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OpenTrials
Completed

NCT Number: NCT00675610

Enhancing Communication and HIV Outcomes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Wayne State University, Detroit, Michigan, United States

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About this study

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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

communication training

Behavioral

providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers

Primary outcomes

  1. patient-provider communication

    Time frame: 1 day- 3 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Acronym: ECHO

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
May 9, 2008
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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