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Effectiveness of HIV Risk Reduction Program Among African American Men

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Richard Crosby, University of Kentucky
ClinicalTrials.gov Identifier:
NCT00314028
First received: April 10, 2006
Last updated: December 13, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • Frequency of unprotected penile vaginal sex [ Time Frame: Measured at Month 3 ]

Secondary Outcome Measures:
  • Frequency of condom use errors and problems [ Time Frame: Measured at Month 3 ]

Enrollment: 270
Study Start Date: April 2003
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00314028

Sponsors and Collaborators
Richard Crosby
Investigators
Study Chair: Andrew Forsythe, PhD National Institute of Mental Health (NIMH)
  More Information

No publications provided

Responsible Party: Richard Crosby, PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT00314028     History of Changes
Other Study ID Numbers: R21 MH066682, R21MH066682, DAHBR 9A-ASPQ
Study First Received: April 10, 2006
Last Updated: December 13, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Kentucky:
African American
Men
Sexually Transmitted Diseases
Condoms

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Genital Diseases, Female
Genital Diseases, Male
Infection
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014