Intervention to Retain HIV-positive Patients in Medical Care (Phase II)

PROJECT OVERVIEW

This research is a collaboration between the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), and six university-affiliated HIV clinics in the United States.

Study title: Intervention Trials to Retain HIV Patients in Medical Care

Study sites: The study will be performed at six HIV clinics affiliated with (1) University of Alabama at Birmingham; (2) Baylor College of Medicine, Houston, Texas; (3) Johns Hopkins University School of Medicine, Baltimore, Maryland; (4) State University of New York, Downstate Medical Center, Brooklyn, New York; (5) Boston Medical Center, Boston, Massachusetts; and (6) University of Miami Miller School of Medicine, Miami, Florida.

Objectives: To examine HIV-positive patients' attendance for HIV primary medical care by using clinical data (without personal identifiers) routinely archived in electronic databases at the six participating clinics.

• To examine the effect of a clinic-wide intervention implemented at the six participating HIV primary care clinics on patient attendance for primary medical care (Phase 1 of the project). The clinic's attendance rate during a 12-month period before the start of the clinic-wide intervention will be compared with the attendance rate during the first 12 months of the intervention and with attendance during two subsequent 12-month intervention periods.
• To examine the extent to which a client-centered intervention delivered by trained interventionists (Phase 2 of the project) improves patient attendance for HIV primary care over and above the effect of the clinic-wide intervention. Initiated after the first 12 months of the clinic-wide intervention, Phase 2 is a three-arm randomized controlled trial conducted at each of the participating six clinics. Specifically, 300 patients will be enrolled in the Phase 2 trial at each clinic. One hundred will be new patients (defined on next page) and 200 will be patients with inconsistent attendance for HIV primary care at the clinic in the prior 12 months (defined on next page). Patients will be randomized to either (1) a comprehensive intervention arm or (2) a limited intervention arm in which patients will receive a longer or a shorter client-centered intervention from two trained interventionists plus the clinic-wide intervention, or (3) the control arm in which patients will receive the clinic-wide intervention and routine HIV clinical care (standard of care) only.