Health providers' perceptions of clinical trials: lessons from Ghana, Kenya and Burkina Faso.
BACKGROUND
Clinical trials conducted in Africa often require substantial investments to support trial centres and public health facilities. Trial resources could potentially generate benefits for routine health service delivery but may have unintended consequences. Strengthening ethical practice requires understanding the potential effects of trial inputs on the perceptions and practices of routine health care providers. This study explores the influence of malaria vaccine trials on health service delivery in Ghana, Kenya and Burkina Faso.


METHODS
We conducted: audits of trial inputs in 10 trial facilities and among 144 health workers; individual interviews with frontline providers (n=99) and health managers (n=14); and group discussions with fieldworkers (n=9 discussions). Descriptive summaries were generated from audit data. Qualitative data were analysed using a framework approach.


RESULTS
Facilities involved in trials benefited from infrastructure and equipment upgrades, support with essential drugs, access to trial vehicles, and placement of additional qualified trial staff. Qualified trial staff in facilities were often seen as role models by their colleagues; assisting with supportive supervision and reducing facility workload. Some facility staff in place before the trial also received formal training and salary top-ups from the trials. However, differential access to support caused dissatisfaction, and some interviewees expressed concerns about what would happen at the end of the trial once financial and supervisory support was removed.


CONCLUSIONS
Clinical trials function as short-term complex health service delivery interventions in the facilities in which they are based. They have the potential to both benefit facilities, staff and communities through providing the supportive environment required for improvements in routine care, but they can also generate dissatisfaction, relationship challenges and demoralisation among staff. Minimising trial related harm and maximising benefits requires careful planning and engagement of key actors at the outset of trials, throughout the trial and on its' completion.
Department of Public Health Research, KEMRI/Wellcome Trust Research Programme (KWTRP), P.O. Box, 230-80108, Kilifi, Kenya.
Vibian
V
Angwenyi
Kintampo Health Research Centre (KHRC), P.O. Box 200, Kintampo, Ghana.
Kwaku-Poku
KP
Asante
Centre National de Recherche et de Formation sur le Paludisme (CNRFP), 01 BP 2208, Ouagadougou 01, Burkina Faso.
Abdoulaye
A
Traoré
Kintampo Health Research Centre (KHRC), P.O. Box 200, Kintampo, Ghana.
Lawrence Gyabaa
LG
Febir
Kintampo Health Research Centre (KHRC), P.O. Box 200, Kintampo, Ghana.
Charlotte
C
Tawiah
Kintampo Health Research Centre (KHRC), P.O. Box 200, Kintampo, Ghana.
Anthony
A
Kwarteng
Centre National de Recherche et de Formation sur le Paludisme (CNRFP), 01 BP 2208, Ouagadougou 01, Burkina Faso.
Alphonse
A
Ouédraogo
Centre National de Recherche et de Formation sur le Paludisme (CNRFP), 01 BP 2208, Ouagadougou 01, Burkina Faso.
Sodiomon Bienvenue
SB
Sirima
Kintampo Health Research Centre (KHRC), P.O. Box 200, Kintampo, Ghana.
Seth
S
Owusu-Agyei
European Vaccine Initiative (EVI),Universitäts Klinikum Heidelberg, Im Neuenheimer Feld 326, 69120, Heidelberg, Germany.
Egeruan Babatunde
EB
Imoukhuede
Disease Control Department, London School of Hygiene and Tropical Medicine (LSHTM), Keppel Street, WC1E 7HT, London, United Kingdom.
Jayne
J
Webster
Disease Control Department, London School of Hygiene and Tropical Medicine (LSHTM), Keppel Street, WC1E 7HT, London, United Kingdom.
Daniel
D
Chandramohan
Department of Public Health Research, KEMRI/Wellcome Trust Research Programme (KWTRP), P.O. Box, 230-80108, Kilifi, Kenya; The Ethox Centre, Department of Public Health, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, United Kingdom; The Centre for Clinical Vaccinology and Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, United Kingdom.
Sassy
S
Molyneux
Department of Public Health Research, KEMRI/Wellcome Trust Research Programme (KWTRP), P.O. Box, 230-80108, Kilifi, Kenya; Disease Control Department, London School of Hygiene and Tropical Medicine (LSHTM), Keppel Street, WC1E 7HT, London, United Kingdom; The Centre for Clinical Vaccinology and Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Old Road Campus, Headington, Oxford, OX3 7LF, United Kingdom.
Caroline
C
Jones
D002050:Burkina Faso; D002986:Clinical Trials as Topic; D003695:Delivery of Health Care; D005869:Ghana; D006268:Health Facilities; D007722:Health Knowledge, Attitudes, Practice; D006282:Health Personnel; D006801:Humans; D007630:Kenya; D017780:Malaria Vaccines
D017780:Malaria Vaccines