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The Treatment Advocacy Program
This study has been completed.
Sponsor:
Centers for Disease Control and Prevention
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
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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 Intervention Model: Factorial Assignment Masking: None (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 (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
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
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
| 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 |
ClinicalTrials.gov processed this record on August 23, 2017