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Intervention to Retain HIV-positive Patients in Medical Care

NCT01537367 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1838

Last updated 2013-09-09

Study results available
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Summary

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 academic medical centers.

Objectives: Using HIV patients' clinical data (without personal identifiers) routinely archived in electronic databases at the six participating clinics do the following:

• To examine the extent to which a client-centered intervention delivered by trained interventionists (Phase 2 trial of the project) improves patient attendance for HIV primary care over and above the effect of the clinic-wide intervention. Phase 2 is a three-arm randomized controlled trial conducted at each of the participating six clinics. 300 patients will be enrolled in the Phase 2 trial at each clinic. One hundred will be new patients and 200 will be patients with inconsistent attendance for HIV primary care at the clinic in the prior 12 months. Patients will be randomized to: (1) an enhanced contact plus behavioral skills arm or (2) an enhanced contact-only arm in which patients will receive a longer or a shorter client-centered intervention from two trained interventionists, or (3) the standard of care arm in which patients will receive the clinic-wide intervention and routine HIV clinical care only.

Conditions

  • Primary Care Appointment Keeping

Interventions

BEHAVIORAL

Enhanced contact plus behavioral skills

The enhanced contact plus behavioral skills arm is the longer experimental arm.

BEHAVIORAL

Enhanced contact only

The enhanced contact only arm is the shorter experimental arm.

BEHAVIORAL

Standard of Care

The standard of care arm is the comparison group arm that receives only standard clinical services.

Sponsors & Collaborators

Principal Investigators

  • Lytt Gardner, Ph.D. · Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01537367 on ClinicalTrials.gov