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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

April 10, 2006
December 13, 2013
April 2003
September 2007   (final data collection date for primary outcome measure)
Frequency of unprotected penile vaginal sex [ Time Frame: Measured at Month 3 ]
Frequency of unprotected penile vaginal sex
Complete list of historical versions of study NCT00314028 on ClinicalTrials.gov Archive Site
Frequency of condom use errors and problems [ Time Frame: Measured at Month 3 ]
Frequency of condom use errors and problems
Not Provided
Not Provided
 
Effectiveness of HIV Risk Reduction Program Among African American Men
Promoting HIV Risk Reduction Among African American Men

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Sexually Transmitted Diseases
  • HIV
  • 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.
  • Active Comparator: 1
    Standard of care treatment
    Intervention: Other: Control standard of care treatment
  • Experimental: 2
    Educational program designed to motivate and provide information on the correct use of condoms
    Interventions:
    • Behavioral: Focus on the Future
    • Other: Control standard of care treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
270
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Male
18 Years to 29 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00314028
R21 MH066682, R21MH066682, DAHBR 9A-ASPQ
Not Provided
Richard Crosby, University of Kentucky
Richard Crosby
National Institute of Mental Health (NIMH)
Study Chair: Andrew Forsythe, PhD National Institute of Mental Health (NIMH)
University of Kentucky
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP