Improving Provider Counseling Interventions in HIV Practice
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stage based counseling
Sponsored by

About this trial
This is an interventional health services research trial for HIV Infections
Eligibility Criteria
Inclusion Criteria:
- HIV seropositive
- English speaking
Exclusion Criteria:
- Cannot give informed consent
Sites / Locations
- Johns Hopkins University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1
2
Arm Description
Provider receives cue sheet to assist with counseling.
Provider does not receive cue sheet.
Outcomes
Primary Outcome Measures
Disclosure of HIV status to sex partners; unprotected sexual encounters.
Secondary Outcome Measures
Full Information
NCT ID
NCT00538993
First Posted
October 1, 2007
Last Updated
October 17, 2018
Sponsor
Johns Hopkins University
Collaborators
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT00538993
Brief Title
Improving Provider Counseling Interventions in HIV Practice
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2003 (Actual)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins University
Collaborators
University of California, San Francisco
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypothesis: HIV clinicians trained to deliver brief counseling messages and receiving cues from a brief computer survey on risk behaviors of their patients can counsel have an impact on patient's risk behaviors.
Detailed Description
This is a randomized controlled study. The purpose of this study is to assess the impact of the cue sheet as an aid to targeted provider behavioral counseling. All enrolled participants are HIV+ adults seen for regular medical care at a site affiliated with the Johns Hopkins AIDS Service. After consenting, participants will take an audio-assisted computer interviews to collect patient risk assessment data. For participants randomized to the intervention arm, the printed output on risk behaviors is then given to the provider along with cues for staged-based counseling for use during the same visit. Participants in the control arm take the same computerized risk assessment but there are no printed cue sheets. Risk behaviors of all participants are assessed at entry, at 6 months, and at 12 months. The main outcome measure is change in HIV transmission behaviors at 12 months for those in the intervention arm compared to the control arm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
470 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Provider receives cue sheet to assist with counseling.
Arm Title
2
Arm Type
No Intervention
Arm Description
Provider does not receive cue sheet.
Intervention Type
Behavioral
Intervention Name(s)
Stage based counseling
Primary Outcome Measure Information:
Title
Disclosure of HIV status to sex partners; unprotected sexual encounters.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV seropositive
English speaking
Exclusion Criteria:
Cannot give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Erbelding, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Improving Provider Counseling Interventions in HIV Practice
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