1. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 1 Prevention Research and National AIDS Plans 20-21 June 2005 Geneva, Switzerland Prof. Roy Mugerwa Department of Medicine Makerere University Medical School

2. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 2 Synopsis Overview of National AIDS Plans Advocacy for Prevention Trials Mobilisation/communication Co-ordination/Networking/Harmonisation Challenges of Prevention Trials

3. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 3 Why a National AIDS Plan A national AIDS plan provides “clear rules” - Attract partners. A well conceived plan could be presented to development partners and other international agencies for collaboration and support.

4. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 4 National AIDS Plan should: Integrate prevention research plans within the overall National AIDS Strategy and response. Address prevention research within the context of poverty alleviation efforts.

5. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 5 National Plans should outline: Legal framework for the conduct of biomedical research. Regulatory bodies and ethical approval mechanisms.

6. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 6 National Plans should emphasize Advocacy for prevention research Solicit Political Commitment and Involvement Social Mobilization -Community support and participation -Information dissem.to the Media and the Public Involve Policy Makers. Define: -Role of National Government Bodies -The role of WHO and UNAIDS -Role of the various partners/stakeholders.

7. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 7 Advocacy strategies include:- Building alliances Mobilization of the community Communication with policy makers, scientists, and donors Involvement of the media Mobilization of resources

8. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 8 Mobilization of the community Participation in planning and implementation of prevention trial activities. Input in the design of the protocol. Input into appropriate informed consent process. Information to the community at large on the proposed research.

9. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 9 Communication Educate people about HIV prevention trials (media, policymakers, civil society, medical community). Engage governments, international agencies, human and civil rights bodies in dialogue on prevention trials. Encourage women and adolescents participation but protect the vulnerable and marginalised.

10. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 10 Mobilisation of Resources Facilitate communication and accountability between funders/ stakeholders and scientists. Facilitate communication/discussion between regional and country HIV/AIDS leaders and WHO/UNAIDS, AAVP

11. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 11 Involve the Media Advocate for HIV prevention research but manage expectations. Focus on HIV prevention trials but not ignore other prevention (TB, ABC). Prevention trials are designed for and tested in the regions of the world where they are most needed.

12. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 12 Co-ordination/Networking Create National and Regional frameworks to support Prevention Trials Harmonise guidelines across regions.

13. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 13 Harmonisation of guidelines across regions: Promote development of regional networks to discuss/co-ordinate capacity building. Harmonise training for NRA and ethics committees: to simplify the review process. Establish Regional Task Forces to develop guidelines for regulatory review of vaccines.

14. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 14 Harmonisation (Cont’d) Incorporate general principles and policies for treatment and care for intercurrent infections. Outline national policies on treatment of study volunteers who seroconvert during trials.

15. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 15 Challenges in Conducting HIV Prevention Trials in Developing Countries Inadequate health care outside the context of research. Excellent services for trial volunteers with poor health services in communities. Improve infrastructures as part of research agenda. Build long term sustainable capacity – financial, human

16. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 16 Challenges (Cont’d) Less developed decision making systems – Legal framework; regulatory bodies; IRBs Ethical concerns (consent, vulnerable populations) Cultural and language barriers.

17. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 17 Challenges (Cont’d) Political suspicions Public mistrust/misconceptions Media-uninformed/misinformation

18. 1/28/2016 Prevention Research and Natioanl Aids Plans Geneva 18 THE ROAD IS RUGGED! BUT THERE IS A WAY