# Understanding Patient, Provider, and Systems Stakeholder Attitudes and Preferences to Optimize Implementation of Long-Acting Injectable Antiretrovirals and Maximize Clinical and Public Health Impact

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2021 · $816,100

## Abstract

Project Summary/Abstract
Long-acting injectable antiretroviral therapy (LAI-ART) represents the next innovation in HIV pharmacotherapy
and offers enormous promise to minimize challenges to daily oral ART, increase suboptimal rates of virologic
suppression in the United States (U.S.), and maximize the ability to end the HIV epidemic. The regimen
recently found non-inferior to oral ART in Phase 3 efficacy trials consists of a an intramuscular injection of two
antiretrovirals, cabotegravir and rilpivirine, given at 4-week intervals after patients have achieved virologic
suppression on oral therapy. In order to translate the promising efficacy of this novel drug platform into real
world effectiveness, implementation science is necessary before, during, and after introduction of the product,
particularly in clinics serving vulnerable urban HIV populations, as innovations are often delayed in reaching
these groups. Implementation research on LAI-ART can identify barriers and bottlenecks to adoption and use
to help ensure equitable utilization. LAI-ART holds appeal for at least two groups of patients: 1) those with a
history of adherence challenges for whom the extended dosing interval could mitigate psychosocial and
structural barriers to daily oral ART; 2) already adherent patients for whom LAI-ART could improve quality of
life. Yet without the benefit of a clinic system to support retention, providers may hesitate to use or even
withhold LAI-ART from patients who have struggled with adherence to care because of the possibility of drug
resistance and viral rebound if doses are missed. For patients on stable oral regimens, clinic burden increases
because of an increase in visit frequency to monthly from every 4-12 months. Clinics need systems that
support both kinds of patients, but the key features of these care delivery systems are as of yet unknown. This
application proposes to comprehensively address the knowledge gap of how best to implement LAI-ART in a
way that meets the needs of patients, providers, and clinics in key urban settings using a mixed-methods,
multi-level study structured by the Consolidated Framework for Implementation Research (CFIR). Leveraging
the expertise of a multidisciplinary team and working in three HIV clinics in high priority Ending the Epidemic
jurisdictions (San Francisco, Chicago, and Atlanta) we propose the following specific aims: 1) Evaluate the LAI-
ART implementation cascade in three urban HIV clinics; 2) Identify preferred attributes of LAI-ART care
delivery among patients and providers; 3) Develop an evidence informed LAI-ART care delivery model to
optimize real-world implementation. The proposed research will result in implementation strategies to guide the
equitable use of LAI-ART and contribute to Ending the Epidemic efforts in the U.S.

## Key facts

- **NIH application ID:** 10144517
- **Project number:** 5R01MH123396-02
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Katerina A Christopoulos
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $816,100
- **Award type:** 5
- **Project period:** 2020-05-01 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10144517

## Citation

> US National Institutes of Health, RePORTER application 10144517, Understanding Patient, Provider, and Systems Stakeholder Attitudes and Preferences to Optimize Implementation of Long-Acting Injectable Antiretrovirals and Maximize Clinical and Public Health Impact (5R01MH123396-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10144517. Licensed CC0.

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