Cabotegravir prep: actionable robust evidence for translation into practice (cabaret)

Active Project Grant Awarded Last action

Award ID
R01AI174862
Recipient
Awarding agency
Obligated
$8,897,998

Award facts

Assistance listing
93.855 Allergy and Infectious Diseases Research
Completion date 79% complete
Originally
Place of performance
Boston, MA 02215, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Despite high efficacy, oral preexposure prophylaxis (prep) has had limited population impact on HIV incidence in the US, in part because of challenges with pill-taking. Bimonthly injections of cabotegravir were recently found to have superior efficacy to daily oral prep among men who have SEX with men (MSM), transgender women, and cisgender women. Long-acting injectable (LAI) prep could mitigate barriers to adherence and persistence, thereby increasing prep coverage. Interest in LAI prep has been high in some groups that are at disproportionately high risk of HIV infection and underrepresented among oral prep users, including black women and black and latino MSM, suggesting that LAI prep could also reduce racial, ethnic, and gender inequities in prep use. However, barriers to LAI prep use may be more common in underserved communities, potentially exacerbating inequities. LAI prep may also increase risk of drug resistance due to its long half-life or delayed detection of HIV infections. This risk may be mitigated by an oral prep ramp-down phase or viral load testing during use, but the feasibility and impact of these strategies are unknown. Robust evidence on early use and outcomes of LAI prep is needed to design implementation strategies to minimize HIV infections, inequities in use, and drug resistance. Large-scale oral prep studies have historically relied on prescription data, with limited ability to evaluate key determinants (e.g., race), barriers to use, or clinical outcomes. Research in healthcare systems can combine the breadth of electronic health record (EHR) data with the depth of qualitative studies to guide efficient and equitable implementation of prep. Our study, cabotegravir prep: actionable robust evidence for translation into practice (cabaret), will evaluate real-world use, population impact, and optimal investment of resources to facilitate the implementation of LAI prep. The settings are 3 racially and ethnically diverse regions of kaiser permanente-northern california, mid-atlantic (DC, virginia, maryland), and georgia-serving 5.6 million members and 13,000 prep users. Aim 1 will extract and analyze EHR data to evaluate LAI prep uptake and persistence, including racial and ethnic inequities in use, and HIV incidence and drug resistance. Focus groups with providers and potential, current, and former LAI prep users will explore facilitators and barriers to LAI prep prescribing and use, with oversampling of black women and black and latino MSM. Aim 2 will use mathematical modeling parameterized with EHR data to estimate the 10-year impact of LAI prep on HIV incidence, inequities in incidence, and drug resistance. Aim 3 will use economic decision modeling to determine the cost and effectiveness features that LAI prep uptake and persistence interventions must have to be prioritized in an efficient and equitable HIV-prevention strategy. A stakeholder advisory group will inform study design, interpretation, and dissemination to maximize impact. This study will produce a body of evidence to guide the translation of LAI prep into practice, with research infrastructure that can integrate new prep products as they emerge.

Transactions

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Subawards

Subrecipient Amount Awarded
Emory University Participate in routine calls and in-person meetings with the study team and provide input to project plan, as needed. Assist in the design, implementation,… $236,763
Fenway Community Health Center, Inc. Provide clinical and behavioral input on the collection, analysis, and interpretation of EHR and qualitative data on HIV risk factors and LAI PrEP continuum… $43,333
Kaiser Foundation Hospitals Will lead qualitative interview guide development and conduct participant interviews. Will recruite, consent participants and oversee interview transcription,… $456,041
Beth Israel Deaconess Medical Center, Inc. The subaward will provide the following support to this project: 1) Participating in development of qualitative research instruments, including surveys as… $82,050
Regents Of The University Of Minnesota Lead Aim 3, using the model adapted in Aim 2 to conduct a budget optimization analysis of interventions to improve uptake and persistence on long-acting PrEP… $225,089
Kaiser Foundation Hospitals Recruite patients and providers for qualitative interviews to identify facilitators and barriers to use. Participate in study meetings and development of… $378,715
Kaiser Foundation Hospitals Serve as lead IRB site for the project. Identigy the study cohort from the KPNC patient population which will be used for data analyses serve as the source… $641,214

Quick answers

Who received award R01AI174862?

R01AI174862 was awarded to Harvard Pilgrim Health Care, Inc. by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on September 21, 2022.

How much is award R01AI174862 worth?

$8,897,998 has been obligated on R01AI174862.

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