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, 

References & Publications (35)

Abdool 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. — View Citation

Abstract: Heidari, Omeid (Johns Hopkins University School of Nursing); Nguyen, Yen ((Johns Hopkins University School of Nursing); Budhathoki, Chakra (Johns Hopkins University School of Nursing); Geiger, Keri (Johns Hopkins University School of Nursing); Stamper, P (Johns Hopkins School of Nursing); Farley, JE (Johns Hopkins University School of Nursing. Evaluating HIV 90-90-90 Targets for Individuals with Drug-Resistant Tuberculosis Treatment in South Africa. 2019.

Amuha 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. — View Citation

Atkins S, Lewin S, Ringsberg KC, Thorson A. Provider experiences of the implementation of a new tuberculosis treatment programme: a qualitative study using the normalisation process model. BMC Health Serv Res. 2011 Oct 17;11:275. doi: 10.1186/1472-6963-11-275. — View Citation

Daftary A, Padayatchi N, O'Donnell M. Preferential adherence to antiretroviral therapy over tuberculosis treatment: a qualitative study of drug-resistant TB/HIV co-infected patients in South Africa. Glob Public Health. 2014;9(9):1107-16. doi: 10.1080/17441692.2014.934266. Epub 2014 Jul 18. — View Citation

Farley JE, Kelly AM, Reiser K, Brown M, Kub J, Davis JG, Walshe L, Van der Walt M. Development and evaluation of a pilot nurse case management model to address multidrug-resistant tuberculosis (MDR-TB) and HIV in South Africa. PLoS One. 2014 Nov 18;9(11):e111702. doi: 10.1371/journal.pone.0111702. eCollection 2014. — View Citation

Farley JE, McKenzie-White J, Bollinger R, Hong H, Lowensen K, Chang LW, Stamper P, Berrie L, Olsen F, Isherwood L, Ndjeka N, Stevens W. Evaluation of miLINC to shorten time to treatment for rifampicin-resistant Mycobacterium tuberculosis. Int J Tuberc Lung Dis. 2019 Sep 1;23(9):980-988. doi: 10.5588/ijtld.18.0503. — View Citation

Farley JE, Ndjeka N, Kelly AM, Whitehouse E, Lachman S, Budhathoki C, Lowensen K, Bergren E, Mabuza H, Mlandu N, van der Walt M. Evaluation of a nurse practitioner-physician task-sharing model for multidrug-resistant tuberculosis in South Africa. PLoS One. 2017 Aug 4;12(8):e0182780. doi: 10.1371/journal.pone.0182780. eCollection 2017. — View Citation

Farley 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. — View Citation

Fisher JD, Fisher WA, Amico KR, Harman JJ. An information-motivation-behavioral skills model of adherence to antiretroviral therapy. Health Psychol. 2006 Jul;25(4):462-73. doi: 10.1037/0278-6133.25.4.462. — View Citation

Gandhi NR, Moll AP, Lalloo U, Pawinski R, Zeller K, Moodley P, Meyer E, Friedland G; Tugela Ferry Care and Research (TFCaRes) Collaboration. Successful integration of tuberculosis and HIV treatment in rural South Africa: the Sizonq'oba study. J Acquir Immune Defic Syndr. 2009 Jan 1;50(1):37-43. doi: 10.1097/QAI.0b013e31818ce6c4. — View Citation

Gebremariam 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. — View Citation

Geneva. Global Tuberculosis Report 2018.; 2018. doi:ISBN 978 92 4 156539 4

Han HR, Kim K, Murphy J, Cudjoe J, Wilson P, Sharps P, Farley JE. Community health worker interventions to promote psychosocial outcomes among people living with HIV-A systematic review. PLoS One. 2018 Apr 24;13(4):e0194928. doi: 10.1371/journal.pone.0194928. eCollection 2018. — View Citation

Hanrahan 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. — View Citation

Havlir 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. — View Citation

Hoffman JA, Cunningham JR, Suleh AJ, Sundsmo A, Dekker D, Vago F, Munly K, Igonya EK, Hunt-Glassman J. Mobile direct observation treatment for tuberculosis patients: a technical feasibility pilot using mobile phones in Nairobi, Kenya. Am J Prev Med. 2010 Jul;39(1):78-80. doi: 10.1016/j.amepre.2010.02.018. Epub 2010 May 26. — View Citation

Holzman SB, Zenilman A, Shah M. Advancing Patient-Centered Care in Tuberculosis Management: A Mixed-Methods Appraisal of Video Directly Observed Therapy. Open Forum Infect Dis. 2018 Apr 26;5(4):ofy046. doi: 10.1093/ofid/ofy046. eCollection 2018 Apr. — View Citation

Hong H, Budhathoki C, Farley JE. Increased risk of aminoglycoside-induced hearing loss in MDR-TB patients with HIV coinfection. Int J Tuberc Lung Dis. 2018 Jun 1;22(6):667-674. doi: 10.5588/ijtld.17.0830. — View Citation

Horvath KJ, Smolenski D, Amico KR. An empirical test of the information-motivation-behavioral skills model of ART adherence in a sample of HIV-positive persons primarily in out-of-HIV-care settings. AIDS Care. 2014 Feb;26(2):142-51. doi: 10.1080/09540121.2013.802283. Epub 2013 Jun 3. — View Citation

Kelly AM, Smith B, Luo Z, Given B, Wehrwein T, Master I, Farley JE. Discordance between patient and clinician reports of adverse reactions to MDR-TB treatment. Int J Tuberc Lung Dis. 2016 Apr;20(4):442-7. doi: 10.5588/ijtld.15.0318. — View Citation

Lessells 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. — View Citation

Louw J, Peltzer K, Naidoo P, Matseke G, Mchunu G, Tutshana B. Quality of life among tuberculosis (TB), TB retreatment and/or TB-HIV co-infected primary public health care patients in three districts in South Africa. Health Qual Life Outcomes. 2012 Jun 28;10:77. doi: 10.1186/1477-7525-10-77. — View Citation

May CR, Cummings A, Girling M, Bracher M, Mair FS, May CM, Murray E, Myall M, Rapley T, Finch T. Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review. Implement Sci. 2018 Jun 7;13(1):80. doi: 10.1186/s13012-018-0758-1. — View Citation

Meintjes 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. — View Citation

Naidoo K, Yende-Zuma N, Padayatchi N, Naidoo K, Jithoo N, Nair G, Bamber S, Gengiah S, El-Sadr WM, Friedland G, Abdool Karim S. The immune reconstitution inflammatory syndrome after antiretroviral therapy initiation in patients with tuberculosis: findings from the SAPiT trial. Ann Intern Med. 2012 Sep 4;157(5):313-24. doi: 10.7326/0003-4819-157-5-201209040-00004. — View Citation

Naidoo 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. — View Citation

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. — View Citation

Seid 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. — View Citation

Shapiro 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. — View Citation

Takarinda 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. — View Citation

Tsui S, Denison JA, Kennedy CE, Chang LW, Koole O, Torpey K, Van Praag E, Farley J, Ford N, Stuart L, Wabwire-Mangen F. Identifying models of HIV care and treatment service delivery in Tanzania, Uganda, and Zambia using cluster analysis and Delphi survey. BMC Health Serv Res. 2017 Dec 6;17(1):811. doi: 10.1186/s12913-017-2772-4. — View Citation

Usabilit.gov. System Usability Scale (SUS). usability.gov. doi:10.1007/s10339

Uwimana J, Zarowsky C, Hausler H, Jackson D. Training community care workers to provide comprehensive TB/HIV/PMTCT integrated care in KwaZulu-Natal: lessons learnt. Trop Med Int Health. 2012 Apr;17(4):488-96. doi: 10.1111/j.1365-3156.2011.02951.x. Epub 2012 Feb 1. — View Citation

Van 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. — View Citation

* 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