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

This study has been completed.
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01537367
First received: February 10, 2012
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Primary Care Appointment Keeping
Behavioral: Enhanced contact plus behavioral skills
Behavioral: Enhanced contact only
Behavioral: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Health Services Research
Official Title: Intervention Trials to Retain HIV-positive Patients in Medical Care

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • The Percentage of Patients Attending a Primary Care Visit in Each of 3 Four-month Periods (First Measure) [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
    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.

  • The Percentage of Kept Divided by Scheduled Primary Care Visits, Excluding Cancelled (Second Measure). [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Counts Per Person (Rates) of Kept Visits. [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: No ]
    The rate of kept clinic visits per person over 12 months.


Enrollment: 1838
Study Start Date: July 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Hide Detailed Description

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537367

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

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01537367     History of Changes
Other Study ID Numbers: CDCHRSA9272007
Study First Received: February 10, 2012
Results First Received: August 7, 2013
Last Updated: August 22, 2013
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Human immunodeficiency virus
HIV primary care

Additional relevant MeSH terms:
HIV Seropositivity
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014