Adherence, PatientLEAP-TB-SANCT04298905
Leveraging mHealth to Enable and Adapt CHW Strategies to Improve TB/HIV Patient Outcomes in SA
A study testing CHW mHealth patient intervention for trigger escalation in people with Adherence, Patient and TB, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adherence, Patient, TB, HIV/AIDS
- What is being tested?
- CHW mHealth patient intervention for trigger escalation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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."
Read the 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:
- 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:
- to conduct a time-limited prospective screening cohort of close contacts of persons diagnosed with RR-TB using respondent driven sampling.
- to evaluate willingness to participate in the trial and determine who screen fails for any reason.
- 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).
- 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.
- to characterize HIV genotypic resistance patterns among participants with a detectable viral load.
- to determine, retrospectively, the impact of HIV resistance patterns on RR-TB treatment outcomes.
- to assess stigma throughout the RR-TB care continuum and evaluate whether the level of stigma changes through different phases of treatment.
- to pilot test the psychometric properties of four novel indicators of intersectional RR- TB-HIV stigma.
- Conditions
- Adherence, Patient, TB, HIV/AIDS, Care Coordination
- Being tested
- CHW mHealth patient intervention for trigger escalation
- Keywords
- mHealth, community health worker, TB/HIV
- Medical subject headings
- Patient Compliance, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW mHealth patient intervention for trigger escalationOther
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):
- Triggered, escalating adherence coaching
- vDOT submissions:
- Triggered, escalating adherence coaching
- Symptom reports:
- Triggered, escalating adherence coaching
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CHW mHealth patient intervention for trigger escalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment success
Treatment success is defined as cure and completion of treatment.
Measured: Up to 12 months
Number of deaths among participants
Number of death (all causes) among participants will be assessed.
Measured: Up to 12 months
Number of participants with treatment failure
Treatment failure is defined as worsening antimicrobial resistance.
Measured: 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.
Measured: Up to 12 months
Secondary outcomes (2)
Time to linkage to care
Time (days) to linkage to care for TB.
Measured: Up to 30 days
Time to treatment initiation
Time (days) to treatment initiation for TB.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start10 Mar 2022
- Primary completion31 May 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Adherence, PatientStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study design overview: LEAP-TB-SA is a pilot randomized controlled trial. There are two arms: mHealth intervention (100) and health education control (100).
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa
- Responsible party
- Sponsor
- Investigators
- Jason E Farley, PhD, MPH, Principal investigator, Johns Hopkins University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298905
- Sponsor's protocol ID
- IRB00211518
- Acronym
- LEAP-TB-SA
- Status last verified
- Jan 2026
- First submitted
- 4 Mar 2020
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Geneva. Global Tuberculosis Report 2018.; 2018. doi:ISBN 978 92 4 156539 4
Naidoo P, Theron G, Rangaka MX, Chihota VN, Vaughan L, Brey ZO, Pillay Y. The South African Tuberculosis Care Cascade: Estimated Losses and Methodological Challenges. J Infect Dis. 2017 Nov 6;216(suppl_7):S702-S713. doi: 10.1093/infdis/jix335.
PubMed 29117342Seid A, Metaferia Y. Factors associated with treatment delay among newly diagnosed tuberculosis patients in Dessie city and surroundings, Northern Central Ethiopia: a cross-sectional study. BMC Public Health. 2018 Jul 28;18(1):931. doi: 10.1186/s12889-018-5823-9.
PubMed 30055593Takarinda KC, Harries AD, Nyathi B, Ngwenya M, Mutasa-Apollo T, Sandy C. Tuberculosis treatment delays and associated factors within the Zimbabwe national tuberculosis programme. BMC Public Health. 2015 Jan 29;15:29. doi: 10.1186/s12889-015-1437-7.
PubMed 25631667Meintjes G, Schoeman H, Morroni C, Wilson D, Maartens G. Patient and provider delay in tuberculosis suspects from communities with a high HIV prevalence in South Africa: a cross-sectional study. BMC Infect Dis. 2008 May 25;8:72. doi: 10.1186/1471-2334-8-72.
PubMed 18501019Gebremariam MK, Bjune GA, Frich JC. Barriers and facilitators of adherence to TB treatment in patients on concomitant TB and HIV treatment: a qualitative study. BMC Public Health. 2010 Oct 28;10:651. doi: 10.1186/1471-2458-10-651.
PubMed 21029405Naidoo P, Peltzer K, Louw J, Matseke G, McHunu G, Tutshana B. Predictors of tuberculosis (TB) and antiretroviral (ARV) medication non-adherence in public primary care patients in South Africa: a cross sectional study. BMC Public Health. 2013 Apr 26;13:396. doi: 10.1186/1471-2458-13-396.
PubMed 23622516Amuha MG, Kutyabami P, Kitutu FE, Odoi-Adome R, Kalyango JN. Non-adherence to anti-TB drugs among TB/HIV co-infected patients in Mbarara Hospital Uganda: prevalence and associated factors. Afr Health Sci. 2009 Aug 1;9 Suppl 1(Suppl 1):S8-15.
PubMed 20589161Van der Walt M, Lancaster J, Odendaal R, Davis JG, Shean K, Farley J. Serious treatment related adverse drug reactions amongst anti-retroviral naive MDR-TB patients. PLoS One. 2013;8(4):e58817. doi: 10.1371/journal.pone.0058817. Epub 2013 Apr 3.
PubMed 23573193Farley JE, Ram M, Pan W, Waldman S, Cassell GH, Chaisson RE, Weyer K, Lancaster J, Van der Walt M. Outcomes of multi-drug resistant tuberculosis (MDR-TB) among a cohort of South African patients with high HIV prevalence. PLoS One. 2011;6(7):e20436. doi: 10.1371/journal.pone.0020436. Epub 2011 Jul 22.
PubMed 21799728Lessells RJ, Swaminathan S, Godfrey-Faussett P. HIV treatment cascade in tuberculosis patients. Curr Opin HIV AIDS. 2015 Nov;10(6):439-46. doi: 10.1097/COH.0000000000000197.
PubMed 26352390Shapiro AE, van Heerden A, Schaafsma TT, Hughes JP, Baeten JM, van Rooyen H, Tumwesigye E, Celum CL, Barnabas RV. Completion of the tuberculosis care cascade in a community-based HIV linkage-to-care study in South Africa and Uganda. J Int AIDS Soc. 2018 Jan;21(1):e25065. doi: 10.1002/jia2.25065.
PubMed 29381257Hanrahan CF, Van Rie A. A proposed novel framework for monitoring and evaluation of the cascade of HIV-associated TB care at the health facility level. J Int AIDS Soc. 2017 Apr 20;20(1):21375. doi: 10.7448/IAS.20.01.21375.
PubMed 28440604Havlir DV, Kendall MA, Ive P, Kumwenda J, Swindells S, Qasba SS, Luetkemeyer AF, Hogg E, Rooney JF, Wu X, Hosseinipour MC, Lalloo U, Veloso VG, Some FF, Kumarasamy N, Padayatchi N, Santos BR, Reid S, Hakim J, Mohapi L, Mugyenyi P, Sanchez J, Lama JR, Pape JW, Sanchez A, Asmelash A, Moko E, Sawe F, Andersen J, Sanne I; AIDS Clinical Trials Group Study A5221. Timing of antiretroviral therapy for HIV-1 infection and tuberculosis. N Engl J Med. 2011 Oct 20;365(16):1482-91. doi: 10.1056/NEJMoa1013607.
PubMed 22010914Abdool Karim SS, Naidoo K, Grobler A, Padayatchi N, Baxter C, Gray AL, Gengiah T, Gengiah S, Naidoo A, Jithoo N, Nair G, El-Sadr WM, Friedland G, Abdool Karim Q. Integration of antiretroviral therapy with tuberculosis treatment. N Engl J Med. 2011 Oct 20;365(16):1492-501. doi: 10.1056/NEJMoa1014181.
PubMed 22010915
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04298905
- Acronym / sponsor ID
- LEAP-TB-SA / IRB00211518
- Conditions
- Adherence, Patient, TB, HIV/AIDS, Care Coordination
- Keywords
- mHealth, community health worker, TB/HIV
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
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:
- 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:
- to conduct a time-limited prospective screening cohort of close contacts of persons diagnosed with RR-TB using respondent driven sampling.
- to evaluate willingness to participate in the trial and determine who screen fails for any reason.
- 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).
- 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.
- to characterize HIV genotypic resistance patterns among participants with a detectable viral load.
- to determine, retrospectively, the impact of HIV resistance patterns on RR-TB treatment outcomes.
- to assess stigma throughout the RR-TB care continuum and evaluate whether the level of stigma changes through different phases of treatment.
- to pilot test the psychometric properties of four novel indicators of intersectional RR- TB-HIV stigma.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study design overview: LEAP-TB-SA is a pilot randomized controlled trial. There are two arms: mHealth intervention (100) and health education control (100).
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: CHW mHealth patient intervention for trigger escalationIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHW mHealth patient intervention for trigger escalationThe 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 | Other | mHealth intervention |
Primary outcome
Number of participants with treatment success
Time frame: Up to 12 months
Treatment success is defined as cure and completion of treatment.
Number of deaths among participants
Time frame: Up to 12 months
Number of death (all causes) among participants will be assessed.
Number of participants with treatment failure
Time frame: Up to 12 months
Treatment failure is defined as worsening antimicrobial resistance.
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.
2 secondary outcomes
Time to linkage to care
Time frame: Up to 30 days
Time to treatment initiation
Time frame: Up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- BackgroundGeneva. Global Tuberculosis Report 2018.; 2018. doi:ISBN 978 92 4 156539 4
- Background: PubMed 29117342Naidoo P, Theron G, Rangaka MX, Chihota VN, Vaughan L, Brey ZO, Pillay Y. The South African Tuberculosis Care Cascade: Estimated Losses and Methodological Challenges. J Infect Dis. 2017 Nov 6;216(suppl_7):S702-S713. doi: 10.1093/infdis/jix335.
- Background: PubMed 30055593Seid A, Metaferia Y. Factors associated with treatment delay among newly diagnosed tuberculosis patients in Dessie city and surroundings, Northern Central Ethiopia: a cross-sectional study. BMC Public Health. 2018 Jul 28;18(1):931. doi: 10.1186/s12889-018-5823-9.
- Background: PubMed 25631667Takarinda KC, Harries AD, Nyathi B, Ngwenya M, Mutasa-Apollo T, Sandy C. Tuberculosis treatment delays and associated factors within the Zimbabwe national tuberculosis programme. BMC Public Health. 2015 Jan 29;15:29. doi: 10.1186/s12889-015-1437-7.
- Background: PubMed 18501019Meintjes G, Schoeman H, Morroni C, Wilson D, Maartens G. Patient and provider delay in tuberculosis suspects from communities with a high HIV prevalence in South Africa: a cross-sectional study. BMC Infect Dis. 2008 May 25;8:72. doi: 10.1186/1471-2334-8-72.
- Background: PubMed 21029405Gebremariam MK, Bjune GA, Frich JC. Barriers and facilitators of adherence to TB treatment in patients on concomitant TB and HIV treatment: a qualitative study. BMC Public Health. 2010 Oct 28;10:651. doi: 10.1186/1471-2458-10-651.
- Background: PubMed 23622516Naidoo P, Peltzer K, Louw J, Matseke G, McHunu G, Tutshana B. Predictors of tuberculosis (TB) and antiretroviral (ARV) medication non-adherence in public primary care patients in South Africa: a cross sectional study. BMC Public Health. 2013 Apr 26;13:396. doi: 10.1186/1471-2458-13-396.
- Background: PubMed 20589161Amuha MG, Kutyabami P, Kitutu FE, Odoi-Adome R, Kalyango JN. Non-adherence to anti-TB drugs among TB/HIV co-infected patients in Mbarara Hospital Uganda: prevalence and associated factors. Afr Health Sci. 2009 Aug 1;9 Suppl 1(Suppl 1):S8-15.
- Background: PubMed 23573193Van der Walt M, Lancaster J, Odendaal R, Davis JG, Shean K, Farley J. Serious treatment related adverse drug reactions amongst anti-retroviral naive MDR-TB patients. PLoS One. 2013;8(4):e58817. doi: 10.1371/journal.pone.0058817. Epub 2013 Apr 3.
- Background: PubMed 21799728Farley JE, Ram M, Pan W, Waldman S, Cassell GH, Chaisson RE, Weyer K, Lancaster J, Van der Walt M. Outcomes of multi-drug resistant tuberculosis (MDR-TB) among a cohort of South African patients with high HIV prevalence. PLoS One. 2011;6(7):e20436. doi: 10.1371/journal.pone.0020436. Epub 2011 Jul 22.
- Background: PubMed 26352390Lessells RJ, Swaminathan S, Godfrey-Faussett P. HIV treatment cascade in tuberculosis patients. Curr Opin HIV AIDS. 2015 Nov;10(6):439-46. doi: 10.1097/COH.0000000000000197.
- Background: PubMed 29381257Shapiro AE, van Heerden A, Schaafsma TT, Hughes JP, Baeten JM, van Rooyen H, Tumwesigye E, Celum CL, Barnabas RV. Completion of the tuberculosis care cascade in a community-based HIV linkage-to-care study in South Africa and Uganda. J Int AIDS Soc. 2018 Jan;21(1):e25065. doi: 10.1002/jia2.25065.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason E Farley, PhD, MPH principal investigator
Johns Hopkins University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHW mHealth patient intervention for trigger escalation in people with Adherence, Patient and TB, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment success (time frame: Up to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04298905, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.