Enhancing Communication and HIV Outcomes (ECHO)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Johns Hopkins University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00675610
First received: May 7, 2008
Last updated: August 18, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
HIV Infections
Behavioral: communication training
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Enhancing Communication and HIV Outcomes

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • patient-provider communication [ Time Frame: 1 day- 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: May 2008
Estimated Study Completion Date: May 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675610

Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New York
Saint Lukes-Roosevelt
New York, New York, United States, 10023
United States, Oregon
Oregon Health Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Mary Catherine Beach, MD, MPH Johns Hopkins University
  More Information

No publications provided

Responsible Party: Mary Catherine Beach, Johns Hopkins University School of Medicine
ClinicalTrials.gov Identifier: NCT00675610     History of Changes
Other Study ID Numbers: ECHO-01, 290-01-0012
Study First Received: May 7, 2008
Last Updated: August 18, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
communication
HIV/AIDS
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on July 13, 2014