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Leveraging mHealth to Enable and Adapt CHW Strategies to Improve TB/HIV Patient Outcomes in SA

NCT04298905 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-01-29

No results posted yet for this study

Summary

mHealth solutions designed to support affordable human resources for health, such as community health workers (CHWs), offer the opportunity to reimagine a patient-centered, system-level solution that may radically change care models in low resource settings. The 'leap' of m-health is most potent and practical in settings where desktop-based infrastructure is lacking and hard-wired internet connectivity is unavailable.

Investigators have demonstrated the feasibility of mHealth and human resource solutions in South Africa and shown marked improvements in screening, linkage and treatment initiation as well as supporting patient adherence through video DOT (vDOT) and early identification of treatment related toxicity. Investigators' strategies have evaluated solutions for individual cascade steps through TB and HIV smartphone and tablet-based m-health applications implemented by a CHW. This study combines these individual cascade step approaches into an innovative TB/HIV cascade intervention study entitled, "Leveraging mHealth to enable and adapt community health worker strategies to improve TB/HIV patient outcomes in South Africa (LEAP-TB-SA) Trial."

Conditions

  • Adherence, Patient
  • TB
  • HIV/AIDS
  • Care Coordination

Interventions

OTHER

CHW mHealth patient intervention for trigger escalation

The CHW dashboard is a tablet-based, per-patient summary of the patient intervention. It is this dashboard that identifies a trigger to escalate the adherence intervention. This dashboard is created by receiving information from the patient's smartphone application as well as the National Health Laboratory Service (NHLS) data feed of laboratory results. The monitoring features included in this dashboard: 1. NHLS laboratory results: Dashboard receives and flags NHLS results for any positive smear or culture (new positive after prior negative results) or detectable viral load (with prior viral suppression) 1. Triggered, escalating adherence coaching: 2. Safety monitoring: reports all abnormal laboratory values to provider 2. Appointment keeping (RETAIN): a. Triggered, escalating adherence coaching 3. vDOT submissions: a. Triggered, escalating adherence coaching 4. Symptom reports: 1. Triggered, escalating adherence coaching

Sponsors & Collaborators

Principal Investigators

  • Jason E Farley, PhD, MPH · Johns Hopkins University School of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2025-05-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT04298905 on ClinicalTrials.gov