Fact CheckerSign in

NCT04298905Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 29 Jan 2026

Brief summary (registry, in English)

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."

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
62 (actual)
First submitted
4 Mar 2020
Start date
10 Mar 2022
Primary completion date
31 May 2025
Lead sponsor
Johns Hopkins University
Diseases
HIV
NCT number
NCT04298905

What you commit to

  • Study type: Interventional
  • Participants enrolled: 62
  • From 10 Mar 2022 to the primary completion date, 31 May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Extrapulmonary or disseminated TB disease

Other

  • 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
  • Severe clinical presentation: BMI \< 18 kg/m2 or a person unable to stand/walk

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kelly Lowensen
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.