Community Engagement in Prime-Boost HIV Vaccine Phase III Trial

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Community Engagement in Prime-Boost HIV Vaccine
Phase III Trial

• Punnee Pitisuttithum MBBS,DTMH,FRCPT
• Faculty of Tropical Medicine
• Mahidol University
• FOR MOPH-TAVEG

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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

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• Randomized, double-blind placebo controlled
  trial
• 16,402 community health volunteer were enrolled
• Vaccine ALVAC-HIV0,1,3,6 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
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• 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

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• 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

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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

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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

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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

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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 channels about 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.

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• 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.

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

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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)
Cultural activities
Volunteer Relation, Club activities
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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

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• 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

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Community engagement for final analysis

• Base on 4 potential results
• Sc1. Vaccines Success Efficacy 50
• Sc2. Modest vaccine success LBgt0,Efficacylt50
• Sc3. Reduction in viral load (VL) with no
  preventive effect
• No vaccine effect

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• 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.

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• 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)

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Sept 09
Oct 09 Mar 10
Jan - Aug 09

• 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

• 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

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• 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
• Volunteers club activities

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• 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 gt50, then
• What next?
• What benefits the community and participants
  will have? ,when? (vaccine),whats the cost?
• Patent issue?

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• 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
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• 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

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

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• 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

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• Frequently asked questions of VE 31.2
• Long term side effects?
• Why no effect on viral load?

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• 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

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• 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

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• 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