Table 2

Trial objectives, endpoints and statistical analysis methods

ObjectivesEndpointsStatistical analysis methods
Primary
To assess the impact of HCV self-testing home delivery on HCV antibody testing rates in PWID and MSMNumber and point estimate of the proportion of participants who report completing the HCV antibody testing in the intervention groups.
Superiority of the proportion of participants who report completing the HCV antibody testing in the intervention groups compared with the control groups (margin 20%)
The primary outcome 1.2 will be evaluated in the MITT population (primary analysis) and will be repeated for the PP population.
The difference pfo,I–pfo,C will be assessed in a one-sided test with a margin of 20% by applying the following hypothesis:
Intervention types (arm 1, 2, 4) as well as the control groups (arm 3, 5) will be considered.
The proportion of individuals reporting HCV completing the test in the following intervention and control groups will be compared (three comparisons):
  • Arm 1 (intervention) vs arm 3 (control) for MSM

  • Arm 2 (intervention) vs arm 3 (control) for MSM

  • Arm 4 (intervention) vs arm 5 (control) for PWID

Secondary
To assess the impact of HCV self-testing on the number of HCV antibody-positive individuals who are aware of their statusNumber and estimate of the proportion of HCV antibody-positive participants made aware of their status in the intervention vs control groupsThe outcome (patient has a positive test result y/n) is defined overall (as primary analysis) and for visit 1 (as additional analysis). The proportion of test positives ppos will be calculated among all patients with test results (=favourable outcome) as well as among all MITT and PP patients.
These proportions will be investigated in the comparison via hypothesis testing.
To assess the impact of HCV self-testing on linkage and completion of HCV RNA confirmatory testing in HCV antibody-positive individualsNumber and estimate of the proportion of HCV antibody-positive participants who are referred to and complete HCV RNA confirmatory testing in the intervention vs control groupsThe outcome (patient is referred to and complete HCV RNA confirmatory testing: y/n) is defined overall (as primary analysis) and for visit 1 (as additional analysis). The proportion of patients referred pref will be calculated among all patients with positive test results as well as among all MITT and PP patients.
These proportions will be investigated in the comparison via hypothesis testing.
To assess the impact of HCV self-testing on treatment initiation in HCV RNA-positive individuals eligible to start treatmentNumber and estimate of the proportion of HCV RNA-positive participants who start treatment in the intervention vs control groupsHere the outcome (patient has started treatment y/n) is defined overall (as primary analysis) and for visit 1 (as additional analysis). The proportion of patients treated ptrt will be calculated among all patients with positive test results as well as among all MITT and PP patients.
The comparisons will refer to proportion with number with patients with a positive test result in the denominators (a+b, f+g).
To assess the acceptability and feasibility of HCV self-testing at baseline and after study participation. Information about knowledge, attitudes and practices related to HCV and risk-taking behaviours may also be collectedAnalysis of survey responses using proportions and meansThe secondary outcome 2.4 will be evaluated for the PP and MITT population.
Intervention types (arm 1, 2, 4) as well as the control groups (arm 3, 5) will be considered separately.
Descriptive statistics for survey responses will be reported either in absolute numbers and proportions or summarised by mean, median, SD, minimum, maximum and quartiles by arm and visit.
To assess the cost of HCV self-testingCost per test completed, cost per person diagnosed (serology, RNA) in the intervention vs control groups
  • MITT: all participants in ITT who were randomised to HCV self-testing (arm 1–5). PP: all participants in ITT who fully complied with the protocol (ie, primary endpoint variable is available).

  • HCV, hepatitis C virus; MITT, modified intention-to-treat; MSM, men who have sex with men; PP, per-protocol; PWID, people who inject drugs.