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N/A Completed N=1,153 Randomized Health Services Research

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

Source: ClinicalTrials.gov NCT02533089 ↗
Enrolled (actual)
1,153
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment. — 297; 348 Participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Proportion of Cases Successfully Treated, Defined as the Total Number of Cases Cured and Completing Treatment.
297; 348 —
SECONDARY
Proportion of Default Cases (Treatment Interrupted >= 2 Consecutive Months)
4; 6 —
SECONDARY
Proportion of Successes Among HIV Co-infected Cases
0; 0 —

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02533089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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