Friendship Based HIV/STI (Sexually Transmitted Infections) Intervention for African American Females

Not Applicable

Completed

• Conditions: Sexual Behavior; Sexually Transmitted Diseases; HIV Infections
• Interventions: Behavioral: Project ÒRÉ

• Registration Number: NCT00109421
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

The Project ÒRÉ intervention is a half-day community-based HIV/STI intervention program for friendship groups of adolescents that is tailored to African American culture. The four participating community sites will be assigned to either the Project ÒRÉ intervention or a standard health promotion program. Sexually experienced African American adolescent females will recruit members of their friendship group for the five-hour program. All participants will complete questionnaires before and immediately following the programs and another one 3 months later. Immediately following the program some of the Project ÒRÉ groups will also participate in a focus group to provide feedback about the program.

Detailed Description

A group-randomized controlled design to test the efficacy of the Project ÒRÉ intervention, a community-based adolescent social network HIV/STI intervention tailored to African American culture. Four community based organization sites (CBOs) will be randomly assigned to an experimental or attention control condition. In both conditions, sexually experienced African American adolescent females will recruit members of their friendship group for the five-hour program. In the experimental condition, the intervention group will receive the half-day Project ÒRÉ intervention. The attention control group will receive a standard health promotion control program which has been used previously with similar populations. All participants will complete pre-, post- and 3-month follow-up self-administered questionnaires. In the experimental condition, a subset of groups will participate in a process evaluation focus group immediately following the program.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-04-27
• Study First Submitted QC: 2005-04-27
• Study First Posted: 2005-04-28
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2016-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 420

Inclusion Criteria

• Female
• Between the ages of 14-18
• Self-identifies as African American
• Sexually experienced
• Willing to participate in a single five-hour workshop and a one-hour follow-up session
• Willing to nominate 2-5 close female friends ages 14-21 to participate in the study with her
• Lives in the experimental intervention community
• Ability to obtain permission from parent or legal guardian and assent from minors or consent from those above age of majority

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Exclusion Criteria

• Individual reports predominantly same gender sexual behavior
• Recent homelessness
• Visibly distraught or unstable (i.e. suicidal, manic, exhibiting violent behavior, etc.)
• Intoxicated or under the influence of psychoactive agents

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental arm	Project ÒRÉ	In the experimental condition, the intervention group will receive the half-day Project ÒRÉ intervention. All participants will complete pre-, post- and 3-month follow-up self-administered questionnaires. A subset of groups will participate in a process evaluation focus group immediately following the program.

Primary Outcome Measures

Name	Time	Method
Conduct elicitation research in the study community	18 Months	To conduct elicitation research in the study community to: assess the applicability of the existing Project ÒRÉ intervention modules, modify the intervention for the specific populations that are targeted in the current study, and incorporate local data in the production of three brief videos involving youth in the study community

Secondary Outcome Measures

Name	Time	Method
Test the efficacy of the intervention	18 Months	To use a group-randomized controlled design to conduct a test of the efficacy of the Project ÒRÉ intervention.
Conduct a qualitative process evaluation	18 Months	To conduct a qualitative process evaluation to assess the acceptability of the experimental intervention in a new community using a subset of the participants in the experimental condition.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States