The Treatment Advocacy Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00164333
First received: September 9, 2005
Last updated: September 26, 2012
Last verified: September 2012
  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 2

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:


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
Study Completion Date: April 2008
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Dogan Eroglu, PhD. Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
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 26, 2012
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on October 01, 2014