Considerations for preparing a randomized population health intervention trial: lessons from a South African–Canadian partnership to improve the health of health workers
نویسندگان
چکیده
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. DESIGN 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. CONCLUSION 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.
منابع مشابه
Protecting health workers from infectious disease transmission: an exploration of a Canadian-South African partnership of partnerships
BACKGROUND Health workers are at high risk of acquiring infectious diseases at work, especially in low and middle-income countries (LMIC) with critical health human resource deficiencies and limited implementation of occupational health and infection control measures. Amidst increasing interest in international partnerships to address such issues, how best to develop such collaborations is bein...
متن کاملLessons From Zika Policies to Improve Gender Equity
Gender equity is easily supported in theory but harder to pursue in practice. In this article, the case of Zika travel policies is used to illustrate some glaring gaps related to gender, for both men and women, at both international and national levels. Zika travel policies have not considered new evidence on biological or social determinants of health, putting babies at risk of exposure. The a...
متن کاملA Partnership Model for Improving Service Delivery in Remote Papua New Guinea: A Mixed Methods Evaluation
Background The Community Mine Continuation Agreement Middle (CMCA) and South Fly Health Program (the Health Program) is a partnership for improving health service delivery in remote Papua New Guinea (PNG). The Health Program is delivered by a private contractor working in partnership with existing health service providers to improve service delivery using existing government systems, where poss...
متن کاملGoverning Collaborative Healthcare Improvement: Lessons From an Atlantic Canadian Case
The Atlantic Healthcare Collaboration for Innovation and Improvement in Chronic Disease (AHC) Quality Improvement Collaborative (QIC) in Eastern Canada provided an approach to spur system-level reform across multiple health systems for patients and families living with chronic disease. Developed and led by senior executives with a unique governance approach and involving clinical front-line tea...
متن کاملThe Effects of a Mutrition Education on the Nutritional Knowledge and Attitude of Health Care Workers
Objectives and methods: This was an intervention field trial to determine the effects of a nutrition education program (a modudle prepared specifically for the porpose) on the nutritional knowledge and attitude of volunteer Health care workers of Tehran University of Medical Sciences (TUMS) in city of Tehran in 1999. The study population consisted of 121 female health care workers from four ran...
متن کامل