R01AI174862

CABOTEGRAVIR PREP: ACTIONABLE ROBUST EVIDENCE FOR TRANSLATION INTO PRACTICE (CABARET) - PROJECT SUMMARY

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.

Harvard Pilgrim Health Care

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.855 - Allergy and Infectious Diseases Research

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

Boston, Massachusetts 022153369 United States

Single Zip Code

NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) (PA-20-185)

Termination This project grant was reported as terminated by the Department of Government Efficiency (DOGE) in July 2025. See All
Amendment Since initial award the total obligations have increased 264% from $896,392 to $3,263,063.