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

HIV/AIDS Clinical Trial

— LEAP-TB-SA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04298905
• Other study ID #: IRB00211518
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 10, 2022
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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."

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: December 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Adherence, Patient
• Care Coordination
• HIV Infections
• HIV/AIDS
• TB

Intervention

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: 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) Triggered, escalating adherence coaching: Safety monitoring: reports all abnormal laboratory values to provider Appointment keeping (RETAIN): a. Triggered, escalating adherence coaching vDOT submissions: a. Triggered, escalating adherence coaching Symptom reports: Triggered, escalating adherence coaching

Locations

Country	Name	City	State
United States	Kelly Lowensen	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	University of Witwatersrand, South Africa

Country where clinical trial is conducted

United States, 

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment success	Treatment success is defined as cure and completion of treatment.	Up to 12 months
Primary	Number of deaths among participants	Number of death (all causes) among participants will be assessed.	Up to 12 months
Primary	Number of participants with treatment failure	Treatment failure is defined as worsening antimicrobial resistance.	Up to 12 months
Primary	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	Time to linkage to care	Time (days) to linkage to care for TB.	Up to 30 days
Secondary	Time to treatment initiation	Time (days) to treatment initiation for TB.	Up to 30 days