Frequency of HIV diagnoses among people using oral and LA PrEP

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000371
• EU PAS number:
  EUPAS1000000371
• Study ID:
  1000000371
• Official title and acronym:
  Frequency of HIV diagnoses among people using oral and LA PrEP
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The purpose of the study is to understand patterns of PrEP use among people who acquire HIV to improve public health and clinical practice. ; This study will also provide crucial real-world evidence on HIV acquisition on PrEP, PrEP coverage, HIV testing and sexually transmitted infection (STI) screening in individuals receiving either oral or LA PrEP. Analysis is based on the OPERA cohort.
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Planned: 28/06/2024

Actual: 28/06/2024

Study start date

Planned: 06/12/2024

Actual: 22/11/2024

Date of final study report

Planned: 31/10/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

ViiV Healthcare

Study protocol

Initial protocol

OPERA_CAB PrEP_Oral and LA PrEP HIV Diagnoses_Final Protocol Anonymised 23 Oct 2024.pdf

Regulatory

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