Intervention to Retain HIV-positive Patients in Medical Care (Phase II)
|ClinicalTrials.gov Identifier: NCT01537367|
Recruitment Status : Completed
First Posted : February 23, 2012
Results First Posted : August 23, 2013
Last Update Posted : September 9, 2013
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 or disease||Intervention/treatment||Phase|
|Primary Care Appointment Keeping||Behavioral: Enhanced contact plus behavioral skills Behavioral: Enhanced contact only Behavioral: Standard of Care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1838 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Primary Purpose:||Health Services Research|
|Official Title:||Intervention Trials to Retain HIV-positive Patients in Medical Care|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Experimental: Enhanced contact only
Patients allocated to the Enhanced contact only arm will receive:
HIV information and education
Enhanced contact over time
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.
- The Percentage of Patients Attending a Primary Care Visit in Each of 3 Four-month Periods (First Measure) [ Time Frame: 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). [ Time Frame: 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.
- Mean Counts Per Person (Rates) of Kept Visits. [ Time Frame: 12 months after enrollment ]The rate of kept clinic visits per person over 12 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01537367
|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|
|Study Director:||Lytt Gardner, Ph.D.||Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention|