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Completed

NCT Number: NCT00231972

Enhancing HIV Prevention by Using Behavioral Intervention Among HIV-Infected Men

This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management in promoting safer sex practices in HIV-infected men.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fenway Community Health

Boston, Massachusetts, 02115, United States

About this study

In recent years, the spread of HIV and other STDs has increased, especially among men who have sex with men. This increase signifies continued sexual risk taking within this population. In order to curb the increase of HIV infections, prevention programs are needed. A standard prevention case management program has been developed; however, new programs that further improve outcomes are needed. This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management (PCM) in promoting safer sex practices in HIV-infected men.

Participants in this 1-year open-label study will be randomly assigned to receive either PCM alone or a behavioral intervention called Project Enhance, in addition to PCM. The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. PCM will entail standard case management, as well as referrals to specific services that each individual may need. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • HIV infected
  • Receives primary health care at Fenway Community Health
  • Identifies as a man who has sex with men
  • Has engaged in unprotected anal or vaginal intercourse within 3 months of study enrollment

Exclusion criteria

  • All episodes of unprotected anal intercourse occurred with only a single primary partner who is also HIV infected
  • Plans to relocate over the upcoming year

Treatment and study plan

Project Enhance

Behavioral

The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.

Other names: Project Enhance Behavioral Intervention

Standard prevention case management (PCM)

Behavioral

Participants will receive standard PCM for HIV prevention.

Other names: Project Enhance Prevention Case Management

Primary outcomes

  1. Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up

    Time frame: Measured at Months 3, 6, 9, and 12

Secondary outcomes

  1. Incidence of sexually transmitted diseases

    Time frame: Measured at Months 3, 6, 9, and 12

  2. Higher risk-reduction self-efficacy

    Time frame: Measured at Months 3, 6, 9, and 12

  3. Increased behavioral intentions to engage in safer behaviors

    Time frame: Measured at Months 3, 6, 9, and 12

  4. Increased risk-reduction strategies (other than condom use)

    Time frame: Measured at Months 3, 6, 9, and 12

Sponsors and collaborators

Lead sponsor

Fenway Community Health

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Enhancing HIV Prevention Among HIV Infected Men

Acronym: Enhance

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Oct 4, 2005
Registry last updated
Apr 8, 2011

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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