Enhancing Communication and HIV Outcomes (ECHO)

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: communication training

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

1. 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.
2. The intervention will reduce disparities in medication self-efficacy, adherence, and HIV-1 RNA suppression.

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
  • New York
    • New York, New York, United States, 10023
      • Saint Lukes-Roosevelt
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria (Providers):

1. Currently providing primary care to at least 10 HIV-infected patients in the clinic
2. Physician, Nurse-Practitioner, or Physician-Assistant
3. Agree to give written informed consent.

Inclusion Criteria (Patients):

1. HIV-infected patient of one of the participating providers
2. Has had at least one prior visit with that provider
3. Currently taking antiretroviral therapy
4. Capable of understanding and giving written informed consent
5. Age > 20 years old
6. English-speaking
7. African-American (or people of African descent living in the United States), Hispanic, or non-Hispanic White race/ethnicity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: usual care; providers are not trained and patients are not coached
Experimental: intervention arm; providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers	Behavioral: communication training; providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
patient-provider communication	1 day- 3 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Mary Catherine Beach, MD, MPH, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: May 7, 2008
• First Submitted That Met QC Criteria: May 7, 2008
• First Posted (Estimate): May 9, 2008

Study Record Updates

• Last Update Posted (Estimate): April 1, 2015
• Last Update Submitted That Met QC Criteria: March 31, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: communication; Treatment Experienced; HIV/AIDS
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: ECHO-01; 290-01-0012