Positive Health Check evaluation: A type 1 hybrid design randomized trial to decrease HIV viral loads in patients seen in HIV primary care

Megan A Lewis, Camilla Harshbarger, Carla Bann, Olivia Burrus, Susana Peinado, Bryan R Garner, Olga Khavjou, Ram K Shrestha, Shawn Karns, Craig B Borkowf, Brittany A Zulkiewicz, Alexa Ortiz, Carla A Galindo, Michelle DallaPiazza, Pam Holm, Vincent C Marconi, Charurut Somboonwit, Shobha Swaminathan, Positive Health Check Study Team, Megan A Lewis, Camilla Harshbarger, Carla Bann, Olivia Burrus, Susana Peinado, Bryan R Garner, Olga Khavjou, Ram K Shrestha, Shawn Karns, Craig B Borkowf, Brittany A Zulkiewicz, Alexa Ortiz, Carla A Galindo, Michelle DallaPiazza, Pam Holm, Vincent C Marconi, Charurut Somboonwit, Shobha Swaminathan, Positive Health Check Study Team

Abstract

For people with HIV, important transmission prevention strategies include early initiation and adherence to antiretroviral therapy and retention in clinical care with the goal of reducing viral loads as quickly as possible. Consequently, at this point in the HIV epidemic, innovative and effective strategies are urgently needed to engage and retain people in health care to support medication adherence. To address this gap, the Positive Health Check Evaluation Trial uses a type 1 hybrid randomized trial design to test whether the use of a highly tailored video doctor intervention will reduce HIV viral load and retain people with HIV in health care. Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only. The primary aim is to determine the effectiveness of the intervention. A second aim is to understand the implementation potential of the intervention in clinic workflows, and a third aim is to assess the costs of intervention implementation. The trial findings will have important real-world applicability for understanding how digital interventions that take the form of video doctors can be used to decrease viral load and to support retention in care among diverse patients attending HIV primary care clinics.

Keywords: HIV; Medication adherence; Retention in care; Type 1 hybrid trial; Video doctor intervention; Viral load.

Conflict of interest statement

Declaration of Competing Interest Shobha Swaminathan COI: Gilead Sciences, Viiv Healthcare.

Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

Figures

Fig. 1.
Fig. 1.
Overview of Positive Health Check evaluation trial design. Note: EMR = Electronic Medical Record.

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Source: PubMed

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