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McGill Family Medicine Studies Online, 15:e03

Page history last edited by reem.elsherif@mail.mcgill.ca 3 years, 7 months ago

Aqib, Asma (2020). The feasibility of the platform trial design for the development of a mobile health application for improving treatment adherence among persons living with HIV. McGill Family Medicine Studies Online, 15:e03

 

Download Thesis here

 

Abstract

Background: The I-Score study was conducted in Canada and France to develop and validate a Patient-Reported Outcome Measure (PROM), identifying barriers to improve Anti-Retroviral Treatment adherence (ART) in People Living with HIV (PLWH). The conceptual framework of the PROM is based on qualitative studies conducted on PLWH in high-income countries. Subsequently, stakeholders (PLWH and HIV clinicians) were engaged for the development and implementation of the PROM. The aim was to deliver the validated PROM to patients and healthcare providers via a mobile health application (‘mHealth app’) while continuing to develop various aspects and design features of the mHealth app. To enable an effective and unbiased approach towards evaluating different developer versions of the mHealth app, an adaptive trial design called Platform Trial (PT) has been proposed. As this is a novel trial design, not all challenges and practicalities relevant for proper trial conduct are understood. Therefore, before commencing the PT, it is important to explore all the ethical, pragmatic or technical challenges associated with the design that has been reported in the literature. The I-score study also aims to accommodate patient diversity and to contextualize, personalize and generalize the mHealth app to a diverse population of PLWH in Montreal. Therefore, for ensuring proper planning and set up of the trial and for ensuring the external validity of the outcomes, it is important to characterize the study population. The purpose of this thesis was to 1) inform the I-score study about the ethical, pragmatic, and technical challenges of PT reported in literature 2) to characterize a study population, the ‘Cohorte de Montreal’ (CM), composed of PLWH from 4 HIV clinics in Montreal, 3) and to identify similarities and differences in the characteristics of PLWH among these different clinics.

 

Methods: Phase 1: I conducted a descriptive literature review to identify ethical, pragmatic, and technical issues related to the conduct of a PT. The literature review was conducted using two databases (Medline via Pubmed & EMBASE via Ovid). Phase 2: Through a descriptive cross-sectional study of the Cohorte de Montreal (CM) data, I characterized the target population and explored commonalities and differences in the demographic and clinical characteristics of PLWH in the four clinics, with a focus on the PLWH from the McGill University Health Network.

 

Results: Phase 1: 459 articles were screened by title and abstract; 164 full-text articles were assessed for eligibility and 27 were eventually included in the synthesis. I identified several ethical issues related to informed consent, equipoise, and justice, as well as various pragmatic or technical issues including biases, logistical or statistical matters that may challenge the integrity, and validity of a PT. Phase 2: PLWH followed at MUHC differed slightly from the other clinics on various demographic characteristics. Namely, a higher proportion of women, larger ethnic diversity and a higher proportion of heterosexual individuals from endemic countries were observed in the MUHC clinics compared to other clinics. However, the clinical characteristics of PLWH at MUHC (mean CD4 counts and the proportion of PLWH with undetectable viral loads) were comparable across all clinics.

 

Conclusion: Several factors may impede the proper roll-out of a PT in the context of developing a mobile health app in larger patient populations. However, with adequate preventive measures, pre-planning, and involvement of all stakeholders, these limiting factors may be controlled. PT design enables contextualization, personalization, and generalization of the results if rolled out in large and diverse study populations. Finally, PT has promising utility in the seamless evaluation of interventions that undergo continuous development, including the mHealth app 

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