Evaluating interventions to reduce behaviour associated with HCV reinfection in men who have sex with men: study protocol for a non-blinded, phase 2, randomised trial

Table 2 Collection of outcomes in the ICECREAM study trial

	Questionnaire 1 (month 0 or M0)	Questionnaire 2 (month 6 or M6 and R0)	Questionnaire 3 (month 12 or R6)	Questionnaire 4 (month 18 or R12)	Questionnaire 5 (month 24 or R18)
Demographic characteristics	X
HIV-status and PrEP-use	X	X	X	X	X
Previous HCV infections and treatment	X	X	X	X	X
Sexual relationships and sexual behaviour^a	X	X	X	X	X
STI testing and testing outcomes^b	X	X	X	X	X
Alcohol and drug use	X	X	X	X	X
Sexual well-being	X	X	X	X	X
Motivation to reduce risk behaviour	X	X	X	X	X
HCV threat appraisal	X	X	X	X	X
Influence COVID-19 measures on sexual behaviour	X	X	X	X	X
Influence monkeypox on sexual behaviour	X	X	X
Testing intervention-related endpoints^c			X
Behavioural intervention-related endpoints^d			X	X	X
Usability and acceptability of testing and behavioural intervention			X	X	X

Abbreviations: HCV hepatitis C virus, HIV human immunodeficiency virus, M0 month 0, M6 month 6, PrEP pre-exposure prophylaxis, R0 randomisation month 0, R6 randomisation month 6, R12 randomisation month 12, R18 randomisation month 18, RNA ribonucleic acid, STI sexually transmitted infection
^aIncluding variables included in the HCV-MOSAIC risk score, number of sex partners and condomless anal sex acts with casual partners, and changes in disinfecting behaviour (self-reported)
^bIncluding testing for chlamydia, gonorrhoea, genital herpes and/or syphilis (self-reported)
^cNumber of free HCV tests used and number of HCV-positive test results
^dIncluding website statistics (e.g. frequency of use, time spent on the intervention and proportion completing all modules of the intervention, types of goals set and proportion individuals reporting change in risk behaviour identified in the goal setting module

ISSN: 1745-6215