Training Lay Healthcare Workers to Optimize TB Care and Improve Outcomes in Malawi

Task shifting of less complex healthcare tasks to lay health workers (LHWs) is increasingly employed strategy to address the global shortage of skilled health workers. Despite availability of effective treatment, tuberculosis (TB) remains an important cause of mortality with 1.3 million lives lost globally to TB in 2012. The greatest proportion of new TB cases occurs in Africa and over 95% of TB deaths occur in low income countries (LICs). In response to the combined 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. Randomised trials show LHWs improve access to basic health services and TB treatment outcomes, however, insufficient training and supervision are recognized barriers to their effectiveness.

The investigators' goal is to improve TB care provided by LHWs in Malawi by implementing and evaluating a knowledge translation (KT) strategy designed to facilitate incorporation of evidence into LHW practice. The investigators will employ a mixed methods design including a pragmatic cluster randomized controlled trial to evaluate effectiveness of the strategy and qualitative methods to understand barriers and facilitators to scalability and sustainability of the program.

Study Overview

• Status: Completed
• Conditions: Tuberculosis
• Intervention / Treatment: Other: KT intervention

• Study Type: Interventional
• Enrollment (Actual): 1153
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Malawi, Malawi
    • 4 Districts, SE zone of Malawi (Balaka, Machinga, Mangochi, Mulanje)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all health centers in participating districts that routinely provide TB care will be included.
• LHWs who have received the intervention and patients receiving care at participating health centers will be eligible to participate in interviews

Exclusion Criteria:

• health centers that do not routinely provide TB care
• LHWs unwilling or unable to give informed consent.
• 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, patients presenting to a health center they are not routinely followed at.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KT intervention; Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.	Other: KT intervention; Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.
No Intervention: Control; Control sites will receive no intervention, with LHW training left to the discretion of the health centers TB focus LHW. Control sites will not have access to the point of care tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment.	primary outcome =proportion of cases successfully treated, defined as the total number of cases cured and completing treatment.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months)	secondary outcome =proportion of default cases (treatment interrupted >= 2 consecutive months)	1 year
Proportion of Successes Among HIV Co-infected Cases	secondary outcome = proportion of successes among HIV co-infected cases	1 year

Collaborators and Investigators

• Sponsor: Dignitas International
• Collaborators: Unity Health Toronto
• Investigators: Principal Investigator: Lisa M Puchalski Ritchie, MD,PhD, Li Ka Shing Knowledge Institute

Publications and helpful links

General Publications

• Puchalski Ritchie LM, Kip EC, Mundeva H, van Lettow M, Makwakwa A, Straus SE, Hamid JS, Zwarenstein M, Schull MJ, Chan AK, Martiniuk A, van Schoor V. 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 Jul 2;11(7):e048499. doi: 10.1136/bmjopen-2020-048499.
• Puchalski Ritchie LM, van Lettow M, Makwakwa A, Kip EC, Straus SE, Kawonga H, Hamid JS, Lebovic G, Thorpe KE, Zwarenstein M, Schull MJ, Chan AK, Martiniuk A, van Schoor V. Impact of a tuberculosis treatment adherence intervention versus usual care on treatment completion rates: results of a pragmatic cluster randomized controlled trial. Implement Sci. 2020 Dec 11;15(1):107. doi: 10.1186/s13012-020-01067-y.
• Puchalski Ritchie LM, van Lettow M, Makwakwa A, Chan AK, Hamid JS, Kawonga H, Martiniuk AL, Schull MJ, van Schoor V, Zwarenstein M, Barnsley J, Straus SE. The impact of a knowledge translation intervention employing educational outreach and a point-of-care reminder tool vs standard lay health worker training on tuberculosis treatment completion rates: study protocol for a cluster randomized controlled trial. Trials. 2016 Sep 7;17(1):439. doi: 10.1186/s13063-016-1563-2.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: August 20, 2015
• First Submitted That Met QC Criteria: August 25, 2015
• First Posted (Estimate): August 26, 2015

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis
• Other Study ID Numbers: TB KT intervention