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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00109421
Other study ID # ATN 034
Secondary ID
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
Health authority
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

Study Design


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
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