Frequency of HIV diagnoses among people using oral and LA PrEP (223555)

Study type

• Study topic:
  Disease /health condition

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

  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
• 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:
  (Obj 1) People in OPERA aged ≥18 years with ≥1 clinical encounter during the calendar year of interest and no evidence of prior HIV diagnosis. ; (Obj 1a) People with an incident HIV diagnosis identified in Obj 1. ; (Obj 2-5) People without HIV in OPERA aged ≥18 years who initiated any new PrEP formulation during the study period with or without prior PrEP use. ; (Obj 6) People without HIV in OPERA aged ≥18 years who could benefit from PrEP and are not on PrEP
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  23000

Study design details

• Study design:
  A cohort study using secondary data from the OPERA (Observational PharmacoEpidemiology Research & Analysis) cohort
• Main study objective:
  To assess the annual incidence of HIV diagnoses among all people without HIV in current study.
• Setting:
  OPERA is a multi-site observational database collecting data prospectively from the complete electronic health records (EHR) from clinical care throughout the US.
• Outcomes:
  - Annual number of new HIV diagnoses; - PrEP use, characteristics among people with an incident HIV diagnosis; - Characteristics of people who initiate oral and LA PrEP; - Incidence of HIV diagnoses following oral/LA PrEP initiation; - Days with an oral PrEP prescription and LA PrEP coverage; - Frequency of HIV testing and STI screening at oral/LA PrEP initiation; - Characteristics among people who could benefit from PrEP
• Data analysis plan:
  The analysis will be performed on OPERA cohort using secondary data from electronic medical records.