HIV Prevention Program for African American Teen Males

Study Overview
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Brief Summary
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The purpose of this study is to test if sexual health interventions can reduce the incidence of STIs among African American teens (15 to 21 years old). By doing this study, we hope to help African American teens improve their condom use skills and encourage them to use condoms more frequently. If the number of STIs in this population can be decreased, the health of African American teen males will greatly improve. We also believe that sexual partners (typically African American teen females) will also benefit.

Detailed Description
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Based on the observation that African Americans are vastly more likely than their white and Hispanic counterparts to be infected by the human immunodeficiency virus (HIV), the Centers for Disease Control and Prevention (CDC) has termed AIDS a health crisis for African Americans and has called for a heightened national response to this glaring racial disparity. The crisis is especially dramatic in the Southern United States. Thus, the search for effective interventions tailored to this population is a national priority. This study expands upon a previous study conducted among young African American men. In the previous study we developed and tested the efficacy of a brief, clinic-based, program designed to interactively promote safer sex for African American men (18 to 29 years of age) engaging in sex with women. Adjusted findings from the previous study provided relatively robust support for program efficacy, with men who received the intervention program being about two-thirds less likely, than controls, to acquire an STI during a 6-month period. This study expands on the work performed in the previous study by developing and testing a version for younger African American males (i.e., teen males). The purpose of this study is to test the efficacy of a brief, clinic-based and theory-guided, intervention designed to reduce STI incidence among African American teen (15 to 20 years old) males presenting themselves for STI testing.

Official Title
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A Brief, Clinic-Based, HIV Prevention Program for African American Teen Males

Conditions
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HIV Infections, Sexually Transmitted Infections

Intervention / Treatment
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* Behavioral: Male Sexual Health Program
* Behavioral: Focus on the Future Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 15, but not more than 23 years of age attending the clinic for the expressed purpose of being tested for sexually transmitted infections engaging in penetrative sex (penile-vaginal or penile-anal) at least once in the past 2 months willingness to return for the two planned follow-up assessments Exclusion Criteria: self-report of being HIV positive

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 23 Years

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Active Comparator: Male Sexual Health Program<br> | Behavioral: Male Sexual Health Program<br>* An attention equivalent control condition entailing a 60-minute one-to-one session that will didactically teach teens about several aspects of male sexual health. The content and objectives are related only to knowledge acquisition. In addition to this program, teens randomized to the control condition will receive standard-of-care services from the clinic. This involves the provision of free condoms (one size fits all condoms) and a brief (nurse-delivered) counseling message to practice safer sex.<br>|
| Experimental: Focus on the Future Program<br> | Behavioral: Focus on the Future Program<br>* A 60-minute, theory-guided program designed to increase the quality and frequency of teens' condom use within the context of making safer choices regarding partners and sexual behaviors. The program is explicitly designed to increase the quality and frequency of teen's condom use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of laboratory-confirmed STIs |  | 2- and 6-month follow-up, as well as 12-month follow-up medical records review | 
| Self-report of unprotected penetrative sex (past 30 days) |  | 2- and 6-month follow-up | 
| Self-report of number of penetrative (penile-vaginal or penile-anal) sex partners (past 30 days) |  | 2 and 6-month follow-up | 
| Self-report of negative experiences with the correct use of condoms (past 30 days) |  | 2- and 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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African American, Men, Condoms, Randomization, Brief Intervention, HIV, HIV Seronegativity