N/A
N=1,838
Intervention to Retain HIV-positive Patients in Medical Care
Primary Care Appointment Keeping
Bottom Line
View on ClinicalTrials.gov: NCT01537367 ↗Enrolled (actual)
1,838
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: The Percentage of Patients Attending a Primary Care Visit in Each of 3 Four-month Periods (First Measure) — 55.8; 55.6; 45.7 percent in care each 4 month period
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced contact plus behavioral skills (Behavioral); Enhanced contact only (Behavioral); Standard of Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centers for Disease Control and Prevention
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Patients Attending a Primary Care Visit in Each of 3 Four-month Periods (First Measure) |
55.8; 55.6; 45.7 | — |
| PRIMARY The Percentage of Kept Divided by Scheduled Primary Care Visits, Excluding Cancelled (Second Measure). |
72.5; 70.9; 67.2 | — |
| SECONDARY Mean Counts Per Person (Rates) of Kept Visits. |
4.12; 4.15; 3.59 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01537367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.