Transcript Presentation - Centre for AIDS Research, University of Southampton

Involving the Community in
Randomised Microbicide Clinical
Trials:
Lessons from 6 MDP African
Clinical Trial Sites So Far
Richard I. Mutemwa
CAR/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 Coordinator
Basic Science
Laboratory
Clinical
Community Involvement
(/Liaison)
Social Science
CTU
Southampton
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



What keeps women on the study?





Continuous feedback loop, concerns addressed
Hope – in case the drug works for her!!
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:



“Trial Rush”:



‘Random-ization? What’s that?’
‘Placebo – do you mean it’s `fake`?’
‘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