Effectiveness of HIV Risk Reduction Program Among African American Men

December 13, 2013 updated by: Richard Crosby

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Behavioral: Focus on the Future
Focus on the Future is an educational program designed to promote proper condom use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of unprotected penile vaginal sex
Time Frame: Measured at Month 3
Measured at Month 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of condom use errors and problems
Time Frame: Measured at Month 3
Measured at Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Richard Crosby

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Study Chair: Andrew Forsythe, PhD, National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

April 10, 2006

First Submitted That Met QC Criteria

April 10, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

December 16, 2013

Last Update Submitted That Met QC Criteria

December 13, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21MH066682 (U.S. NIH Grant/Contract)
  • DAHBR 9A-ASPQ (NIMH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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