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

January 23, 2026 updated by: Sarit Golub, Hunter College of City University of New York

Harnessing Data Science to Improve HIV Care Continuum Outcomes: A Hybrid Type 2 Trial Evaluating a Machine-Learning Algorithm-Based Implementation Strategy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Community Care Management Partners Health Home

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

All care management agencies that comprise the Community Care Management Partners (CCMP) Health Home and serve patient with HIV will be included. Randomization occurs at the level of the Care Management Agency. Data will be extracted from the CCMP electronic medical record on all PWH patients (approximately 2600) in the Health Home.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • None, other than those listed above.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Predictive Emergency Room Alerts (perA)Implementation Strategy
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)
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.
Other: Standard of Care Implementation Strategy
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
Care managers interact with patients according to their standard of care protocols

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ER visits
Time Frame: Each 18 month cluster period (36 months total)
Number of ER visits made by patients
Each 18 month cluster period (36 months total)
Hospitalizations
Time Frame: Each 18 month Cluster Period (36 months total)
Number of days of Hospitalization
Each 18 month Cluster Period (36 months total)
Viral Suppression
Time Frame: Each 18 month cluster period (36 months total)
Number of timepoints at which patient was virally suppressed
Each 18 month cluster period (36 months total)
CD4 Count
Time Frame: Each 18 month Cluster Period (36 months total)
CD4 Level at each data collection timepoint
Each 18 month Cluster Period (36 months total)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hunter College of City University of New York

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sarit A. Golub, PhD, MPH, Hunter College of The City University of New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MH136903 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

State health department requirements regarding these electronic medical record data prohibit sharing IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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