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

Primary Purpose

Sexual Behavior, Sexually Transmitted Diseases, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project ÒRÉ
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexual Behavior focused on measuring adolescent, female, community-based, social network, HIV/STI intervention, High HIV-risk African American adolescent females

Eligibility Criteria

14 Years - 21 Years (Child, Adult)FemaleAccepts 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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental arm

Attention control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 27, 2005
Last Updated
February 27, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00109421
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Behavior, Sexually Transmitted Diseases, HIV Infections
Keywords
adolescent, female, community-based, social network, HIV/STI intervention, High HIV-risk African American adolescent females

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm 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.
Arm Title
Attention control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Project ÒRÉ
Other Intervention Name(s)
ÒRÉ
Intervention Description
Community-based adolescent social network HIV/STI intervention tailored to African American culture
Primary Outcome Measure Information:
Title
Conduct elicitation research in the study community
Description
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
Time Frame
18 Months
Secondary Outcome Measure Information:
Title
Test the efficacy of the intervention
Description
To use a group-randomized controlled design to conduct a test of the efficacy of the Project ÒRÉ intervention.
Time Frame
18 Months
Title
Conduct a qualitative process evaluation
Description
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.
Time Frame
18 Months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Margaret Dolcini, Ph.D.
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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

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