Charles Shagi Winner of the

PREVENTION RESEARCH ADVOCACY COMMUNITY PREPAREDNESS IN HIV PREVENTION TRIALS AND USE OF EXISTING METHODOLOGIES MDP 301 trial in Mwanza, Tanzania Charles Shagi Winner of the “2010 OmololuFalobi award for excellence in HIV prevention research community advocacy”

Context • Microbiocide Development Programme (MDP)known as MDP 301 was a multi-centre, randomised, double blind, placebo controlled phase-III trial • took place 2005- 2009, preceded by a 2-yr feasibility study • funded by (DFID) & the UK Medical Research Council (MRC)

Cont.. • In Tanzania, Zambia, Uganda and S/Africa • Engaged a number of African/Europe research institutions- for Tanzania was mainly AMREF, NIMR and LSTHM • AMREF participated mainly in clinical recruitment, follow-up and community engagement

Cont… • Mwanza City, Northern Tanzania was one of the study sites recruited 1146 women working in bars, hotels, guest houses, food/ recreational facilities as occupational cohort • MDP 301 results were released in 2009 “HIV ‘prevention’ gel PRO 2000 proven ineffective”. More information about the MDP 301 microbicides trial can be found at http://www.mdp.mrc.ac.uk/

Community Liaison System [CLS] • CLS was established as a main component to the trial (additional to the basic ones e.g. clinical team, data monitor) • Enabled effective communication among community stakeholders • Trial participants (had elected their leaders) • health service providers • Local government and community leaders • Other stakeholders

Community preparation requires a variety of tools, mechanisms and strategies to facilitate authentic partnerships between communities and researchers including providing a user-friendly project nameBranded as ‘MWAMKO’ extracted from swahili: ‘mwanamkeamuakuhusumaishayako CLS … 6

CLS.. cont • CLS persisted throughout during the trial and post-trial period • Functioned in 10 administrative wards of Mwanza city • Participants were invited for screening at mobile clinics those eligible got enrolled to the trial for the duration of 52 weeks.

CLS used extensive participatory approaches and processes- Participatory Rural Appraisal- Participatory learning & actionsStakeholders Advisory Group (SAG) CLS Community Advisory Committee (CAC) formed by participants’ representatives Participation of stakeholders improved referrals and link for trial participants Community participation

Participatory mapping identified geographical clusters of bars, restaurants and other facilities that became the foundation for community representation and participation in Mwanza

advantages of CLS • Improved understanding of the objectives of the trial and anticipated results • Allowed moral support, interactions, sharing and address challenges jointly • Promoted male partner involvement • Increased access to other services • HIV counseling and testing • Family planning • STI management • Referral to CTC for those tested HIV+

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Conclusion • Community Liaison System remains a very crucial component in clinical trials, promotes study adherence & preparations for study outcome (retention in MWAMKO was 80%) • Study participants are proud of being part of research

AKNOWLEDGEMENTS .Communities participating in prevention research .AMREF/NIMR/LSHTM collaboration in Tanzania .MDP 301 trial sites staff and leadership .COP (Community of Practices) forums .GCM (Global Campaign for Microbicides) .AMAG (African Microbicides Advocacy Group) .AVAC (Global Advocacy for HIV prevention) ASANTENI SANA

Charles Shagi Winner of the