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

HIV Infections Clinical Trial

— Enhance  

Official title:

Enhancing HIV Prevention Among HIV Infected Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231972
• Other study ID #: R01MH068746
• Secondary ID: DAHBR 9A-ASPGR01
• Status: Completed
• Phase: N/A
• First received: September 30, 2005
• Last updated: April 7, 2011
• Start date: December 2003
• Est. completion date: July 2008

Study information

• Verified date: February 2011
• Source: Fenway Community Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Project 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.
• Standard prevention case management (PCM)
Participants will receive standard PCM for HIV prevention.

Locations

Country	Name	City	State
United States	Fenway Community Health	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Fenway Community Health	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up		Measured at Months 3, 6, 9, and 12	No
Secondary	Incidence of sexually transmitted diseases		Measured at Months 3, 6, 9, and 12	No
Secondary	Higher risk-reduction self-efficacy		Measured at Months 3, 6, 9, and 12	No
Secondary	Increased behavioral intentions to engage in safer behaviors		Measured at Months 3, 6, 9, and 12	No
Secondary	Increased risk-reduction strategies (other than condom use)		Measured at Months 3, 6, 9, and 12	No