JMIR Publications

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 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 (iARTs). 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 three 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 (RCT) with n=180 women in Miami, FL and assessed for feasibility, usability and acceptability, as well as to evaluate the associations between receiving i.ARTs and viral suppression, ART refills, and clinic attendance.

Results:

Phase 1 participant recruitment began in September 2021.

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. Clinical Trial: We will apply for Clinicaltrials.gov registration prior to Phase 3 when we enroll our first participant in the RCT. This is anticipated to occur in April 2023.