Understanding the acceptability and adherence to paediatric antiretroviral treatment in the new formulation of pellets (LPV/r): the protocol of a realist evaluation

Abstract

BackgroundImproving 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 HIV-infected 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.MethodsWe 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 disseminationThis 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.DiscussionIn 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.

The Effect of Detectable HIV Viral Load among HIV-Infected Children during Antiretroviral Treatment: A Cross-Sectional Study

“…Adherence to ART is an important determinant of treatment outcome. It could be argued that effective ART has made HIV a chronic disease and therefore issues affecting children living with HIV are similar to those affecting children with chronic diseases in general [ 33 ]. HIV-infected patients also require almost perfect levels of adherence to achieve long-lasting non-dVL with suboptimal adherence to ART being the most common cause of virologic failure [ 34 ].…”

Cost-Effectiveness of Preemptive Switching to Efavirenz-Based Antiretroviral Therapy for Children With Human Immunodeficiency Virus

“…In addition, although we do not directly model resistance mutations that accumulate over time, these are in part accounted for in our data inputs for initial virologic suppression and late failure risks for second-line ART. Although novel formulations of LPV/r, such as pellets [11, 37], may improve tolerability, our sensitivity analyses based on NEVEREST-3 data suggest that even with plausible lower late failure risks for LPV/r, the switch strategy remains a cost-effective or cost-saving alternative to both LPV/r strategies, while we await widespread access to DTG for children.…”

Designing and evaluating provider results-based financing for tuberculosis care in Georgia: a realist evaluation protocol

“…Furthermore, discussions within the research team were instrumental in refining and constructing the IPT. First, we built on a review of the literature on adherence carried out in the frame of the RELIVING study9 and on literature reviews carried out on performance-based financing (PBF) and RBF, including one on PBF in low-income and lower middle-income countries 10…”