title: Considerations for preparing a randomized population health intervention trial: lessons from a South African-Canadian partnership to improve the health of health workers.
abstract: BACKGROUND
  Community-based cluster-randomized controlled trials (RCTs) are increasingly being conducted to address pressing global health concerns. Preparations for clinical trials are well-described, as are the steps for multi-component health service trials. However, guidance is lacking for addressing the ethical and logistic challenges in (cluster) RCTs of population health interventions in low- and middle-income countries.
  
  
  OBJECTIVE
  We aimed to identify the factors that population health researchers must explicitly consider when planning RCTs within North-South partnerships.
  
  
  METHODS
  We reviewed our experiences and identified key ethical and logistic issues encountered during the pre-trial phase of a recently implemented RCT. This trial aimed to improve tuberculosis (TB) and Human Immunodeficiency Virus (HIV) prevention and care for health workers by enhancing workplace assessment capability, addressing concerns about confidentiality and stigma, and providing onsite counseling, testing, and treatment. An iterative framework was used to synthesize this analysis with lessons taken from other studies.
  
  
  RESULTS
  The checklist of critical factors was grouped into eight categories: 1) Building trust and shared ownership; 2) Conducting feasibility studies throughout the process; 3) Building capacity; 4) Creating an appropriate information system; 5) Conducting pilot studies; 6) Securing stakeholder support, with a view to scale-up; 7) Continuously refining methodological rigor; and 8) Explicitly addressing all ethical issues both at the start and continuously as they arise.
  
  
  CONCLUSIONS
  Researchers should allow for the significant investment of time and resources required for successful implementation of population health RCTs within North-South collaborations, recognize the iterative nature of the process, and be prepared to revise protocols as challenges emerge.
authors.affiliation: School of Population and Public Health, University of British Columbia, Vancouver, Canada; annalee.yassi@ubc.ca.
authors.forename: Annalee
authors.initials: A
authors.lastname: Yassi
authors.affiliation: School of Population and Public Health, University of British Columbia, Vancouver, Canada.
authors.forename: Lyndsay Michelle
authors.initials: LM
authors.lastname: O'Hara
authors.affiliation: Centre for Health Systems Research & Development, University of the Free State, Bloemfontein, South Africa.
authors.forename: Michelle C
authors.initials: MC
authors.lastname: Engelbrecht
authors.affiliation: Centre for Health Systems Research & Development, University of the Free State, Bloemfontein, South Africa.
authors.forename: Kerry
authors.initials: K
authors.lastname: Uebel
authors.affiliation: Provincial Occupational Health Unit, Free State Department of Health, University of the Free State, Bloemfontein, South Africa.
authors.forename: Letshego Elizabeth
authors.initials: LE
authors.lastname: Nophale
authors.affiliation: Vancouver Coastal Health, Vancouver, Canada.
authors.forename: Elizabeth Ann
authors.initials: EA
authors.lastname: Bryce
authors.affiliation: School of Population and Public Health, University of British Columbia, Vancouver, Canada.
authors.forename: Jane A
authors.initials: JA
authors.lastname: Buxton
authors.affiliation: School of Population and Public Health, University of British Columbia, Vancouver, Canada.
authors.forename: Jacob
authors.initials: J
authors.lastname: Siegel
authors.affiliation: School of Population and Public Health, University of British Columbia, Vancouver, Canada.
authors.forename: Jerry Malcolm
authors.initials: JM
authors.lastname: Spiegel
mesh_terms: D002170:Canada; D005240:Feasibility Studies; D015658:HIV Infections / Q000517:prevention & control; D006282:Health Personnel; D006801:Humans; D007391:International Cooperation; D016032:Randomized Controlled Trials as Topic / Q000941:ethics / Q000379:methods*; D013019:South Africa; D014397:Tuberculosis, Pulmonary / Q000517:prevention & control
keywords: building relationships; cluster-randomized controlled trials; ethical issues; feasibility studies; iterative process; pilot testing; population health; pre-trial considerations; receptor capacity