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Involving the Community in Randomised Microbicide Clinical Trials:

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

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Involving the Community in Randomised Microbicide Clinical Trials:

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  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

  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`?’ • “TrialRush”: • ‘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

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