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Completed

NCT Number: NCT01224184

Young Women's CoOp Study

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.

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Key information

Age range

16 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

RTI International; Substance Abuse Treatment Evaluations and Interventions (SATEI) Community-Based Field Site - Durham, Durham, North Carolina, United States

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About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Young Women's CoOp

Behavioral

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).

Staying Healthy and Eating Well

Behavioral

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.

Primary outcomes

  1. Changes in behaviors, including condom use, substance use and violence prevention

    Time frame: 3, and 6- months post-intervention

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Adapting the Women's CoOp for At-Risk Teens

Acronym: YWC

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 19, 2010
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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