Clinical trial NCT01224184: Young Women's CoOp Study
Official title: Adapting the Women's CoOp for At-Risk Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Sexual Risk
Sexually Transmitted Diseases
Substance Abuse
Violence
Victimization
Keywords: HIV
Sexually Transmitted Diseases
Substance Abuse Detection
Randomized Controlled Trial
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2010-10-19
Enrollment: 237
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Eligibility 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

Primary outcomes:
measure: Changes in behaviors, including condom use, substance use and violence prevention
timeFrame: 3, and 6- months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: RTI International; Substance Abuse Treatment Evaluations and Interventions (SATEI) Community-Based Field Site - Durham
state: North Carolina
city: Research Triangle Park
country: United States
facility: RTI International - Headquarters
state: North Carolina
Study officials:
affiliation: RTI International
name: Felicia Browne, ScD
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
citation: Browne, F. A., Wechsberg, W. M., White, V. L., Middlesteadt Ellerson, R., Raiford, R. L., Carry, M. G., Herbst, J.H. (in press).