Transcript Injecting Drug Users in Thailand`s Tenofovir PREP Trial Community

Injecting Drug Users in Thailand’s
Tenofovir PREP Trial
Community Participation in HIV-related
Clinical Research
Karyn Kaplan
International AIDS Conference
Mexico 2008
• Placebo-controlled 300 mg daily oral Tenofovir to prevent
HIV (safety and efficacy trial) – Thailand only IDU site
• Study group: >2,400 HIV-negative, HBV-negative injecting
drug users (IDU) at Bangkok Metropolitan Authority
methadone clinics (17 sites)
• Extended from 1 year to >3 (participants don’t know end
point)
• Expanded original study population size from 1,600 to
2,400
• Sponsors: Thai-US CDC Collaboration
Community Concerns
• Lack of community
involvement or
consultation in design and
development of protocol
• Investigators refused to
incorporate any changes
or amendments until
after the trial was
approved by IRBs
• Best current prophylactic
methods (clean injecting
equipment) not available
to trial participants
• Potential for coerced
participation, as
recruitment was done by
methadone providers at
the site of service
• No harm reduction policy
in Thailand; zero NSP,
sub-standard MMT
• Lack of protection
mechanism for
participants despite
recent, violent drug war
(cont’d.)
• No commitment by trial
sponsors to promote safety
of trial participants when
accessing services
• No commitment to work
with MOPH towards access
or price reductions of
Tenofovir for Thailand
• Unclear standard of
care for seroconverters
and HIV+ IDU who are
screened out
Engaging in Dialogue
Numerous TDN/Ally Meetings with PI, Trial Researchers (Bangkok)
Gates Foundation Meetings (Seattle)
UNAIDS Consultations (Pattaya, Geneva)
Civil Society Groups
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Thai Drug Users’ Network
Thai AIDS Treatment Action Group (TTAG)
Thai Network of PLWHA (TNP+)
Foundation for AIDS Rights
Thai NGO Coalition on AIDS (TNCA)
MSF-Belgium/Thailand (MSF-B)
Specific Actions for Researchers
• Asked researchers NOT to commence recruitment until
community concerns resolved
• Requested community advisory team of key affected groups
and advocates be appointed to trial
• Demanded on-site, third-party needle/syringe provision (MSF
or TDN)
• Suggested hiring INDEPENDENT, NON-MMT clinic staff to
conduct recruitment/counseling
• Asked for MONITORING informed consent process/counseling
for quality control
• Suggested TRAINING counselors in harm reduction counseling
and appropriate recruitment techniques and FIRE counselors
not abiding by ethical rules and standards for
recruitment/counseling
More Suggested Actions
Regarding Referral system development (for HIV+ screened out, and HIV
sero-converters in trial)
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TRAIN health care providers in ARV-Street Drug Interactions, and
harm reduction approach/counseling
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DEVELOP MECHANISM TO ENSURE ARV ACCESS (escort insufficient;
evidence that hospitals tell PLWHA that ARV quotas are full, even non-IDU
PLWHA face this reality)
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HIRE “ombudsman” or trial staff (non-MMT clinic staff) whose
responsibility is solely to deal with problems or complaints from trial
participants
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PROVIDE referral information to each trial participant about
supportive services or organizations, such as the Thai Drug Users’ Network
and AIDS ACCESS Foundation’s anonymous hotlines (HIV, drug use) as a
matter of protocol
• AND MUCH MORE: All refused
Ethical Violations
Par. 29, Declaration of Helsinki (and reaffirmed
by World Medical Association): “extreme care”
must be taken in making use of placebocontrolled trial ; should only use this
methodology in absence of existing proven
prophylactic, diagnostic, and therapeutic
methods
• This position supported by clinicians and
researchers globally, including MSF-Belgium
Community Update
• Non-IDU – estimated 50%
• Non-drug users
• Not taking TDF because afraid of long-term
effects to their health
• Not informed about when trial will end
• “Can leave any time” – but in actuality,
convinced to stay without being given tangible
information
Concerns and Recommendations
• Anecdotal information points to invalid data
• Future trials must involve target study
population, must provide critical education
(HIV, hepatitis) in ongoing manner, be
transparent and open in communication with
study population, and work with allied
organizations expressing an interest to
support the trial to make it better and reduce
trial-related harms.
Good Participatory Practice (GPP)
TTAG is involved in pro-actively improving clinical trials
among highly vulnerable groups, including through
the development of GPP core principles for adequate
standards of community engagement, participation
and input.
The GPP guidelines cover issues of: scientific and
ethical integrity, respect, clarity in roles and
responsibilities, shared ownership, participatory
management, transparency, autonomy, standard of
prevention, access to care, shared accountability,
building research literacy.