Abstract:
Background: Improving access to paediatric HIV
treatment requires both large-scale treatment
programmes and medication that is adapted to infants
and children’s needs. The WHO recommends lopinavir/
ritonavir as first-line antiretroviral therapy for all HIVinfected
children younger than 3 years. There is currently
little evidence on the acceptability of, and adherence to, a
formulation of this combination treatment if given in the
form of pellets. This protocol presents how we will carry a
realist evaluation to assess the factors that contribute to
the acceptability and adherence to the new pellets
formulation in
3 hospitals in Kenya.
Methods: We structured the protocol along the realist
evaluation cycle following 4 steps: (1) the initial
programme theory, (2) the study design, (3) the data
collection methods and (4) the data analysis plan.
Theories of behavioural sciences were reviewed for
frames that could provide insights into how using such
new formulations may contribute to better acceptability
and adherence.
Ethics and dissemination: This study was approved
by the Institutional Review Board of the Institute of
Tropical Medicine, the Ethical Committee of the University
Hospital Antwerp and the Kenyatta National Hospital/
University of Nairobi Ethics and Research Committee. We
aim to disseminate the findings through international
conferences and peer-reviewed journals and to share
them with Drugs for Neglected Diseases initiative’s (DNDi)
programme managers and with the Kenyan healthcare
providers.
Discussion: In developing this study, we encountered
some challenges. First, methods to measure the
acceptability of any formulation and adherence to it are
not standardised. The second challenge is common in
realist evaluation and relates to how to choose from
different potentially interesting theoretical frameworks. We
identified relevant and empirically tested theories from
behavioural science that may be helpful in our study. We
will test them in 3 settings by exploring the multilevel
factors that influence acceptability and adherence of this
new paediatric Antiretroviral (ARV) formulation.
