Effectiveness of HIV Risk Reduction Program Among African American Men

Study Overview
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Brief Summary
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This study will test the effectiveness of a brief clinic-based program designed to promote the correct use of condoms among young African-American men newly diagnosed with a sexually transmitted disease.

Detailed Description
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Sexually transmitted diseases (STDs), including HIV infections, are most commonly spread through unprotected sexual intercourse. STDs are a major health concern, especially among young ethnic minorities in the United States. The rate of STDs is significantly greater in urban areas where ethnic minorities, particularly African-American males, are commonly represented. Despite this knowledge, safe sexual practices, including correct condom use, are not the norm among minority males. It is believed that educational outreach designed to motivate and inform on the correct use of condoms will be effective in encouraging safer sex practices. This study will test the effectiveness of a brief clinic-based program designed to promote the correct use of condoms among young African-American men newly diagnosed with an STD. Participants in this single blind study will be randomly assigned to an experimental or control group. Upon being diagnosed with an STD, men in both groups will receive standard of care follow-up treatment. Men in the experimental group will also receive a one-on-one educational session on condom use. The educational session will be led by a health educator and will last about 30 minutes, depending on the existing skills and learning abilities of the participants. Using information provided by the participants on past experience with condoms, the health educator will attempt to correct misunderstandings about and problems with condom use. Upon enrollment, all men will respond to a series of pre-recorded questions and will be required to demonstrate their ability to apply condoms to a penile model. The same questions and procedure will be repeated 3 months later.

Official Title
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Promoting HIV Risk Reduction Among African American Men

Conditions
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HIV, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: Focus on the Future
* Other: Control standard of care treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Identifies as African American Clinically diagnosed with an STD Reports at least one episode of condom use with a female within 3 months of study entry (this requirement does not restrict men who also have sex with men from study participation) Fluent in English Exclusion Criteria: Known HIV infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Standard of care treatment | Other: Control standard of care treatment<br>* Standard of care treatment is the normal treatment that someone would receive for the particular sexually transmitted disease or virus.<br>|
| Experimental: 2<br>Educational program designed to motivate and provide information on the correct use of condoms | Behavioral: Focus on the Future<br>* Focus on the Future is an educational program designed to promote proper condom use.<br>Other: Control standard of care treatment<br>* Standard of care treatment is the normal treatment that someone would receive for the particular sexually transmitted disease or virus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of unprotected penile vaginal sex |  | Measured at Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of condom use errors and problems |  | Measured at Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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African American, Men, Sexually Transmitted Diseases, Condoms