Oral and Long-Acting Injectable Cabotegravir Preexposure Prophylaxis Use Among U.S. Veterans Using Veterans Health Administration Services, 2021-2025 (306339)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  APRETUDE
• Medicinal product name, other:
  Cabotegravir
• Study drug International non-proprietary name (INN) or common name:
  CABOTEGRAVIR
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AJ04) cabotegravir

  cabotegravir
• Medical condition to be studied:
  HIV infection

Population studied

• Short description of the study population:
  Veterans in care, 18 years or older without evidence of HIV infection at index date.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  0

Study design details

• Study design:
  Non-interventional study
• Main study objective:
  • Objective Set 1: Estimate annual HIV diagnosis rates among Veterans in care and describe the history of PrEP use among newly diagnosed HIV patients.; • Objective Set 2: Characterize Veterans not on PrEP but who could benefit from it and evaluate rates of HIV/STI testing and diagnoses over 12 months. ; • Objective Set 3: ; - Describe demographic, clinical and sexual behavioral characteristics of Veterans initiating oral or cabotegravir long-acting (CAB LA) PrEP.; - Estimate the proportion of CAB LA PrEP users initiating PrEP with oral lead-in (OLI) versus direct-to-injection (DTI). ; - Describe adherence to oral PrEP and CAB LA injectable PrEP. ; - Describe patterns of PrEP use, including discontinuation, resumption, and duration of use for both oral and CAB LA PrEP. ; - Describe HIV and STI testing, diagnoses, and antimicrobial treatment prescription for STI by PrEP modality. ; - For CAB LA PrEP users diagnosed with HIV, analyze the timing of HIV diagnoses relative to PrEP usage, injection schedules, HIV treatment, virologic suppression, STI diagnoses, and HIV drug resistance.
• Setting:
  The data used will be extracted from VHA’s Corporate Data Warehouse (CDW), a comprehensive, continually updated repository of information from VHA’s electronic health records (EHR) and administrative files.
• Comparators:
  Not Applicable
• Outcomes:
  1. Yearly incidence proportion of HIV diagnoses among individuals in Veterans Health Administration (VHA) care and history of PrEP use among incident HIV cases; 2. Characteristics of individuals in VHA care without evidence of HIV infection who are not on PrEP but could benefit from PrEP; 3. Incidence proportions and rates of HIV testing and diagnoses, and STI screening/testing and diagnoses among individuals in VHA care who are not on PrEP but could benefit from PrEP ; 4. Demographic, clinical and sexual behaviour characteristics of individuals in VHA care with no evidence of HIV infection who initiate PrEP (oral or CAB LA injectable) during the study period; 5. Adherence to oral and CAB LA injectable PrEP (proportion of days covered, timing and completion of injections), proportion of CAB LA PrEP users with oral lead in (OLI) or direct to injection (DTI) ; 6. Patterns of oral PrEP and CAB LA PrEP use ; 7. Patterns of HIV and other STI testing/screening, diagnosis and STI treatment among individuals in VHA care initiating PrEP; 8. HIV testing history, timing of CAB LA injections, HIV treatment prescribed, viral load measurement timings and results, concomitant STI diagnosis, and HIV drug resistance testing results among CAB LA PrEP users diagnosed with HIV
• Data analysis plan:
  All analyses in this study will be descriptive, focusing on estimating frequencies of outcomes across various objectives.
• Summary results:
  All data analyses will be computed in a descriptive manner. Results will be published via study reports.