Intervention to Retain HIV-positive Patients in Medical Care

NCT ID: NCT01537367

Last Updated: 2013-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1838 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-02-29

Brief 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.

Detailed Description

Design: Phase 1 uses a pre-post comparison of clinic attendance rates before and during a clinic-wide intervention. Phase 2 uses a randomized controlled trial experimental design.

Target population: Adults in primary medical care for HIV infection at 6 sites: (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.

Primary endpoints: The proportion of patients attending one or more HIV primary care visits in each of three four-month periods over the 12-months. A second measure will be the percentage of kept divided by scheduled primary care visits, excluding cancelled visits.

Duration of study: In the Phase 2 trial, the enrollment period will run six months and the three-arm intervention will run 12 months.

Main eligibility criteria: Phase 1: All patients presenting at the clinics beginning April 1, 2009 will receive the clinic-wide intervention. Attendance data from electronic medical records will be archived at the clinics (and transmitted later to CDC) beginning on April 1, 2008, one year before the start of the clinic-wide intervention. Patients with at least one scheduled clinic appointment qualify for inclusion in the study database. In Phase 2, patients 18 years of age and older (19 years of age in Alabama) who meet one of the following criteria are eligible to enroll: (1) new patients (first or second care visit at the clinic), or (2) patients who have inconsistent attendance for HIV primary care--defined as having had at least one no-show for a primary care appointment in the prior 12 months and patients not seen for HIV primary care at least once in each of two consecutive 6-month periods (among persons who have been patients at the clinic for at least 12 months.)

Study procedures: In Phase 1, attendance data maintained in electronic databases at the six participating clinics will be used (without personal identifiers) to examine attendance rates before and during the clinic-wide intervention. The Phase 1 clinic-wide intervention will include hanging posters in the clinic and having clinic staff distribute brochures that address the importance of attending HIV care on a regular basis, the importance of re-scheduling and canceling appointments, and having HIV primary care providers deliver brief messages about the importance of regular clinic attendance to all patients.

In Phase 2 trial, eligible patients (determined by review of attendance data from the clinic's database) will be consented, enrolled, and randomized to receive either (1) an enhanced contact plus skills intervention or (2) an enhanced contact only intervention from two trained interventionists, or (3) to receive standard of care at the clinic (no contact with the interventionists). The Phase 2 trial intervention includes periodic one-on-one meetings with the interventionists to address barriers to care (attitudes about HIV and unmet needs such as transportation, child care, housing, mental health, and drug use). The interventionists will work in collaboration with the patient's existing case manager(s) to help address these needs. Additionally, the interventionists will develop a personalized retention plan based on the patient's responses to a retention risk screener, deliver information and motivational statements about the importance of regular medical care for HIV infection, help the patient learn how to navigate a complex medical system, maintain contact (e.g., via telephone or outreach visits) with patients between clinic appointments, and make reminder telephone calls a few days before appointments.

Attendance data:

Enrollees' HIV primary care clinic attendance will be monitored quarterly through electronic medical records for at least 18 months, six months before and 12 months during the intervention. Patients who are not enrolled in the trial will continue to receive regular medical care at the clinic as well as the clinic-wide intervention.

Analysis methods: In Phase 1, a cohort of patients at each clinic will be identified and followed over time to compare their attendance (through electronic medical records) before and during the clinic-wide intervention using appropriate methods for making pre-post comparisons. In the Phase 2 trial, attendance will be compared by intervention arm and further broken down by demographic (e.g., gender, race/ethnicity) and clinical subgroups (e.g., viral load at baseline, self-reported substance use) to examine variables that may modify the intervention effect.

Data Management:

Data management and analysis will be the primary responsibility of CDC, although sites will also participate in data analysis activities. CDC will train sites in data management and in the use of the Secure Data Network (SDN) to transmit data files to CDC. CDC will provide all necessary data management guidelines to research sites.

Protocol Development:

CDC and HRSA will have the lead responsibility for the development of the project protocol for local IRB review by all cooperating institutions participating in the research project. HRSA in collaboration with CDC, will organize and conduct site investigators' meetings to discuss the project's progress and plan for the next year's milestones.

Protocol Modifications:

All protocol modifications will be approved by local site IRBs. Local IRB approvals will be obtained before protocol changes are implemented. CDC will maintain copies of current local site IRB approval letters and approved consent forms.

Conditions

Primary Care Appointment Keeping

Keywords

Human immunodeficiency virus; HIV primary care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Enhanced contact only

Patients allocated to the Enhanced contact only arm will receive:

HIV information and education

• Specific to importance of coming to care regularly
• Generic and tailored components
• Approximately 10 minutes in length

Enhanced contact over time

• Collect locator information
• Follow-up contact after medical visit (face-to-face or phone)
• Appointment reminders (telephone, e-mail, text message)
• Periodic telephone contact across time (support, update locator info, refer any unmet needs to Case Manager)
• Attempt to make immediate contact following a missed visit and re-schedule appointment (use locator contact info)

Group Type: EXPERIMENTAL

Enhanced contact only

Intervention Type: BEHAVIORAL

The enhanced contact only arm is the shorter experimental arm.

Enhanced contact plus behavioral skills

Enhanced contact plus behavioral skills is the longer experimental intervention arm.

Group Type: EXPERIMENTAL

Enhanced contact plus behavioral skills

Intervention Type: BEHAVIORAL

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

Standard of Care

Patients assigned to control arm will receive the standard services offered to all patients at the clinic.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: BEHAVIORAL

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

Interventions

Enhanced contact plus behavioral skills

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

Intervention Type: BEHAVIORAL

Enhanced contact only

The enhanced contact only arm is the shorter experimental arm.

Intervention Type: BEHAVIORAL

Standard of Care

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients must meet ONE of the following three clinic attendance criteria:

• Intake visit or 1st or 2nd HIV primary care visit at the clinic
• At least one no-show for an HIV primary care appointment in the prior 12 months (includes patients who may not have had a full 12-month history at the clinic)
• Not seen for HIV primary care at least once in each of two consecutive 6-month periods (among patients who have been seen at the clinic for at least 12 months)
• In addition, patients must meet ALL of the following personal criteria:

• 18 year of age or older (at least 19 years of age in Alabama)
• An HIV-positive patient receiving care at the clinic
• Able to speak English or Spanish
• No plans to move out of the area in the next 12 months
• Able to provide informed consent

Exclusion Criteria

• Failure to meet one of the three attendance criteria or failure to meet all of the personal criteria.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Health Resources and Services Administration (HRSA)

FED

Sponsor Role: collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lytt Gardner, Ph.D.

Role: STUDY_DIRECTOR

Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention

Locations

1917 Clinic of the University of Alabama-Birmingham

Birmingham, Alabama, United States

Adult HIV Clinic of the Jackson Health System

Miami, Florida, United States

Moore Clinic of the Johns Hopkins University Medical Institutions

Baltimore, Maryland, United States

Boston University Medical Center, HIV Clinic

Boston, Massachusetts, United States

SUNY Downstate Medical Center, STAR Health Center

Brooklyn, New York, United States

Baylor College of Medicine-Thomas Street Health Center

Houston, Texas, United States

Countries

United States

Other Identifiers

CDCHRSA9272007

Identifier Type: -

Identifier Source: org_study_id