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SureAdhere Background and Evidence

SureAdhere Background and Evidence

Owned by Mckenna Garfein (Unlicensed)

SureAdhere and VDOT Background

Originally developed in a rigorous academic environment at the University of California San Diego (UCSD), the SureAdhere platform has been heavily evaluated through partnerships between academic researchers and public health organizations across a diverse range of resource settings and context globally. To date, there are 28 articles that evaluate SureAdhere’s VOT platform for TB treatment support published in academic journals, 17 of which were either authored by the original UCSD research team prior to SureAdhere’s commercialization, or which utilized SureAdhere to augment VOT for a new environment.

This rich evidence base has been used to inform digital adherence guidance at the CDC and WHO - both of which have approved VOT as an acceptable alternative to in-person DOT where appropriate.

A sample of 5 studies are highlighted below with summarized findings including a recent  study in JAMA Network Open (conducted using SureAdhere’s VOT platform at the NYC Department of Health) demonstrates that electronic DOT is non-inferior to in-person DOT for TB treatment adherence, which will likely strengthen the CDC’s current guidance on eDOT for TB in the US and support further uptake of VOT as a chosen standard of care for TB treatment support globally. 

  • A study in California assessed VDOT for monitoring tuberculosis treatment across 5 health districts to compare adhernece between 174 patients using VDOT an d159 patients using in-person DOT. Results found the median fraction of exposed doses observed among VDOT participants was higher (93.0%,IQR 83.4%-97.1%) than among patients receiving DOT (66.4%, IQR55.1%-89.3%). VDOT cost 32% (range 6%-46%) less than DOT. The study concluded VDOT was considered feasible, acceptable, and achieved high adherence at a lower cost that DOT. 

  • A multicentre, analyst-blindind, randomized controlled study was conducted across 22 clinics in England to test whether levels of treatment observation were improved with VOT. Participants were randomly assigned to either VOT or DOT. The primary outcome was completion of 80% or more scheduled treatment observations over the first 2 months following enrollment. Results showed superiority was determined by a 15% different in proportions of patients with primary outcome (60% vs 75%). The study concluded that VOT is a more effect approach to observation of tuberculosis treatment than DOT. VOT is likely to be preferable to DOT for many patients across a broad range of settings, providing a more acceptable, effective and cheaper option for supervision of daily and multiple daily doses than DOT. 

  • A study conducted in Hanoi, Vietnam across three outpatient tuberculosis clinics aimed to evaluate the feasibility of using asynchronous VDOT to support treatment adherence among patients with bacteriologically confirmed pulmonary tuberculosis. In this cohort study, 40 of 78 eligible participants (51.3%) agreed to commence VDOT. Among participating patients, 27 (71.1%) of patients took all required doses and a median of 88.4% (IQR 75.8%-93.7%) of doses were correctly recorded and uploaded. Participants rated the VDOT interface highly. The study concluded VDOT was feasible and resulted in high rates of treatment adherence in a resource-limited setting.

  • A pilot cohort study was conducted at a TB clinic in Kampala City, Uganda to evaluate the feasibility of using VDOT for supporting TB treatment adherence. Patients aged 18-65 with >3months remaining of their TB treatment were enrolled and trained to use the VDOT mobile application. The primary outcome was adherence measured as the fraction of expected doses observed. Results found that of the 5150 videos expected, 4231 (82.2%) were received. The median FEDO was 85% (IQR 66%-94%) and 92% of patients reported being very satisfied with using VDOT. The study concluded that VDOT was feasible and acceptable for monitoring and supporting TB treatment, suggesting digital technology holds promise in improving patient monitoring in Uganda. 

  • A study conducted by the New York City Health Department in collaboration with the US CDC enrolled 216 participants in a 2-period crossover, non-inferiority trial with initial randomization to VDOT or in-person DOT across 4 clinics. Participants were asked to complete 20 medication doses using 1 DOT method, then switched methods for another 20 doses. The percentage difference was -2.6% consistent with conclusion of non-inferiority. The study concluded that this trial provides evidence supporting the efficacy of this digital adherence technology, and for the inclusion of electronic DOT in the standard of care. 

Evidence

In addition to the 5 studies noted above, an exhaustive list of research on VOT is included below:

  • R.S. Garfein, K. Collins, F. Munoz, et al., Feasibility of tuberculosis treatment monitoring by video directly observed therapy: a binational pilot study, Int J Tuberc Lung Dis 19, 2015, 1057–1064. https://pubmed.ncbi.nlm.nih.gov/26260824/

  • Holzschuh EL, Province S, Johnson K, Walls C, Shemwell C, Martin G, Showalter A, Dunlay J, Conyers A, Griffin P, Tausz N. Use of Video Directly Observed Therapy for Treatment of Latent Tuberculosis Infection - Johnson County, Kansas, 2015. MMWR Morb Mortal Wkly Rep. 2017 Apr 14;66(14):387-389. doi: 10.15585/mmwr.mm6614a3. PMID: 28406884; PMCID: PMC5657805. https://pubmed.ncbi.nlm.nih.gov/28406884/

  • Chuck C, Robinson E, Macaraig M, Alexander M, Burzynski J. Enhancing management of tuberculosis treatment with video directly observed therapy in New York City. Int J Tuberc Lung Dis. 2016 May;20(5):588-93. doi: 10.5588/ijtld.15.0738. PMID: 27084810. https://pubmed.ncbi.nlm.nih.gov/27084810/

  • F.A. Muñoz, C. Cota, L. Andrade, L. Perez, G. Rangel-Gómez and R.S. Garfein, Innovating method to monitoring HIV/TB co-infection treatment in a US-Mexico border city: video-TAES pilot study, In: 21st annual conference of the Union–North America Region, Vancouver, BC, Canada 2017.

  • 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. PMID: 29732378; PMCID: PMC5917780. https://pubmed.ncbi.nlm.nih.gov/29732378/

  • Ingram D. Video directly observed therapy: Enhancing care for patients with active tuberculosis. Nursing. 2018 May;48(5):64-66. doi: 10.1097/01.NURSE.0000531912.91585.85. PMID: 29697568. https://pubmed.ncbi.nlm.nih.gov/29697568/

  • Lam CK, McGinnis Pilote K, Haque A, Burzynski J, Chuck C, Macaraig M. Using Video Technology to Increase Treatment Completion for Patients With Latent Tuberculosis Infection on 3-Month Isoniazid and Rifapentine: An Implementation Study. J Med Internet Res. 2018 Nov 20;20(11):e287. doi: 10.2196/jmir.9825. PMID: 30459146; PMCID: PMC6280031. https://pubmed.ncbi.nlm.nih.gov/30459146/

  • R.S. Garfein, L. Liu, J. Cuevas-Mota, et al., Tuberculosis treatment monitoring by video directly observed therapy in 5 health districts, California, USA, Emerg Infect Dis 24, 2018, 1806–1815. https://pubmed.ncbi.nlm.nih.gov/30226154/

  • Richard S. Garfein, Riddhi P. Doshi, Synchronous and asynchronous video observed therapy (VOT) for tuberculosis treatment adherence monitoring and support, Journal of Clinical Tuberculosis and Other Mycobacterial Diseases, Volume 17, 2019, 100098, ISSN 2405-5794. https://pubmed.ncbi.nlm.nih.gov/31867442/

  • UNITED KINGDOM - Story A, Aldridge RW, Smith CM, Garber E, Hall J, Ferenando G, Possas L, Hemming S, Wurie F, Luchenski S, Abubakar I, McHugh TD, White PJ, Watson JM, Lipman M, Garfein R, Hayward AC. Smartphone-enabled video-observed versus directly observed treatment for tuberculosis: a multicentre, analyst-blinded, randomised, controlled superiority trial. Lancet. 2019 Mar 23;393(10177):1216-1224. doi: 10.1016/S0140-6736(18)32993-3. Epub 2019 Feb 21. PMID: 30799062; PMCID: PMC6429626. https://pubmed.ncbi.nlm.nih.gov/30799062/

  • Do D, Garfein RS, Cuevas-Mota J, Collins K, Liu L. Change in Patient Comfort Using Mobile Phones Following the Use of an App to Monitor Tuberculosis Treatment Adherence: Longitudinal Study. JMIR Mhealth Uhealth. 2019 Feb 1;7(2):e11638. doi: 10.2196/11638. PMID: 30707103; PMCID: PMC6376328. https://pubmed.ncbi.nlm.nih.gov/30707103/

  • Fraser H, Keshavjee S. Video-observed therapy for tuberculosis: strengthening care. Lancet. 2019 Mar 23;393(10177):1180-1181. doi: 10.1016/S0140-6736(19)30293-4. Epub 2019 Feb 21. PMID: 30799059. https://pubmed.ncbi.nlm.nih.gov/30799059/

  • Garfein RS, Liu L, Cuevas-Mota J, Collins K, Catanzaro DG, Muñoz F, Moser K, Chuck C, Higashi J, Bulterys MA, Raab F, Rios P. Evaluation of recorded video-observed therapy for anti-tuberculosis treatment. Int J Tuberc Lung Dis. 2020 May 1;24(5):520-525. https://pubmed.ncbi.nlm.nih.gov/32398202/

  • Bommakanti KK, Smith LL, Liu L, Do D, Cuevas-Mota J, Collins K, Munoz F, Rodwell TC, Garfein RS. Requiring smartphone ownership for mHealth interventions: who could be left out? BMC Public Health. 2020 Jan 20;20(1):81. doi: 10.1186/s12889-019-7892-9. PMID: 31959145; PMCID: PMC6971938. https://pubmed.ncbi.nlm.nih.gov/31959145/

  • Garrett R. Beeler Asay, Chee Kin Lam, Brock Stewart, Joan M. Mangan, Laura Romo, Suzanne M. Marks, Sapna Bamrah Morris, Caroline L. Gummo, Chris E. Keh, Andrew N. Hill, Anila Thomas, Michelle Macaraig, Kristen St John, Teresita J. Ampie, Christine Chuck, and Joseph Burzynski, 2020: Cost of Tuberculosis Therapy Directly Observed on Video for Health Departments and Patients in New York City; San Francisco, California; and Rhode Island (2017–2018) American Journal of Public Health 110, 1696_1703. https://pubmed.ncbi.nlm.nih.gov/32941064/

  • NORWAY - Bendiksen R, Ovesen T, Asfeldt AM, Halvorsen DS, Gravningen K. Use of video directly observed treatment for tuberculosis in Northern Norway. Tidsskr Nor Laegeforen. 2020 Jan 13;140(1). English, Norwegian. doi: 10.4045/tidsskr.19.0322. PMID: 31948218. https://pubmed.ncbi.nlm.nih.gov/31948218/

  • Burzynski J, Macaraig M, Nilsen D, Schluger NW. Transforming essential services for tuberculosis during the COVID-19 pandemic: lessons from New York City. Int J Tuberc Lung Dis. 2020 Jul 1;24(7):735-736. doi: 10.5588/ijtld.20.0283. PMID: 32718411. https://pubmed.ncbi.nlm.nih.gov/32718411/

  • Perry A, Chitnis A, Chin A, Hoffmann C, Chang L, Robinson M, Maltas G, Munk E, Shah M. Real-world implementation of video-observed therapy in an urban TB program in the United States. Int J Tuberc Lung Dis. 2021 Aug 1;25(8):655-661. doi: 10.5588/ijtld.21.0170. PMID: 34330351; PMCID: PMC8327629. https://pubmed.ncbi.nlm.nih.gov/34330351/

  • VIETNAM - T.A. Nguyen, M.T. Pham, T.L. Nguyen, et al., Video directly observed therapy to support adherence with treatment for tuberculosis in Vietnam: a prospective cohort study, Int J Infect Dis 65, 2017, 85–89. https://pubmed.ncbi.nlm.nih.gov/29030137

  • INDIA - Holzman SB, Atre S, Sahasrabudhe T, Ambike S, Jagtap D, Sayyad Y, Kakrani AL, Gupta A, Mave V, Shah M. Use of Smartphone-Based Video Directly Observed Therapy (vDOT) in Tuberculosis Care: Single-Arm, Prospective Feasibility Study. JMIR Form Res. 2019 Aug 27;3(3):e13411. doi: 10.2196/13411. PMID: 31456581; PMCID: PMC6734854. https://pubmed.ncbi.nlm.nih.gov/31456581/

  • UGANDA - Sekandi JN, Buregyeya E, Zalwango S, Dobbin KK, Atuyambe L, Nakkonde D, Turinawe J, Tucker EG, Olowookere S, Turyahabwe S, Garfein RS. Video directly observed therapy for supporting and monitoring adherence to tuberculosis treatment in Uganda: a pilot cohort study. ERJ Open Res. 2020 Apr 6;6(1):00175-2019. https://pubmed.ncbi.nlm.nih.gov/32280670/

  • MOLDOVA - Ravenscroft L, Kettle S, Persian R, Ruda S, Severin L, Doltu S, Schenck B, Loewenstein G. Video-observed therapy and medication adherence for tuberculosis patients: randomised controlled trial in Moldova. Eur Respir J. 2020 Aug 6;56(2):2000493. doi: 10.1183/13993003.00493-2020. PMID: 32381495. https://pubmed.ncbi.nlm.nih.gov/32381495/

  • BELARUS - Sinkou H, Hurevich H, Rusovich V, Zhylevich L, Falzon D, de Colombani P, Dadu A, Dara M, Story A, Skrahina A. Video-observed treatment for tuberculosis patients in Belarus: findings from the first programmatic experience. Eur Respir J. 2017 Mar 22;49(3):1602049. doi: 10.1183/13993003.02049-2016. PMID: 28331042; PMCID: PMC5380873. https://pubmed.ncbi.nlm.nih.gov/28331042/

  • CHINA -  Guo X, Yang Y, Takiff HE, Zhu M, Ma J, Zhong T, Fan Y, Wang J, Liu S. A Comprehensive App That Improves Tuberculosis Treatment Management Through Video-Observed Therapy: Usability Study. JMIR Mhealth Uhealth. 2020 Jul 31;8(7):e17658. doi: 10.2196/17658. PMID: 32735222; PMCID: PMC7428914. https://pubmed.ncbi.nlm.nih.gov/32735222/

  • CAMBODIA -  Rabinovich L, Molton JS, Ooi WT, Paton NI, Batra S, Yoong J. Perceptions and Acceptability of Digital Interventions Among Tuberculosis Patients in Cambodia: Qualitative Study of Video-Based Directly Observed Therapy. J Med Internet Res. 2020 Jul 27;22(7):e16856. doi: 10.2196/16856. PMID: 32716309; PMCID: PMC7418013. https://pubmed.ncbi.nlm.nih.gov/32716309/

  • VIETNAM - Nguyen LH, Tran PTM, Dam TA, Forse RJ, Codlin AJ, Huynh HB, Dong TTT, Nguyen GH, Truong VV, Dang HTM, Nguyen TD, Nguyen HB, Nguyen NV, Khan A, Creswell J, Vo LNQ. Assessing private provider perceptions and the acceptability of video observed treatment technology for tuberculosis treatment adherence in three cities across Viet Nam. PLoS One. 2021 May 7;16(5):e0250644. doi: 10.1371/journal.pone.0250644. PMID: 33961645; PMCID: PMC8104441. https://pubmed.ncbi.nlm.nih.gov/33961645/

  • Burzynski J, Mangan JM, Lam CK, Macaraig M, Salerno MM, deCastro BR, Goswami ND, Lin CY, Schluger NW, Vernon A; eDOT Study Team. In-Person vs Electronic Directly Observed Therapy for Tuberculosis Treatment Adherence: A Randomized Noninferiority Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2144210. doi: 10.1001/jamanetworkopen.2021.44210. PMID: 35050357; PMCID: PMC8777548.  https://pubmed.ncbi.nlm.nih.gov/35050357/

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