Transcript Population effect of ART therapy to Reduce HIV Transmission

Population effect of ART therapy to
Reduce HIV Transmission - PopART
A study to assess the feasibility of
increased HIV voluntary
counselling and testing (VCT) and
universal access to antiretroviral
therapy (ART) to reduce HIV
incidence
Dr Ade Fakoya,
Senior Advisor: HIV and Health Services,
International HIV/AIDS Alliance
PopART Membership
United Kingdom
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Imperial College London
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Geoffrey Garnett
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Sarah Fidler
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Christophe Fraser
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Becky Baggaley
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Jonathan Weber
Institute of Global Health
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Peter Piot
LSHTM
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Richard Hayes
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David Ross
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Debby Watson-Jones
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Johanna Hanefeld
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MRC CTU
– Adbel Babiker
– Sheena McCormack
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UCL
– Andrew Phillips
International HIV/ AIDS
Alliance
– Ade Fakoya
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Africa: PIs
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Uganda ( MRC-UVRI)
Zambia ( Zambart)
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The Prevention- Treatment gap…..
By the end 2007:
 3 million were receiving ART
--about 1 million people added
 6.7 million in need
 2.7 million new infections
PopART – The Goal
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A comprehensive feasibility study to address the
key assumptions underpinning the Universal
Testing and Treatment concept (UTT)
To determine whether a larger randomised trial is
possible
‘Know your status’. ‘Take Lifelong treatment
if you are positive’
‘Grace’
18 years old
Both brother and mother are
positive
HIV positive ( 12 years )
CD4 – 61
Viral Load 110,000
Not on ARV treatment
PopART- four levels of exploration
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‘Logistical feasibility’ – pilot studies in districts in
Uganda and Zambia. ‘ Test the approach’
‘acceptability’ – individual, community ,
population, government
‘wider implications’ – health economics human
rights, drug issue ( resistance, toxicity, )
Mathematical modelling ( data to support
assumptions,
Feasibility Study Design
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Engage with country stakeholders
National stakeholder and community
engagement and acceptability of interventions
Compilation of data on HIV epidemiology, testing
and treatment monitoring
Development of HIV incidence measurement
Field testing of novel point of care assays
Some key questions
Key area
Main issues
Acceptance of Treatment as
prevention
At individual , community and country levels, What
will be the uptake of ARV treatment for those who
may not need it for clinical need
Logistical Provision of treatment
in health systems which are
already over- stretched
Is it logistically feasible , what coverage is actually
possible, will it divert funding from other areas,
will it increase waiting lists for those who need
treatment to actually stay alive
Starting and staying on treatment
Drop out rate, the survival , the residual HIV
transmission
Resistance to ARV drugs
What is the optimum regimen for TAP,
what will the strategy do to population levels of
resistance
at what level resistance will assumptions become
how will resistance be monitored at a population level
Some key questions
Key area
Main issues
Marginalised groups
In a generalised epidemic, what will be the focus
and special attention required for hard to
reach groups including sex workers, men
who have sex with men, drug users , people
who move (including migrants )
Human rights
Will a focus on a public health approach further
erode human rights,
is it acceptable for individuals to take treatment
when they don’t need it.
What about other health needs?
What about marginalised populations?
Adherence
What level of adherence is important to ensure
success?
PopART: Feasibility
Mathematical modelling
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Undertake critical evaluation of current models
Develop an HIV transmission model
Inform the design of the Cluster randomised trial( CRT),
Determine the predicted effect size; For a given effect
size, the model will be used to estimate the minimum
proportion of the HIV+ve population that will need to be
identified and treated.
Estimate the minimum threshold that needs to be
reached to ensure a substantial public health impact.
PopART Modelling Led by IC
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What % HIV+ threshold of detection is required to
demonstrate an effect
What % uptake of ART is required to demonstrate an
effect
What is the risk of viral drug resistance and toxicity
What is the cost benefit analysis
► Set parameters for RCT
Epidemiology led by LSHTM, MRC CTU
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two selected communities of approximately 25 000
people
comprehensive VCT package ( house-to-house testing,
mobile testing units, work place testing and village
facilities.
All individuals identified as HIV+ve will be immediately
referred into local standard care health care facilities
Random selected population (10% of the total) enrolled
into a pilot RCT: either standard care (CD4 driven
initiation of ART) or a UTT strategy where irrespective of
CD4 T-cell count ART will be immediately offered.
PopART Pilot - Human Rights
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Human rights based approaches an explicit part
of the feasibility and pilot study.
Two broad elements:
1/to better understand the effect and interaction of
PopART interventions on human rights,
2/develop best practice human rights approaches
especially in community interventions but at all levels
of rights based approaches for treatment as
prevention.
PopART Pilot - Human Rights
Specific objectives
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To explore the human right dimensions of the concept of treatment
as prevention (TAP) and ensure that the pilot study adheres to
human rights principles, including the right to information,
participation, non-discrimination and equity.
To explore areas of investigation relating to the acceptability and
feasibility of treatment as prevention at individual, community and
national level
To understand the potential barriers to universal HIV testing and
immediate uptake of HIV treatment.
To develop individual and community based interventions that
address the barriers to successful recruitment and participation in
any future CRT of treatment as prevention, while ensuring human
rights of the individual are fulfilled, protected and guaranteed.
PopART Pilot - Human Rights
How will this work in practice?
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Human rights/social science working group consisting of staff
from each of the implementing partners, including the MRC
Uganda and Zambart who develop and implement a detailed
methodology.
Local Community advisory group in each country
*Ethics reference/advisory group made up of key external
experts/individuals who can advise on the human rights
dimension of treatment as prevention and the issues which
arise during the execution of the study.
PopART Pilot - Human Rights
Possible Methods include*
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Ethnographies
In-depth interviews over time (3 year study)
Work with policymakers at national level and
district level.
The human rights part of the research will focus
on the individual level, but also on how to
achieve greater acceptability for the inclusion of
rights based approaches with policymakers at all
levels.
* The HR working group will develop these in detail as part of the study and will be led by
country context.
PopART Pilot - Human Rights
Your thoughts?
Specifically around the areas of study and
investigation
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More detail and information
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Ade Fakoya at the AIDS Alliance
[email protected]
Johanna Hanefeld at London School of Hygiene and
Tropical Medicine [email protected]
Combination prevention- no magic
bullets
Summary I
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There will be a population effect of ARV
treatment roll out
Despite the enormous assumptions in the
mathematical modelling, UTT and Universal
Access to HIV treatment care and prevention are
closer together than it would appear
Need community engagement to find out what
affected communities and individuals think.