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

HIV Infections Clinical Trial

Official title:

PROJECT ÒRÉ: An Innovative Friendship Based HIV/STI Intervention for High Risk African American Females

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109421
• Other study ID #: ATN 034
• Status: Completed
• Phase: N/A
• First received: April 27, 2005
• Last updated: February 27, 2017
• Start date: November 2004
• Est. completion date: November 2009

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 21 Years

Eligibility

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

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

Related Conditions & MeSH terms

• HIV Infections
• Infection
• Sexual Behavior
• Sexually Transmitted Diseases

Intervention

Behavioral:
• Project ÒRÉ
Community-based adolescent social network HIV/STI intervention tailored to African American culture

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conduct elicitation research in the study community	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	18 Months
Secondary	Test the efficacy of the intervention	To use a group-randomized controlled design to conduct a test of the efficacy of the Project ÒRÉ intervention.	18 Months
Secondary	Conduct a qualitative process evaluation	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.	18 Months