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


Morgan M. Philbin, Department of Sociomedical Sciences, Columbia University Mailman School of Public Health, New York, NY, United States.
Tara McCrimmon, Department of Sociomedical Sciences, Columbia University Mailman School of Public Health, New York, NY, United States.
Victoria A. Shaffer, Department of Health Sciences, University of Missouri, Columbia, MO, United States.
Deanna Kerrigan, Department of Prevention and Community Health, Milken Institute School of Public Health, George Washington University, Washington, DC, United States.
Margaret Pereyra, Department of Sociomedical Sciences, Columbia University Mailman School of Public Health, New York, NY, United States.
Mardge H. Cohen, Department of Medicine, John H. Stroger Jr Hospital of Cook County, Chicago, IL, United States.
Oluwakemi Sosanya, Department of Medicine, Montefiore Medical Center, Bronx, NY, United States.
Anandi N. Sheth, Department of Medicine, Emory University School of Medicine, Atlanta, GA, United States.
Adaora A. Adimora, Department of Medicine, Department of Epidemiology, University of North Carolina Chapel Hill, Chapel Hill, NC, United States.
Elizabeth F. Topper, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.
Aadia Rana, Department of Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, AL, United States.
Bani Tamraz, School of Pharmacy, University of California San Francisco, San Francisco, CA, United States.
Lakshmi Goparaju, Department of Medicine, Georgetown University Medical Center, Washington, DC, United States.
Tracey E. Wilson, Department of Community Health Sciences, State University of New York, Downstate Health Sciences University, Brooklyn, NY, United States.
Maria Alcaide, Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, United States.

Document Type

Journal Article

Publication Date



JMIR research protocols








HIV treatment; long-acting injectable ART; oral ART; patient decision aid; study protocol; women’s health


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. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35646.


Prevention and Community Health