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”