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 Imperial College London

– Geoffrey Garnett– Sarah Fidler– Christophe Fraser– Becky Baggaley– Jonathan Weber

Institute of Global Health– Peter Piot

LSHTM– Richard Hayes– David Ross– Debby Watson-Jones– Johanna Hanefeld

MRC CTU– Adbel Babiker– Sheena McCormack

UCL – Andrew Phillips

International HIV/ AIDS Alliance

– Ade Fakoya

Africa: PIs Uganda ( MRC-UVRI) Zambia ( Zambart)

The Prevention- Treatment gap…..

By the end 2007:3 million were receiving ART

--about 1 million people added6.7 million in need2.7 million new infections

PopART – The Goal

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

‘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

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 asprevention

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 treatmentin health systems which arealready 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 ofresistance 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

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

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

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

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 RightsSpecific objectives

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 RightsHow will this work in practice?

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 RightsPossible Methods include*

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 RightsYour thoughts?

Specifically around the areas of study and investigation

More detail and information– Ade Fakoya at the AIDS Alliance

afakoya@aidsalliance.org– Johanna Hanefeld at London School of Hygiene and

Tropical Medicine johanna.hanefeld@lshtm.ac.uk

Combination prevention- no magic bullets

Summary I

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.