Viewing Study NCT00109421



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Study NCT ID: NCT00109421
Status: COMPLETED
Last Update Posted: 2017-02-28
First Post: 2005-04-27

Brief Title: Friendship Based HIVSTI Sexually Transmitted Infections Intervention for African American Females
Sponsor: University of North Carolina Chapel Hill
Organization: University of North Carolina Chapel Hill

Study Overview

Official Title: PROJECT ÒRÉ An Innovative Friendship Based HIVSTI Intervention for High Risk African American Females
Status: COMPLETED
Status Verified Date: 2016-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The Project ÒRÉ intervention is a half-day community-based HIVSTI 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 HIVSTI 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None