Study size and documentation to detect injection-related hepatitis C in prison.

We used existing data on hepatitis C prevalence, injection-related hepatitis C transmission and needle use in prisons and new data on infectiousness, to estimate the size of study required to detect injection-related hepatitis C in UK prisons. A pilot study of 500 prisoners followed for 10 weeks would have a 65% chance of detecting a hepatitis C seroconversion, conservatively assuming one injection per prisoner per week, and a 3% transmission rate per injection, but uncertainty might persist as to whether transmission had occurred during a short incarceration or before it. If the actual transmission rate was 10%, as recently documented, then such a study would have more adequate statistical power. A definitive study of 3000 prisoners for 10 weeks would expect to detect about six seroconversions, even with conservative estimates of injection frequency and transmission rate. Adequate design and power of these studies is important because of the complacency that could result from false-negative findings. We suggest six risk-factor themes that studies should document.