A Patient Decision Aid (i.ARTs) to Facilitate Women's Choice Between Oral and Long-Acting Injectable Antiretroviral Treatment for HIV: Protocols for its Development and Randomized Controlled Pilot Trial

• Type of Material: Article
• Authors: Morgan M Philbin, Columbia University; Tara McCrimmon, Columbia University; Victoria A Shaffer, University of Missouri; Deanna Kerrigan, George Washington University; Margaret Pereyra, Columbia University; Mardge H Cohen, John H. Stroger Jr Hospital of Cook County; Oluwakemi Sosanya, Montefiore Medical Center; Anandi Sheth, Emory University; Adaora A Adimora, The University of North Carolina at Chapel Hill; Elizabeth F Topper, Johns Hopkins Bloomberg School of Public Health; Aadia Rana, University of Alabama at Birmingham School of Medicine; Bani Tamraz, University of California, San Francisco; Lakshmi Goparaju, Georgetown University Medical Center; Tracey E Wilson, SUNY Downstate Health Sciences University; Maria Alcaide, University of Miami Leonard M. Miller School of Medicine
• Language: English
• Date: 2022-09-01
• Publisher: JMIR Research Protocols
• Publication Version: Final Published Version
• Copyright Statement: ©Morgan M Philbin, Tara McCrimmon, Victoria A Shaffer, Deanna Kerrigan, Margaret Pereyra, Mardge H Cohen, Oluwakemi Sosanya, Anandi N Sheth, Adaora A Adimora, Elizabeth F Topper, Aadia Rana, Bani Tamraz, Lakshmi Goparaju, Tracey E Wilson, Maria Alcaide. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.09.2022.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.2196/35646
• Title of Journal or Parent Work: JMIR Research Protocols
• Volume: 11
• Issue: 9
• Start Page: e35646
• End Page: e35646
• Keywords: study protocol; women’s health; HIV treatment; patient decision aid; long-acting injectable ART; oral ART
• Research Categories: Health Sciences, Epidemiology; Health Sciences, Medicine and Surgery

Abstract

Background: Many women with HIV (WWH) have suboptimal adherence to oral antiretroviral therapy (ART) due to multilevel barriers to HIV care access and retention. A long-acting injectable (LAI) version of ART was approved by the US Food and Drug Administration in January 2021 and has the potential to overcome many of these barriers by eliminating the need for daily pill taking. However, it may not be optimal for all WWH. It is critical to develop tools that facilitate patient-provider shared decision making about oral versus LAI ART modalities to promote women's adherence and long-term HIV outcomes. Objective: This study will develop and pilot test a web-based patient decision aid called i.ART+support (i.ARTs). This decision aid aims to support shared decision making between WWH and their providers, and help women choose between oral and LAI HIV treatment. Methods: The study will occur in 3 phases. In phase 1, we will utilize a mixed methods approach to collect data from WWH and medical and social service providers to inform i.ARTs content. During phase 2, we will conduct focus groups with WWH and providers to refine i.ARTs content and develop the web-based decision aid. In phase 3, i.ARTs will be tested in a randomized controlled trial with 180 women in Miami, Florida, and assessed for feasibility, usability, and acceptability, as well as to evaluate the associations between receiving i.ARTs and viral suppression, ART pharmacy refills, and clinic attendance. Results: This study was funded in March 2021. Columbia University's IRB approved the study protocols (approval number IRB-AAAT5314). Protocols for phase 1 interviews have been developed and interviews with service providers started in September 2021. We will apply for Clinicaltrials.gov registration prior to phase 3, which is when our first participant will be enrolled in the randomized controlled trial. This is anticipated to occur in April 2023. Conclusions: This study is the first to develop a web-based patient decision aid to support WWH choices between oral and LAI ART. Its strengths include the incorporation of both patient and provider perspectives, a mixed methods design, and implementation in a real-world clinical setting.