The Treatment Advocacy Program

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by Centers for Disease Control and Prevention. Recruitment status was Active, not recruiting

First Received on September 9, 2005. No Changes Posted

Sponsor:	Centers for Disease Control and Prevention
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00164333

Purpose

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.

Condition	Intervention	Phase
HIV	Behavioral: TAP: Treatment Advocacy Program	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	The Treatment Advocacy Program

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

Self-reported, unprotected (without condoms) anal or vaginal sex with HIV-negative or unknown-status partners.

Secondary Outcome Measures:

Self-reported incidences of missed doses of treatment regimen.

Estimated Enrollment:	300
Study Start Date:	September 2004
Estimated Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164333

Locations

United States, Illinois
Howard Brown Medical Center
Chicago, Illinois, United States, 60613

Sponsors and Collaborators

Centers for Disease Control and Prevention

Investigators

Principal Investigator:

Dogan Eroglu, PhD.

Centers for Disease Control and Prevention

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00164333 History of Changes
Other Study ID Numbers:	CDC-NCHSTP-3797, R 18/CCR520972-01
Study First Received:	September 9, 2005
Last Updated:	September 9, 2005
Health Authority:	United States: Federal Government

ClinicalTrials.gov processed this record on February 13, 2012