Young Women's CoOp Study

Study Overview
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Brief Summary
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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
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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: Efficacy of the Young Women's Coop - analysis complete, manuscript being drafted Summary of qualitative findings from interviews and focus groups - published September 2013 Homelessness and abuse- in final preparation Correlates of gang affiliation - manuscript complete, CDC clearance obtained, under review. Post intervention social determinants - re-analyses and re-write

Official Title
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Adapting the Women's CoOp for At-Risk Teens

Conditions
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HIV, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence, Victimization

Intervention / Treatment
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* Behavioral: Young Women's CoOp
* Behavioral: Staying Healthy and Eating Well


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutrition<br>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<br>* 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.<br>|
| Experimental: Young Women's<br>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<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in behaviors, including condom use, substance use and violence prevention |  | 3, and 6- months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Sexually Transmitted Diseases, Substance Abuse Detection, Randomized Controlled Trial