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

Running, not enrolling · Not applicable

Conditions studied: Adherence, Patient, TB, HIV/AIDS, Care Coordination

In brief

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."

Key facts

Study ID

NCT04298905

Run by

Johns Hopkins University

People needed

62

Starts

2022-03-10

Expected to finish

2026-12-31

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any person 18 years of age or older with pulmonary TB
• HIV positive
• Outpatient TB treatment (including short course RR-TB treatment) or admission < 30 days is expected

You may not qualify if…

• Unwilling or unable to provide informed consent, including inability to consent in one of the approved languages
• Patients who require hospitalization for TB treatment at treatment initiation
• Extrapulmonary or disseminated TB disease
• Severe clinical presentation: BMI < 18 kg/m2 or a person unable to stand/walk

Where it is running

• Kelly Lowensen — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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