Transcript Research Ethics Training for Community Representatives

new ARV-based prevention tools
how the research is happening
how we need to be involved
Anna Forbes, MSS
Consultant, HIV and women’s health
HIV Research Catalyst Forum
21 May 2010
differences between treatment
trials and prevention trials
HIV treatment trials:
HIV prevention trials:
• enroll those who need
treatment & may get
immediate benefit
• enrolling healthy people
– no immediate benefit
to person
• may help prevent
disease progression
• may help prevent
disease transmission
• only benefits those with
the disease
• benefits society;
everyone at risk of HIV
Vaccines
Male and female condoms
PrEP
PEP
Microbicides
PMTCT
HIV
Prevention
Cervical barriers:
vaginal diaphragms
Male
circumcision
Clean injecting
equipment
Voluntary
counselling and
testing
what do we need to know?
 Is the product safe? For whom?
 Adolescents? Women – pregnant? breast-feeding?
 HIV-negative only? Or HIV-positive also?
 Topical products -- vaginal application only? rectal only?
 Is it effective? For whom?
 e.g. circumcision: lowers men’s risk, not women’s
 Usable with condoms/other barriers?
the product pipeline
3 in
large-scale
efficacy
trials
human safety
trials
preclinical
testing
early-stage
concepts
Source: Alliance for
Microbicide
Development
expected trial results -effectiveness
2010
2011
2012+
PrEP
PrEP
PrEP
Men who have sex
with men
Heterosexual
men/women
Serodiscordant
couples
PrEP
Treatment
Injection drug
users
Serodiscordant
couples
PrEP
PrEP
Men who have sex
with men
Women
First ARV-based
Microbicide
PrEP/Microbicid
es
Women
Women
what else do we need to know?
 Does the community see the as ethical?
 What roles do they play in set up, implementation, results
distribution?
 Is the test product acceptable?
 Do trial participants use it?
 Would people use it in real life, after the trial?
going through informed consent
Family
Planning
Condoms +
experimental gel
Inform
ed
conse
nt to
enrol
INFORMED
CONSENT to
be SCREENED
Recruitment
Screening Visit 1:
Participant
gets
information
about the trial
in her own
language
Hears more about
trial, gets screened
for HIV, STI and
pregnancy.
Baseline data are
collected
INFORMED
CONSENT to
be ENROLLED
Screening Visit
2:
Gets test results,
STI treatment if
needed,
counselling, info.
on trial
reinforced
Condoms
+ placebo
Randomization:
Participant is
assigned by chance
to a group
who says when research is ethical?
Ethics
committees
Ethical
research
Researchers
and sponsors
Community
and advocates
the challenge of adherence
 Prevention technology trials measure
both tool + behavior
add
How well tool works
+
How consistently people use it
=
How well it prevents transmission
educating communities is vital
 People use a new product when:
It is affordable and accessible
It works the way they think it will
(realistic expectations)
Their peers like it and/or use it
Its benefit seems worth the effort/cost