Post on 21-Jan-2016
description
Involving the Community in Randomised Microbicide Clinical Trials:
Lessons from 6 MDP African Clinical Trial Sites So Far
Richard I. MutemwaCAR/S3RI
The Presentation
What the Microbicide (MDP) trial is all about
MDP Structure & Southampton Overall Trial Milestones
the community strand within it The Community Involvement
Programme to date
What it is all about….
The MDP is a partnership set up to develop topical vaginal Microbicides for the prevention of HIV transmission
Funded by DfID Co-ordinated jointly by MRC/CTU
& Imperial College (St Mary’s Hosp.)
Univ. of Southampton is a partner
What it is all about…II
This is a Phase III trial Intention to test the efficacy of one
candidate topical Microbicide gel: Pro 2000, in the prevention of HIV transmission thru heterosexual sex
The Phase III trial is set up in 6 African sites: Ug (Masaka), Tz (Mwanza), Zm (Mazabuka), SA (Joburg, Durban, Mtubatuba)
MDP Structure & Soton
MDP Working Groups Responsible CoordinatorBasic Science
Laboratory
Clinical CTU
Community Involvement
(/Liaison)
Southampton
Social Science LSHTM
Statistics
Data CTU
Trial Milestones
Site Preparation: contracts, advocacy, launch
Feasibility Study: recruitment/retention/follow-up, tools design, community issues, HIV incidence/prevalence, sexual behaviour
Pilot Study: tools pre-test, r-r-f with placebo product, community response to product
Phase III (upcoming – April/May)
COMMUNITY ROLE: intervention rather than data collection research
The Community Involvement Programme
Implemented through CLOs
Communication-centred Liaison (CABs, CAGs, CACs) Communication materials/media Clinical Process: counsellors,
reception Service: services provided, quality of
service
Phased: entry – middle – exit
The CIP…II
Pluralistic Approach to Community: Public/Private (Non-Gov) Orgs Leaders Women of reprod. age (Study participants) Their partners/men Others – social networks/opinion
‘consultants’ In-built dedicated monitoring
system Media: radio, suggestion boxes,
meetings, counsellors, community reps, etc.
Community feedback: -ve & +ve
The CIP – Lessons What attracts women to the study?
‘Familiarity’ of the CLO: enrolled women do help too
Clear, simple messages in local language: purpose, safety, other relevant clinical services, compensation
Continuous feedback loop, concerns addressed Hope – in case the drug works for her!!
What keeps women on the study? Continuous feedback loop, concerns addressed
– otherwise explained why not Sustained hope Consistency in messaging and sustained
communication Demonstrated, consistent confidentiality
What makes women leave the study? Rumour, stigma Perceived lack of confidentiality Partner hostility Issues about compensation: did you consult? Other priorities: education, work, household
economy, migration, marriage, health, pregnancy, sexually inactive, etc.
The CIP – Lessons II Liaison: No ‘one shoe fits all’
Defining ‘community’ Representation: ‘Can I speak for
myself, please’ Community ‘grows’ with the Trial :
Entry, Mid-Phase, (Mature/Exit) Action Speaks Louder: little acts of
compassion mean a lot more ‘I feel I’m a good leader ‘cos I feel I
represent a good project’ Social Marketing: Selling a clinical
trial (research) Vs selling boreholes ‘Will I have the drug free later?’ ‘Okay. But, then, why don’t you just
give the product to everybody, we start using it, and then you see if it works!’
Pressure from Hope: presence of a product (probably) enhances compliance and minimizes loss to follow-up or dropping-out (feasibility vs. pilot)
The CIP – Some Challenges Partner/Men involvement: ‘Don’t tell
my partner, please’ ‘High-Brow’ Benefits: ‘You brought the
money and the product, we gave you our people’s sacrifices’
Compensation: ‘What? That is too little’ Terms/Notions:
‘Random-ization? What’s that?’ ‘Placebo – do you mean it’s `fake`?’
“Trial Rush”: ‘They said that they don’t care about us.
Prove to us that you’re different’ ‘They gave us everything we asked for.
We don’t understand why you are so reluctant’
Bottom-line: Is a common front for all trialists/researchers achievable?
How about possibility of overarching GLP guidelines (in the lines of GCP)?
for ethical & informed consent purposes