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

Primary Purpose

Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
KT intervention
Sponsored by
Dignitas International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tuberculosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

KT intervention

Control

Arm Description

Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2015
Last Updated
March 23, 2020
Sponsor
Dignitas International
Collaborators
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02533089
Brief Title
Training Lay Healthcare Workers to Optimize TB Care and Improve Outcomes in Malawi
Official Title
Training Lay Healthcare Workers to Optimize TB Care and Improve Outcomes in Malawi
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dignitas International
Collaborators
Unity Health Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
1153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KT intervention
Arm Type
Experimental
Arm Description
Multifaceted KT strategy employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
KT intervention
Intervention Description
Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.
Primary Outcome Measure Information:
Title
Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment.
Description
primary outcome =proportion of cases successfully treated, defined as the total number of cases cured and completing treatment.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months)
Description
secondary outcome =proportion of default cases (treatment interrupted >= 2 consecutive months)
Time Frame
1 year
Title
Proportion of Successes Among HIV Co-infected Cases
Description
secondary outcome = proportion of successes among HIV co-infected cases
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa M Puchalski Ritchie, MD,PhD
Organizational Affiliation
Li Ka Shing Knowledge Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
4 Districts, SE zone of Malawi (Balaka, Machinga, Mangochi, Mulanje)
City
Malawi
Country
Malawi

12. IPD Sharing Statement

Citations:
PubMed Identifier
34215610
Citation
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.
Results Reference
derived
PubMed Identifier
33308257
Citation
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.
Results Reference
derived
PubMed Identifier
27604571
Citation
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.
Results Reference
derived

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

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