Effectiveness of HIV Risk Reduction Program Among African American Men
Primary Purpose
Sexually Transmitted Diseases, HIV
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Focus on the Future
Control standard of care treatment
Sponsored by
About this trial
This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring African American, Men, Sexually Transmitted Diseases, Condoms
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Standard of care treatment
Educational program designed to motivate and provide information on the correct use of condoms
Outcomes
Primary Outcome Measures
Frequency of unprotected penile vaginal sex
Secondary Outcome Measures
Frequency of condom use errors and problems
Full Information
NCT ID
NCT00314028
First Posted
April 10, 2006
Last Updated
December 13, 2013
Sponsor
Richard Crosby
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00314028
Brief Title
Effectiveness of HIV Risk Reduction Program Among African American Men
Official Title
Promoting HIV Risk Reduction Among African American Men
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Richard Crosby
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases, HIV
Keywords
African American, Men, Sexually Transmitted Diseases, Condoms
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Standard of care treatment
Arm Title
2
Arm Type
Experimental
Arm Description
Educational program designed to motivate and provide information on the correct use of condoms
Intervention Type
Behavioral
Intervention Name(s)
Focus on the Future
Intervention Description
Focus on the Future is an educational program designed to promote proper condom use.
Intervention Type
Other
Intervention Name(s)
Control standard of care treatment
Intervention Description
Standard of care treatment is the normal treatment that someone would receive for the particular sexually transmitted disease or virus.
Primary Outcome Measure Information:
Title
Frequency of unprotected penile vaginal sex
Time Frame
Measured at Month 3
Secondary Outcome Measure Information:
Title
Frequency of condom use errors and problems
Time Frame
Measured at Month 3
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Forsythe, PhD
Organizational Affiliation
National Institute of Mental Health (NIMH)
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of HIV Risk Reduction Program Among African American Men
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