, physical activity and general wellness.
Experimental: Young Women's
Participants in this group will participate in three individual sessions and one group session of the young woman-focused intervention about HIV/STIs, pregnancy, alcohol and other drug use, violence, gangs and other issues. This intervention is an adaptation of the evidence-based Women's CoOp (Principal Investigator (PI): Dr. Wendee M. Wechsberg).
Behavioral: Young Women's CoOp
Participants in this group will participate in three individual sessions and one group session of the young woman-focused intervention about HIV/STIs, pregnancy, alcohol and other drug use, violence, gangs and other issues. This intervention is an adaptation of the evidence-based Women's CoOp (PI: Dr. Wendee M. Wechsberg).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in behaviors, including condom use, substance use and violence prevention
Time Frame: 3, and 6- months post-intervention
3, and 6- months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RTI International

Collaborators

Centers for Disease Control and Prevention

Investigators

  • Principal Investigator: Felicia Browne, ScD, RTI International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

October 13, 2010

First Submitted That Met QC Criteria

October 18, 2010

First Posted (Estimated)

October 19, 2010

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5UR6PS000665-04 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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