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

University of North Carolina (UNC)

Status: Completed

Conditions: Sexually Transmitted Diseases; Sexual Behavior; HIV Infections

Treatments: Behavioral: Project ÒRÉ

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00109421

ATN 034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 patients

Sex: Female

Ages: 14 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

Experimental arm

Experimental group

Description:

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.

Treatment:

Behavioral: Project ÒRÉ

Attention control group

No Intervention group

Description:

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.