Table 4 Definition and measure of secondary and tertiary outcomes
Secondary outcomes | Definition | Measure |
|---|---|---|
 PrEP initiation/uptake | Receiving a prescription and taking the first dose of the medication | First dose of Rx dispensed to the patient and recorded at pharmacy/dispensing venue + self-report |
 Long-term sustained PrEP adherence | PrEP use at 6, 12, and 18 months post-randomization | Self-report + detectable level of TDF in DBS 6, 12, and 18 months post-randomization |
 HCV incidence/re-infection | New HCV infection | At scheduled visit: HCV-Ab positive (never infected) or detectable HCV-RNA (previously infected and cured) |
 STI or HIV incidence/STI re-infection | New STI or HIV infection in a previously uninfected person/previously infected and cured person | At scheduled visit: Any positive test result for Neisseria gonorrheae, Chlamydia trachomatis, syphilis, or HIV |
 Behavioral disinhibition | Changes or increase in sexual or injection risk behaviors | Self-report at each visit |
Tertiary outcomes | Definition | Measure |
 Ongoing PrEP use | Any PrEP use during any period | Any detectable level of TDF in DBS/Self-report of use |
 HCV SVR within those initiating | 12-week sustained viral response post-end of treatment | First dose of medication dispensed to the patient and recorded at pharmacy/dispensing venue + self-report/HCV-RNA negative at 12 weeks post end of treatment |