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Pilot Feasibility Stud. 2020 Feb 21;6:29. doi: 10.1186/s40814-020-0559-6. eCollection 2020.

A type II implementation-effectiveness hybrid quasi-experimental pilot study of a clinical intervention to re-engage people living with HIV into care, 'Lost & Found': an implementation science protocol.

Pilot and feasibility studies

Joseph Cox, Blake Linthwaite, Kim Engler, David Lessard, Bertrand Lebouché, Nadine Kronfli

Affiliations

  1. 1Chronic Viral Illness Service (CVIS), McGill University Health Centre (MUHC) - Glen Site, 1001, Decarie boulevard - D02.4110, Montreal, QC H4A 3J1 Canada.
  2. 2Research Institute of the McGill University Health Centre (RI-MUHC), 2155 Guy Street, 5th Floor, Montreal, QC H3H 2R9 Canada.
  3. 3Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, McGill University, MUHC Glen Site Room E.05.1616, 1001 Boul. Decarie, Montreal, QC H4A 3J1 Canada.
  4. 4Department of Epidemiology, Biostatistics, and Occupational Health, Faculty of Medicine, McGill University, Purvis Hall, 1020 Pine Avenue West, Montreal, QC H3A 1A2 Canada.
  5. 5Department of Family Medicine, Faculty of Medicine, McGill University, 5858 Chemin de la Côte des Neiges, Montreal, QC H3S 1Z1 Canada.

PMID: 32110432 PMCID: PMC7035655 DOI: 10.1186/s40814-020-0559-6

Abstract

BACKGROUND: At the McGill University Health Centre (MUHC), 10% of patients living with HIV do not return for care annually. Currently, no formal system exists to re-engage out-of-care (OOC) patients. Lost & Found, developed using an implementation science approach, is an intervention to re-engage OOC patients. It is based on existing evidence-based interventions and will be adapted for use by nurses at the MUHC. The aims of this study are to simultaneously assess both implementation and effectiveness of Lost & Found in order to determine the viability of a future multisite stepped-wedge cluster randomised trial.

METHODS: Lost & Found consists of two core elements: identifying and contacting OOC patients. Based on formative work involving MUHC nurses, and the use of a combined implementation framework (enhanced Replicating Effective Programs, Tailored Implementation for Chronic Diseases, and Proctor et al.'s implementation outcomes), we will adapt the intervention to our clinic. Adaptations include the creation of an OOC risk prediction tool, an automated real-time OOC list, and prioritization of high-risk OOC patients for re-engagement. Delivery and ongoing adaptation of the intervention will follow a three-pronged implementation strategy consisting of (1) promoting adaptability; (2) planning, engaging, executing, evaluating, and reflecting cycles; and (3) internal facilitation. This 15-month quasi-experimental pilot study adopts a type II implementation-effectiveness hybrid design. To evaluate implementation, a convergent parallel mixed-methods approach will guide the mixing of qualitative and quantitative data at time points throughout the study. In addition, descriptive and pre-post analyses, for each of the implementation and sustainability phases, will inform evaluations of the cumulative effectiveness and sustainability of the Lost & Found intervention.

DISCUSSION: This study will provide preliminary evidence for (1) the utility of our chosen implementation strategies and (2) the effectiveness of the intervention. Ultimately, this information may be used to inform future re-engagement efforts using implementation science in other HIV care centres. In addition, the procedures and measurement tools developed for this study will be foundational to the development of a multi-site, randomised stepped wedge study that would provide more robust evidence in support of the Lost & Found intervention.

© The Author(s). 2020.

Keywords: HIV; Implementation science; Implementation strategies; Lost to follow-up; Nursing; Out-of-care; Re-engagement

Conflict of interest statement

Competing interestsJC has received consulting fees from ViiV Healthcare, Merck, and Gilead; research funding from ViiV Healthcare, Merck, and Gilead; and payment for lectures from Gilead. BL2 has rece

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