Evaluating an Algorithm-Based Implementation Strategy to Improve HIV Care Outcomes

NCT07279376 | Enrolling By Invitation

• 1 other identifier: R01MH136903
• Study Type: interventional
• Target: 2,600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV (Human Immunodeficiency Virus)

Keywords

HIV; emergency room; implementation science; machine-learning algorithm

Outcome Measures

Primary Outcomes (4)

• ER visits

  Number of ER visits made by patients

  Each 18 month cluster period (36 months total)

• Hospitalizations

  Number of days of Hospitalization

  Each 18 month Cluster Period (36 months total)

• Viral Suppression

  Number of timepoints at which patient was virally suppressed

  Each 18 month cluster period (36 months total)

• CD4 Count

  CD4 Level at each data collection timepoint

  Each 18 month Cluster Period (36 months total)

Study Arms (2)

Predictive Emergency Room Alerts (perA)Implementation Strategy

ACTIVE COMPARATOR

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)

Standard of Care Implementation Strategy

OTHER

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

Interventions

Standard of care OTHER

Care managers interact with patients according to their standard of care protocols

Standard of Care Implementation Strategy

predictive emergency room alerts (pERA) OTHER

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.

Predictive Emergency Room Alerts (perA)Implementation Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be members of one of the Care Management Agencies that comprise the Community Care Management Partners (CCMP) Health Home
• Participants must be living with HIV

You may not qualify if:

• None, other than those listed above.

Sponsors & Collaborators

• Hunter College of City University of New York: lead

Study Sites (1)

Community Care Management Partners Health Home

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Emergencies

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sarit A. Golub, PhD, MPH

  Hunter College of The City University of New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 12, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)