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Puchalski RitchieLM, etal. BMJ Open 2021;11:e048499. doi:10.1136/bmjopen-2020-048499
Open access
Process evaluation of an implementation
strategy to support uptake of a
tuberculosis treatment adherence
intervention to improve TB care and
outcomes in Malawi
Lisa M Puchalski Ritchie ,1,2,3,4 Esther C Kip,5 Hayley Mundeva,2
Monique van Lettow ,5,6 Austine Makwakwa,7 Sharon E Straus,1,2
Jemila S Hamid,8 Merrick Zwarenstein,9 Michael J Schull,1,10 Adrienne K Chan,1,10
Alexandra Martiniuk,11,12 Vanessa van Schoor13
To cite: Puchalski RitchieLM,
KipEC, MundevaH, etal.
Process evaluation of an
implementation strategy
to support uptake of a
tuberculosis treatment
adherence intervention to
improve TB care and outcomes
in Malawi. BMJ Open
2021;11:e048499. doi:10.1136/
bmjopen-2020-048499
►Prepublication history for
this paper is available online.
To view these les, please visit
the journal online (http:// dx. doi.
org/ 10. 1136/ bmjopen- 2020-
048499).
Received 30 December 2020
Accepted 17 June 2021
For numbered afliations see
end of article.
Correspondence to
Dr Lisa M Puchalski Ritchie;
lisa. puchalskiritchie@ utoronto.
ca
Original research
© Author(s) (or their
employer(s)) 2021. Re- use
permitted under CC BY- NC. No
commercial re- use. See rights
and permissions. Published by
BMJ.
ABSTRACT
Objective To assess implementation and to identify
barriers and facilitators to implementation, sustainability
and scalability of an implementation strategy to provide lay
health workers (LHWs) with the knowledge, skills and tools
needed to implement an intervention to support patient
tuberculosis (TB) treatment adherence.
Design Mixed- methods design including a cluster
randomised controlled trial and process evaluation
informed by the RE- AIM framework.
Setting Forty- ve health centres (HCs) in four districts in
the south east zone of Malawi, who had an opportunity to
receive cascade training.
Participants Forty- ve peer- trainers (PTs), 23 patients
and 20 LHWs.
Intervention Implementation strategy employing peer-
led educational outreach, a clinical support tool and peer
support network to implement a TB treatment adherence
intervention.
Outcome measures Process data were collected
from study initiation to the end- of- study PT meeting,
and included: LHW and patient interviews, quarterly PT
meeting notes, training logs and study team observations
and meeting notes. Data sources were rst analysed in
isolation, followed by method, data source and analyst
triangulation. Analyses were conducted independently by
two study team members, and themes revised through
discussion and involvement of additional study team
members as needed.
Results Forty- one HCs (91%) trained at least one LHW.
Of 256 LHWs eligible to participate at study start 152
(59%) completed training, with the proportion trained per
HC ranging from 0% to 100% at the end of initial cascade
training. Lack of training incentives was the primary
barrier to implementation, with intrinsic motivation to
improve knowledge and skills, and to improve patient care
and outcomes the primary facilitators of participation.
Conclusion We identied important challenges to and
potential facilitators of implementation, scalability and
sustainability, of the TB treatment adherence intervention.
Findings provide guidance to scale- up, and use of the
implementation strategies employed, to address LHW
training and supervision in other areas.
Trial registration number NCT02533089.
BACKGROUND
Tuberculosis (TB) remains an important
cause of morbidity and mortality globally, with
10 million new cases and 1.5 million deaths
attributed to TB in 2018.1 Despite steady
improvement since the global TB incidence
peak in 2004,2 continued effort is needed
to accelerate the annual rate of decline to
achieve targets toward ending the global TB
epidemic by 2030.3 Although one of many
factors, incomplete treatment continues to
contribute to the high global TB burden,
with treatment success rates for 2017 of 85%
of new cases and 56% of multi- drug resistant
TB globally.4
Similar to the global pattern, TB inci-
dence peaked in Malawi in 2003 at 403 cases
Strengths and limitations of this study
►This process evaluation provided an in- depth under-
standing of barriers and facilitators to implementa-
tion, scalability and sustainability of the tuberculosis
adherence intervention.
►The main limitation of this study is reliance on self-
report data which is subject to a number of sources
of bias including recall and social desirability bias.
►Use of a mixed- methods approach with data collec-
tion through multiple methods and sources, allowed
for triangulation across data sources, helping to re-
duce the impact of self- report bias on our ndings.
►As only lay health workers participated in the pres-
ent study ndings may not be generalisable to other
healthcare worker cadres.
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per 100 000 population,5 and has gradually declined to
181/100 000 in 2018.5 TB treatment completion rates for
this period have similarly improved, but vary substantially
across districts (66%–90%) and remain below the 90%
target set out in the 2021–2025 national TB and leprosy
control strategic plan.6
In response to the global shortage of skilled health
workers, currently estimated at 7.2 million and increasing
with an estimated shortage of 12.9 million by 2035,7
outpatient TB care is commonly task- shifted to lay health
workers (LHWs) in many low- income and middle-
income countries (LMICs) where the shortage is greatest.
While systematic reviews have found LHWs effective in
improving TB treatment success rates compared with
usual care, the effect size is generally small.8 9 Despite
the recognised need to optimise the impacts of LHW
programmes, a recent systematic review found rela-
tively few studies examining strategies to improve health
provider practices in LMICs in general and LHW prac-
tices in particular.10While adequate training and super-
vision are recognised as essential to optimising the
effectiveness of LHW programmes, evidence of effective-
ness for approaches to training and supportive supervi-
sion for LHW programmes are lacking,8 11 with training
alone found to have small effects on LHW practice.10
With 28 nurses and two physicians per 100 000 popula-
tion,12 Malawi is among the countries considered to be in
crisis, with respect to human resources for health. LHWs,
known as health surveillance assistants in Malawi, are a
paid cadre of health workers totalling more than 9000 in
2017, which is insufficient to meet the ministry of health
target of 1 LHW per 10 000 population.13 LHWs in Malawi
provide a number of preventative and curative tasks, and
are the principal providers of outpatient TB care.14 Given
the crucial role of LHWs in providing TB care in Malawi
and LMICs in general, effective and sustainable options
to address LHW training, and supervision are needed.
In collaboration with local stakeholders, we conducted
formative work to identify training and supervision needs
among LHWs providing TB care in Malawi,15 and devel-
oped and pilot tested a TB treatment adherence interven-
tion to address the identified knowledge and skill gap.16 17
The TB adherence intervention was designed to support
TB treatment adherence by addressing two common
barriers to adherence, identified through an extensive
search of both the international and Malawi specific TB
and general adherence literature.18 Specifically the inter-
vention targeted lack of patient understanding of TB
and its treatment, and poor patient- provider interaction,
both known to negatively impact treatment adherence.
The TB adherence intervention is reported elsewhere in
detail17 19 but in short required LHWs to ask about adher-
ence at each patient interaction, assess factors related
to or risk factors for non- adherence, and to support
adherence through provision of education and counsel-
ling appropriate for the patients stage of treatment or
to seek additional support for patients as needed (such
as referral for assessment of unexpected or severe side
effects). To enable LHWs to implement the intervention,
an implementation plan employing three strategies was
developed, including: educational outreach to address
knowledge gaps in LHWs understanding of TB (trans-
mission, importance of adherence, consequences of non-
adherence), and provide skills in patient counselling and
adherence support; a clinical support tool to act as a clin-
ical support to address adherence during patient inter-
actions and providing a guide to adherence assessment
and counselling: and a peer support network to allow
for lessons learnt during training and supervision to be
shared among peer trainers, to support peer trainers in
their role.
The pilot trial, conducted in a single district employing
educational outreach and a clinical support tool to support
implementation, found the intervention to be feasible
and acceptable to participants, and while not statistically
significant given the small sample size, showed improve-
ment in TB treatment completion rates.16 17 Given these
findings and stakeholder interest in exploring potential
scale- up, we refined the intervention and implementa-
tion strategy based on feedback and our implementation
experience in the pilot study and evaluated the refined
intervention using a mixed- methods design. Effective-
ness of the intervention in improving TB treatment
completion rates was evaluated in a cluster randomised
controlled trial, reported in detail elsewhere,20 with find-
ings of the process evaluation reported here.
METHODS
Study aim
Our objective was to assess implementation and to identify
barriers and facilitators to implementation, sustainability
and scalability of an implementation strategy to provide
LHWs with the knowledge, skills and tools needed to
implement an intervention to support patient TB treat-
ment adherence: to inform scale up and to assess the
potential for this approach to be used to address training
and supervision needs in other areas of care provided by
LHWs.
Intervention
A detailed description of the development process and the
original intervention has previously been published.15 16
Based on feedback and our implementation experience
in the pilot study, the intervention was refined for the
present study (see table 1 for detailed description of the
intervention and implementation strategy). In brief, our
strategy employed onsite peer- led educational outreach, a
clinical support tool and peer support network to imple-
ment a TB treatment adherence intervention. The imple-
mentation strategy was designed to address LHW training
and supervision needs to support implementation of an
evidence- based approach to providing TB adherence
support. The educational outreach component utilised a
train- the- trainer approach, with TB focus LHWs trained
as peer- trainers (PTs), who then provided cascade
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training (on- site, peer led, training) to LHWs providing
TB care at intervention health centres (HCs). The clin-
ical support tool was designed as a guide to patient
education and counselling, and as a clinical support and
guide to patient assessment and adherence counselling.
In addition, to support development of a peer support
network, a small phone stipend was provided quarterly
to facilitate communication between PTs outside formal
quarterly group meetings. Limited additional support was
available to PTs by contacting the study team by phone,
Table 1 Description of the intervention and implementation strategy
Description
Intervention
Aim(s) ►Address an identied gap in the training and supervision needs of LHWs providing TB care in
Malawi, with the goal of improving TB care and adherence support, and through this improve
patient outcomes including TB treatment success rates.
Content ►Training content focused on understanding TB disease transmission and treatment, as well as,
common reasons for non- adherence, and approaches to patient education and counselling to
support treatment adherence.
Goal ►TB treatment adherence and challenges encountered during treatment to be assessed and
support provided at each patient encounter to achieve adherence goals.
Implementation strategy
Educational outreach ►Peer- led educational outreach provided by TB focus LHWs trained as peer trainers (PT). TB
focus LHWs receive two additional weeks of TB specic training and are responsible for
provision of outpatient TB care at the health centre level.
►PTs trained in both content and approach to training and supportive supervision off- site over
1 week by a master trainer (LMPR). Expenses related to travel, accommodation, and meals to
attend training reimbursed; training stipends not provided.
►PTs asked to provide eight cascade training sessions each a minimum of 60 min over a 4- month
period, onsite at their base health centre during regular work hours. Training period later
extended by 2–3 weeks due to delays in receipt of training manuals at some sites, as well as,
PT and/or LHW absences due to annual leave and attendance at off- site meetings or trainings.
►Organisation and timing of cascade training was left to the discretion of PTs. PTs at liberty to
provide additional sessions as needed for LHWs who missed sessions or to train new staff.
►All LHWs routinely involved in provision of TB care were invited but not required to participate
in training. Training stipends were not provided.
►Methods of supportive supervision discussed and practiced during PT training but approach
used left to the discretion of the PTs.
►Certicates were provided for PTs and LHWs who completed training.
Clinical support tool ►Clinical support tool provided in Chichewa, designed as a laminated ip chart, able to stand on
the desk top during patient encounters or to fold at when carried out to the eld.
►The patient side of the tool uses simple pictorials to outline the course of a patient through
treatment, designed as an aid to patient counselling.
►The provider side of the tool is designed as a clinical support, and outlines an approach to
assessing adherence and challenges encountered during treatment, as well as, approaches
addressing challenges and to providing counselling and support.
►An additional leaf on the provider side of the tool provides a drug dosing chart for standard
treatment regimens, for easy reference during patient encounters.
Peer support network ►Small telephone stipends were provided quarterly to PTs to support development of a peer
support network among PTs trained together.
►No guidance or encouragement was provided beyond the phone stipend, with participation in
and process of peer- support left to the discretion of the PTs.
PT support/mentorship ►PT free to contact the study team by phone with questions or concerns as needed.
►In order to evaluate the intervention as close to real world conditions as possible, outside
support from study team generally limited to quarterly PT meetings and occasional eld visits
from the study team while collecting process evaluation data and/or during routine site visits
from Dignitas International mentors providing support and mentorship to frontline clinical staff
in the study districts.
►Dignitas mentor support withdrawn from two of the four study districts at the end of cascade
training as a result of restructuring of NGO catchment areas.
LHWs, lay health workers; NGO, non- governmental organization; TB, tuberculosis.
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quarterly PT meetings and occasional filed visits from the
study team and/or Dignitas International mentors during
routine site visits to provide support and mentorship to
front- line staff.
PTs were trained off- site over 1 week. Training was
provided by LMPR, who also conducted the PT training
in the pilot study. Training was provided in English,
with support from a sociolinguistic level translator, and
a second study team member in attendance to support
training in one large district. PTs received certificates
from the study team at completion of PT training, as
well as training materials (training manual in Chichewa,
stationary, training log book) and a supply of clinical
support tools for their site, also in Chichewa. PTs were
asked to provide cascade training onsite during regular
work hours at their base HC, with all LHWs routinely
providing TB care at the HC encouraged but not
required to participate in training. LHWs who completed
the cascade training were provided with certificates by the
study team. Training stipends were not provided.
Study design
The study protocol for the complete mixed- methods
study including both the pragmatic cluster randomised
controlled trial and process evaluation components was
previously published and is presented briefly here.19
Effectiveness of the intervention in improving TB treat-
ment success rates was assessed within the context of a
pragmatic cluster randomised trial in four districts in the
south east zone of Malawi, with 51 HCs randomised to the
intervention arm and is reported in detail elsewhere.20
The process evaluation employed a mixed- methods design
informed by the Reach, effectiveness, adoption, imple-
mentation, and maintenance (RE- AIM) framework,21 22
and our experience with the pilot study. In keeping with
our pragmatic design, data sources for the process eval-
uation were selected to limit contact with participants in
order to reduce the potential for process evaluation data
collection to act as a booster to implementation. Thereby
optimising our ability to assess intervention effectiveness
as close to real world conditions as possible. Process eval-
uation data sources included: interviews with LHWs and
patients at intervention sites, and a document review of
training logs, quarterly PT meeting notes, mentor field
visit reports, and study team meeting notes.
We defined reach as the number and proportion of
LHWs who completed cascade training. Effectiveness
included benefits to patients including impact on TB
treatment completion rates and providers as a result of
the intervention, challenges encountered, areas where
further improvement was needed to achieve effective-
ness goals, and any negative effects attributed to imple-
mentation of the intervention. Adoption was defined
as the number and proportion of HCs with at least one
trained LHW providing care in addition to the sites PT.
Implementation included fidelity of the cascade training,
provision of supportive supervision and use of the clin-
ical support tool during patient care. Maintenance was
defined as ongoing use of the intervention beyond the
initial implementation period to the end of the 1- year
trial period, including efforts to ensure new staff were
appropriately trained and able to participate in imple-
mentation. Barriers and facilitators to implementation,
scalability and sustainability, were defined to include
both perceived and experienced barriers and facilitators.
Suggestions for programme improvement included both
efforts trailed by participants to improve implementation
during the course of the study, as well as suggestions,
based on participants experience during the study period.
Participants
The study was conducted in four districts in the South East
zone of Malawi, with 51 of 103 HCs routinely providing
TB care randomised to the intervention arm. All HCs
randomised to the intervention arm that had an oppor-
tunity to participate in cascade training were eligible for
inclusion in the process evaluation.
Interview participants included LHWs at intervention
sites and patients/guardians for patients less than 18
years of age who began TB treatment on or after the trial
start date (1 October 2016) and who were followed at
a participating HC. Two to four participants from each
group (LHWs and patients) were selected in each data
collection period from each district and a maximum of
two from any one HC.
LHWs were selected for interviews using mixed
purposeful sampling to represent the range of LHW
(age, gender, years of experience) and HC character-
istics (rural/urban), with three LHWs chosen to be
interviewed at both study onset and conclusion. Conve-
nience sampling was used to select patients/guardians
for interviews. Patient/guardians were selected to repre-
sent the range of characteristics in terms of age, gender,
and TB characteristics (new/recurrent, pulmonary/
non- pulmonary).
Informed written consent was obtained from all inter-
view participants. Consent was obtained from guardians
and assent obtained for children under 18 years of age.
Patient and public involvement
Patients or the public were not involved in the design,
conduct, reporting or dissemination plans of our research.
Data collection
Process evaluation data were collected throughout the
implementation period beginning with PT training which
took place between 9 May and 3 June 2016, through to
the final end of study quarterly PT meetings in October
of 2017. See figure 1 for timing of data collection for each
data source.
Quarterly meetings
PTs were brought together at the end of the cascade
training period and then quarterly for the remainder of
the implementation period. Meetings focused on sharing
ideas and experiences, providing updates on the progress
of training and implementation, and posing questions to
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the study team. Meetings were held in English with in- line
translation provided as needed by the research assistant
(RA) and study coordinator (SC). Notes were taken
independently by two study team members. An initial
meeting report was compiled by the RA from the hand
written notes, and was circulated to the other study team
members for review and revised as necessary.
Quarterly meetings were also held with members of
the health management teams in study districts, typically
immediately following PT meetings and regular contact
maintained with AM who is based in the National TB
control programme. Meetings focused on providing
updates to leadership on implementation progress and
to receive updates on any TB policy and/or program-
ming changes and/or system challenges with potential
to impact implementation. Brief notes were taken and
discussed by the team following meetings to ensure
accuracy.
Training logs, study team and mentorship data
PTs were provided with a log book and asked to use the
book to document the details of and their experiences
during cascade training and ongoing implementation.
Items of interest to be documented in the log book
included: number of LHWs trained; changes/additions
made to cascade training; challenges to training or imple-
mentation; questions or concerns for discussion with the
study team or PT group. Log books were reviewed by
the study team at quarterly meetings and verbal reports
provided when logs books were not available.
Notes were taken during regular study team meetings,
to document study progress, challenges encountered and
to document feedback from mentors, input from district
and national ministry of health staff, and experiences
of the study team during field visits during collection of
interview data. One mentor prepared and submitted a
more formal report, however, this mentor was based in
one of the two districts that Dignitas International was
withdrawn from and therefore only a first quarter report
was provided.
Interviews
Interviews were conducted with patients and LHWs at
intervention sites at two time points during the imple-
mentation period. Interviews were conducted at a time
convenient to participants, in a private location at or
near the participants’ HC. The first round of interviews
was conducted in the first quarter of implementation
(November and December 2016) and the second round
conducted in the final quarter of the implementation
period (August and September 2017). LHW interviews
were conducted by a trained RA and patient interviews
conducted by the SC. Both the RAs and SC were native
Malawians, and fluent in English and Chichewa. Inter-
views were conducted face to face, in Chichewa, using a
semistructured interview guide. LHW interviews began
with collection of basic demographic data and details
of their participation in the cascade training. This was
followed by open ended questions asking about their
experience with the training, use of the clinical support
tool, supervision received and suggestions for improve-
ment. Patient interviews similarly started with collection
of demographic data, including current and past TB
diagnosis if any. Patient interviews also began with open-
ended questions with probing as necessary to ensure
topics of interest were addressed. Topics of interest in
patient interviews included: understanding of TB and its
treatment, experience in receiving TB care at their base
HC including experience with the clinical support tool,
and suggestions for how provision of TB care could be
improved.
Figure 1 Process evaluation data sources and Timeline. LHW, lay health worker.
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Interviews were digitally audio recorded, transcribed
verbatim and translated to English. To ensure accuracy
and conceptual equivalence all interviews were verified
by the SC, who operates at the level of a socio- linguistic
translator.23
Analysis
Document review
Meeting and study team notes, including reports from
mentors, quarterly PT meetings, and meetings with district
and national Ministry of Health staff, were reviewed inde-
pendently and discussed (ECK and LMPR) on a regular
basis and notes made of ongoing and/or emerging
themes throughout the implementation period.
Interviews
LHW interviews were analysed using directed content
analysis,24 with interviews as the unit of analysis. NVivo
V.10 (QSR International, Southport, UK) was used to
organise and code the data. An initial coding framework
was developed based on findings from the pilot study.
Analysis occurred in two rounds. First, two study team
members (ECK and HM) read and coded the transcripts
independently. The coding framework was then revised
through discussion and consensus, and input from a
third study team member (LMPR) as needed. The revised
coding framework was then applied independently by the
same two study team members with discrepancies again
resolved through consensus. Themes were sought across
individuals with consideration of gender, age, years of
experience providing TB care, district, and time of inter-
view (first and last quarter of 1- year implementation
period).
Patient interviews were analysed using conventional
content analysis,24 again with interviews as the unit of
analysis and NVivo used to organise and code the data.
Transcripts were coded independently by two study team
members (ECK and HM). Based on this initial round of
independent coding, an initial coding framework was
developed by the two coders through discussion, with
involvement of a third study team member (LMPR) as
needed. The initial coding framework was then applied
independently by the same two study team members, in
two further rounds with minor refinement of the frame-
work between rounds.
Triangulation
Methods, data source and analyst triangulation25 were
employed with interviews, quarterly meeting and study
team meeting notes. Convergence and divergence in
themes and subthemes was sought first across data
collection methods and then across analysts. Findings
from all sources were considered together to provide a
comprehensive assessment of implementation, including
potential inaccuracies in self- report data contributing to
assessment of RE- AIM dimensions, and a comprehensive
understanding of barriers and facilitators to implementa-
tion, sustainability and scalability.
RESULTS
Characteristics of participants
Forty- five of 51 HCs randomised received the interven-
tion. Six HCs did not have an opportunity to receive
cascade training and were excluded from the process eval-
uation. Reasons for HCs not receiving cascade training
included: four TB focus LHWs who were on leave or at
other trainings did not attend PT training, one PT died
immediately following PT training and before begin-
ning cascade training at his base HC and one participant
reported at the end of training that their HC no longer
provided TB care. PT attendance at quarterly meetings
varied from 80% to 89%. Seven PTs did not attend the
final meeting and could not be reached to confirm final
numbers of LHWs trained and remaining at the HC.
Twenty- three patients participated in interviews.
Patients ranged from 11 to 59 years of age, 13 (57%) were
female, the majority of patients had been diagnosed with
a first episode of pulmonary TB, with only 2 (9%) diag-
nosed with non- pulmonary TB and 5 (22%) diagnosed
with a second TB episode.
Twenty LHWs participated in interviews, with three
LHWs interviewed in both the first and last quarter of
implementation. LHWs ranged from 30 to 57 years of
age, from 4 to 20 years of experience working as a LHW
and from 1 to 20 years providing TB care. Ten (50%) of
LHWs interviewed were female.
Implementation process outcomes
Example quotes for RE- AIM categories where applicable
are provided in table 2.
Reach
Of the 256 LHWs eligible for training at the start of cascade
training, 152 (59%) LHWs completed the training by
the end of the initial training period. The proportion
of LHWs receiving cascade training varied across sites,
ranging from 0% to 100%. An additional 17 LHWs, who
had initially declined to participate or were transferred
into implementation sites after the initial training period,
completed cascade training by the end of the study, for a
total of 169.
Effectiveness
There was no significant effect of the intervention on
TB treatment success, adjusted OR 1.35 (95% CI 0.93
to 1.98), with high variation in implementation quality a
potential contributing factor.20
LHW interview participants and quarterly PT meeting
notes, revealed a variety of benefits of the intervention to
LHWs including: increased knowledge, improved skills
in patient–provider interactions and counselling, better
collaboration among providers, and improved patient
care. While some PTs reported use of the phone stipend
to discuss challenges or problem solve with their peers
during initial cascade training and reported this support
as essential to their success, few reported continued use
of the peer support network beyond the first quarter of
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Table 2 Example quotes for RE- AIM, barrier and facilitator results categories
Result category Sub- category Example quotes
Re- AIM
Reach No quotes
Effectiveness
Benets to LHW
Participants
Increased Knowledge and
Skills
‘I thought they were very useful because, sometimes when we are
assisting a patient, we do not explain in detail things concerning TB
due to inadequate information regarding TB’
‘Now when we know the side effects it helps us to know how we can
help a person who is meeting those problems.’
‘The training was really important, some HSAs (LHWs) had no
idea about TB but now they have knowledge on TB transmission,
treatment, prevention and how to attend a patient.’
Improved patient
interactions and counselling
‘It (the training) helped us to talk to the client thoroughly because it
guides us to do this and do that, but it also helped our client to feel
that we are together because it becomes like a conversation’
Better coordination among
providers
‘We were assisting each other with the peer trainer to deal with the
challenges.’
‘After this training I have seen some changes, for some H.S.As (LHWs)
who took part in the training have started being active in TB work,
making sure that when someone comes in other departments such as
doctor, nurse, they are able to refer those that are coughing to us and
they are being helped.’
Improved patient care ‘In the past we were just not sure … but the training helped us to know
the dangerous signs that can encourage you to refer a patient to the
clinician.’
Patient experience/
perspective
Value supportive care
received from LHWs
‘Since I started receiving medication here I have never faced any insult,
they welcome me well and they also make sure that I am taking my
drugs accordingly’
Opportunity to discuss
challenges during treatment
‘They (LHWs) do ask us and I’m able to explain the good things and
the problems I am facing like at the beginning my feet were getting
swollen and I was feeling dizzy, then I was told to meet with the doctor
so that he should give me the drugs, so they gave me the drugs and I
got better’
LHWs primary source of
patient information
‘I got this information from the health workers (LHWs) who were seeing
me here, in all the clinics I have visited, and when I was diagnosed with
TB, I was being told this information, ……yeah, so that information we
get it from the clinics’
Good understanding of TB
and its treatment
‘The explanation they gave me, they said that… if a person is taking
the drugs properly that means the person gets better very well but for
the person who is not taking the drugs without adherence can face
some difculties in his/her body.’
‘ In addition for TB to be treated, the one taking drugs must make sure
that drugs are taken according to directions, without skipping because
if the person skips then the TB can become incurable’
Clinical support tool helpful
in understanding TB
treatment and importance
of adherence
‘The way I see it, we should not change (the tool), because here things
are clear (pointing on the pictures) that here is the beginning, (rst
picture on the tool) and here things are changing after given care, then
later things are better and lastly the person has been healed.’
Mixed understanding of TB
transmission
‘It (TB) is transmitted by coughing and by breathing air’
‘To my side it’s hard to explain on how one gets TB because I don’t
know what happens.’
Mixed understanding of
personal TB diagnosis (TB
type)
‘It is the same TB of the bones (extra- pulmonary again)’ [recurrent TB
patient]
‘They just said it is TB, they didn’t say the type of TB’
Adoption No quotes.
Implementation
Continued
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Result category Sub- category Example quotes
Training Variability in number and
duration of training sessions
‘The peer trainer and us because of time were meeting for certain
hours, 2 hrs or 3hrs for almost 2 weeks…we completed 8 modules’
‘They taught us three to four days… Yes …we completed the training’
Training incomplete or not
offered
‘Aaaah no… We didn’t nish. They (PT) just explained to us in a
summary what he learnt from the training. We didn’t have a serious
training.’
Supportive supervision Improved supportive
supervision
‘There is change (in supervision) because we interact with him well,
they advise us where necessary and when we also have a problem we
go and ask him.’
‘The peer trainer will just sit down observing what is happening on how
we are chatting with client using the tool. So if there is a certain part
we are going wrong the peer trainer comes in, because supervision is
not policing its part of supporting.’
Valued local support and
mentorship
‘Before getting the training the supervision was poor, but as of
now since the peer trainer is ours here at this facility therefore the
supervision is readily available now and …the supervision is what
makes us not forgetting the training’
Clinical support tool Use of clinical support tool
increased overtime
‘No, I just saw this it (the tool) stays there at the table, so I just read the
text.’(patient rst quarter of implementation)
‘(Tool used during patient encounter) Several times, each and
every time I come here they show me.’ [Patient nal quarter of
implementation]
‘(we use the clinical support tool) Every time when we meet the client,
because for the client to understand us it needs a procedure so the
tool helps us to go step by step’ [LHW nal quarter of implementation]
Maintenance Ongoing use of programme ‘(the program) It was good, very helpful and it is still helping us till
now.’ [nal quarter of implementation]
Barriers to Implementation, scalability and sustainability
Lack of Incentives ‘As I explained others were reluctant to participate due to lack of
incentives.’
‘We think differently, there was a need for something…. Like an
incentive for instance… if the peer trainer was given something for
participants, their number (number of LHWS participating) would
increase.’
PT Busy ‘They (PT) are a very busy person.’
‘Although others were saying that they were busy but for me the issue
was about incentives.’
PT Workload ‘(The PT) Should be a person who is not involved in many programs.’
PT attitude and/or
condence
‘But for our peer trainer didn’t do anything for this project to work well.
I inquired (and learned) more information about the program from other
health centres.’
‘For this program to be well implemented the one who was trained was
supposed to be the rst person telling us what he/she learnt. He just
kept the information without bringing it on the actual ground. So we
could not do things that we were not told. The information was hidden
from us.’
‘He was afraid to share with us what he learnt from the training.’
Facilitators of Implementation, scalability and sustainability
Provides incentives ‘Just a request…if there is some money it would be good to give the
people during the training…that would be helpful.’
Train more than one PT
per site
‘There was a need to train 3 to 4 persons … a problem comes when
the person is not available and it’s hard for the person to share the
information exactly the way it was explained at the training. If 2 to 3
person are trained as peer trainers, they can be reminding each other.’
Table 2 Continued
Continued
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implementation. While some frustration with challenges
in recruiting eligible LHWs to participate in training was
reported by some PTs, no negative outcomes as a result
of implementation were reported and many PTs indi-
cated they would be interested in continuing in their role
as PT.
Patient interview results were somewhat less consistent,
with mixed effects in some areas. All patients reported
and valued receiving supportive care from the LHW
providers. In addition, the majority of participants noted
LHWs to probe for and provide an opportunity to discuss
and address challenges faced during the course of treat-
ment, with reports of LHWs failing to assess challenges
encountered predominantly occurring in the initial
implementation period. The majority of patients reported
LHWs to be their primary source of TB information, and
showed a good understanding of TB and its treatment.
Patients found the clinical support tool as part of their
education and counselling beneficial, noting it improved
their understanding of TB treatment and the importance
of adherence to successful treatment. Understanding of
TB transmission however was mixed, and did not seem
to improve substantially over time. In addition, patient
understanding of their TB type, was mixed, with approx-
imately half of patients interviewed reporting they were
not told what type of TB they have. This finding also did
not change substantially overtime. No negative outcomes
were reported by patients with respect to their current TB
treatment.
Adoption
Of the 45 HCs that had an opportunity to receive
cascade training, 41 (91%) reported at least 1 LHW had
completed training. No clear pattern was evident for HC
setting (rural vs urban) or HC funding type (Ministry of
Health or non- ministry funded) with respect to willing-
ness of LHWs to participate in implementation.
Implementation
Tailoring of cascade training was permitted at the
discretion of the PT provided all content was covered
and opportunities for practice and discussion were avail-
able. Similarly, approaches to supportive supervision
were discussed and practiced during PT training, but
PTs were free to select the techniques most suitable to
their style and team needs. The initial cascade training
period was extended by 2–3 weeks to accommodate staff
absences.
While all PTs reported providing complete cascade
training, both PTs and LHWs reported variability in
number and duration of sessions including: providing
fewer than the recommended eight sessions by extending
the length of individual sessions, providing replace-
ment sessions for staff as needed and training new staff
transferred into the HC after the initial training period.
However, interviews with LHWs revealed a few instances
where training was incomplete or not offered despite PT
reports. Similarly, although provision of supportive super-
vision was variable with respect to amount and approach
to supervision provided, particularly beyond the initial
period of cascade training, LHWs generally reported
supportive supervision to be improved compared with
preimplementation levels and the availability of local
support and mentorship from their PT valued. Use of the
clinical support tool in patient education and counsel-
ling changed over the course of the 1- year trial period,
starting with relatively low levels of use with 7/11 (64%)
of patients interviewed reporting never seeing the tool
and 3/11 (27%) reporting see the tool 2 or more times
in the first quarter, to high levels use with 1/12 (8%) of
patients reporting never seeing the tool and 11/12 (92%)
reporting seeing the tool on 2 or more TB clinic visits by
the final quarter of the study.
Result category Sub- category Example quotes
Intrinsic motivation Desire to improve
knowledge and skills
‘It was just my opportunity to add some expertise.’
‘I just wanted to help because if one turns to be a defaulter he/she
faces a lot of challenges. … I was really concerned, so when the peer
trainer briefed us about TB adherence training I decide to participate
because I wanted to learn more about TB adherence. It was like my
opportunity to know more about TB/HIV adherence.’
Desire to improve patient
care and outcomes
‘I wish good health for patients, so I wanted to be one of the
participants in order for me to counsel them properly about TB issues.’
Outside support Visits from study team and/
or mentors
‘You should come more often to encourage us, even if it is coming
without anything you can just come to see how TB services are going
on’
‘If you have the chance you could be visiting us and nd us all we were
trained so that you ask us in the group like what challenges are you
facing etc. that could be helpful and encourage us’.
LHWs, lay health workers; TB, tuberculosis.
Table 2 Continued
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Maintenance
All sites who participated in cascade training reported
ongoing use of their training and clinical support tool in
provision of care at 1- year postimplementation. As a result
of transfers to other HCs, two HCs no longer had any
trained LHWs on site, however PTs at these HCs remained
onsite and were engaged in direct provision of TB care.
In addition, several PTs reported plans to provide cascade
training to LHWs who had previously declined to partic-
ipate and to new staff as needed to support continued
implementation, with one site reporting completion of 4
of 8 modules at the time of the end of study meeting.
Barriers to and facilitators of implementation, sustainability
and scalability
Example quotes for barriers and facilitators are provided
in table 2.
Lack of incentives was the primary barrier identi-
fied, and was the most common reason given by LHWs
declining to participate. In addition although not specif-
ically stated, it appeared that lack of stipends may have
played a role in the few reports of PTs refusing to provide
training or providing a substantially reduced version of the
training only. A second barrier noted was that the PT and
LHWs were busy, however explanations suggested that in
some cases, lack of incentives may have played a role. As
one participant noted, ‘they say they are busy but to me it
is really just about incentives’. A third barrier noted was
that more than one PT was needed due to the demands
of the TB focus person role. Additionally, although not
described as such PT attitude, lack of interest and perhaps
lack of confidence, appeared to play a role in some cases,
where interview participants reported PTs not willing to
provide training or providing only a condensed version of
training, despite LHWs requests to participate.
Facilitators commonly noted as suggestions to address
noted barriers, included to provide incentives, and train
more than one PT per site. Intrinsic motivation was a
commonly noted facilitator, with a desire to improve
knowledge and skills, noted to over- ride the desire
for incentives among some participants. A desire to
improve patient care and outcomes were also commonly
reported reasons for participation. Although PTs were
free to contact the study team by phone with questions
or concerns as needed, this was rarely exercised with
PTs typically waiting for quarterly meetings to raise ques-
tions to the study team. Despite this, participants felt that
regular monitoring and check- ins from the study team to
provide support and motivation by providing opportu-
nities for questions and discussion, particularly early in
implementation, would facilitate implementation.
DISCUSSION
The TB treatment adherence intervention was designed
based on formative work to address an identified gap in
knowledge and skills among LHWs providing TB care in
Malawi, and employed evidence- based implementation
strategies to support its use. This process evaluation
highlighted important barriers to and facilitators of
implementation, scalability and sustainability of the inter-
vention. As well as challenges not previously identified in
the pilot evaluation of the intervention, which in contrast
to the present study, achieved high levels of implemen-
tation and found a non- significant improvement in TB
treatment completion rates.16 17
Although many sites achieved high levels of imple-
mentation, substantial variability was found both
within and across districts, particularly with respect to
reach, which ranged from 0% to 100%. This finding is
in contrast to those of the pilot study16 17 where only a
single LHW initially declined to participate and later
requested and completed make up training sessions to
catch up to peers and to allow their participation. While
several factors may have contributed, lack of financial
incentives was the principal reason given by LHWs who
chose not to participate. Although standard practice at
the time, incentives were also not provided in the pilot
study, where, while suggested as a potential facilitator,
lack of incentives did not deter participation. At the
time of the current study, a policy change no longer
permitting training stipends had been recently imple-
mented, with reports of training refusals occurring
among several healthcare workers cadres in the study
districts as a result.
A second noted barrier to implementation noted by
LHWs was being too ‘busy’, however, comments associ-
ated with this reason suggest that lack of incentives was
related to this response in some cases. Additionally,
recognition that implementation was occurring in the
context of a formal study, appeared to further exacer-
bate the incentive issues, with some participants noting
‘incentives’ common practice in studies conducted in
their area. Given this it is possible that lack of incentives
may be less of a deterrent to participation once the policy
has become standard and under routine programmatic
conditions.
Although impacts are somewhat mixed, incentives are
a frequently noted barrier to and facilitator of implemen-
tation in LMICs. Systematic reviews have found modest
to moderate effects of financial incentives on healthcare
worker practice,10 and monetary incentives linked to
motivation and performance, and attrition in commu-
nity health worker programmes,11 with several studies
finding lack of financial incentives, an important barrier
to implementation.26–28
Two systematic reviews, however, have found the
impact of incentives less clear, noting the potential for
important negative effects. While both reviews found that
both financial and non- financial incentives can enhance
performance, performance based financial incentives
could lead to neglect of unincentivised tasks29 and noted
concerns of potential negative impacts from incentives
particularly to unpaid volunteer LHWs that may under-
mine the high moral status placed on volunteer LHWs in
some settings.30
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PTs work load was the third common barrier to imple-
mentation noted by LHW participants, who suggested
that more than one PT be trained per site to ensure
one PT could always be available to provide support and
supervision. Additionally, PT lack of interest or confi-
dence was also noted as an important barrier by some
LHW participants. Lack of confidence was also noted
initially by some PTs in our pilot study, but resolved with
encouragement from the study team and their peers, with
no notable impact on implementation. Similar to the
stipend issue, it is unclear why lack of interest or confi-
dence was more persistent over time among PTs in the
current study. While it is possible this barrier may be of
less importance under routine programmatic conditions,
based on findings in our companion study31 addition of
leadership training for PTs may be considered to support
PTs and improve their effectiveness in this role.
Several studies have found workload to be an important
barrier to implementation in both community health
worker and LHW programmes. Work overload was noted
to negatively impact participation of community health
workers in implementation of a micronutrient dissemi-
nation programme.26 In a systematic review of determi-
nants of performance in Malaria prevention and control
programmes, Chipukuma et al32 found poor performance
among LHWs as a result of large population coverage
and multiple tasks. They noted however that this effect
could be mitigated by appropriate training, supervision
and adequate resources. Finally, Glenton et al’s30 system-
atic review of barriers and facilitators to implementation
of LHW programmes in maternal and child health, found
unrealistic LHW workloads including large coverage
areas to negatively impact LHW performance.
Among LHWs who elected to participate, the primary
reasons given were intrinsic motivations, including
wanting to improve personal knowledge and skills, and to
provide better care and through this to improve patient
outcomes. Intrinsic motivation and positive effects of
participation in the intervention was also noted in the
pilot study17 31 and companion study,31 and suggest that
emphasis on these outcomes when introducing the
programme may help to motivate participation.
Two studies have previously identified intrinsic moti-
vations as an important facilitator of implementation
in LHW programmes. Intrinsic motivators including
altruism, social recognition, knowledge gain and career
development, were identified as facilitators to maternal
and child health LHW programmes, in Glenton et al30
systematic review. Grant et al33 found a team based goals
and incentives programme reinforcing intrinsic motiva-
tion to improve teamwork, motivation and performance
among health teams which included LHWs. Future work
to evaluate this and other approaches to optimising
intrinsic motivators are needed, given the prohibitive cost
of the stipend approach to facilitating implementation,
particularly in large LHW programmes.
Based on observations in the pilot study where PTs
maintained contact by phone to provide support to
each other outside the formal quarterly meetings, we
provided a phone credit stipend to PTs trained together
in the current study to support development of a peer
support network. In contrast to the pilot study, PT contact
appeared to be limited outside the formal quarterly meet-
ings, particularly outside the initial period of cascade.
However, a few PTs noted support from peers during this
initial period as instrumental to their success. The reason
for this difference is unclear, and given the mixed reports
of value placed on availability of peer support, warrants
further evaluation. Similar to our experience in the pilot
study, Sodhi et al27 found peer support important to imple-
mentation of an intervention for midlevel health workers
in Malawi employing peer- led educational outreach.
Given these findings, further research to assess options
for and impacts of peer networks to support implementa-
tion efforts in Malawi and LHW programmes in general
is needed.
While the importance of supportive supervi-
sion to the success of LHW programmes is widely
recognised11 32 as noted by Kot et al29 evidence to direct
selection of approaches for and implementation of
supportive supervision are lacking. Additionally chal-
lenges to provision of adequate supportive supervision
have been noted due to staff shortages and resource issues
leading to logistical challenges.34 Based on its recognised
importance we elected to explore the impact of including
training in supportive supervision as a component of PT
training, as a feasible and sustainable option to providing
supportive supervision at the local level. However, the
impact of this addition to the PT training is unclear. Many
LHW participants in the process evaluation interviews, as
well as, participants in a companion study on PT leader-
ship style,31 noted receiving and appreciating supportive
supervision from their PTs. This suggests that support
at this level is feasible and well received, however nega-
tive reports with respect to PT supervision suggest that
more work is needed to optimise supportive supervision
provided by PTs to support implementation. PTs also
suggested that supportive supervision through regular
monitoring and ‘check in’s’ from the study team would
be appreciated as opportunities to bolster motivation and
address questions that arise during implementation. As
a potential facilitator inclusion of training in and provi-
sion of supportive supervision from master trainers is an
important area for future implementation and evaluation.
Limitations
The primary limitation of this study is reliance on PT self-
report data, which is subject to a number of sources of bias
including recall bias and social desirability bias. Indeed, at
least one PT initially gave a false report of the number of
LHWs they had trained, only revealing the true number
at the final quarterly meeting, which were much less that
initially reported. Additionally several PTs did not attend
the final meeting and could not be reached to confirm
the final numbers of trainees. As a result final numbers
of LHWs trained and remaining at intervention sites
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may be under and over estimates, respectively, although
the difference is likely to be small as relatively few were
trained beyond the initial training period and few trans-
ferred or left their posts over the 1- year trial period. Use of
a mixed- methods approach with data collection through
multiple methods and sources, helped to mitigate the
effects of self- report bias to some degree by creating
opportunities from more neutral sources to provide addi-
tional information, allowing for analysis of concordance
and discordance across data sources. In addition, as the
process evaluation data was predominantly qualitative in
nature, scores could not be calculated for RE- AIM dimen-
sions. Although participating sites were reflective of the
distribution of HCs with respect to rural/urban location
and ministry/non- ministry funding, due to the relatively
small number of urban and non- ministry funded sites, it
was not possible to assess for factors impacting implemen-
tation that may be unique to these sites. As only LHWs
participated in the current study, findings may not be
generalisable to other healthcare worker cadres.
CONCLUSIONS
This process evaluation identified important challenges
to and potential facilitators of implementation, scal-
ability and sustainability, of the TB treatment adherence
intervention and use of the implementation strategies
employed that were not previously identified in the pilot
study. The primary barrier identified was lack of stipends,
with intrinsic motivation and increased support for and
from PTs important potential facilitators. As provision of
training stipends is not feasible for wide spread imple-
mentation given the large LHW workforce in Malawi.
Solutions to addressing identified barriers are essential
to scale- up of the current intervention and to use of the
implementation strategies and in particular, the training
approach employed, to address LHW training needs in
other areas. Suggestions identified in the current study
include a focus on intrinsic motivators and ensuring
sufficient number and adequate training of PTs both in
programme content and approaches to supportive super-
vision. These may be insufficient alone to address the
lack of incentives in the current climate. Required rather
than optional participation under regular programmatic
conditions may further support implementation and it
is hoped that resistance will reduce as the non- incentive
policy becomes standard.
Given the lack of a significant effect of the interven-
tion on patient TB treatment outcomes and substantial
challenges to implementation encountered in this large
scale implementation study, further research to assess
effectiveness of the intervention in the context of high
levels of implementation quality and fidelity is needed,
before wide scale implementation can be considered. In
addition, further work to develop implementation strat-
egies to address barriers to implementation are needed
before wider scale implementation of the TB adherence
intervention or use of the strategies employed to support
other implementation activities can be considered.
Author afliations
1Department of Medicine, University of Toronto, Toronto, Ontario, Canada
2Knowledge Translation Program, St Michael's Hospital Li Ka Shing Knowledge
Institute, Toronto, Ontario, Canada
3Emergency Medicine, University Health Netowrk, Toronto, Ontario, Canada
4Institute of Health policy, management, and evaluation, university of toronto,
toronto, ontario, canada
5Dignitas International, Zomba, Malawi
6University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada
7Malawi National TB control Program, Lilongwe, Malawi
8Department of Mathematics and Statistics, University of Ottawa, Ottawa, Ontario,
Canada
9Family Medicine, Schulich School of Medicine and Dentistry Department of Family
Medicine, London, Ontario, Canada
10Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
11The George Institute for Global Health, Newtown, New South Wales, Australia
12The University of Sydney, Sydney, New South Wales, Australia
13Dignitas International, Toronto, Ontario, Canada
Acknowledgements Jan Barnsley for her consultation into the qualitative
approach used in the pilot and current studies. We also wish to thank the LHW
participants in the study.
Contributors All authors contributed to the study design (LMPR, ECK, AM, MvL,
AM, SES, JSH, MZ, MS, AC, ALCM and VvS). LMPR led all aspects of the study
and was responsible for the rst draft of the manuscript. LMPR, ECK, AM, HK and
SES contributed to the revisions of the educational outreach programme, training
manual and clinical support tool. ECK conducted patient interviews, and veried all
transcripts. ECK, HM and LMPR conducted the analysis. All authors (LMPR, ECK, AM,
MvL, AM, SES, JSH, MZ, MS, ALCC, AM and VvS) participated in critical revisions of
the manuscript, read and approved the nal manuscript.
Funding This work was supported by the Canadian Institutes of Health Research
KAL-139700. SES is funded by a Tier 1 Canada Research Chair and the Squires
Chalmers Chair in Medicine. A Martiniuk was funded by a National Health and
Medical Research Foundation (NHMRC) Translating Research into Practice (TRIP)
Fellowship from 2016 to 2019.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in
the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Ethics approval This study has been approved by the St. Michael's Hospital
Research Ethics Board (protocol #15-282) and the Malawi National Health Sciences
Research Committee (protocol # 15/9/1479). Written consent was obtained from
interview participants.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available. Data from this study will not
be shared in keeping with the guarantee during the consent process that transcript
data would be accessible only to the study team.
Open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY- NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non- commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the use
is non- commercial. See:http:// creativecommons. org/ licenses/ by- nc/ 4. 0/.
ORCID iDs
Lisa MPuchalski Ritchie http:// orcid. org/ 0000- 0002- 1791- 5368
Moniquevan Lettow http:// orcid. org/ 0000- 0002- 0679- 285X
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