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ACTIVE NOT RECRUITING
NCT04298905
NA

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

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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."

Official title: Leveraging mHealth to Enable and Adapt Community Health Worker Strategies to Improve TB/HIV Patient Outcomes in South Africa (LEAP-TB-SA) Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2022-03-10

Completion Date

2026-12-31

Last Updated

2026-01-29

Healthy Volunteers

No

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

Locations (1)

Kelly Lowensen

Baltimore, Maryland, United States