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Completed

NCT Number: NCT00314028

Effectiveness of HIV Risk Reduction Program 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.

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Key information

Conditions

Sexually Transmitted Diseases Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Genital Diseases HIV Infections Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focus on the Future

Behavioral

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

Control standard of care treatment

Other

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

Primary outcomes

  1. Frequency of unprotected penile vaginal sex

    Time frame: Measured at Month 3

Secondary outcomes

  1. Frequency of condom use errors and problems

    Time frame: Measured at Month 3

Sponsors and collaborators

Lead sponsor

Richard Crosby

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Promoting HIV Risk Reduction Among African American Men

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Apr 12, 2006
Registry last updated
Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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