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."

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

Adherence, Patient

HIV/AIDS

Care Coordination

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.

CHW mHealth patient intervention for trigger escalation

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

Treatment success is defined as cure and completion of treatment.

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

Treatment failure is defined as worsening antimicrobial resistance.

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

Time (days) to treatment initiation for TB.

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.

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.

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status