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

NCT ID: NCT00109421

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2009-11-30

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.

Conditions

Sexual Behavior; Sexually Transmitted Diseases; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental arm

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.

Group Type: EXPERIMENTAL

Project ÒRÉ

Intervention Type: BEHAVIORAL

Community-based adolescent social network HIV/STI intervention tailored to African American culture

Attention control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Project ÒRÉ

Community-based adolescent social network HIV/STI intervention tailored to African American culture

Intervention Type: BEHAVIORAL

Other Intervention Names

ÒRÉ

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M. Margaret Dolcini, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

ATN 034

Identifier Type: -

Identifier Source: org_study_id