Enhancing Communication and HIV Outcomes (ECHO)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Behavioral: communication training |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Enhancing Communication and HIV Outcomes |
- patient-provider communication [ Time Frame: 1 day- 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 240 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Behavioral: communication training
providers are trained to communicate with patients about adherence and patients are coached to discuss adherence with providers
|
Detailed 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
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Mary Catherine Beach, Johns Hopkins University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00675610 History of Changes |
| Other Study ID Numbers: | ECHO-01, 290-01-0012 |
| Study First Received: | May 7, 2008 |
| Last Updated: | August 18, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins University:
|
communication HIV/AIDS Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on June 18, 2013