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.

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 each site.

Primary endpoints: The percentage of patients who attended at least one HIV primary care visit in each of two consecutive 6-month periods during 12-month intervals. A second measure will be the proportion of scheduled HIV primary care clinic appointments kept during 12 months per patient.

Duration of study: In Phase 1, the clinic-wide intervention will be evaluated after 12 months and then will continue through the end of Phase 2. In Phase 2, the enrollment period and client-centered intervention will run approximately 18 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). The first visit could be for primary care or it could be an intake visit. Clinics will have flexibility as to whether they enroll during an intake visit. If the intake visit is long (e.g., over an hour), clinics may elect not to enroll on that visit. If the intake is shorter, clinics may decide to approach the patient for enrollment.) 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 [this includes patients who may not have had a full 12-month history at the clinic] 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, eligible patients (determined by review of attendance data from the clinic's database) will be consented, enrolled, and randomized to receive either (1) a longer comprehensive intervention or (2) a shorter limited intervention from two trained interventionists plus the clinic-wide intervention, or (3) to continue receiving only the clinic-wide intervention and routine HIV clinical care. The client-centered intervention (described in detail later) 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 (described later), deliver information and motivational statements about the importance of regular medical care for HIV infection, help the patient (especially new patients) 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. 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.

Phase 1 and Phase 2 also include surveys of the HIV primary care providers and patients. The provider surveys (Appendix 4) will be used to document whether providers talked with their patients about the importance of regular clinic attendance. The patient surveys will ask patients whether they received the messages as well as materials (e.g., brochure) from providers (Appendix 5). A small sample of patients at each clinic will be surveyed every 60 days during Phase 1 and Phase 2.

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 Phase 2, attendance will be compared by intervention arm and further broken down by demographic (e.g., gender, race/ethnicity) and clinical subgroups (e.g., length of time living with HIV, 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.

• Experimental: Limited Intervention Arm

  Patients allocated to this 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)
  Intervention: Behavioral: CDC/HRSA Patient-centered Behavioral Intervention
• Experimental: Comprehensive Intervention Arm

  Patients allocated to this 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, follow-up on unmet needs)
  • Attempt to make immediate contact following a missed visit and re-schedule appointment (use locator contact info)

  Client-centered intervention, including:

  • Retention risk screener
  • Coaching/support, navigation, skills enhancement (problem-solving, organizational, communication skills)
  • Accompaniment during medical visit or to other services in medical center
  Intervention: Behavioral: CDC/HRSA Patient-centered Behavioral Intervention
• Active Comparator: Control
  Patients assigned to control arm will receive the standard services offered to all patients at the clinic.
  Intervention: Behavioral: CDC/HRSA Patient-centered Behavioral Intervention

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.