Effectiveness of HIV Risk Reduction Program Among African American Men

HIV Clinical Trial

Official title:

Promoting HIV Risk Reduction Among African American Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314028
• Other study ID #: R21MH066682
• Secondary ID: R21MH066682DAHBR
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2006
• Last updated: December 13, 2013
• Start date: April 2003
• Est. completion date: September 2007

Study information

• Verified date: December 2013
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• Sexually Transmitted Diseases

Intervention

Behavioral:
• Focus on the Future
Focus on the Future is an educational program designed to promote proper condom use.

Other:
• Control standard of care treatment
Standard of care treatment is the normal treatment that someone would receive for the particular sexually transmitted disease or virus.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Richard Crosby	National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of unprotected penile vaginal sex		Measured at Month 3
Secondary	Frequency of condom use errors and problems		Measured at Month 3