NCT01224184

Young Women's CoOp Study

Adapting the Women's CoOp for At-Risk Teens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: RTI International · Academic / Other
• Sex: Female
• Age: 16 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

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.

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

Conditions

• HIV
• Sexual Risk
• Sexually Transmitted Diseases
• Substance Abuse
• Violence
• Victimization

Interventions

Type	Name	Description
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).
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.

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2010-10-19
• Last updated: 2025-01-08

Locations

2 sites across 1 country: United States