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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00164398
Other study ID # CDC-NCHSTP-3986
Secondary ID CCR 920974
Status Completed
Phase Phase 2
First received September 9, 2005
Last updated September 10, 2012
Start date June 2004
Est. completion date September 2008

Study information

Verified date September 2012
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 is to encourage Provider participants to evaluate high risk HIV transmission behaviors and offer prevention messages to their HIV+ patients which will, in turn, reduce rates of unprotected anal and/or vaginal sex with partners of known HIV sero-negativity or unknown HIV serostatus. It is hypothesized that patients of providers participating in the HIP intervention will report higher reduction in sexual risk practices, when compared to the patients of the providers who were randomized into the control condition.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 2008
Est. primary completion date October 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Provider participants: (1) licensed MD, NP or PA on staff at the participating institution; (2) has a minimum panel of 5 HIV+ patients; (3) sees patients at least one-half day per week in the clinical setting; (4) is willing to participate in all intervention training sessions; and (5) is willing and able to provide full informed consent.

HIV+ patient participants:(1) report at least 1 encounter of unprotected anal or vaginal sex with known HIV- or unknown serostatus partner in the preceding six months; (2) patient's Primary Provider is enrolled as a participant in the study; (3) age 18 years or older; and (4) willing and able to provide informed consent.

Exclusion Criteria:

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
HIP: HIV Intervention for Providers


Locations

Country Name City State
United States University of California San Francisco - CAPS San Francisco California

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 and unknown-status persons.
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