Process Evaluation of Pragmatic Cluster-Randomized Trials of Digital Adherence Technologies for Tuberculosis Treatment Support: A Mixed-Method Study in Five Countries
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Period
2.2. Study Population
2.3. Description of the Interventions
2.4. Context for the Intervention
2.5. Data Collection
2.6. Analysis
3. Results
3.1. Summary of Inputs
“I wish there would be another training so that I can really know the program. I was just able to do that by fiddling with my cellphone.”—HCP in the Philippines
“That’s when we have a problem when the patient doesn’t have a cell phone and they don’t have a support system, so we give them a pillbox.”—HCP in the Philippines
3.2. Intervention Fidelity
“Sometimes I receive a message that says, “you did not take your medicine today.” At that time, I came here [to the health facility] and explained that I have taken the medicine, but my house has a network problem. This inconvenience happens because of network, not because I didn’t take it.”—PwTB in Ethiopia
“I didn’t use the stickers [medication labels] during that time because I had lost my phone, do you get me? I arrived there and told the sister [TB nurse], that’s when they gave me the box.”—PwTB in South Africa
“Patients do not want to be visited to their home as there are TB patients whose families do not know that they have TB.”—HCP in Ethiopia
“This new system (adherence platform) has simplified our work, for instance when you enter the office in the morning, you look on the tablet to monitor patients’ treatment adherence, make follow up on patients’ with bad adherence.”—HCP in Tanzania
“But look, if the program (adherence platform) already recorded that the dose is missed, why does it have to be colored (verified) again? It is logical, right?”—HCP in Ukraine
3.3. Intervention Coverage
“Well, it’s clear that if you are a person having a smart pillbox and the doctor calls you 10 times in a month, you’ve already opened the smart pillbox so that the doctor doesn’t bother you, doesn’t call you. And we have some (meaning patients) who say to us: you are so concerned about my health... Because we call them often.”—HCP in Ukraine
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
ASCENT | Adherence Support Coalition to End TB |
CRT | cluster-randomized trial |
DAT | digital adherence technology |
DS-TB | drug-sensitive tuberculosis |
HCP | healthcare provider |
PwTB | person with tuberculosis |
RCT | randomized controlled trial |
SMS | short message service |
TB | tuberculosis |
RCT | randomized controlled trial |
WHO | World Health Organization |
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Indicator | Data Sources | Content Analysis Categorization | |
---|---|---|---|
Input | |||
1 | No. of healthcare providers that received implementation training during the pilot and main enrollment period | Country training report | HCP implementation training |
2 | No. of implementation support visits made to health facilities by ASCENT staff during the main enrollment period | Facility visits and call logs | NA |
3 | Percentage of PwTB who own a mobile phone which is not shared | ASCENT sub-study 1 a | PwTB with access to or own a mobile phone |
Process | |||
4 | No. of automated SMS reminders sent by adherence platform per PwTB enrolled during the main enrollment period | Adherence platform SMS log | Automated SMS reminders sent by adherence platform |
5 | Percentage of treatment days with an automated SMS reminder sent by the adherence platform | Adherence platform SMS log | |
6 | No./percentage of PwTB that switched from medication label to smart pillbox during their treatment | Adherence platform PwTB record | PwTB switch from medication labels to smart pillbox during treatment |
7 | No. of home visits per PwTB by initial DAT received during the main enrollment period. | Adherence platform HCW action report | Home visits during the main enrollment period |
8 | No./percentage of PwTB who were shown their adherence data at the facility by the HCP | ASCENT sub-study 1 a | NA |
9 | Total number of adherence platform logins per facility during main enrollment period | Adherence platform usage record | NA |
10 | Percentage of weekdays in the main enrollment period where there was at least one visit to the adherence platform at facility level | Adherence platform usage record | HCP interaction with the adherence platform |
11 | Average minutes a HCP was logged onto platform per day | Adherence platform usage record | |
12 | Average percentage of ASCENT tablets used to access adherence platform during main enrollment period | Adherence platform usage record | |
Output | |||
13 | Percentage of PwTB who started a DAT in the main enrollment period | Adherence platform PwTB record and facility TB register | NA |
14 | Average percentage of doses digitally recorded of all doses recorded during main enrollment period | Adherence platform dosing report | NA |
15 | Patterns of manual doses added to the adherence platform more than 7 days after the original date during main enrollment period | Adherence platform dosing report | NA |
Outcome | |||
16 | Can the use of DATs and differentiated care influence PwTB–HCP relationship? | ASCENT sub-study 1 a, 2 b and 3 c | People with TB–HCP relationship |
Indicator | Ethiopia | Philippines | South Africa | Tanzania | Ukraine | |
---|---|---|---|---|---|---|
1 | Number of HCPs trained/facility a | 3.0 (155/52) | 4.9 (157/32) | 2.6 (79/30) | 2.0 (72/36) | 7.4 (89/12) |
2 | Number of implementation support visits/facility b | 1.7 (89/52) | 2.4 (78/32) | 1.3 (39/30) | 1.8 (65/36) | 0.7 (8/12) |
3 | Phone ownership (not shared) among PwTB using the pillbox c | 72% (36/50) | 62% (31/50) | 90% (44/49) | 70% (43/61) | NA |
Phone ownership (not shared) among PwTB using the labels c | 70% (35/50) | 64% (33/52) | 97% (28/29) | 68% (26/38) | NA |
Indicator | Ethiopia | Philippines | South Africa | Tanzania | Ukraine | |
---|---|---|---|---|---|---|
Number of participants starting a DAT in the main enrollment phase overall and by initial DAT received: total (pillbox/labels/unknown) | 2518 (1375/1141/2) | 2844 (1472/1370/2) | 1834 (1754/74/6) | 2339 (1656/683/0) | 842 (842/NA/0) | |
Automated SMS reminders: | ||||||
4 | Number of SMS reminders sent a (number of reminders per participant) | 133,615 (53.1) | 130,802 (46.0) | 111,237 (60.7) | 72,188 (30.9) | NA |
5 | % treatment days same-day reminder was sent—pillbox | 23% (46,560/205,291) | 18% (33,939/193,732) | 21% (66,359/310,157) | 13% (31,889/243,261) | NA |
% treatment days same-day reminder was sent—labels | 32% (54,263/169,238) | 38% (52,565/139,513) | 37% (4792/12,975) | 15% (14,136/96,605) | NA | |
% treatment days previous-day reminder was sent—pillbox | 8% (16,319/205,291) | 9% (18,117/193,732) | 12% (37,394/310,157) | 8% (18,518/243,261) | NA | |
% treatment days yesterday reminder was sent—labels | 10% (16,473/169,238) | 19% (26,181/139,513) | 21% (2692/12,975) | 8% (7645/96,605) | NA | |
DAT type summary | ||||||
6 | % switch from labels (initial DAT received) to pillbox | 1% (8/1141) | 5% (63/1370) | 35% (26/74) | 14% (96/683) | NA |
% started on pillbox in labels arm b | 11% (147/1287) | 19% (329/1264) | 91% (736/812) | 46% (572/1253) | NA | |
Home visits | ||||||
7 | # home visits, as % of # enrolled (platform) | 0.4% (11/2518) | 0.6% (17/2844) | 8% (153/1834) | 25% (576/2339) | 0.4% (3/842) |
# home visits, as % of # enrolled (platform)—pillbox | 1% (11/1375) | 0% (0/1472) | 6% (102/1754) | 8% (127/1656) | 0.4% (3/842) | |
# home visits, as % of # enrolled (platform)—labels | 0% (0/1141) | 1% (17/1370) | 69% (51/74) | 66% (449/683) | NA | |
PwTB shown adherence data | ||||||
8 | % of participants shown platform data—pillbox c | 64% (32/50) | 46% (23/50) | 94% (46/49) | 80% (49/61) | NA |
% of participants shown platform data—labels c | 70% (35/50) | 44% (23/52) | 93% (27/29) | 76% (29/38) | NA | |
Platform Usage (by HCP) | ||||||
9 | # platform visits (this may include multiple logins per day from the same user) | 37,310 | 10,542 | 20,573 | 51,768 | 9608 |
10 | % of weekdays with at least one login to adherence platform d | 69% | 42% | 52% | 68% | 76% |
11 | Arithmetic mean minutes spent on the platform per day | 5.5 | 4 | 11 | 18 | 13 |
12 | % tablet used to access the platform | 89% | 38% (53% smartphone) | 89% | 93% | 8% e (36% desktop; 56% smart phone) |
Indicator | Ethiopia | Philippines | South Africa | Tanzania | Ukraine | |
---|---|---|---|---|---|---|
DAT Coverage | ||||||
13 | % of PwTB who started a DAT in the main enrollment period | NA a | 61.8% (2844/4604) | 73.5% (1834/2494) | 66.0% (2339/3546) | 55.2% (842/1526) |
% of PwTB who started a DAT in the main enrollment period—pillbox | NA a | 51.4% (1150/2236) | 79.8% (1022/1281) | 61.1% (1086/1778) | 55.2% (842/1526) | |
% of PwTB who started a DAT in the main enrollment period—labels | NA a | 71.5% (1694/2368) | 66.9% (812/1213) | 70.9% (1253/1768) | NA | |
DAT Engagement | ||||||
Number of PwTB—pillbox | 1375 | 1472 | 1754 | 1656 | 842 | |
14 | % digital recorded doses—pillbox | 90% (177,599/196,352) | 83% (172,234/208,130) | 88% (207,569/235,417) | 91% (202,282/222,076) | 82% (91,712/111,901) |
15 | % of manual doses added >7 days after the dose day—pillbox | 30% (5075/16,845) | 61% (14,708/24,015) | 44% (3966/9075) | 32% (4623/14,561) | 52% (6858/13,206) |
Number of PwTB—labels | 1141 | 1370 | 74 | 683 | - | |
14 | % digital recorded doses—labels | 81% (126,718/156,832) | 69% (119,304/171,786) | 62% (3815/6154) | 84% (63,862/76,231) | NA |
15 | % of manual doses added >7 days after the dose day—labels | 21% (6016/28,782) | 55% (20,832/37,919) | 47% (541/1149) | 26% (2906/11,108) | NA |
Outcome | ||||||
16 | % participants agreeing that using DAT made them feel more connected to their HCPs—pillbox b | 100% (50/50) | 84.0% (42/50) | 91.8% (41/49) | 96.7% (59/61) | NA |
% participants agreeing that using DAT made them feel more connected to their HCPs—labels b | 98.0% (49/50) | 69.2% (36/52) | 86.2% (25/29) | 94.7% (36/38) | NA |
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Madden, N.; Tadesse, A.W.; Leung, C.L.; Gonçalves Tasca, B.; Alacapa, J.; Deyanova, N.; Ndlovu, N.; Mokone, N.; Onjare, B.; Mganga, A.; et al. Process Evaluation of Pragmatic Cluster-Randomized Trials of Digital Adherence Technologies for Tuberculosis Treatment Support: A Mixed-Method Study in Five Countries. Trop. Med. Infect. Dis. 2025, 10, 68. https://doi.org/10.3390/tropicalmed10030068
Madden N, Tadesse AW, Leung CL, Gonçalves Tasca B, Alacapa J, Deyanova N, Ndlovu N, Mokone N, Onjare B, Mganga A, et al. Process Evaluation of Pragmatic Cluster-Randomized Trials of Digital Adherence Technologies for Tuberculosis Treatment Support: A Mixed-Method Study in Five Countries. Tropical Medicine and Infectious Disease. 2025; 10(3):68. https://doi.org/10.3390/tropicalmed10030068
Chicago/Turabian StyleMadden, Norma, Amare W. Tadesse, Chung Lam Leung, Bianca Gonçalves Tasca, Jason Alacapa, Natasha Deyanova, Nontobeko Ndlovu, Nontobeko Mokone, Baraka Onjare, Andrew Mganga, and et al. 2025. "Process Evaluation of Pragmatic Cluster-Randomized Trials of Digital Adherence Technologies for Tuberculosis Treatment Support: A Mixed-Method Study in Five Countries" Tropical Medicine and Infectious Disease 10, no. 3: 68. https://doi.org/10.3390/tropicalmed10030068
APA StyleMadden, N., Tadesse, A. W., Leung, C. L., Gonçalves Tasca, B., Alacapa, J., Deyanova, N., Ndlovu, N., Mokone, N., Onjare, B., Mganga, A., van Kalmthout, K., Jerene, D., & Fielding, K. (2025). Process Evaluation of Pragmatic Cluster-Randomized Trials of Digital Adherence Technologies for Tuberculosis Treatment Support: A Mixed-Method Study in Five Countries. Tropical Medicine and Infectious Disease, 10(3), 68. https://doi.org/10.3390/tropicalmed10030068