Young Women's CoOp Study (YWC)
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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 |
- 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 |
| Estimated Study Completion Date: | September 2013 |
| Estimated 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 are 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 complete a questionnaire and baseline drug and pregnancy testing, and then are randomized into one of two programs: Young Women's CoOp or Staying Healthy and Eating Well (Nutrition)—both which include 3 individual intervention sessions and 1 group activity. Follow-ups are conducted 3-months post-intervention and 6-months post-intervention and include a questionnaire and drug testing.
Eligibility| Ages Eligible for Study: | 16 Years to 19 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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| 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 | |
| Principal Investigator: | Wendee M Wechsberg, PhD | RTI International |
More Information
Additional Information:
Publications:
| 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: | May 14, 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 Substance-Related Disorders Infection Virus Diseases |
Genital Diseases, Male Genital Diseases, Female Mental Disorders |
ClinicalTrials.gov processed this record on June 17, 2013