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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533089
• Other study ID #: TB KT intervention
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: February 2018

Study information

• Verified date: March 2020
• Source: Dignitas International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1153
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
Malawi	4 Districts, SE zone of Malawi (Balaka, Machinga, Mangochi, Mulanje)	Malawi

Sponsors (2)

Lead Sponsor	Collaborator
Dignitas International	St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Malawi, 

Outcome

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