Prospective Study to Assess Usage, Adherence, Effectiveness of Cabotegravir LA for Pre-Exposure Prophylaxis in the United States in the OPERA Cohort (219844)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000165
• EU PAS number:
  EUPAS1000000165
• Study ID:
  1000000165
• Official title and acronym:
  Prospective Study to Assess Usage, Adherence, Effectiveness of Cabotegravir LA for Pre-Exposure Prophylaxis in the United States in the OPERA Cohort (219844)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is an observational study utilizing prospectively collected electronic health record (EHR) data obtained from the Observational Pharmaco-Epidemiology Research and Analysis (OPERA) clinical cohort to describe the effectiveness, adherence, and usage of cabotegravir (CAB) LA for PrEP and monitor incidence of HIV and HIV treatment outcomes for cases of HIV acquisition among participants on CAB LA for PrEP in the United States.
• Study status:
  Ongoing

Research institutions and networks

Institutions

ViiV Healthcare

Study timelines

Date when funding contract was signed

Actual: 09/11/2022

Study start date

Actual: 20/07/2023

Date of final study report

Planned: 30/06/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Study protocol

Initial protocol

ApretudeUpdateOutcomes_OPERA_Final_Protocol_Anonymised.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable