Clinical trial NCT00314028: Effectiveness of HIV Risk Reduction Program Among African American Men
Official title: Promoting HIV Risk Reduction Among African American Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sexually Transmitted Diseases
HIV
Keywords: African American
Men
Sexually Transmitted Diseases
Condoms
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-04-12
Enrollment: 270
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of unprotected penile vaginal sex
timeFrame: Measured at Month 3
Secondary outcomes:
measure: Frequency of condom use errors and problems
timeFrame: Measured at Month 3
Other outcomes:
Locations:
Study officials:
affiliation: National Institute of Mental Health (NIMH)
name: Andrew Forsythe, PhD
role: STUDY_CHAIR
References: