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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sexual Behavior, Sexually Transmitted Diseases, HIV Infections

Intervention / Treatment
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* Behavioral: Project ÒRÉ


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>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. | Behavioral: Project ÒRÉ<br>* Community-based adolescent social network HIV/STI intervention tailored to African American culture<br>* Other names: ÒRÉ;|
| No Intervention: Attention control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescent, female, community-based, social network, HIV/STI intervention, High HIV-risk African American adolescent females