An interventional study of predictive emergency room alerts (pERA) and Standard of care in HIV (Human Immunodeficiency Virus), sponsored by Hunter College of City University of New York. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by Hunter College of City University of New York · Not applicable, Interventional, and Treatment
This study tests a strategy for helping Care Management Agencies prioritize patients with HIV (PWH) for outreach and support. Under the new strategy, care managers are given a list of highest-priority patients who have been identified by a computer algorithm as being at high risk of going to the emergency room in the next two weeks. This strategy is compared to traditional (standard of care) care management, in which care managers reach out to patients based on a set schedule and their clinical judgement (but not based on a computerized report). We are looking at whether the use of the computer report helps care managers reach the right patients at the right time, preventing them from having to go to the emergency room.
Comprehensive Care Management and Care Coordination (CCM/CC) is a medical case management intervention with demonstrated effectiveness in reducing ED visits and hospitalization for PWH, and improving both health outcomes (viral load, CD4 count) and retention in care. However, despite CCM/CC's effectiveness, there are persistent challenges to its implementation. This project is based on the scientific premise that the effectiveness of the CCM/CC intervention can be greatly improved by utilizing a data-driven implementation strategy that optimizes timely provision of CCM/CC services to the patients who need it most. Our community-based collaborator, Comprehensive Care Management Partners (CCMP) Health Home, has developed and validated a machine-learning algorithm that can reliably predict which of its PWH patients are most likely to visit the ED in the next two weeks. In this project, we will apply this algorithm as a targeted implementation strategy for CCM/CC, focusing service provision on the PWH who need it most, when they need it most. Our core hypothesis (supported by preliminary studies data) is that this "just-in-time" strategy for implementing a care management intervention will overcome both provider-level barriers to the provision of CCM/CC services and patient-level barriers to the receipt of HIV treatment and care. We will conduct a Hybrid 2 implementation-effectiveness trial, guided by the RE-AIM implementation science framework and the behavioral economics theory of Scarcity to collect rigorous data on the impact of this algorithm-driven implementation strategy on the reach, effectiveness, adoption, implementation and maintenance of the CCM/CC intervention
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's planned enrollment of 2,600 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Hunter College of City University of New York is the lead sponsor of 36 studies on the registry; 9 are open to participants now.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Refers to patients within Care Management Agencies that have been randomized to use the pERA implementation strategy to delivery CCM/CC during that study period.
Other: predictive emergency room alerts (pERA)
Refers to patients in Care Management Agencies that have been randomized to use their standard of care implementation strategy to deliver CCM/CC during that study period.
Other: Standard of care
pERA is a machine-learning algorithm-driven implementation strategy that identifies patients at higher risk of emergency room visits and alerts the care manager to follow-up with them.
Care managers interact with patients according to their standard of care protocols
ER visits
Number of ER visits made by patients
Time frame: Each 18 month cluster period (36 months total)
Hospitalizations
Number of days of Hospitalization
Time frame: Each 18 month Cluster Period (36 months total)
Viral Suppression
Number of timepoints at which patient was virally suppressed
Time frame: Each 18 month cluster period (36 months total)
CD4 Count
CD4 Level at each data collection timepoint
Time frame: Each 18 month Cluster Period (36 months total)
Plan to share: No — State health department requirements regarding these electronic medical record data prohibit sharing IPD.
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Acquired Immunodeficiency Syndrome →
Hunter College of City University of New York