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