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The Treatment Advocacy Program

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ClinicalTrials.gov Identifier: NCT00164333
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : September 27, 2012
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: TAP: Treatment Advocacy Program Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Treatment Advocacy Program
Study Start Date : September 2004
Actual Primary Completion Date : May 2007
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Secondary Outcome Measures :
  1. Self-reported incidences of missed doses of treatment regimen.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 27, 2012
Last Verified: September 2012