Study type

Study topic

Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

If ‘other’, further details on the scope of the study

Effectiveness Evaluation
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

APRETUDE

Study drug International non-proprietary name (INN) or common name

CABOTEGRAVIR

Anatomical Therapeutic Chemical (ATC) code

(J05AJ04) cabotegravir
cabotegravir
Population studied

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

Main study objective

To assess the annual incidence of HIV diagnoses among all people without HIV in current study.

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.