Clinical trial NCT00109421: Friendship Based HIV/STI (Sexually Transmitted Infections) Intervention for African American Females
Official title: PROJECT ÒRÉ: An Innovative Friendship Based HIV/STI Intervention for High Risk African American Females
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Sexually Transmitted Diseases
HIV Infections
Keywords: adolescent
female
community-based
social network
HIV/STI intervention
High HIV-risk African American adolescent females
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute of Mental Health (NIMH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2005-04-28
Enrollment: 420
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Conduct elicitation research in the study community
timeFrame: 18 Months
Secondary outcomes:
measure: Test the efficacy of the intervention
timeFrame: 18 Months
measure: Conduct a qualitative process evaluation
timeFrame: 18 Months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: M. Margaret Dolcini, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: