Clinical trial NCT00231972: Enhancing HIV Prevention by Using Behavioral Intervention Among HIV-Infected Men
Official title: Enhancing HIV Prevention Among HIV Infected Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
MSM
Lead sponsor: Fenway Community Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-10-04
Enrollment: 201
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up
timeFrame: Measured at Months 3, 6, 9, and 12
Secondary outcomes:
measure: Incidence of sexually transmitted diseases
timeFrame: Measured at Months 3, 6, 9, and 12
measure: Higher risk-reduction self-efficacy
timeFrame: Measured at Months 3, 6, 9, and 12
measure: Increased behavioral intentions to engage in safer behaviors
timeFrame: Measured at Months 3, 6, 9, and 12
measure: Increased risk-reduction strategies (other than condom use)
timeFrame: Measured at Months 3, 6, 9, and 12
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
Study officials:
affiliation: Fenway Community Health and Brown University
name: Kenneth Mayer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fenway Community Health and Harvard Medical School
name: Steven Safren, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fenway Community Health and Massachusetts General Hospital
name: Conall O'Cleirigh, PhD
role: STUDY_DIRECTOR
References: