ArticleJMIR research protocols2022
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.
Article in JMIR research protocols, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- What Do People with HIV Want to Know About Long-Acting Injectable Cabotegravir/Rilpivirine?AIDS and behavior · 2026Article
- Early Implementation and Outcomes Among People with HIV Who Accessed Long-Acting Injectable Cabotegravir/Rilpivirine at Two Ryan White Clinics in the U.S. South.AIDS research and human retroviruses · 2024Article
- Learning from the first: a qualitative study of the psychosocial benefits and treatment burdens of long-acting cabotegravir/rilpivirine among early adopters in three U.S. clinics.Journal of the International AIDS Society · 2024Article
- "This Is Actually a Really Unique Moment in Time": Navigating Long-Acting HIV Treatment and HIV Cure Research with Analytical Treatment Interruptions-A Qualitative Interview Study in the United States.AIDS research and human retroviruses · 2024Article
- Acceptability of Long-Acting Injectable Antiretroviral Therapy Among People with HIV Receiving Care at Three Ryan White Funded Clinics in the United States.AIDS and behavior · 2024Article
- Low Uptake of Long-Acting Injectables in the First 2.5 Years Following Approval Among a Cohort of People Living With HIV.Open forum infectious diseases · 2024Article
- "What Is the Benefit?": Perceptions and Preferences for Long-Acting Injectable Antiretroviral Therapy Among People Living With HIV.AIDS education and prevention : official publication of the International Society for AIDS Education · 2023Article
- The New Era of Long-Acting Antiretroviral Therapy: When and Why to Make the Switch.Current HIV/AIDS reports · 2023Review
- High Interest in Long-acting Injectable Pre-exposure Prophylaxis (LAI-PrEP) for HIV Prevention Among Men Who Have Sex With Men (MSM): Result From A Nationwide Survey in Malaysia.Journal of community health · 2023Article
- High Acceptability and Perceived Feasibility of Long-Acting Injectable Antiretroviral Treatment Among People Living with HIV Who Are Viremic and Health Workers in Uganda.AIDS patient care and STDs · 2023Article
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Authors and funding
15 authors.
Funding
Abstract
backgroundMany 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.
objectiveThis 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.
methodsThe 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.
resultsThis 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.
conclusionsThis 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.
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