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Enhancing Communication and HIV Outcomes (ECHO)

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ClinicalTrials.gov Identifier: NCT00675610
Recruitment Status : Completed
First Posted : May 9, 2008
Last Update Posted : April 1, 2015
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Mary Catherine Beach, Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: communication training Phase 3

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  (Clinical Trial)
Actual Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Enhancing Communication and HIV Outcomes
Study Start Date : May 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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




Primary Outcome Measures :
  1. patient-provider communication [ Time Frame: 1 day- 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Mary Catherine Beach, MD, MPH Johns Hopkins University

Responsible Party: Mary Catherine Beach, Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00675610     History of Changes
Other Study ID Numbers: ECHO-01
290-01-0012
First Posted: May 9, 2008    Key Record Dates
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Mary Catherine Beach, Johns Hopkins University:
communication
HIV/AIDS
Treatment Experienced

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