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Young Women's CoOp Study (YWC)

Primary Purpose

HIV, Sexual Risk, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Young Women's CoOp
Staying Healthy and Eating Well
Sponsored by
RTI International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV, Sexually Transmitted Diseases, Substance Abuse Detection, Randomized Controlled Trial

Eligibility Criteria

16 Years - 19 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • RTI International; Substance Abuse Treatment Evaluations and Interventions (SATEI) Community-Based Field Site - Durham
  • RTI International - Headquarters

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nutrition

Young Women's

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Changes in behaviors, including condom use, substance use and violence prevention

Secondary Outcome Measures

Full Information

First Posted
October 13, 2010
Last Updated
October 16, 2013
Sponsor
RTI International
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01224184
Brief Title
Young Women's CoOp Study
Acronym
YWC
Official Title
Adapting the Women's CoOp for At-Risk Teens
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RTI International
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence, Victimization
Keywords
HIV, Sexually Transmitted Diseases, Substance Abuse Detection, Randomized Controlled Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
237 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutrition
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Young Women's
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Young Women's CoOp
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Staying Healthy and Eating Well
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in behaviors, including condom use, substance use and violence prevention
Time Frame
3, and 6- months post-intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendee M Wechsberg, PhD
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
RTI International; Substance Abuse Treatment Evaluations and Interventions (SATEI) Community-Based Field Site - Durham
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Facility Name
RTI International - Headquarters
City
Research Triangle Park
State/Province
North Carolina
ZIP/Postal Code
27709
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21473554
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.
Results Reference
background
Citation
Browne, F. A., Wechsberg, W. M., White, V. L., Middlesteadt Ellerson, R., Raiford, R. L., Carry, M. G., Herbst, J.H. (in press).
Results Reference
background

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Young Women's CoOp Study

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