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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00164320
Other study ID # CDC-NCHSTP-3699
Secondary ID R18/CCR420971-01
Status Completed
Phase Phase 2
First received September 9, 2005
Last updated September 9, 2005
Start date May 2004
Est. completion date May 2006

Study information

Verified date September 2005
Source Centers for Disease Control and Prevention
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if the TEAM prevention intervention delivered by a physician and an HIV-positive counselor is effective. It is hypothesized that those who receive the intervention will report a higher reduction in risky sex than those who were in the standard-care condition.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 1) 18 years or older, 2) HIV-infected, 3) Sexually active, 3)Receiving HIV primary care at participating clinic, 4) Can communicate in English or Spanish, 5) No previous enrollment in the TEAM study or intervention.

Exclusion Criteria:

- 1) Participation in a similar study run by the TEAM PI.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
TEAM


Locations

Country Name City State
United States University of Miami School of Medicine Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-reported unprotected (without condoms)anal or vaginal sex with HIV-negative or unknown-status persons.
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