Community Engagement in Prime-Boost HIV Vaccine Phase III Trial

1. Community Engagement in Prime-Boost HIV Vaccine Phase III Trial Punnee Pitisuttithum MBBS,DTM&H,FRCPT Faculty of Tropical Medicine Mahidol University FOR MOPH-TAVEG

2. MOPH-Thai AIDS Vaccine Evaluation Group • Ministry of Public Health, Thailand • Faculty of Tropical Medicine, Mahidol University • Royal Thai Army • US HIV Military Research Program • Supported by NIH, Henry Jackson Foundation

3. Randomized, double-blind placebo controlled trial • 16,402 community health volunteer were enrolled • Vaccine ALVAC-HIV~0,1,3,6 M • AIDSVAX B/E 3,6M • Started in Sept 2003 • Duration 3.5 years • Primary end point : • HIV infection, • Lowering viral set point (Reuk-Gnam., et al.) MOPH, TM, RTA, WRAIR, NIH

4. Screening all sites (N = 26,658) Male 15,973 (60%) Female 10,685 (40%) Enrollment all sites (N = 16,402) Male 10,068 (61%) Female 6,334 (39%) Participants with age under 20 yrs (N =2,540) Male 1,658 (65%) Female 882 (35%) 13,977 volunteers received all 4 vaccinations 90% follow up at three years

5. Community Engagement Activities • Pre screening and Screening period • Follow up phase • Pre and post announcement of the interim analysis • Pre and post announcement of the final results

6. Community Education & Engagement Prior to enrollment Various activities involving participants and communities were implemented with the objectives of • Raising AIDS awareness • Raising project awareness • Understanding of the vaccine and the project • Importance of follow up and solving of Participants impact events (PIEs) • Creating sense of ownership • Understanding of trial results

7. Announcement of Result

8. Community Activities • Community health forum for disseminating trial information and the understanding of HIV vaccine, update the status of the trial, need to follow up • Community engagement implements in routine health campaigns • Health fairs • Mobile unit health check up • Community Advisory Board (CAB) - meeting bimonthly

9. Community Health Forums: • The forum activities are being conducted to reach volunteers’ families and neighbors as well as the community at large for better understanding of the trial process, particularly the importance of the follow-up phase since 2005. • Nearly 400 CHF were conducted in both provinces

10. Community Advisory Board: • A group of voluntary community members, who are actively involved with HIV/AIDS issues in the community, facilitated by investigators and NGOs • To facilitate horizontal and vertical communication channelsabout HIV/AIDS & the vaccine trial for the community • The CAB meets every 2 months; the major issues are empowerment, updating trial information and potential trial results. • CAB and their members are actively involved in the community activities as well as volunteers’ relation activities, including information sharing with other CABs.

11. The chair of the CAB with some members together with the community representatives participated in the World AIDS Vaccine Awareness Day (2008)and expressed their enthusiasm in supporting trial participation and extended well wishes to the trial.

12. Involving NGO of the local community in every activites and later on they took the lead in the community activities.

13. RETENTION ACTIVITIES at the sites ( started from 2005) Extend Service Hours on Sunday and one evening clinic per week Edutainment campaigns/ interactive games Mailing and phone reminders 24-hour phone access Provider based system 16,402 volunteers Enrolled 95% interval Retention Mobile unit activities Quarterly exhibition with educational boards Tracking activities (Home visit) Volunteer Relation, Club activities Cultural activities

14. Volunteer Clubs Activities • to create sense of ownership of the trial among the volunteers • to establish communication channels and closer relationships among the volunteers and trial staff • to strengthen the relationship among the trial volunteers from different sites and link them together

15. Volunteer clubs are now being encouraged to integrate their activities into other community social activities by involving community networks and CAB member in their areas. • In 2006, 38 volunteer clubs were established • They were facilitated by the district health office, MOPH,CRC, and NGOs

16. Community engagement for final analysis Base on 4 potential results • Sc1. Vaccines Success; Efficacy ≥ 50% • Sc2. Modest vaccine success; LB>0,Efficacy<50% • Sc3. Reduction in viral load (VL) with no preventive effect • No vaccine effect

17. The trial is scheduled to have final analysis and the result announcement by late September 2009 • Communication with volunteers and community the trial result is crucial • Assessing the community, volunteers and field staff on the understanding of each scenario prior the announcement is and important clues to prepare educational messages.

18. The communication plan for the final analysis of the trial includes • Pre-Result Announcement (Jan-Aug 2009) • Trial Result Announcement (Sep 2009) • Post Trial Result Announcement (Oct 2009- Mar 2010)

19. Simultaneous result announcement both USA and Thailand via VDO conference Press conference Result communication training workshops for field trial staff Volunteers Scientific community Community at large/Thought leaders Sept’ 09 Jan - Aug’ 09 Oct’ 09 – Mar’ 10 • Introduction of the potential results in target audience • High level public health executives • Field trial staff • Participants • Community at large/leaders in the community • Scientific community

20. Pre-Result Announcement (Jan-Aug 09) Introduction of the potential results in target audience : • High Level Public Health Executives • Field trial staff (Local communication coordinator, clinical site) • Series of training workshop • Participants • Face to face/ focus group discussion during follow up visits • Volunteer’s club activities

21. Examples of questions raised by the participants from in depth discussion • How can they be sure that the result is correct? • Any long term side effects? • Continuing treatment of HIV infected participants? If efficacious of >50%, then • What next? • What benefits the community and participants will have? ,when? (vaccine),what’s the cost? • Patent issue?

22. Scenario2: Efficacy of around 30% • What next? • Can they participate in the future AIDS vaccine trial? • Any follow up care? Scenario 3: Effects on Viral load • Any additive effects? • Can it be used as therapeutic? All these Q with A have been prepared as a manual to all staff and are use for training

23. Trial Result Announcement (Sep 09) Activities include: • Simultaneous Result Announcement both USA and Thailand via VDO Conference • Press conference • at MOPH right after the result announcement, relevant to communication dossiers. • Press conference at both provinces, Chon Buri and Rayong in the afternoon

24. Result Communication Training Workshops for field trial staff • (Chief Provincial Medical Officers, Hospital Directors, Chief District Health Officers, Local Communication coordinators, Clinical site)

25. Post Trial Result Announcement (Oct 2009- Mar 2010) • For volunteers • Schedule individual Appointment (30 volunteers/working day/clinical site) • VDO trial result briefing • Clinic appointment for education , un-blinding and counseling • Update Contact Information for future communication

26. Frequently asked questions of VE +31.2%: • Long term side effects? • Why no effect on viral load?

27. Community at large / Thought Leaders • Community Health Forum at least once after the trial announcement • CAB meeting • Scientific community • Trial Result Seminar for National KOLs and technocrat- Dec 4,09 at The Joint International Meeting of Tropical Medicine and Malaria • International Meeting –AIDSVACCINE 2009,JAN2010

28. Media materials Production Plan All Media Materials base on 4 scenarios will be prepared • VDO CD • Fact sheet/FAQ • Brochure • Flyers • Posters • Banner • Radio spots • TV program/scoop • Advertorial advertisement • Moving advertisement • Website • Newsletter

29. Acknowledgement: • Volunteers including their families & community members • Ministry of Public Health, Thailand • Faculty of Tropical Medicine, Mahidol University • Royal Thai Army • WRAIR/Henry M. Jackson Foundation • DAIDS/NIAID/NIH • sanofi pasteur • GSID (VaxGen Inc.) • WHO/UNAIDS