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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
Richard Crosby
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 29 Years (Adult)MaleAccepts Healthy Volunteers

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

    First Posted
    April 10, 2006
    Last Updated
    December 13, 2013
    Sponsor
    Richard Crosby
    Collaborators
    National Institute of Mental Health (NIMH)
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    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

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    Effectiveness of HIV Risk Reduction Program Among African American Men

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