HIV Infections
Conditions
Keywords
HIV, MSM
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.
Interventions
BEHAVIORALProject Enhance
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.
BEHAVIORALStandard prevention case management (PCM)
Participants will receive standard PCM for HIV prevention.
Sponsors
National Institute of Mental Health (NIMH)
Fenway Community Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up | Measured at Months 3, 6, 9, and 12 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of sexually transmitted diseases | Measured at Months 3, 6, 9, and 12 |
| Higher risk-reduction self-efficacy | Measured at Months 3, 6, 9, and 12 |
| Increased behavioral intentions to engage in safer behaviors | Measured at Months 3, 6, 9, and 12 |
| Increased risk-reduction strategies (other than condom use) | Measured at Months 3, 6, 9, and 12 |
Countries
United States
Outcome results
None listed