Table 5.

End points of the CROPrEP project

1. The real-life effectiveness of daily or event-driven PrEP use:

— HIV incidence among individuals using different PrEP regimens, compared with that of non-PrEP users randomly selected by propensity score from local expanding cohort studies of HIV-negative MSM

— The rate of viral genotype resistance among individuals who seroconvert to HIV during the study period

2. Adherence to PrEP:

— Number, proportion and patterns of prescribed doses taken and missed according to self—reported adherence via online questionnaires and weekly messages, reported pill use, and pill counts

— Testing of FTC/TDF drug concentration in blood samples

— Percentage of participants who switch regimens and their reasons

3. Safety and tolerability:

— Rate of side effects or adverse events related to PrEP use

— Rate of adverse events related to discontinuation of PrEP or switching PrEP regimens

4. PrEP cascade and the motivations and attitudes towards PrEP use:

— The effectiveness of recruitment, according to the origin of roll-out

— The cascade of PrEP use: acceptability, initiation, choice of regimen, and retention in the study

— The knowledge, beliefs, motivations, difficulties, behavior, and expectations of participants, and their knowledge and communication regarding their PrEP use

— Attitudes towards PrEP use and medical care providers

5. The potential effects of PrEP use on sexual behaviors and incidence of sexually transmitted infections (STIs):

— Potential changes in the number of sexual partners and the numbers of casual or steady partners

— Potential changes in condom use

— Potential changes in the incidence of HSV-2 or syphilis

— Changes in the use of sexual networks

— Changes in perception of sexual well-being during sexual intercourse