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Table 5 End points of the CROPrEP project

From: Protocol for a multicenter, real-world study of HIV pre-exposure prophylaxis among men who have sex with men in China (CROPrEP)

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