Effectiveness of HIV Risk Reduction Program Among African American Men

NCT ID: NCT00314028

Last Updated: 2013-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Sexually Transmitted Diseases HIV

Keywords

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African American Men Sexually Transmitted Diseases Condoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Standard of care treatment

Group Type ACTIVE_COMPARATOR

Control standard of care treatment

Intervention Type OTHER

Standard of care treatment is the normal treatment that someone would receive for the particular sexually transmitted disease or virus.

2

Educational program designed to motivate and provide information on the correct use of condoms

Group Type EXPERIMENTAL

Focus on the Future

Intervention Type BEHAVIORAL

Focus on the Future is an educational program designed to promote proper condom use.

Control standard of care treatment

Intervention Type OTHER

Standard of care treatment is the normal treatment that someone would receive for the particular sexually transmitted disease or virus.

Interventions

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Focus on the Future

Focus on the Future is an educational program designed to promote proper condom use.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Richard Crosby

OTHER

Sponsor Role lead

Responsible Party

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Richard Crosby

PI

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andrew Forsythe, PhD

Role: STUDY_CHAIR

National Institute of Mental Health (NIMH)

Other Identifiers

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R21MH066682

Identifier Type: NIH

Identifier Source: secondary_id

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DAHBR 9A-ASPQ

Identifier Type: -

Identifier Source: secondary_id

R21MH066682

Identifier Type: NIH

Identifier Source: org_study_id

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