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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 9, 2005 | ||||
| Last Updated Date | September 9, 2005 | ||||
| Start Date ICMJE | September 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Self-reported, unprotected (without condoms) anal or vaginal sex with HIV-negative or unknown-status partners. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Self-reported incidences of missed doses of treatment regimen. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Treatment Advocacy Program | ||||
| Official Title ICMJE | The Treatment Advocacy Program | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study | ||||
| Condition ICMJE | HIV | ||||
| Intervention ICMJE | Behavioral: TAP: Treatment Advocacy Program | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 300 | ||||
| Completion Date | June 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00164333 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDC-NCHSTP-3797, R 18/CCR520972-01 | ||||
| Study Sponsor ICMJE | Centers for Disease Control and Prevention | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Centers for Disease Control and Prevention | ||||
| Verification Date | September 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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