Data Science and Qualitative Research for Decision Support in the HIV Care Cascade

NCT06604663 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80000

Last updated 2026-01-12

No results posted yet for this study

Summary

The goal of this study is to determine whether clinical prediction algorithms derived using statistical machine learning methods can be used to improve patient outcomes in large HIV care programs in sub-Saharan Africa and elsewhere.

There are two main questions to be answered. First, can the prediction algorithms accurately identify those who are at risk for (a) missing scheduled clinic visits and/or (b) treatment failure, evidenced by elevated HIV viral load? And second, can the risk predictions be used in a structured way to (a) improve retention in care and/or (b) reduce the number of patients having elevated viral load? Researchers will develop machine learning prediction algorithms, incorporate the risk prediction information into the electronic health record, provide guidance to clinical health workers on use of the point-of-care interface tools that display risk prediction information, and incorporate feedback from clinic staff to modify and co-develop the protocol for using risk predictions for improving patient outcomes.

They will then compare the proportion of patients having missed visits and longer-term loss to follow up, and the proportion with elevated viral load, between clinics that use the information from the risk prediction algorithms and those that do not.

Conditions

  • Human Immunodeficiency Virus
  • Treatment Adherence
  • Treatment Compliance
  • Patient No Show
  • Patient Engagement
  • Patient Dropouts
  • HIV Viremia

Interventions

BEHAVIORAL

Activation of the CDSS system

Activation of the CDSS system, whereby outreach workers and clinicians have access to and ability to act upon lists of patients who are at highest risk of missing their upcoming clinical appointment.

Sponsors & Collaborators

  • Moi University College of Health Sciences

    collaborator UNKNOWN
  • Moi Teaching and Referral Hospital

    collaborator OTHER
  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH
  • Brown University

    lead OTHER

Principal Investigators

  • Joseph W Hogan, ScD · Brown University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2026-01-31
Completion
2026-10-31

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06604663 on ClinicalTrials.gov