HCV CHIM Community Advisory Committee

12:00 to 1:04pm Eastern Time

Six of seven members were in attendance: Camilla Broderick, Jake Eberts, Carolina Reid, Thomas Smiley, Jennifer van Gennip, Pam Young. Eberts and van Gennip co-chaired. Colors are used as pseudonyms in these notes.

Agenda: In our pre-survey, the top item to discuss was co-design (“What should a co-design process look like so if the vaccine is successful, those who would benefit the most will look favorably on it?”). Next two were Compensation (“How should we approach compensation for participants? Hourly? Visits? On-study? (And how much should compensation be?)”) and how to address genetic diversity in recruitment. Fourth was how to account for people who want to drop out of the study early due to symptomatic infection.

Co-design w/PWID community

Red: former PWIDs who may not actively using drugs may be best candidates to team up

Concerns raised over PWID CHIMs

Blue: When we’re talking about co-design, we mean the higher level advocacy and consultation (≠ PWIDs in trials, though that’s related). Major issue in terms of consulting with PWIDs may be consistency.

Blue: Perhaps focus groups for PWIDs? This helps avoid issues of relying on individuals, gives us broader feedback. 1Day can help fund but doesn’t have expertise in working with this group, so we’d need others to implement 

• Red: This would also be a good way to identify promising people who are very interested in further advocacy and engagement
• Yellow: Action Hep C could help coordinate researchers/people willing to carry out focus groups through member network
• Orange: We need to make sure this pre-work and post-work align. That is, if you’re in the focus group, you are kept updated and connected (and have priority access to vaccines!) 

Question: Does co-design/involvement necessitate PWIDs in trials? Is this optional? Or should it be avoided?

Red: Having them as trial subjects might be viewed badly — wary of lab rat stuff. (Purple agrees).

Blue/Green: properly explained CHIMs can make things much more clear, and lab rat issue can maybe be avoided if it’s clear not just PWIDs were volunteers.

Green: Scientific value is of highest concern — can they be engaged consistently

Purple: Concern of infecting others is very serious

Orange: Possibility of passing hep C on seems too risky

Consensus: Inclusion of hep C, PWID advocacy groups important. Focus groups of PWIDs seem like a strong method to incorporate feedback and opinions while avoiding having to rely on any single person. (No consensus on utility, feasibility, or ethics of hypothetical trials among PWIDs.)

Compensation

Blue: Compensation should be high, maybe $20,000 for healthy volunteers as a goal. It’s a big number at face for sure. Argument for it is that value of HCV CHIM is huge in itself, participation requires a lot from volunteers in terms of time and potential discomfort, and having a larger $ sum would make recruitment go faster.

Orange: My initial worry is the $ seeming too large — what if people just jump at the number?

Blue: Do we think informed consent processes can be designed to help avoid this? There’s some research suggestion people motivated by $ still have rational risk calculation

Red: A lengthy onboarding process would help weed out people who might not be thinking too clearly. It’s funny, 20k is a lot but for some reason 15k sounds more defensible! ($19,995 anyone?)

Purple: I lean towards higher, I think that’s fair given what’s asked of people

Orange: would definitely want to stagger for milestones, etc. Then also separate amount for living long term, maybe weekly “you’re infected with this so here’s compensation” in addition to the compensation for visits

Blue: 180 days of infection before treatment * 8 hours per day * $15.50 (Toronto minimum wage) = $22,320, so the number isn’t totally out of nowhere

Blue: idea of differential compensation for worse symptoms, e.g. a bonus for jaundice [Not to exceed 10-20% of the regular compensation]. Could help solve potential problem where people with spontaneous clearance (and generally worse symptoms) just drop out early from study. 

Purple: Compensation for greater symptoms does seem more fair 

Orange: I think it’s dicey because things are too subjective regarding symptoms

Yellow: It’s a little dicey because one of the primary symptoms is malaise — hard to quantify.

Red: What about compensation for particular hardships incurred due to illness? like cab fare reimbursement etc. or if someone has to miss work. Compensate based on impact to daily life.

Green: We should raise the compensation floor to where this doesn’t come up anyway. Also, differential compensation becomes a problem because how do you calculate that for e.g. a lawyer versus a paperboy?

Rough consensus: Higher compensation is better given the value of the trials and the significant asks made of volunteers over a long time period. If there is a solid way to objectively assess severity of symptoms, there may be room for additional bonus compensation for those with symptomatic acute infection. Additional expenses incurred by participation should be considered for reimbursement as well, but ideally, the floor of compensation should be high enough such that it overcomes these considerations.