Evidence map›Paper›PMID 28360249›Full record

Trial reportBMJ open2017

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

Ariadna Nebot Giralt, Christiana Nöstlinger, Janice Lee, Olawale Salami, Marc Lallemant, Onyango Ouma, Isaac Nyamongo, Bruno Marchal

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Ariadna Nebot GiraltDepartment of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.ORCID 0000-0002-5318-8815
Christiana NöstlingerDepartment of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.
Janice LeeDrugs for Neglected Diseases Initiative, Geneva, Switzerland.
Olawale SalamiDrugs for Neglected Diseases Initiative, Nairobi, Kenya.
Marc LallemantDrugs for Neglected Diseases Initiative, Geneva, Switzerland.
Onyango OumaInstitute of Anthropology, Gender and African Studies, University of Nairobi, Nairobi, Kenya.
Isaac NyamongoInstitute of Anthropology, Gender and African Studies, University of Nairobi, Nairobi, Kenya.
Bruno MarchalDepartment of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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 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.

Indexed as

Administration, OralAnti-HIV AgentsCaregiversChildCultureData CollectionDelivery of Health CareDrug CombinationsHIV InfectionsHumansKenyaLopinavirMedication AdherencePatient SatisfactionRitonavirSocioeconomic FactorsAnti-HIV AgentsDrug CombinationsLopinavirlopinavir-ritonavir drug combinationRitonavirTabletsacceptabilityadherenceKenyaPaediatric antiretroviral treatmentrealist evaluation

Identifiers

PMID28360249
PMCPMC5372016

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.