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

NCT04298905 | Active Not Recruiting

• 1 other identifier: IRB00211518
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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."

Conditions

Adherence, Patient; TB; HIV/AIDS; Care Coordination

Keywords

mHealth; community health worker; TB/HIV

Outcome Measures

Primary Outcomes (4)

• Number of participants with treatment success

  Treatment success is defined as cure and completion of treatment.

  Up to 12 months

• Number of deaths among participants

  Number of death (all causes) among participants will be assessed.

  Up to 12 months

• Number of participants with treatment failure

  Treatment failure is defined as worsening antimicrobial resistance.

  Up to 12 months

• Number of participants lost to follow-up

  Loss to follow-up is defined as 2 or more consecutive months of missed treatment.

  Up to 12 months

Secondary Outcomes (2)

• Time to linkage to care

  Up to 30 days

• Time to treatment initiation

  Up to 30 days

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

mHealth intervention

ACTIVE COMPARATOR

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

Interventions

CHW mHealth patient intervention for trigger escalation OTHER

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

mHealth intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Witwatersrand, South Africa: collaborator

Study Sites (1)

Kelly Lowensen

Baltimore, Maryland, 21224-3750, United States

Location

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MeSH Terms

Conditions

Patient Compliance; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jason E Farley, PhD, MPH

  Johns Hopkins University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study design overview: LEAP-TB-SA is a pilot randomized controlled trial. There are two arms: mHealth intervention (100) and health education control (100).

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: March 10, 2022
• Primary Completion: May 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)