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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tuberculosis

Intervention / Treatment
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* Other: KT intervention


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KT intervention<br>Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network. | Other: KT intervention<br>* Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.<br>|
| No Intervention: Control<br>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?
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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 |