Community Engagement (Punnee Pitisuttithum)

A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC-
HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX®

B/E) Boosting in HIV-Uninfected Thai Adults
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
1
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
• 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
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
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
5
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
Announcement
of Result
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
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
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.
• 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.
• Involving NGO of the local community in

every activites and later on they took the
lead in the community activities.
12
RETENTION ACTIVITIES at the sites

( started from 2005)
Extend Service
Mailing Edutainment
24-hour Hours
and campaigns/
Provider phone on Sunday
phone interactive
based access and one evening
reminders games
system clinic per week
16,402
volunteers 95%
Enrolled interval
Retention
Mobile
Tracking Quarterly
unit Volunteer Cultural
activities exhibition
activities Relation, activities
(Home with educational
Club
visit) boards
activities
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
• 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
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
16
• 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.
17
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)
18
Jan - Aug’ 09 Sept’ 09 Oct’ 09 – Mar’ 10

Introduction of  Simultaneous r  Volunteers
the potential esult announce
results in target ment both USA  Scientific
audience and Thailand vi
community
• High level a VDO
public health conference
executives  Press  Community at
• Field trial staff conference large/Thought
 Result leaders
• Participants
• Community at communication
large/leaders in training
the community workshops for
field trial staff
• Scientific
community
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
20
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? 21
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
22
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
23
• Result Communication Training Workshops

for field trial staff
 (Chief Provincial Medical Officers,

Hospital Directors, Chief District Health
Officers, Local Communication
coordinators, Clinical site)
24
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
25
Frequently asked questions of VE +31.2%:

• Long term side effects?
• Why no effect on viral load?
26
• 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
27
Media materials Production Plan

• VDO CD • TV program/scoop
• Fact sheet/FAQ • Advertorial
• Brochure advertisement
• Flyers • Moving advertisement
• Posters • Website
• Banner • Newsletter
• Radio spots
All Media Materials base on 4 scenarios will be
prepared
28
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
29

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A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC-

HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX®

Prime-Boost HIV Vaccine Phase III Trial

Punnee Pitisuttithum MBBS,DTM&H,FRCPT

MOPH-Thai AIDS Vaccine Evaluation Group

• Ministry of Public Health, Thailand

• Randomized, double-blind placebo controlled trial

Screening all sites (N = 26,658)

Community Engagement Activities

Community Education & Engagement Prior

Community Health Forums:

• The forum activities are being conducted to

Community Advisory Board:

• The chair of the CAB with some members

• Involving NGO of the local community in

RETENTION ACTIVITIES at the sites

Volunteer Clubs Activities

• to establish communication channels and

• to strengthen the relationship among the

• Volunteer clubs are now being encouraged

Community engagement for final analysis

Base on 4 potential results

• The trial is scheduled to have final analysis and the

The communication plan for the final

Jan - Aug’ 09 Sept’ 09 Oct’ 09 – Mar’ 10

Pre-Result Announcement (Jan-Aug 09)

Examples of questions raised by the participants

Scenario2: Efficacy of around 30%

Trial Result Announcement (Sep 09)

• Result Communication Training Workshops

 (Chief Provincial Medical Officers,

Post Trial Result Announcement

Frequently asked questions of VE +31.2%:

• Community at large / Thought Leaders

Media materials Production Plan

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