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

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
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Behavioral: communication training
providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers
|
- patient-provider communication [ Time Frame: 1 day- 3 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
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 |