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

January 27, 2026 updated by: Johns Hopkins University

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

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."

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Mycobacterium tuberculosis (TB) is the leading cause of death for persons living with HIV (PLWH) in South Africa (SA). Estimates suggest that if factoring in immediate lost to follow-up, a mere 52% of TB/HIV co-infected individuals have successful treatment outcomes. Factors contributing to this bleak reality occur throughout the TB/HIV cascade and include: limited capacity for TB screening; delays in linkage or failure to link into care; treatment non-adherence; and long and toxic treatment regimens that lead to disengagement in care. Reducing mortality and improving TB treatment outcomes among PLWH requires system-level, patient-centered interventions that enhance movement along both cascades. Through innovative mobile health (mHealth) approaches, designed to optimize human resources, and create efficiency for all users and engage patients in care, it is possible to reduce system bottlenecks and rapidly improve treatment outcomes.

Studies addressing the TB or HIV care cascades are increasingly common, yet few offer an integrated, sustainable approach to TB/HIV co-infection and, to date, no intervention spans the entire cascade. The TB/HIV care cascade begins with diagnosis of TB in a PLWH or in a person newly diagnosed with both diseases. Patients newly diagnosed with TB and HIV face a burdensome model of care influenced by: a) timing of HIV treatment initiation; b) worsened symptom profiles associated with immune reconstitution syndrome; c) higher pill burden; d) differential adherence challenges; e) and more frequent care visits for directly observed therapy (DOT) and laboratory evaluations. Many, have struggled with adherence to HIV regimen, prior to the TB diagnosis. Data found that 44% of PLWH on anti-retroviral therapy (ART) present with viral suppression to first TB visit, suggesting the need to further intensify adherence interventions in this group.

Hypothesis: The intervention will have fewer composite negative TB outcomes (i.e. treatment failure, loss to follow-up, and death) compared to attention controls.

Primary Aims:

1. to determine the feasibility, acceptability and impact of a mHealth triggered, escalating adherence intervention by community health workers (CHW) to improve rif-resistant (RR)-TB treatment outcomes among PLWH in Kwa-Zulu Natal, Province of South Africa through a pilot randomized controlled trial. H1. the mHealth triggered, escalating adherence intervention by CHW's will improve treatment success for RR-TB and HIV co-infected patients compared to attention control participants.

Secondary Aims:

  1. to conduct a time-limited prospective screening cohort of close contacts of persons diagnosed with RR-TB using respondent driven sampling.
  2. to evaluate willingness to participate in the trial and determine who screen fails for any reason.
  3. to evaluate study process indicators to further refine the behavioral and technological components of the intervention (patient symptom reporting; vDOT submission compliance; CHW adherence coaching sessions; intervention theoretical models; and mHealth application feature enhancements to support care coordination).
  4. to characterize the emergence of resistance among patients with non-adherence to RR-TB treatment, by obtaining two additional sputum specimens (i.e., 1) on treatment initiation for all patients and 2) among participants with a 30-day period of less than optimal adherence (defined as <90% of vDOT submissions or patient/provider report non-adherence) and/or treatment failure (defined as positive culture with evidence of additional antimicrobial resistance) to fully characterize resistance patterns through genotypic and phenotypic resistance testing as well as next generation molecular sequencing.
  5. to characterize HIV genotypic resistance patterns among participants with a detectable viral load.
  6. to determine, retrospectively, the impact of HIV resistance patterns on RR-TB treatment outcomes.
  7. to assess stigma throughout the RR-TB care continuum and evaluate whether the level of stigma changes through different phases of treatment.
  8. to pilot test the psychometric properties of four novel indicators of intersectional RR- TB-HIV stigma.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224-3750
        • Kelly Lowensen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Individuals randomized to standard of care will receive a standardized adherence education session and provided with a paper-based diary to track appointments and adherence. Instructions will be provided on the importance of daily adherence in the primary health care facility closest to patients' residence, as per standard of care. Directly observed therapy (DOT) is recommended for all patients at patients' nearest clinic. All patients are seen face-to-face monthly for adherence monitoring, monthly symptom reports and laboratory evaluations per standard of care treatment guidelines. All research participants will also receive a clinic visit quality checklist to ensure completeness of standard of care procedures.
Active Comparator: mHealth intervention
Individuals randomized to the intervention arm will receive the same standardized adherence education, followed by an orientation session to the study intervention. This orientation will include education on basic smartphone operations and use. The CHW will set up appointment reminders for clinic visits as well as daily adherence reminders for submission of the video DOT sessions and symptom reports. A smartphone capable of downloading apps, receiving short message service (SMS) and access wifi and cellular connectivity will be provided to intervention patients. All patients are seen face-to-face monthly for adherence monitoring, monthly symptom reports and laboratory evaluations per standard of care treatment guidelines. All research participants will also receive a clinic visit quality checklist to ensure completeness of standard of care procedures.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment success
Time Frame: Up to 12 months
Treatment success is defined as cure and completion of treatment.
Up to 12 months
Number of deaths among participants
Time Frame: Up to 12 months
Number of death (all causes) among participants will be assessed.
Up to 12 months
Number of participants with treatment failure
Time Frame: Up to 12 months
Treatment failure is defined as worsening antimicrobial resistance.
Up to 12 months
Number of participants lost to follow-up
Time Frame: Up to 12 months
Loss to follow-up is defined as 2 or more consecutive months of missed treatment.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to linkage to care
Time Frame: Up to 30 days
Time (days) to linkage to care for TB.
Up to 30 days
Time to treatment initiation
Time Frame: Up to 30 days
Time (days) to treatment initiation for TB.
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

University of Witwatersrand, South Africa

Investigators

  • Principal Investigator: Jason E Farley, PhD, MPH, Johns Hopkins University School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Actual)

May 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (Actual)

March 6, 2020

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00211518

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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