Community involvement

Community involvement

in UK-based clinical research on HIV vaccines, microbicides and other new prevention technologies

Julian Meldrum – www.julian-meldrum.net

Questions for discussion

What kinds of community involvement are possible, desirable or necessary, especially here in the UK?

When to separate and when to mix vaccines, microbicides, PEP?

What forums or other organisational structures exist now or should be developed to support UK community involvement?

Defining community

“Community is the group of people who will participate in or are likely to be affected by or have an influence on the conduct of the research.”

– Community Working Group of the US-funded HIV Prevention Trials Network (www.hptn.org)

UK clinical trials

Phase I (no UK Phase III) but on scale too large to recruit from health staff and academic community alone

Multi-sponsor (MRC, IAVI, EuroVac) Multi-centre (London, Oxford, Wales) Overlaps between vaccine and

microbicide trial research teams Further trials overseas (Africa, Asia?)

Models for UK involvement in HIV prevention research Outreach to potential trial volunteers Mobilising to advocate for new

prevention methods Monitoring impact of (perceived) new

technologies on HIV prevention efforts (gay men, African communities in UK)

Options for ‘community expert’ and trial volunteer input to research process, e.g. on standards of care

Vaccines vs Microbicides

Both sexes vs women as volunteers? One-off trial participation vs option to

volunteer for a series of trials? Level of active participation needed? Level of involvement of positive

people: different underlying reasons? Stage of development (components

vs formulated products)?

Vaccines + Microbicides

Prospect of partial efficacy and testing in combination with other prevention methods = complex messages

Potential impact on future treatment and/or prevention options for individuals and communities

Potential social hazards for ‘low risk’ Phase I volunteers due to HIV stigma

Use of ARVs in prevention

Post-exposure prophylaxis – could be made available now but RCT not possible; economics & logistics?

Pre-exposure prophylaxis (tenofovir) –RCT possible and essential; issues of targeting, economics & logistics?

Use in microbicides – tenofovir, NNRTIs: need to target HIV-ve users, evaluate resistance risks, logistics?

Community Advisory Boards

Driven by needs of Phase III trials, where role is:Liaison between community and

researchers.Advise [on] the development and

implementation of research.Identify potential research ideas.

(HIV Prevention Trials Network)

What is the role for a UK Community Advisory Board?

Clearly, not to prepare for a Phase III trial. So is it needed at all?

This presentation sets out the case for an important role which needs to be differentiated, however, from those of other forums for community involvement in HIV prevention technology research

Outreach and trial volunteer support (1 of 3)

Recruiting volunteers to a small one-off trial is possible without reference to community or volunteer experience

Recruiting thousands for a research programme over several years is unlikely to be possible without serious attention to community issues and the volunteers’ experience in the trials

Outreach and trial volunteer support (2 of 3) Trial investigators must be

responsible for volunteer recruitment, retention and support

However, a media, outreach and volunteer support strategy for each trial/trial series could benefit from access to a Community Advisory Board that includes past trial volunteers and HIV community groups

Outreach and trial volunteer support (3 of 3)

Volunteers should be encouraged to see themselves as part of a process beyond the immediate trial; they should be able to comment on their experiences of involvement (positive as well as negative) and be given an opportunity to be kept informed about the research after the trial

Mobilising communities for advocacy (1 of 2)

Advocacy issues related to microbicides, vaccines and use of ARVs for prevention are distinct and may be best kept separate

Advocacy needs alter as options move nearer to adoption in practice (or appear to move away, with greater awareness of technical challenges)

Mobilising communities for advocacy (2 of 2)

The existence of the UK Campaign for Microbicides does not reduce the need for a CAB to consider trial design, volunteer support, etc

Such campaigns and any CAB would need to exchange information on a regular basis but separating out the roles is mutually beneficial

Monitoring impacts on HIV prevention Existing forums (CHAPS, African HIV

Prevention Network) are the best place to discuss these issues

The THT ‘Expert Seminar’ model which invites stakeholders to discuss an issue is the best pattern for now

A CAB and campaign groups can and should help to identify issues to discuss and take to those forums

Proposal for UK-CAB

The proposal is, that the UK-CAB should extend its work on treatment research and access to cover research on HIV prevention technologies – in a well-defined and sustainable way, taking full account of the existence and need for other forums for community involvement

Proposal for UK-CAB

Use of ARVs for prevention is an obvious area for the UK-CAB to explore, as it builds on the experience of treatment advocates in relation to the use of ARVs for treatment. In fact, the relationship is so close that it might best be integrated with other work on ARVs.

Proposal for UK-CAB

Microbicide trials are already recruiting HIV positive women for initial safety and acceptability studies. It is obviously appropriate for the UK CAB to be considering the need for training and support to those involved in that process. The use of ARVs as microbicides could further strengthen the case for UK CAB involvement.

Proposal for UK-CAB

While there is important UK-based HIV vaccine research, it may be at a greater remove from direct clinical application than ARV or microbicide prevention research

However, there is real value for both community organisations and researchers in having a dialogue …

Proposal for UK-CAB

Issues for UK trials may include: Media strategy to place trials in broader

context and prevent damaging hype Rationale for (not) pursuing potential

therapeutic use in HIV positive people Communicating other exclusion criteria Managing seropositivity (if applicable) Reviewing protocols and volunteer info,

including feedback options during/after trial