Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-01-09 @ 7:14 PM
Study NCT ID:
NCT04298905
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-27
First Post:
2020-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Leveraging mHealth to Enable and Adapt CHW Strategies to Improve TB/HIV Patient Outcomes in SA
Sponsor:
Johns Hopkins University
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEAP-TB-SA
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."
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."
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: