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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kelly Lowensen Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.