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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01224184
Other study ID # 5UR6PS000665-04
Secondary ID
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:

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Study Design

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


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
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