Enhancing Communication and HIV Outcomes

Phase 3

Completed

• Conditions: HIV Infections

• Registration Number: NCT00675610
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-07
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-09
• Primary Completion: 2009-05
• Study Completion: 2010-05
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
patient-provider communication	1 day- 3 months

Trial Locations

Locations (3)

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Saint Lukes-Roosevelt; 🇺🇸 New York, New York, United States

Oregon Health Science University; 🇺🇸 Portland, Oregon, United States