Enhancing Communication and HIV Outcomes (ECHO)
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
communication training
Sponsored by
About this trial
This is an interventional health services research trial for HIV Infections focused on measuring communication, HIV/AIDS, Treatment Experienced
Eligibility Criteria
Inclusion Criteria (Providers):
- Currently providing primary care to at least 10 HIV-infected patients in the clinic
- Physician, Nurse-Practitioner, or Physician-Assistant
- Agree to give written informed consent.
Inclusion Criteria (Patients):
- HIV-infected patient of one of the participating providers
- Has had at least one prior visit with that provider
- Currently taking antiretroviral therapy
- Capable of understanding and giving written informed consent
- Age > 20 years old
- English-speaking
- African-American (or people of African descent living in the United States), Hispanic, or non-Hispanic White race/ethnicity
Sites / Locations
- Wayne State University
- Saint Lukes-Roosevelt
- Oregon Health Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
usual care
intervention arm
Arm Description
providers are not trained and patients are not coached
providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers
Outcomes
Primary Outcome Measures
patient-provider communication
Secondary Outcome Measures
Full Information
NCT ID
NCT00675610
First Posted
May 7, 2008
Last Updated
March 31, 2015
Sponsor
Johns Hopkins University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT00675610
Brief Title
Enhancing Communication and HIV Outcomes
Acronym
ECHO
Official Title
Enhancing Communication and HIV Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this research is to improve communication between the patients with HIV and their health care providers. The overall purpose of doing so is to reduce disparities in medication self-efficacy, adherence to therapy, and HIV viral load suppression. The investigators will conduct a randomized controlled trial to test the effectiveness of a combined provider and patient communication intervention conducted at two separate visits compared to usual care in improving the quality of patient-provider communication, patients' medication self-efficacy, patient adherence to therapy, and HIV RNA suppression.
Detailed Description
The goal of this research is to improve communication between the patients with HIV and their health care providers. The overall purpose of doing so is to reduce disparities in medication self-efficacy, adherence to therapy, and HIV viral load suppression. We will conduct a randomized controlled trial to test the effectiveness of a combined provider and patient communication intervention conducted at two separate visits compared to usual care in improving the quality of patient-provider communication, patients' medication self-efficacy, patient adherence to therapy, and HIV RNA suppression. The following primary and secondary hypotheses will be addressed.
Primary Hypothesis.
1) There will be more and higher quality patient-provider communication about antiretroviral medication adherence in the intervention compared to control arm at both visit 1 (V1) and visit 2 (V2).
Secondary Hypotheses
Higher quality patient-provider communication in the intervention arm will be associated with
higher patient ratings of communication (overall, HIV-specific, adherence-specific, and interpersonal style of provider) at V1 and V2;
increased patient preference for a shared decision-making role at V1 and V2;
more positive health beliefs at V1 and V2;
higher patient medication self-efficacy at V1 and V2;
better adherence to antiretroviral medication (assessed by 3-day recall) at V2; and
a greater percentage of patients with HIV-1 RNA suppression at V2.
The intervention will reduce disparities in medication self-efficacy, adherence, and HIV-1 RNA suppression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
communication, HIV/AIDS, Treatment Experienced
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
usual care
Arm Type
No Intervention
Arm Description
providers are not trained and patients are not coached
Arm Title
intervention arm
Arm Type
Experimental
Arm Description
providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers
Intervention Type
Behavioral
Intervention Name(s)
communication training
Intervention Description
providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers
Primary Outcome Measure Information:
Title
patient-provider communication
Time Frame
1 day- 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (Providers):
Currently providing primary care to at least 10 HIV-infected patients in the clinic
Physician, Nurse-Practitioner, or Physician-Assistant
Agree to give written informed consent.
Inclusion Criteria (Patients):
HIV-infected patient of one of the participating providers
Has had at least one prior visit with that provider
Currently taking antiretroviral therapy
Capable of understanding and giving written informed consent
Age > 20 years old
English-speaking
African-American (or people of African descent living in the United States), Hispanic, or non-Hispanic White race/ethnicity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Catherine Beach, MD, MPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Saint Lukes-Roosevelt
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Oregon Health Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Enhancing Communication and HIV Outcomes
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