Back to resultsHIP: HIV Intervention for Providers
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HIP: HIV Intervention for Providers
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV
Eligibility Criteria
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: -
Sites / Locations
- University of California San Francisco - CAPS
Outcomes
Primary Outcome Measures
Self-reported, unprotected (without condoms) anal or vaginal sex with HIV-negative and unknown-status persons.
Secondary Outcome Measures
Full Information
NCT ID
NCT00164398
First Posted
September 9, 2005
Last Updated
September 10, 2012
Sponsor
Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT00164398
Brief Title
HIP: HIV Intervention for Providers
Official Title
HIP: HIV Intervention for Providers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
HIP: HIV Intervention for Providers
Primary Outcome Measure Information:
Title
Self-reported, unprotected (without condoms) anal or vaginal sex with HIV-negative and unknown-status persons.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dogan Eroglu, PhD.
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco - CAPS
City
San Francisco
State/Province
California
ZIP/Postal Code
94105
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20827218
Citation
Rose CD, Courtenay-Quirk C, Knight K, Shade SB, Vittinghoff E, Gomez C, Lum PJ, Bacon O, Colfax G. HIV intervention for providers study: a randomized controlled trial of a clinician-delivered HIV risk-reduction intervention for HIV-positive people. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):572-81. doi: 10.1097/QAI.0b013e3181ee4c62.
Results Reference
derived
Learn more about this trial
HIP: HIV Intervention for Providers
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