TY - JOUR
T1 - A Patient Decision Aid (i.ARTs) to Facilitate Women's Choice Between Oral and Long-Acting Injectable Antiretroviral Treatment for HIV
T2 - Protocols for its Development and Randomized Controlled Pilot Trial
AU - Philbin, Morgan M.
AU - McCrimmon, Tara
AU - Shaffer, Victoria A.
AU - Kerrigan, Deanna
AU - Pereyra, Margaret
AU - Cohen, Mardge H.
AU - Sosanya, Oluwakemi
AU - Sheth, Anandi N.
AU - Adimora, Adaora A.
AU - Topper, Elizabeth F.
AU - Rana, Aadia
AU - Tamraz, Bani
AU - Goparaju, Lakshmi
AU - Wilson, Tracey E.
AU - Alcaide, Maria
N1 - Publisher Copyright:
© JMIR Publications Inc.. All rights reserved.
PY - 2022/9/1
Y1 - 2022/9/1
N2 - 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.
AB - 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.
KW - HIV treatment
KW - long-acting injectable ART
KW - oral ART
KW - patient decision aid
KW - study protocol
KW - women's health
UR - http://www.scopus.com/inward/record.url?scp=85139727804&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85139727804&partnerID=8YFLogxK
U2 - 10.2196/35646
DO - 10.2196/35646
M3 - Article
C2 - 36099004
AN - SCOPUS:85139727804
SN - 1929-0748
VL - 11
JO - JMIR Research Protocols
JF - JMIR Research Protocols
IS - 9
M1 - e35646
ER -