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 |