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
  Purpose

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.


Condition Intervention
HIV
Sexual Risk
Sexually Transmitted Diseases
Substance Abuse
Violence
Victimization
Behavioral: Young Women's CoOp
Behavioral: Staying Healthy and Eating Well

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Adapting the Women's CoOp for At-Risk Teens

Resource links provided by NLM:


Further study details as provided by RTI International:

Primary Outcome Measures:
  • Changes in behaviors, including condom use, substance use and violence prevention [ Time Frame: 3, and 6- months post-intervention ] [ Designated as safety issue: No ]

Enrollment: 237
Study Start Date: May 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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
  Eligibility

Ages Eligible for Study:   16 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224184

Locations
United States, North Carolina
RTI International; Substance Abuse Treatment Evaluations and Interventions (SATEI) Community-Based Field Site - Durham
Durham, North Carolina, United States, 27703
RTI International - Headquarters
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
RTI International
Investigators
Principal Investigator: Wendee M Wechsberg, PhD RTI International
  More Information

Additional Information:
Publications:
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.

Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT01224184     History of Changes
Other Study ID Numbers: 5UR6PS000665-04
Study First Received: October 13, 2010
Last Updated: October 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by RTI International:
HIV
Sexually Transmitted Diseases
Substance Abuse Detection
Randomized Controlled Trial

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 16, 2014