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| Content Provider | Taylor & Francis Online |
|---|---|
| Author | Nophale, Letshego Elizabeth Yassi, Annalee Bryce, Elizabeth Ann Buxton, Jane A. Engelbrecht, Michelle C. Siegel, Jacob O'Hara, Lyndsay Michelle Uebel, Kerry Spiegel, Jerry Malcolm |
| Abstract | BackgroundCommunity-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.ObjectiveWe aimed to identify the factors that population health researchers must explicitly consider when planning RCTs within North–South partnerships.DesignWe 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.ResultsThe 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.ConclusionResearchers 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. |
| File Format | PDF HTM / HTML |
| ISSN | 16549716 16549880 |
| DOI | 10.3402/gha.v7.23594 |
| Journal | Global Health Action |
| Volume Number | 7 |
| Issue Number | 1 |
| Language | English |
| Publisher | Taylor & Francis |
| Publisher Date | 2014-05-02 |
| Access Restriction | Open |
| Subject Keyword | Cluster-randomized controlled trials Population health Pre-trial considerations Receptor capacity Feasibility studies Pilot testing Building relationships Ethical issues Iterative process |
| Content Type | Text |
| Resource Type | Article |
| Subject | Public Health, Environmental and Occupational Health Health Policy |
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