Young Women's CoOp Study

HIV Clinical Trial

— YWC  

Official title:

Adapting the Women's CoOp for At-Risk Teens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224184
• Other study ID #: 5UR6PS000665-04
• Status: Completed
• Phase: N/A
• First received: October 13, 2010
• Last updated: October 16, 2013
• Start date: May 2010
• Est. completion date: September 2013

Study information

• Verified date: October 2013
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 19 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	RTI International; Substance Abuse Treatment Evaluations and Interventions (SATEI) Community-Based Field Site - Durham	Durham	North Carolina
United States	RTI International - Headquarters	Research Triangle Park	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
RTI International	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

References & Publications (2)

Browne FA, Wechsberg WM, White VM, Ellerson RM, Raiford JL, Carry MG, Herbst JH. The influence of social determinants on sexual risk among out-of-school African American female adolescents. Vulnerable Child Youth Stud. 2014;9(2):139-150. Epub 2013 Sep 6. — View Citation

Wechsberg WM, Browne FA, Ellerson RM, Zule WA. Adapting the evidence-based Women's CoOp intervention to prevent human immunodeficiency virus infection in North Carolina and international settings. N C Med J. 2010 Sep-Oct;71(5):477-81. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in behaviors, including condom use, substance use and violence prevention		3, and 6- months post-intervention	No

External Links

•   Click here for more information about this study: Young Women's CoOp Study Flier