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Enhancing Communication and HIV Outcomes (ECHO)

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Johns Hopkins University

Status and phase

Completed
Phase 3

Conditions

HIV Infections

Treatments

Behavioral: communication training

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00675610
ECHO-01
290-01-0012

Details and patient eligibility

About

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.

Full 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.

Enrollment

186 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

186 participants in 2 patient groups

usual care
No Intervention group
Description:
providers are not trained and patients are not coached
intervention arm
Experimental group
Description:
providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers
Treatment:
Behavioral: communication training

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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