Original Article

The Effect of a mHealth Intervention on Anti‑tuberculosis

Medication Adherence in Delhi, India: A Quasi‑Experimental
Study
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Sahadev Santra1, Suneela Garg2, Saurav Basu3, Nandini Sharma2, Mongjam Meghachandra Singh2, Ashwani Khanna4
1
Junior Resident, Director Professor, 3Senior Resident, Department of Community Medicine, Maulana Azad Medical College, 4State Programme Officer, Chest
2
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Clinic (TB), Lok Nayak Hospital, New Delhi, India

Abstract
Background: Suboptimal adherence to anti‑tuberculosis medication in patients is associated with adverse treatment outcomes including
treatment failure, relapse, and emergence of drug resistance. Objectives: We conducted the present study with the objectives of evaluating
the effectiveness of a mHealth package on the medication adherence of patients with tuberculosis (TB) on antitubercular (directly observed
treatment short‑course [DOTS]) treatment. Methods: We conducted Quasi‑experimental study at six DOTS centers of Delhi among 220 newly
diagnosed TB patients. We included adult TB patients (18 years and above) who were on DOTS therapy ≥30 days, had access to a mobile phone
and were able to read messages and receive calls. We excluded patients with impaired hearing, blindness and those on non‑DOTS therapy or
having multidrug‑resistant/extensively drug‑resistant TB. Participants in the intervention group received amHealth package for 90 days. The
medication adherence of the study participants was measured using Morisky, Green, and Levine Adherence Scale. Results: A total of 130
men and 90 women were recruited for the study. Occupational interference and forgetfulness were the most common reasons for medication
nonadherence in the patients. In the intervention group, the medication adherence to antitubercular medication (daily DOTS regimen) was
85.5% at baseline which increased to 96.4% at endline (postintervention) (P = 0.004). No significant change was observed in the control
group (P = 0.328). The increase in adherence was observed across the following subgroups: age, gender, education, and Socioeconomic status.
Conclusions: The mHealth intervention in TB patients was effective in improving the adherence to DOTS therapy.

Key words: Directly observed treatment short‑course, India, medication adherence, mHealth, tuberculosis

Introduction resistance.[5] Moreover, it is well‑established that factors like

Tuberculosis (TB) is an air‑borne infection caused by
Mycobacterium tuberculosis which causes 1.4 million
deaths a year representing one of the top ten causes of death
worldwide.[1] India accounts for almost a quarter (~23%) of
the global burden of TB with an estimated 10 million incident
cases.[2] The failure to adequately treat TB increases the risk
of treatment failure and premature death, that accounts for
80% of the disability‑adjusted life years lost on account of
the disease.[3]
Adherence to anti‑tubercular medication for 6 months or
until treatment completion is essential for achieving complete
cure in drug‑sensitive tuberculosis cases. [4] However,
suboptimal adherence to anti‑tubercular treatment (ATT)
significantly accentuates the risk of treatment failure and drug
the long duration of treatment, potential side‑effects of ATT,
discontinuation of therapy by patients on perceived well‑being,
and out‑of‑pocket expenses associated with inhibition of timely
drug refill can undermine medication adherence.[6‑8]
Under the Revised National Tuberculosis Control Program
(RNTCP) (now National Tuberculosis Elimination
Address for correspondence: Dr. Saurav Basu,
Department of Community Medicine, Maulana Azad Medical College,
New Delhi, India.
E‑mail: saurav.basu1983@gmail.com
This is an open access journal, and articles are distributed under the terms of the Creative
Commons Attribution‑NonCommercial‑ShareAlike 4.0 License, which allows others to
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Access this article online For reprints contact: WKHLRPMedknow_reprints@wolterskluwer.com

Quick Response Code: Submitted: 14‑Jul‑2020 Revised: 18‑Dec‑2020

Website:
Accepted: 21‑Jan‑2021 Published: 20-Mar-2021
www.ijph.in

How to cite this article: Santra S, Garg S, Basu S, Sharma N, Singh MM,
DOI: Khanna A. The effect of a mhealth intervention on anti-tuberculosis
10.4103/ijph.IJPH_879_20 medication adherence in Delhi, India: A quasi-experimental study. Indian
J Public Health 2021;65:34-8.

34 © 2021 Indian Journal of Public Health | Published by Wolters Kluwer - Medknow

 Santra, et al.: mHealth improves anti-TB medication adherence
Program [NTEP]), India is the second‑largest provider of
the Directly observed treatment short‑course (DOTS) in the
world.[2] Adherence support via direct observation was the
hallmark of the RNTCP until 2018 with the patient taking
the DOTS medication in the presence of the DOTS provider
during the intensive phase for 2 months in new and 3 months
in previously treated cases. The RNTCP (now NTEP) since
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2018 has transitioned to a daily medication regimen from a
thrice‑weekly regimen with a variable refill duration.[9] The
daily regimen has the advantage of higher effectiveness and
enhanced patient convenience when coupled with a longer refill
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duration, but it may lack daily direct observation of drug intake
during the intensive phase, reflecting a need for deploying
alternative adherence monitoring and support mechanisms.
mHealth refers to the application of the mobile telephonic
platform enabling support for public health and clinical
practice with scope for low‑cost, ubiquitous, and universal
access. The use of text messages and voice calls to improve
adherence behavior has proven efficacy in chronic conditions,
but the evidence in TB patients,[10,11] especially in the Indian
context is limited.
We conducted the present study with the objectives of evaluating
the effectiveness of a mHealth package on the medication
adherence of patients with TB on antitubercular (DOTS)
treatment.
Materials and Methods
Design and participants
We conducted a quasi‑experimental study during an 8‑month
study period during 2018–19 at six DOTS centers under
the jurisdiction of a major hospital in Central Delhi. The
intervention and the control sites included three DOTS centers
each that were selected purposively, being separated from
each other by a distance of at least three kilometers each. The
study design precluded any chances of contamination from the
sharing of the intervention contents and was also necessary
for administrative reasons.
We enrolled consenting adult TB that were: (a) on DOTS
therapy for a minimum period of 30 days and a maximum
of 90 days, (b) had access to a mobile phone (c) were
able to read messages and receive calls on their mobile
phones. We excluded patients with impaired hearing,
blindness and those on non‑DOTS therapy or diagnosed with
multidrug‑resistant/extensively drug‑resistant‑TB.
Study outcomes
The primary outcome of this study was adherence to TB
treatment assessed with the 4‑item Morisky‑Green‑Levene
adherence scale (MGLS).[12]
Outcome measurement
Nonadherence to anti‑tuberculosis medications was defined as
a score <4 as per the MGLS, i.e., if the response to at least one
of the four questions was answered as “yes” by the participant.
Indian Journal of Public Health ¦ Volume 65 ¦ Issue 1 ¦ January-March 2021
The recall period was the previous 15 days. The outcomes
were ascertained at baseline during the study enrolment and
subsequently, after 90 days of intervention.
Sample size and sampling method
We enrolled a total of 110 patients with TB in both the
intervention and control groups. Based on a previous study,
the expected adherence to DOTS therapy in drug‑sensitive
TB cases is 84%.[13] The sample size was adequate at 80%
power to detect a postintervention enhancement in medication
adherence ≥10% compared to the preintervention levels,
while also accounting for up to 10% attrition. The participants
were selected by the consecutive sampling method from each
of the DOTS centers that were visited on a rotation basis.
Standard care
TB patients (without HIV infection) under the daily regimen
are instructed to take their anti‑tubercular medications
regularly at the time of refill collection by the DOTS providers.
Intervention
We developed a mHealth package comprising of 30 unique
text‑messages in the local language, Hindi and a weekly
real‑time two‑way phone call that lasted for approximately
10 min. The mHealth package duration was 90 days comprising
once‑daily text message (90 text‑messages sent in total) and
once a week voice call (12 voice calls in total). The messages
and calls motivated patients to persist with their anti‑tubercular
medications, provided reminders for adherence to medications and
also addressed patient concerns regarding potential drug‑related
adverse effects. The package contents were pretested among 25
TB patients at a DOTS center in a secondary care hospital in Delhi
to assess message readability and comprehension. Participants
of the control group did not receive the mHealth package and
instead continued to receive standard care.
Statistical analysis
The data were analyzed using IBM SPSS Version 25 replace
with IBM SPSS Statistics for Windows, Version 25.0 (Armonk,
NY: IBM Corp). Categorical variables were expressed in
frequency and proportion and continuous variables as mean and
standard deviation. Association between categorical variables
was assessed using the Chi‑square test of independence. We
further compared the parameters to assess: (1). Pre‑intervention
or baseline differences in the intervention and control group, (2).
Postintervention difference between the intervention and
control group (between‑group differences), (3) Pre‑  and
post‑intervention differences within both the intervention and
control group (within‑group differences). The McNemar’s test was
applied to test for within‑group (paired) differences for categorical
outcomes, and the Chi‑square difference in proportion test for
between‑group (unpaired) differences for categorical outcomes.
A value of P ≤ 0.05 was considered statistically significant.
Ethics: We obtained ethical approval from the Institutional
Ethics Committee. All the participations provided written and
informed consent. The study was prospectively registered with
the clinical trial registry of India (CTRI/2018/08/015306).
35
 Santra, et al.: mHealth improves anti-TB medication adherence

Results current residence for >10 years compared to the control

group that had more female patients, Muslims by religion
Participant characteristics and meat containing diet. The sociodemographic and clinical
A total of 130 men and 90 women were recruited for the
characteristics of the participants in both the groups were
study [Figure 1]. Patients excluded on not meeting selection
comparable in terms of age, SES, BMI, and educational
criteria were 10 patients that were illiterate and another seven
status [Table 1].
patients who did not own a mobile phone. Furthermore,
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68 patients also refused to participate citing either lack of time,
perceived lack of benefit, and nondisclosure of mobile phone
numbers due to concerns over privacy.
The mean age of the study participants was 45.7 (±9.6) years.
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Medical adherence in patients with tuberculosis at baseline:
High adherence, medium, and low adherence to the
anti‑tubercular DOTS regimen were observed in 188 (85.45%),
9 (8.63%), and 13 (5.9%), respectively, with similar adherence

One hundred ten patients in each group were enrolled from rates observed in both the intervention and control groups.
the six DOTS center constituting the control and intervention On dichotomizing adherence status, high medication
groups, respectively. Majority (45%) of the participants adherence was present in 188 (85.45%) and low in 32 (14.5%)
belonged to the lower middle class. participants [Table 2].

At baseline, the intervention group had a significantly higher Reasons for medication nonadherence
proportion of participants who were male, belonging to the Among the participants reporting low medication
Hindu religion, vegetarian by diet, and residing in their adherence (n = 32), the male gender was the only

Table 1: Characteristics of participants at baseline (n=220)

Characteristics Intervention group (n=110), n (%) Control group (n=110), n (%) Total (n=220), n (%) P value
Age (mean±SD) 44.8±10.8 46.7±8.5 45.7±9.6
Gender
Men 70 (63.6) 60 (54.5) 130 (59.1) 0.17
Women 40 (36.4) 50 (45.5) 90 (40.9)
Religion
Hindu 76 (69.1) 60 (54.5) 136 (61.8) 0.02
Muslim 34 (30.9) 50 (45.5) 84 (38.1)
Residence (years)
<10 30 (27.3) 12 (10.9) 42 (19.1) 0.002
≥10 80 (72.7) 98 (89.1) 178 (80.9)
Educational status
Primary 22 (20) 30 (27.3) 52 (23.6) 0.42
Middle 53 (48.2) 50 (45.4) 103 (46.8)
High school and above 35 (31.8) 30 (27.3) 65 (29.6)
SES
Upper/upper middle 22 (20) 20 (18.2) 42 (19.1) 0.77
Lower middle 51 (46.4) 48 (43.6) 99 (45)
Upper lower/lower 37 (33.6) 42 (38.2) 79 (35.9)
BMI (mean±SD) 17.1±2.2 17.4±1.7 17.2±1.9 0.18
Dietary type
Vegetarian 23 (20.9) 28 (25.4) 51 (23.2) 0.42
Non Vegetarian 87 (79.1) 82 (74.6) 169 (76.8)
Tobacco smoking
Present 25 (22.7) 28 (25.4) 53 (24.1) 0.63
Absent 85 (77.3) 82 (74.6) 167 (75.9)
Time since initiation of DOTS (months)
≤2 63 (57.2) 55 (50) 118 (53.6) 0.27
>2‑3 47 (42.8) 55 (50) 102 (46.4)
Previous history of TB
Present 5 (4.5) 4 (3.6) 9 (8.2) 0.73
Absent 105 (95.5) 106 (96.4) 211 (91.8)
Awareness of duration of TB treatment
Present 21 (19.1) 23 (20.9) 44 (20) 0.73
Absent 89 (80.9) 87 (79.1) 176 (80)
SD: Standard deviation, SES: Socioeconomic status, BMI: Body mass index, TB: Tuberculosis, DOTS: Directly Observed Treatment Short‑course

36 Indian Journal of Public Health ¦ Volume 65 ¦ Issue 1 ¦ January-March 2021

 Santra, et al.: mHealth improves anti-TB medication adherence

sociodemographic characteristic that was significantly Effectiveness of the intervention

associated with medication nonadherence (P < 0.001). The
most common reasons attributed to nonadherent behavior were
occupational interference (31.2%), forgetfulness (25%), lack
of knowledge of DOTS (12.5%), feeling better (9.3%), and
nondisclosure to the family (6.2%) (n = 32).
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The mHealth package phone call attendance was regular in
100 (91%) subjects while 102 (92.7%) reported regularly
reading the text messages. The proportion of participants’
adherent to DOTS in the intervention group increased from
85.5% at baseline to 96.4% at endline, postintervention. We
found an increase in adherence across the following subgroups:

age, gender, education, and SES [Table 3].

Discussion
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The present study conducted in six DOTS centers located

Figure 1: Flow‑diagram of the quasi‑experimental study (n = 220)
in Delhi, India found a comprehensive health package was
effective in enhancing medication adherence among patients
with TB on DOTS therapy, compared to standard care. The
improvement in adherence was observed across different
subgroups including patients with a limited educational
background.
A study from a Deccan state in India by Narreddy et al. reported
95% of TB patients receiving text‑message and Interactive
Voice Response packages were completely adherent to their
prescribed medication.[14] In South Africa, Wagstaff et al.
demonstrated SMS text‑reminders promoted the TB testers to
return to clinics.[15] Other African studies have also reported
small gains in DOTS adherence, treatment cure rates and clinic
attendance attained through text‑message interventions.[16]
There are several limitations to the study. First, the
sociodemographic characteristics of the intervention and

Table 2: Medical adherence to anti‑tubercular treatment regimen at baseline

Medication adherence Intervention group (n=110), n (%) Control group (n=110), n (%) Total (n=220), n (%) P value
High adherent 94 (85.5) 94 (85.4) 188 (85.5) 0.93
Moderate adherent 10 (9.1) 9 (8.2) 19 (8.6)
Low adherent 6 (5.4) 7 (6.4) 13 (5.9)

Table 3: Medication adherence of TB patients after mHealth intervention (n=218)

Characteristic Total Intervention group (n=110) Control group (n=108) P value+
Adherent Adherent (endline) Adherent Adherent
(baseline) (n=94) (n=106) (baseline) (n=94) (endline) (n=97)
Age (in Years)
18‑40 140 60 (63.8) 67 (63.2) 59 (62.8) 60 (61.8) 0.91
≥41 80 34 (36.2) 39 (36.8) 35 (37.2) 37 (38.2)
Gender
Male 130 57 (60.6) 67 (63.2) 46 (48.9) 48 (49.5) 0.04
Female 90 37 (39.4) 39 (36.8) 48 (51.1) 49 (50.5)
SES
Upper/Upper middle 42 28 (29.8) 34 (32) 34 (36.2) 35 (36.1) 0.54
Lower middle/Lower 178 66 (70.2) 72 (68)* 60 (63.8) 62 (63.9)
Education
Upto Middle 155 66 (70.2) 73 (68.8)* 70 (74.5) 72 (74.2) 0.39
High school and above 65 28 (29.8) 33 (31.2) 24 (25.5) 25 (25.8)
+
Between‑group differences at endline (Chi square difference in proportion). *Statistically significant (P<0.005) within group‑differences at endline
(McNemar test)

Indian Journal of Public Health ¦ Volume 65 ¦ Issue 1 ¦ January-March 2021 37

 Santra, et al.: mHealth improves anti-TB medication adherence
control group differed significantly due to the divergent
demographic composition of the respective catchment
areas of the selected DOTS centers. Some of these factors
could be associated with medication adherence behaviors,
although, the educational status of the participants in both
groups was comparable. Moreover, more than two‑thirds
of the participants were educated up‑to middle school only,
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suggesting the utility and relevance of the intervention
in real‑world health settings of the developing world.
Nevertheless, in this study, participants lacking basic or
digital literacy were excluded, limiting the generalizability
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of the study findings in probably the most vulnerable
patient subgroups. However, the evidence generated in this
study provides proof of the concept of the deployment and
acceptability of a comprehensive mHealth package among
patients with TB in India.
Second, we did not prospectively follow‑up the participants
to determine their treatment outcomes. Third, the possibility
of overestimation of the adherence rates due to an element
of socialdesirability bias cannot be ruled out. Fourth,
replicating the mHealth model applied in the present study
can be a challenge for developing world TB control programs
due to issues of feasibility and cost. The real‑time audio
call component of the present study that enabled two‑way
communication between the patient and a highly qualified
provider may not be viable in resource‑constrained settings.
Finally, adherence is a dynamic process that varies with the
time elapsed since diagnosis, especially in chronic diseases
requiring long‑term drug intake, indicating the need for more
frequent monitoring.[17]
Conclusions
A mHealth intervention is a useful mechanism for the provision
of adherence support to TB patients, especially in a daily
regimen scenario, in the absence of direct observation of
treatment. Future studies should explore the role of divergent
mHealth packages that also factor the intervention feasibility
and cost‑effectiveness.
Financial support and sponsorship
Funding source is National Tuberculosis Elimination Program,
Government of National Capital Territory, Delhi.
38 Indian Journal of Public Health ¦ Volume 65 ¦ Issue 1 ¦ January-March 2021
Conflict of interest
There are no conflicts of interest.
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