Effectiveness of HIV Risk Reduction Program Among African American Men
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sexually Transmitted Diseases HIV |
Behavioral: Focus on the Future Other: Control standard of care treatment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Promoting HIV Risk Reduction Among African American Men |
- Frequency of unprotected penile vaginal sex [ Time Frame: Measured at Month 3 ]
- Frequency of condom use errors and problems [ Time Frame: Measured at Month 3 ]
| Estimated Enrollment: | 300 |
| Study Start Date: | April 2003 |
| Study Completion Date: | May 2006 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Standard of care treatment
|
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.
|
|
Experimental: 2
Educational program designed to motivate and provide information on the correct use of condoms
|
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.
|
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| Ages Eligible for Study: | 18 Years to 29 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00314028 History of Changes |
| Other Study ID Numbers: | R21 MH066682, DAHBR 9A-ASPQ |
| Study First Received: | April 10, 2006 |
| Last Updated: | January 18, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
African American Men Sexually Transmitted Diseases Condoms |
Additional relevant MeSH terms:
|
Sexually Transmitted Diseases Infection Virus Diseases Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on March 14, 2013
