Research protocol of the realist evaluation of acceptability to paediatric antiretroviral in form of the pellets

BACKGROUND Adherence to antiretroviral treatment (ART) is an important determinant of treatment outcome. However, adherence to ART must be almost perfect to achieve lasting viral suppression. Sub-optimal adherence to ARVs is... [ view full abstract ]

BACKGROUND

Adherence to antiretroviral treatment (ART) is an important determinant of treatment outcome. However, adherence to ART must be almost perfect to achieve lasting viral suppression. Sub-optimal adherence to ARVs is the most common cause of virological failure of ART regimens. In addition, non-adherence to antiretrovirals (ARVs), which can take many different forms, can have important public health implications, such as promoting viral mutations and drug resistance.

Currently, few drugs are approved for HIV+ infants and toddlers and most of paediatric combination antiretroviral therapies (cARTs) are limited and difficult to administer. The current treatment combinations for infants are normally formulated as syrup with high alcohol content, tasting very bitter, difficult for the administration, unstable in tropical climates and expensive.

The Drugs for Neglected Diseases initiative (DNDi) is currently testing a new formulation in the form of pellets in two hospitals in Nairobi and one in Kisumu, Kenya. Initial observations indicate a different degree of uptake of the new formulation by the caregivers and therefore a different degree of adherence to the treatment. In order to examine this, a realist evaluation was set up with the aim of developing a good understanding of the acceptability as well as to assess the factors that contributes to the acceptability and adherence to the new paediatric ART formulation.

In this evaluation, we started by defining an initial program theory (PT), focused on how caregiver-infant couples move to initiation, implementation and long-term adherence and how and why they may drop out. Individual-level, context-related, structural and socio-cultural and health system-related factors are included.

We adopted a multiple case study design defining the case as caregiver-infant couple and are currently carrying out the data collection in three Kenyan hospitals, including caregiver-infant couples who transitioned from syrup to the new pellet formulation. Our data collection techniques will include in-depth interviews, focus group discussions, participant observations, and document reviews. Our data analysis will be oriented by the Intervention-Actors-Context-Mechanism-Outcome configuration and will be organized in two rounds. For developing our analysis, we will use qualitative methods and we will review the documentation of the research process.

We will briefly present the main findings and discuss how we solved methodological challenges related to multi-disciplinary teams, the ‘co-production’ of the initial programme theory, the interaction between mechanisms at individual, organizational and family-level.

Acknowledgment:
I would like to acknowledge the funding of this study by the Drugs for Neglected Diseases initiative (DnDi).