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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00109421
Enrollment
420
Registered
2005-04-28
Start date
2004-11-30
Completion date
2009-11-30
Last updated
2017-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Sexual Behavior, Sexually Transmitted Diseases

Keywords

adolescent, female, community-based, social network, HIV/STI intervention, High HIV-risk African American adolescent females

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.

Interventions

BEHAVIORALProject ÒRÉ

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
14 Years to 21 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Conduct elicitation research in the study community18 MonthsTo 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

Secondary

MeasureTime frameDescription
Test the efficacy of the intervention18 MonthsTo use a group-randomized controlled design to conduct a test of the efficacy of the Project ÒRÉ intervention.
Conduct a qualitative process evaluation18 MonthsTo 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026