Training Lay Healthcare Workers to Optimize TB Care and Improve Outcomes in Malawi
Phase: NA
Conditions: Tuberculosis
Sponsor: Dignitas International

Title: Training Lay Healthcare Workers to optimize TB care and improve outcomes in Malawi 
NCT #: 02533089 
Date: June 15, 2016 
Document Type: Study Protocol with SAP 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Background/Rationale: 
The global shortage of skilled healthcare workers is estimated at 4.2 million, with1.5 million 
healthcare workers needed in Africa (1). Task shifting of less complex healthcare tasks to LHWs 
is increasingly employed to address this shortage (2). Despite availability of effective treatment, 
TB remains an important cause of mortality with 1.3 million lives lost globally to TB in 2012(3). 
The greatest proportion of new TB cases occurs in Africa and over 95% of TB deaths occur in 
low income countries (LICs) (3). In response to the high TB burden and severe healthcare 
worker shortages in these settings, outpatient TB care is among the tasks commonly shifted to 
LHWs.  
 
LHWs are community members who have received some training but are not healthcare 
professionals (4). Randomised trials show LHWs improve access to basic health services and TB 
treatment outcomes by providing care and adherence support in the community (4, 5). However, 
insufficient training and supervision are recognized barriers to their effectiveness (5). LHW 
training is typically conducted off-site (6), an approach that is expensive in both direct and 
opportunity costs due to disruption in care provision, and thus, limits training. Given their 
relative low cost and proven effectiveness, educational outreach and reminder KT strategies offer 
a promising solution to addressing LHW training needs by increasing incorporation of best 
evidence into LHW practice.  
 
Malawi has among the lowest healthcare worker to population ratios with 2 physicians and 34 
nurses/midwives per 100,000 people (7). In response, Malawi scaled up its LHW cadre to 
>10000. As the primary providers of outpatient TB care LHWs have a pivotal role in addressing 
the high TB burden in Malawi, with over 20000 new TB notifications in 2012 (8). In spite of 
ongoing efforts, poor treatment adherence remains an important contributor to the high TB 
burden in Malawi with treatment completion rates ranging from 58 to 70% in our recent study in 
Zomba district(9).  
 
Despite their critical role, LHWs (termed health surveillance assistants, HSAs, in Malawi) in our 
recent study identified lack of disease and job-specific training as the key barrier to their role as 
TB care providers (10). This project aims to address this knowledge-to-action gap by refining, 
implementing and evaluating a KT strategy designed to improve LHW TB knowledge and 
counselling skills, and through this improve TB care provided by LHWs and TB outcomes. 
Based on the findings of our previous study, knowledge users in Malawi are keen to improve and 
further explore the strategy in preparation for scale up. 
 
Study Goals and Objectives: 
Our goal is to improve tuberculosis (TB) care provided by Lay Health Workers (LHWs) in 
Malawi by refining, implementing and evaluating a knowledge translation (KT) strategy 
designed to facilitate incorporation of evidence into LHW practice. 
  
Specific objectives: 
1. Improve TB outcomes by implementing and evaluating a KT strategy developed and tested by 
our group to address an identified gap in care provided by LHWs in Malawi.  

2. Identify barriers and facilitators to scalability and sustainability of this KT strategy, and its 
potential to address other gaps in care provided by LHWs. 
 
Research Question(s): 
1. Is a KT strategy to improve LHW TB knowledge and skills, effective in improving TB care 
and outcomes in Malawi? 
2. What are the barriers and facilitators to scalability and sustainability of the TB intervention 
and to the use of KT strategies to address other gaps in care provided by LHWs? 
 
Methods: 
Design: This project will employ a mixed methods design. We will conduct a pragmatic cluster 
(RCT) to evaluate effectiveness and understand how to scale up and sustain the strategy. 
Qualitative interviews with LHW participants and patients, and document analysis of training 
logs, quarterly peer trainer meeting and mentorship meeting notes, will be used to gain an 
understanding of barriers/facilitators to implementation, scalability and sustainability of the 
program.  
 
Setting, Participants, & Randomization: 
Dignitas International works closely with the Malawi MOH to support health system 
strengthening and build capacity among healthcare workers to improve clinical care and 
outcomes. This project will include all HCs providing TB care among the 124 HCs in 4 districts 
in which DI operates, excluding the district included in our preliminary study and 1 district that 
declined to participate.  As TB care is provided at health centers (HCs) on a rotating basis 
patients receive care from several LHWs during treatment. Given this system of care, a cluster 
RCT (with allocation at the HC level) was chosen to prevent contamination. HCs will be 
randomly allocated using a computer-generated random number list prepared by the statistician, 
stratified by district and HC status as anti-retroviral (ARV) initiation sites. These stratification 
variables are chosen to address district level variations in operationalization of TB policy and the 
potential for LHWs at ARV initiation sites to have received additional clinical training relevant 
to TB care. 
 
TB focused LHWs (TBLHWs) at participating HCs will be contacted through the district health 
offices. TBLHWs are general LHWs who receive 2 weeks of additional TB training and are 
responsible for TB care at the HC level. TBLHWs were selected as peer trainers by the MOH 
given their status and responsibilities as the local head of TB care. Our previous work found 
TBLHWs effective in this role as they were seen as experts by general LHWs particularly after 
they were trained and assumed the role of peer trainer. All LHWs routinely providing TB care 
will be eligible and invited to participate in the training with refusal to participate the only 
exclusion criteria. Health Centers and TBLHWs will be enrolled by the study coordinator. Given 
the nature of the intervention blinding is not possible.  
 
Interview participants will include LHWs who have received the intervention and 
patients/guardians who begin TB treatment on or after the trial start date and who are followed at 
a participating health center. 
 

Inclusion/Exclusion Criteria: 
The trial will include all Health centers providing TB care among the 124 HCs in 4 districts in 
which DI operates, excluding the district in which the pilot study was conducted and a second 
district that declined to participate. Health centers will be excluded if they do not routinely 
provide TB care. 
LHWs who have completed the educational outreach training and TB patients of participating 
health centers who begin TB treatment during the trial period presenting for TB care on days the 
study research assistant is collecting data will be eligible for participation in the qualitative 
study. Exclusion criteria for interview participants include: TB patients less than 18 years of age 
unaccompanied by a parent or guardian, patients/guardians or LHWs unwilling or unable to give 
informed consent, patient not usually treated at the participating health center, patients deemed 
by the local healthcare team to be too ill to participate. 
Sample Size:  
Although 124 health centers are available for participation in the 4 study districts, a small 
number do not routinely provide TB care. In addition, based on our experience in the preliminary 
study, where several clusters were lost due to staff shortages necessitating transfer of TB cases or 
failed to accrue eligible TB cases in small remote health centers, we have estimated the sample 
size for the present study conservatively as follows. Based on an alpha of .05, power of .80, 
baseline successful treatment completion of .80 at 1year, ICC of 0.1 based on our pilot study data 
and an estimated 100 clusters (HCs that provide TB care), a minimum of 6 patients are required 
per cluster to detect a clinically significant .10 increase in proportion of successful treatment 
completion.  
Interviews will be conducted with LHWs and patients at 2 time points during the trial, with an 
estimated 10-15 participants from each group required each time to reach saturation and allow 
for sampling from all participating HCs for a total of 40-60 participants. 
KT Intervention: 
The current strategy builds on our earlier work, which identified a gap in LHW TB knowledge 
and job-specific training. The multifaceted KT strategy will employ peer-trainer led educational 
outreach, a point of care reminder tool, and a peer mentoring network, chosen based on evidence 
for effectiveness of this approach with mid-level health workers in South Africa (12,13,14) and 
feedback from our prior study (9). Improved patient TB knowledge and positive patient-provider 
interactions, two common barriers to adherence (15,16,17,18), are targeted through improved 
LHW skills in patient education and adherence counselling. Although evidence for communities 
of practice is poor (19), we include a peer mentorship network based on previous feedback from 
peer trainers to evaluate its potential role and cost implications. 
 

The educational outreach component will employ on-site training, led by the TBLHWs trained as 
peer trainers, delivered to small groups of general LHWs (typically 5-10) who provide TB care. 
Sessions will use both didactic and interactive techniques including case based learning and role 
playing to convey TB and adherence knowledge, and counselling skills, and to allow for practice 
with the point of care tool, critical reflection, and exchange of ideas among LHWs. Topics 
include: TB transmission and treatment; common causes and consequences of non-adherence; 
approaches to support adherence and address non-adherence while maintaining a positive 
patient-provider relationship. Based on our previous study two sessions will be added and the 
training period extended by 1 month to allow more time for each topic, and a reference manual 
provided in Chichewa. 
 
Peer Trainers will be trained over 5 days off-site by Lisa Puchalski Ritchie in English with the 
help of a socio-linguistic level interpreter. Training will include content and techniques for peer-
training and supportive supervision. Peer trainers will be mentored by DI clinical staff during 
regular field visits conducted at HCs they provide support to. Based on knowledge user feedback 
from our earlier work, development of a peer-support network will be encouraged through 
quarterly in-person meetings bringing together peer trainers in each district, to share experience, 
offer peer-support and provide an additional opportunity for mentorship from the implementation 
team. To encourage development of the network, peer trainers will receive monthly phone credit 
throughout the study period. If effective this credit may be sustainable by the MOH particularly 
during the initial roll out, which is the most challenging time for new peer trainers. 
 
Training 
Peer trainers will provide a minimum of 8 sessions each lasting 60-90 minutes over a 4-month 
period, on-site during regular work hours, with all general LHWs providing TB care invited to 
participate. Extra sessions as refreshers or to train new staff will be left to the discretion of the 
peer trainers. Training materials and certificates of completion will be provided in English and 
Chichewa. Incentives will not be provided as training of general LHWs to assist with TB care is 
part of the TBLHWs job description, training will occur during regular work hours, and 
providing incentives would limit sustainability. 
 
The  point of care tool provided in Chichewa (English version attached), is a two-sided laminated 
flip chart point of care tool, that can stand on a desk or be carried during field visits. The patient 
side uses simple pictorials to illustrate a patient and TB bacterium’s course through treatment 
and acts as an aid to LHWs in providing patient education and adherence counselling. The LHW 
side provides a reminder to trigger an adherence discussion during patient interactions and 
supports side-effect management and constructive approaches to addressing non-adherence. 
Based on our earlier work, a drug dosing reference will be added to the tool. 
 
Control Group 
LHWs in control sites will receive usual training at the discretion of the HCs’ TBLHW; the 
content, format, and duration of which varies considerably and ranges from a 1-2 hour briefing 
on medication dispensing and form completion to a few days working alongside the TBLHW as 
they provide patient care. They will not receive access to the point of care tool or the peer 
network. 
 

Outcomes:  
The primary trial outcome of interest is proportion of cases successfully treated, defined 
according to the World Health Organization criteria (20), as the total number of cases cured and 
completing treatment. Secondary trial outcomes include: proportion of default cases (treatment 
interrupted >= 2 consecutive months) and proportion of successes among HIV co-infected cases.  
Qualitative outcomes of interest include barriers and facilitators to implementation, scalability, 
sustainability, and to identify potential program improvements.  
Participant Recruitment/Consent: 
Two to four participants from each group (LHWs and Patients) will be selected in each data 
collection period from each district and a maximum of 2 from any one HC.  
 
LHWs will be selected for interviews using mixed purposeful sampling. A list of trained LHWs 
compiled by the peer trainers will provide the initial sampling frame. LHWs will be selected 
from the list to represent the range of LHW characteristics in terms of gender, age, years of 
experience and HC characteristics (rural/urban). Three LHWs chosen to reflect the range of 
responses (positive to negative) in the first round of interviews will be selected to be interviewed 
at both study onset and conclusion. The study and research assistant will be introduced to the 
general LHWs by the peer trainers. LHWs will then be approached in person or by telephone if 
the selected LHW is not present on site at the time of the health center visit by the study RA 
using the recruitment script (appendix C). 
 
Convenience sampling will be used to select patients/guardians for interviews. . Patients will be 
selected to represent the range of characteristics in terms of age, gender, and TB characteristics 
(new/recurrent,  pulmonary/non-pulmonary). A research assistant will attend HCs on days 
identified by HC staff as typically busy. The research assistant will be introduced to patients by 
the LHWs working in the health center during health center visits. After being introduced the RA 
will approach patients in person using the recruitment script (appendix D). 
 
LHW participants in the educational intervention are health center personnel, who receive 
routine training and supervision. LHWs in intervention sites routinely involved in care of TB 
patients will be encouraged but not required to attend training sessions. The educational 
intervention and point of care tool will be revised in collaboration with and approved by the 
National TB program (NTP) to ensure consistency with National TB treatment guidelines. As  
undergoing training is a routine expectation of health center staff and the training will be 
approved by the NTP, individual consent is not required for participation in the intervention.  
Written informed consent will be obtained in person by the study RA prior to beginning the 
interview (appendix E and F). In order to ensure participant understanding, in addition to 
providing the consent form in Chichewa, the study RA will read through the consent form out 
loud. Participants will then be given an opportunity to read the consent form and to have any 
questions they may have answered by the study team. Once all questions are answered to the 

participants’ satisfaction, they will be asked if they wish to participate, and the form signed and 
witnessed. For patients under 18 years of age, consent will be obtained from their parent or 
guardian using the same process, and assent (appendix H) obtained for children old enough to 
participate in interviews after parental consent has been obtained 
A copy of the consent form which includes contact information for the co-principal investigators, 
Dr. Sharon Straus and Dr. Puchalski Ritchie, and local Co-PI Dr. Monique van Lettow, both the 
St. Michaels’ Hospital ethics review board and Malawi National Health Sciences Research 
Committee. Participants are free not to answer any question or to withdraw from the study at any 
time without penalty. 
Data Collection: 
Trial data will be collected at the end of the 1 year trial period. A digital copy will be made of 
TB registers from all included health centers at the end of the 1 year trial period. Digital copies 
will be password protected and stored on a secure server accessible only to the study team. Once 
double data entry and verification of the database is complete the digital copies will be 
destroyed.  
Interviews will be conducted with LHWs and patients at 2 time points; in the first 3 months after 
training and in the last 3 months of the trial to assess barriers to implementation and 
sustainability. 2-3 LHWs will be interviewed both times, in order to capture change within and 
across individuals over time. Participants will be interviewed by a trained research assistant 
fluent in English and Chichewa, using a semi-structured interview guide (Appendix A and B) to 
ensure key areas of interest are addressed and to allow for emergence of novel themes.            
Interviews will be conducted in a private location (at or near the participants’ health center) at a 
time convenient to participants, with interviews expected to last 30 to 60 minutes. Interviews will 
be audio recorded digitally using unique numeric identifiers only.  
 
Training logs, quarterly peer trainer and mentorship meeting notes will be collected by the RA 
for analysis. No identifying data will be collected during the document review, with documents 
identified by unique numeric codes only.  
Data Management: 
No paper copies of the recruitment list will be maintained. The electronic copy of the recruitment 
list will be password protected and stored on an encrypted USB and secure server, maintained 
separate from the unique numeric identifier list, and accessible only to the principal 
investigators, a study co-ordinator and research assistant. The recruitment list will be destroyed 
once the study is complete. 
 
Digitized health center TB registers will be password protected and stored on an encrypted USB 
and secure server. Identifying data (name, village name, and TB number) will be used to verify 
records from double data entry only. Once verified name, village name and TB number will be 
removed from the database, and records maintained using a unique ID number only. No personal 
identifiers will be collected from interview participants. Only unique numeric identifiers will be 

utilized for audio recordings and transcripts. Audio recordings will be destroyed by the principal 
investigator once analysis is complete. 
 
Consent forms, training logs, quarterly peer trainer and mentorship meeting notes will be stored 
in a locked cabinet in a locked room in dignitas international Malawi until transferred to li ka 
shing, and accessible only by (Co-PIs, study coordinator and research assistant). No identifying 
data will be released at any time, with results reported in aggregate form only. Electronic records 
including the trial outcome database, transcripts, training logs, quarterly peer trainer and 
mentorship meeting notes will be destroyed after 10 years.  
 
Analysis Plan:  
The primary outcome of interest is proportion of treatment successes at 1 year. Multilevel 
modeling will be used to compare proportion of treatment successes among control and 
intervention groups with analysis adjusted for correlation due to clustering and stratification. 
Multilevel modeling will also allow us to examine similarity and differences between and within 
district (strata) and healthcare center (cluster) outcomes. Analysis will be conducted on an 
intention to treat basis and performed using SAS and R statistical software. 
 
Interviews will be conducted by a trained Malawian research assistant (RA) fluent in both 
English and Chichewa, and functioning at the level of a socio-linguistic translator (21). 
Interviews will be audio taped, transcribed verbatim, and translated by the RA who conducted 
the interview. Twenty percent of transcripts will be re-translated by a second RA as a quality 
check. Should discrepancies in conceptual equivalence be observed, all transcripts will be 
translated by a second interpreter and discrepancies resolved by consensus. Interviews and 
training log entries will be analyzed using qualitative content analysis.  Two study team 
members will read and code the transcripts, training logs, and meeting reports, independently 
with discrepancies resolved through consensus. Nvivo 10 will be used to code and organize data 
into themes. Themes will be sought within and across individuals, participant groups, and data 
collection periods, to allow for assessment of change and emergence of themes over time. 
Results from qualitative data sources will be triangulated using the technique of integration, with 
data from all sources considered in detail to provide a more comprehensive understanding of the 
barriers and facilitators of sustainability and scalability of the intervention, and to use of the 
approach to address other gaps in care provided by LHWs. 
 
Dissemination Plan: 
Study findings will be submitted for peer reviewed publication and for presentation at 
appropriate international conferences. In addition, study findings will be disseminated to 
participants and stakeholders through presentation at a local meeting and a one page lay to be 
made available to participants and to be posted in the TB clinic of participating health centers.  
 
Ethical Considerations:  
Risks/Benefits: 
There are no known risks to participation in this study. It is possible that LHWs may view the 
training sessions as an additional burden. However, we think this unlikely as training will occur 

onsite during regular work hours, LHWs will be encouraged but not required to attend, and given 
the positive perceptions of the intervention in the pilot study and expressed need for additional 
training found in our formative qualitative study. It is possible that participants may be distressed 
by interview questions. In order to minimize this risk, interviews will be conducted at a time and 
location convenient to the participant. In the unlikely event that participants are distressed by the 
interview questions the interview will be immediately terminated. 
Potential benefits to LHWs participating in the intervention include additional training and an 
opportunity to provide input into improving the intervention to better suit their needs. There are 
no direct benefits to patients participating in interviews, although they may appreciate the 
opportunity to provide input to allow for improvement of the intervention for the benefit of 
future TB patients. 
Confidentiality: 
No paper copies of the recruitment list will be maintained. The electronic copy of the recruitment 
list and digitized copy of the TB register will be password protected and stored on an encrypted 
USB and secure server, maintained separate from the unique numeric identifier list, and 
accessible only to the principal investigators, a study co-ordinator and research assistant. 
Digitized TB register records will be destroyed once data entry has been verified and the 
recruitment list destroyed at the completion of the study. Consent forms and training logs, 
meeting reports and mentorship notes,  will be stored in a locked cabinet in a locked room. No 
identifying data will be released at any time, with results reported in aggregate form only. 
Ethical Approval: 
Ethical approval for this study will be obtained from the St. Michael’s Hospital, and the Malawi 
National Health Science Committee. 
Timeline: 
The project will take approximately 24 months from start to finish including local dissemination.  
Based on our experience with the preliminary study we have scaled back the frequency of data 
collection for the present study and amended the timeline outlined below accordingly. 
Timeline (month) & Deliverable 
1-4 Finalize revisions, pilot new tool, train study team and peer trainers, randomize HCs 
5-8 LHW training 
9-18 Data collection, 4 quarterly meetings, initial qualitative data analysis 
19-24 Finalize qualitative, quantitative and economic analysis; report and manuscript 
preparation; dissemination meetings 
 
Potential Challenges/Solutions: 

Staff turnover can present a challenge in Malawi. For this reason peer trainers will be 
empowered to provide extra training sessions as needed, new peer trainers trained by DI mentors 
if needed, and multiple knowledge users (KUs) have been engaged at all levels of the ministry of 
health,  to ensure continuity and facilitate engagement of new KUs as necessary. As staff 
shortages resulted in a loss of clusters in our previous study we have estimated our sample size 
conservatively based on a lower number of clusters than we anticipate will begin the study. As 
providing stipends is common in Malawi, not doing so may represent a challenge. But as this 
was a minor issue in our preliminary study and is in keeping with recent policy changes in 
Malawi we do not anticipate this will be a significant issue. 
 
Significance of Results: 
 
Despite availability of effective treatment, TB has a substantial impact on mortality in Malawi 
and other LICs. LHWs provide a potential solution to addressing the severe healthcare worker 
shortages and high TB burdens in these settings. However, to date expansion of the LHW cadre 
and task shifting of outpatient TB care in Malawi, has failed to achieve the desired impact. Our 
project aims to refine, implement and evaluate a knowledge translation intervention previously 
piloted in a single district in Malawi, designed to improve uptake of evidence into routine 
practice of LHWs providing TB care in Malawi. Given the increasing role of LHW in LICs, 
approaches to addressing knowledge gaps among LHWs through adequate training and 
supervision are essential to improving health outcomes.  
The results of this project will inform the efforts of the Malawi Ministry of Health’s National TB 
control program who are keen to implement the program nationally if proven effective. In 
addition, this project has potential to generate principles that will inform programs to improve 
practice in other areas of care provided by LHWs in Malawi and in other LICs. 
 
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