Enhancing Communication and HIV Outcomes

HIV Infections Clinical Trial

— ECHO  

Official title:

Enhancing Communication and HIV Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675610
• Other study ID #: ECHO-01
• Secondary ID: 290-01-0012
• Status: Completed
• Phase: Phase 3
• First received: May 7, 2008
• Last updated: March 31, 2015
• Start date: May 2008
• Est. completion date: May 2010

Study information

• Verified date: March 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: May 2010
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• communication training
providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan
United States	Saint Lukes-Roosevelt	New York	New York
United States	Oregon Health Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient-provider communication		1 day- 3 months	No