Intervention Trials to Retain HIV-positive Patients in Medical Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,838
- 试验地点
- 12
- 主要终点
- The Percentage of Patients Attending a Primary Care Visit in Each of 3 Four-month Periods (First Measure)
研究概览
简要总结
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.
详细描述
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.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Failure to meet one of the three attendance criteria or failure to meet all of the personal criteria.
结局指标
主要结局
The Percentage of Patients Attending a Primary Care Visit in Each of 3 Four-month Periods (First Measure)
时间窗: 12 months after enrollment
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).
时间窗: 12 months after enrollment
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.
次要结局
- Mean Counts Per Person (Rates) of Kept Visits.(12 months after enrollment)