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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

May 7, 2008
August 18, 2009
May 2008
May 2009   (final data collection date for primary outcome measure)
patient-provider communication [ Time Frame: 1 day- 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00675610 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Enhancing Communication and HIV Outcomes
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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
HIV Infections
Behavioral: communication training
providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers
  • 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
    Intervention: Behavioral: communication training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
240
May 2010
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00675610
ECHO-01, 290-01-0012
No
Mary Catherine Beach, Johns Hopkins University School of Medicine
Johns Hopkins University
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Mary Catherine Beach, MD, MPH Johns Hopkins University
Johns Hopkins University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP