Effectiveness of HIV Risk Reduction Program Among African American Men

Richard Crosby

Status and phase: Completed; Phase 3

Conditions: Sexually Transmitted Diseases; HIV

Treatments: Other: Control standard of care treatment; Behavioral: Focus on the Future

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00314028

DAHBR 9A-ASPQ

R21MH066682 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 patients

Sex: Male

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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270 participants in 2 patient groups

1

Active Comparator group

Description:

Standard of care treatment

Treatment:

Other: Control standard of care treatment

2

Experimental group

Description:

Educational program designed to motivate and provide information on the correct use of condoms

Treatment:

Behavioral: Focus on the Future

Other: Control standard of care treatment