1. Involving the Community in Randomised Microbicide Clinical Trials: Lessons from 6 MDP African Clinical Trial Sites So Far Richard I. Mutemwa CAR/S3RI

2. 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

3. 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

4. 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)

5. MDP Structure & Soton MDP Working GroupsResponsible Coordinator Basic Science Laboratory ClinicalCTU Community Involvement (/Liaison) Southampton Social ScienceLSHTM Statistics DataCTU

6. 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

7. 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

8. 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

9. 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.

10. 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)

11. 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