Young Women's CoOp Study (YWC)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
RTI International
ClinicalTrials.gov Identifier:
NCT01224184
First received: October 13, 2010
Last updated: October 16, 2013
Last verified: October 2013

October 13, 2010
October 16, 2013
May 2010
September 2013   (final data collection date for primary outcome measure)
Changes in behaviors, including condom use, substance use and violence prevention [ Time Frame: 3, and 6- months post-intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01224184 on ClinicalTrials.gov Archive Site
Not Provided
  • Identify the mechanisms—through both qualitative and quantitative methods—that influence the intervention outcomes [ Time Frame: 3 months post-intervention ] [ Designated as safety issue: No ]
  • Identify the mechanisms—through both qualitative and quantitative methods—that influence the intervention outcomes [ Time Frame: 6-months post-intervention ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Young Women's CoOp Study
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.

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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV
  • Sexual Risk
  • Sexually Transmitted Diseases
  • Substance Abuse
  • Violence
  • Victimization
  • 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.
  • 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.
    Intervention: Behavioral: Staying Healthy and Eating Well
  • 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).
    Intervention: Behavioral: Young Women's CoOp
Wechsberg, W. M., Browne, F. A., Middlesteadt Ellerson, R., & Zule, W. A. (2010). Adapting the evidence-based Women's CoOp HIV prevention intervention in North Carolina and international settings. North Carolina Medical Journal, 71(5), 477-481.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
237
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Female
16 Years to 19 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01224184
5UR6PS000665-04
No
RTI International
RTI International
Centers for Disease Control and Prevention
Principal Investigator: Wendee M Wechsberg, PhD RTI International
RTI International
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP