Clinical trial NCT00675610: Enhancing Communication and HIV Outcomes
Official title: Enhancing Communication and HIV Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: communication
HIV/AIDS
Treatment Experienced
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2008-05-09
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: patient-provider communication
timeFrame: 1 day- 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: New York
country: United States
facility: Saint Lukes-Roosevelt
state: New York
city: Portland
country: United States
facility: Oregon Health Science University
state: Oregon
Study officials:
affiliation: Johns Hopkins University
name: Mary Catherine Beach, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: