Effectiveness of HIV Risk Reduction Program Among African American Men

Phase 3

Completed

• Conditions: HIV; Sexually Transmitted Diseases
• Interventions: Other: Control standard of care treatment; Behavioral: Focus on the Future

• Registration Number: NCT00314028
• Lead Sponsor: Richard Crosby

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2006-04-10
• Study First Submitted QC: 2006-04-10
• Study First Posted: 2006-04-12
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-13
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Control standard of care treatment	Standard of care treatment
2	Focus on the Future	Educational program designed to motivate and provide information on the correct use of condoms
2	Control standard of care treatment	Educational program designed to motivate and provide information on the correct use of condoms

Primary Outcome Measures

Name	Time	Method
Frequency of unprotected penile vaginal sex	Measured at Month 3

Secondary Outcome Measures

Name	Time	Method
Frequency of condom use errors and problems	Measured at Month 3