Post on 13-Dec-2015
HOW ARE MDP PREPARING COMMUNITIES AT TRIAL SITES?
MDP301
MDP 301 trial messages
Community Liaison system at each MDP trial site Community advisory groups include combination of participants,
community members and local stakeholders Continuous 360 feedback loop
Main trial messages: PRO 2000 investigational product Trial designed to detect 35-40% reduction in risk of HIV infection Trial measuring ‘effectiveness’ of PRO 2000 as the effect dependent
on how frequently participants use the gel
Result Scenarios
Prior to release of HPTN 035 results – possible result scenarios and the implications for MDP 301 explained to participants, community and stakeholders
HPTN035 results explained to MDP 301 trial communities Reinforced message that PRO 2000 may not reduce risk of HIV Explained similarities and differences between HPTN035 and MDP
301 Used this opportunity to present possible outcomes of MDP 301
Preparing for the Results
Dissemination working groups – developing messages and resources to: Prepare communities for the release Explain the different possible scenarios Explain how results are assessed Explain how results will be presented Explain implications of each possible result scenario
Managing Expectations
MDP 301 may demonstrate that PRO 2000 does not reduce the risk of HIV infection for women
MDP 301 may demonstrate PRO 2000 reduces the risk of HIV infection but is not considered a viable HIV prevention option
MDP 301 may demonstrate PRO 2000 reduces the risk of HIV infection and is a viable HIV prevention option: Further development could be delayed – funding, support, product Other studies will be necessary Regulatory bodies need to review findings Process of licensure will take many years –prioritise trial countries Microbicide research ongoing
Community Expectations
HPTN 035 results increased expectations of MDP 301 showing PRO 2000 effective against HIV infection
Desire for additional HIV prevention options – especially for women
Ideally want choice of range of HIV prevention productsAcknowledgement of time lag to availability – but desire for
effective product to move forward speedily.Recognition that implementing a microbicide that could
reduce the risk of HIV infection by 35-40% challenging in health systems – but seen as an opportunity to reinvigorate existing limited prevention package for women.
Result Dissemination
Prior to release: National and provincial Ministries of Health Regulatory bodies National and local ethics committees Key advisory group members – including participants
At release: Participants – plus un-blinding Local stakeholders, NGOs, CBOs Communities
Achievements
Regardless of the outcome – MDP 301 has offered: HIV prevention and risk reduction education Condom negotiation skills Condoms – male and female Treatment for curable STIs
Reduced risk for many women
Provided opportunity to discuss sexual health with partners
Staff perspective
MDP 301 offered further educational opportunities to many staff
Staff are proud of the impact they have had in their own communities
“To me MDP has been more of an educational institute in which we were not only multi-skilled but also given a
chance to engage and empower women and communities in the true sense of the word”