Comprehensive Prevention Strategy (Guy de Bruyn)
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Transcript of Comprehensive Prevention Strategy (Guy de Bruyn)
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Care and Prevention
in HIV Vaccine Trials:a site perspective
Guy de Bruyn
Perinatal HIV Research Unit
University of the WitwatersrandChris Hani Baragwanath Hospital
Johannesburg, South Africa
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Access to care (modified from Grady)
Care which is part of the scientific
design
Care needed to safely complete the trial Care for injuries and adverse events
Post trial access
Ancillary care Care that some participants will
predictably need
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Dialogue?
a comprehensive care package should
be agreed upon through ahost/community/sponsor dialogue
which reaches consensus prior to
initiation of a trial (UNAIDS 2000,
#16)
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Protocol mandates
Avoiding pregnancy during the
vaccination period
Assessing symptoms of illness Ensuring adequate standard of care to
control participants
Counselling pre/post-test, risk reduction,safer sex
Providing condoms
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Care needed to safely complete the trial
Resuscitation equipment
Laboratory monitoring of haematologic
parameters and other clinicallaboratory values of potential interest
Anaemia
Leukopaenia
Alteration of hepatic enzyme tests
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Ancillary care in HIV Vaccine trials
Some questions
What kind of care is needed?
For how long? By whom?
Whose responsibility?
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Ancillary care some examples
Hypertension May be diagnosed incidentally during the conduct
of trial procedures
Treatment is lifelong
Management is multi-modal, i.e. requires attentionto weight, nutrition, exercise, in addition topossible pharmacotherapy
Facilitating access to services TOP
Psychosocial support rape/trauma/DV
Mental illness
Dental care
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What is the standard of prevention?
HIV counseling and testing
Some protocols may not provide results in real-
time, depending on the complexity of ruling out
vaccine-induced seropositivity Impact on testing outside of the trial setting
Other VCTs, blood donation, organ donation, testing for
insurance purposes
What about partners? Should we offer CHCT and who is able to do that?
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More Standard of Prevention
Risk reduction counselling
Efforts to standardize that intervention,
such as pilot efforts within DAIDS
networks
Condom promotion vs. provision
Male / Female / both
What other means should be used topromote condom uptake
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What about additional HIV prevention
technologies?
Male circumcision
STI treatment
Diagnostics Directed versus syndromic therapy
Post-exposure prophylaxis
Pre-exposure prophylaxis Other investigational agents
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What is the Threshold of
Evidence for New PreventionTools?
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Cochrane Review of HIV and Circumcision in
High Risk Heterosexual Men
Siegfried et al. Lancet Infect Dis 2005
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Phambili timelines
17Mar06. MCC
submission. GMO
submission
8May06. HREC
submission
12Sep06. IBC
submission
13Oct06. MCC approval
19Oct06. HREC approval
24Jan07. First pt
enrolled
19 Sep 2007
STEP trial interim resultsJuly 2005 Orange
Farm MC trial
results
December 2006
Kenyan and Ugandan
MC trial results
7March 2007
First Phambili
participant
provided MC
8Nov06. IBC approval
21Nov06. GMO approval
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Location ofStudies ofAcceptability
Thirteen studiesfrom nine sub-Saharan Africancountries
Bailey R IAS 2007
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Public Sector Circumcisions CHB
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Local Expertise
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Implementing at the Trial Site / Facilities
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