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NCT00164333 Clinical Trial

The Treatment Advocacy Program

HIV Clinical Trial

Official title:
The Treatment Advocacy Program

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00164333
Other study ID # CDC-NCHSTP-3797
Secondary ID R 18/CCR520972-0
Status Completed
Phase Phase 2
First received September 9, 2005
Last updated September 26, 2012
Start date September 2004
Est. completion date April 2008

Study information
Verified date September 2012
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of the study is to test the efficacy of TAP, a behavioral intervention, in improving sexual safety and treatment adherence among gay and bisexual men infected with HIV. It is hypothesized that those who are in the intervention group will report reductions in unprotected sex with HIV-negative and unknown-status partners; and will show stricter adherence to their treatment regimens, compared to the individuals in the standard-of-care, control group.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date April 2008
Est. primary completion date May 2007
Accepts healthy volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- HIV+ men who have sex with other men, age 18 or over, in HIV care at one of the collaborating clinics, any sexual contact within the previous six months.

Exclusion Criteria:

- self-reported low likelihood of remaining in treatment or in the study location for 12 months, inability to comprehend the consent quiz administered during the Consent and Enrollment Visit, or unwilling to provide required locator information

Study Design

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

Related Conditions & MeSH terms

Intervention

Behavioral:
• TAP: Treatment Advocacy Program

Locations
Country Name City State
United States Howard Brown Medical Center Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Self-reported, unprotected (without condoms) anal or vaginal sex with HIV-negative or unknown-status partners.
Secondary Self-reported incidences of missed doses of treatment regimen.
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