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

Intervention Trials to Retain HIV-positive Patients in Medical Care

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.

Study Overview

• Status: Completed
• Conditions: Primary Care Appointment Keeping
• Intervention / Treatment: Behavioral: Enhanced contact only; Behavioral: Enhanced contact plus behavioral skills; Behavioral: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 1838
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-2050
      • 1917 Clinic of the University of Alabama-Birmingham
  • Florida
    • Miami, Florida, United States, 33136
      • Adult HIV Clinic of the Jackson Health System
  • Maryland
    • Baltimore, Maryland, United States, 21205-1911
      • Moore Clinic of the Johns Hopkins University Medical Institutions
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center, HIV Clinic
  • New York
    • Brooklyn, New York, United States, 11203
      • SUNY Downstate Medical Center, STAR Health Center
  • Texas
    • Houston, Texas, United States, 77009
      • Baylor College of Medicine-Thomas Street Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Behavioral: Enhanced contact only; The enhanced contact only arm is the shorter experimental arm.
Experimental: Enhanced contact plus behavioral skills; Enhanced contact plus behavioral skills is the longer experimental intervention arm.	Behavioral: Enhanced contact plus behavioral skills; The enhanced contact plus behavioral skills arm is the longer experimental arm.
Active Comparator: Standard of Care; Patients assigned to control arm will receive the standard services offered to all patients at the clinic.	Behavioral: Standard of Care; The standard of care arm is the comparison group arm that receives only standard clinical services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Patients Attending a Primary Care Visit in Each of 3 Four-month Periods (First Measure)	Kept visits for each patient were assessed in 4-month periods over the 12 months of the intervention. This is a binary measure, requiring attendance at least once in each of the three 4-month periods.	12 months after enrollment
The Percentage of Kept Divided by Scheduled Primary Care Visits, Excluding Cancelled (Second Measure).	Primary care visits are scheduled appointments for HIV-positive patients to see a physician, nurse practitioner, or physician assistant (a provider who can prescribe medication) at the HIV clinic.	12 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Counts Per Person (Rates) of Kept Visits.	The rate of kept clinic visits per person over 12 months.	12 months after enrollment

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention
• Collaborators: Health Resources and Services Administration (HRSA)
• Investigators: Study Director: Lytt Gardner, Ph.D., Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: February 10, 2012
• First Submitted That Met QC Criteria: February 22, 2012
• First Posted (Estimate): February 23, 2012

Study Record Updates

• Last Update Posted (Estimate): September 9, 2013
• Last Update Submitted That Met QC Criteria: August 22, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Human immunodeficiency virus; HIV primary care
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections; HIV Seropositivity
• Other Study ID Numbers: CDCHRSA9272007