Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:54 PM
Study NCT ID:
NCT01537367
Status:
COMPLETED
Last Update Posted:
2013-09-09
First Post:
2012-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Intervention to Retain HIV-positive Patients in Medical Care
Sponsor:
Centers for Disease Control and Prevention
Organization:
Study Overview
Official Title:
Intervention Trials to Retain HIV-positive Patients in Medical Care
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Phase II
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: