title: A knowledge translation intervention to improve tuberculosis care and outcomes in Malawi: a pragmatic cluster randomized controlled trial.
abstract: BACKGROUND
  Lay health workers (LHWs) play a pivotal role in addressing the high TB burden in Malawi. LHWs report lack of training to be a key barrier to their role as TB care providers. Given the cost of traditional off-site training, an alternative approach is needed. Our objective was to evaluate the effectiveness of a KT intervention tailored to LHWs needs.
  
  
  METHODS
  The study design is a pragmatic cluster randomized trial. The study was embedded within a larger trial, PALMPLUS, and compared three arms which included 28 health centers in Zomba district, Malawi. The control arm included 14 health centers randomized as controls in the larger trial and maintained as control sites. Seven of 14 PALMPLUS intervention sites were randomized to the LHW intervention (PALM/LHW intervention arm), and the remaining 7 PALMPLUS sites maintained as a PALM only arm. PALMPLUS intervention sites received an educational outreach program targeting mid-level health workers. LHW intervention sites received both the PALMPLUS intervention and the LHW intervention employing on-site peer-led educational outreach and a point-of-care tool tailored to LHWs identified needs. Control sites received no intervention. The main outcome measure is the proportion of treatment successes.
  
  
  RESULTS
  Among the 28 sites, there were 178 incident TB cases with 46/80 (0.58) successes in the control group, 44/68 (0.65) successes in the PALMPLUS group, and 21/30 (0.70) successes in the PALM/LHW intervention group. There was no significant effect of the intervention on treatment success in the univariate analysis adjusted for cluster randomization (p = 0.578) or multivariate analysis controlling for covariates with significant model effects (p = 0.760). The overall test of the intervention-arm by TB-type interaction approached but did not achieve significance (p = 0.056), with the interaction significant only in the control arm [RR of treatment success for pulmonary TB relative to non-pulmonary TB, 1.18, 95% CI 1.05-1.31].
  
  
  CONCLUSIONS
  We found no significant treatment effect of our intervention. Given the identified trend for effectiveness and urgent need for low-cost approaches to LHW training, further evaluation of tailored KT strategies as a means of LHW training in Malawi and other LMICs is warranted.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01356095 .
authors.affiliation: Department of Medicine, University of Toronto, Toronto, Ontario, Canada. lisa.puchalskiritchie@utoronto.ca.|Department of Emergency Medicine, University Health Network, Toronto General Hospital, RFE-GS-480, 200 Elizabeth St., Toronto, Ontario, M5G 2C4, Canada. lisa.puchalskiritchie@utoronto.ca.|Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada. lisa.puchalskiritchie@utoronto.ca.
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Puchalski Ritchie
authors.affiliation: Department of Medicine, University of Toronto, Toronto, Ontario, Canada. mjs@ices.on.ca.|Dignitas International, Toronto, Canada. mjs@ices.on.ca.|Sunnybrook Health Sciences Center, Toronto, ON, Canada. mjs@ices.on.ca.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Schull
authors.affiliation: Dignitas International, Toronto, Canada. amartiniuk@george.org.au.|George Institute for Global Health, Sydney, Australia. amartiniuk@george.org.au.|The University of Sydney, Sydney, Australia. amartiniuk@george.org.au.|Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. amartiniuk@george.org.au.
authors.forename: Alexandra L C
authors.initials: AL
authors.lastname: Martiniuk
authors.affiliation: Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada. jan.barnsley@utoronto.ca.
authors.forename: Jan
authors.initials: J
authors.lastname: Barnsley
authors.affiliation: Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. tamara.arenovich@utoronto.ca.
authors.forename: Tamara
authors.initials: T
authors.lastname: Arenovich
authors.affiliation: Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. m.vanlettow@dignitasinternational.org.|Dignitas International, Zomba, Malawi. m.vanlettow@dignitasinternational.org.
authors.forename: Monique
authors.initials: M
authors.lastname: van Lettow
authors.affiliation: Department of Medicine, University of Toronto, Toronto, Ontario, Canada. a.chan@dignitasinternational.org.|Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada. a.chan@dignitasinternational.org.|Dignitas International, Toronto, Canada. a.chan@dignitasinternational.org.|Sunnybrook Health Sciences Center, Toronto, ON, Canada. a.chan@dignitasinternational.org.
authors.forename: Adrienne K
authors.initials: AK
authors.lastname: Chan
authors.affiliation: Faculty of Health Sciences, University of Ottawa, Ottawa, Canada. Edward.Mills@uottawa.ca.
authors.forename: Edward J
authors.initials: EJ
authors.lastname: Mills
authors.affiliation: National TB Control Program, Ministry of Health, Lilongwe, Malawi. a_makwakwa@yahoo.com.
authors.forename: Austine
authors.initials: A
authors.lastname: Makwakwa
authors.affiliation: Dignitas International, Toronto, Canada. merrick.zwarenstein@ices.on.ca.|Knowledge translation unit, Lung Institute, University of Cape Town, Cape Town, South Africa. merrick.zwarenstein@ices.on.ca.|Stellenbosch University Faculty of Health Sciences, Tygerberg, South Africa. merrick.zwarenstein@ices.on.ca.|Depart of Family Medicine, Western University, London, Ontario, Canada. merrick.zwarenstein@ices.on.ca.
authors.forename: Merrick
authors.initials: M
authors.lastname: Zwarenstein
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D044966:Anti-Retroviral Agents / Q000627:therapeutic use; D000995:Antitubercular Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003142:Communication; D003150:Community Health Workers / Q000193:education*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000453:epidemiology; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007223:Infant; D033181:Information Dissemination; D008295:Malawi; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010379:Peer Group; D014376:Tuberculosis / Q000188:drug therapy* / Q000453:epidemiology; D055815:Young Adult
chemical_list: D044966:Anti-Retroviral Agents; D000995:Antitubercular Agents