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Table 4 Definition and measure of secondary and tertiary outcomes

From: M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID

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