HIV/AIDS

Consultative meeting to review the impact of scaling up anti-retroviral therapy (ART) on the HIV epidemic – what can longitudinal community studies contribute to the evidence base?

WHO, Department of HIV/AIDS
17-18 March 2003

Meeting

::Background
:: Meeting Summary
:: Agenda
:: List of Participants

Background

It is universally acknowledged that access to effective HIV/AIDS treatment and care is highly inequitable. In response, WHO has set a target of 3 million people on anti-retroviral therapy (ART) by 2005. It is widely predicted that this will synergize HIV prevention interventions, but some are concerned that there will also be significant negative externalities. Divergencies of opinion exist because there are very few data.

WHO promotes an evidence-based approach to public health. Because HIV/AIDS is a global emergency, it is accepted that an imperfect knowledge base cannot constrain comprehensive prevention and care efforts. Rather, it mandates a research agenda on how widely available ART will impact on risk perceptions, sexual behaviour and HIV transmission in resource-limited settings with generalized epidemics.

There are only a few studies in the world that have collected detailed behavioural and biological data during the pre-ART era, on sexual behaviour, risk factors for infection, trends in HIV incidence and prevalence and cause-specific mortality. There is great scientific and programmatic value in continuing to collect these data as a standardized package of ART is introduced systematically in line with national programmes. The main constraint is the need to commit to life-long treatment. Governments can be included as partners and may be willing to take on this long-term responsibility.

Meeting Summary

The meeting brought together researchers from those few studies in the world that have collected detailed behavioural and biological data during the pre-ART era, on sexual behaviour, risk factors for infection, trends in HIV incidence and prevalence and cause-specific mortality in resource-limited settings. These were assembled to consider how ART may need to be introduced as the focus moves from observation to intervention; and if it was to be introduced, what impact widely available ART may have in different contexts and communities on risk perceptions, sexual behaviour and HIV transmission. A newly developed collaboration in clinical research on ART in developing countries was represented. Groups with expertise in forming networks and collaborations for data sharing and meta-analysis were included to inform ideas an the practicality and feasibility of data sharing. Funders were included as the impact of wider ART on HIV risks, prevention and transmission is a critical research and development issue. The SRM team, WHO, organized the meeting and led discussions.

  • Whilst the different groups knew about each other, this was the first time that they focused the discussions on introducing treatment in the community studies
  • WHO had been restrictive in exactly which cohorts fulfilled the tight criteria for the meeting. Despite this when the groups presented their study sites and science it was apparent that there was great diversity of approach.
  • Funders were appreciative of the opportunity that the cohorts now provided to assemble unique data and new knowledge; and the need for rapid action to preserve and continue some of the cohorts up for renewal

Given the existing diversity, it was felt important to widen the network to other groups that were involved in some of the community-based activities or could contribute some data in some of the relevant areas, as ART is introduced.

The anticipated outputs of the meeting were:

1. agreement to establish a network of longitudinal studies (involving some or all) which will be implementing a standard package of ART

There was consensus about the value of setting up a network of the studies both to assist in the implementation of ART and in sharing data about the impact this had in the various communities. All groups were interested and felt that a network could contribute to their own science and the future viability of funding.

However, there were already differences in approach to ART. The Africa Centre and Mbeya were proposing ARV trials; Chamulibwa was already planning to implement ART in the cohort; Rakai had considered ART but had not yet decided how to move. The remainder recognised this was an issue to deal with but either did not have the clinical infrastructure or current focus (Manicaland and Karonga) or were unsure how this fitted in with national policy and how to proceed (NIMR Kisesa and ENARP).

There were also several issues with delivery of ART in the communities:
- the design and implementation at the district level of a standard ART package in line with national policy, especially for groups with little clinical focus to date.
- what could be learnt across the groups about ARV delivery in rural districts.
- how the research team could provide assurance that ART, once started, would be continued, in line with international policy and standard of care.
- how drugs may be procured for the study sites in partnership with Government, with a feeling in some quarters that the research sites were already privileged and other districts may also want to start (i.e. equity issue of where to start).

WHO was felt to have an important role in this process for several reasons: - it was leading the design of a district blueprint for ARV delivery into which district-specific results could feed.
- it would examine the implications of the mechanism developed by the DART study (where Ministers of Health in Uganda and Zimbabwe pledged long-term care and support for trial participants after the trial was over) in an ethics meeting. - it worked with Governments, and could argue for the special contribution research communities would make in ART scale-up and the need to support them to do so.

2. consensus on the unique data and results that will be generated, and agreement on how to work towards common protocols and methodologies; and data sharing

There was clear agreement by all that the broad array of data that could be generated from the community cohorts as ART was implemented were unique, and indeed that these cohorts could never now be set up as they were too geared to observation alone. However it was evident that different approaches were being adopted in the various sites, and that different data sets were being collected.

It was thus impossible during this first meeting to construct one set of common protocols that all could use. This would need to be examined in more detail; and it was likely that ways would also need to be explored and identified so that linked data could be pooled and shared, and the different contexts taken into consideration. A summary description of the studies involved in the meeting is attached. A systematic assessment of the kind of data collected by the different projects in this context will have to be conducted.

3. description of the structures, resources and funding needed to take this forward

It was agreed that there was no time to waste. Several studies were finding it difficult to keep going, or were renewing funding. Given the small number of community-based cohorts the loss of any would compromise the network; and limit the ability to understand the ways ART could impact on community responses and HIV prevention.

With its central location, and mandate and ability to work with Governments, it was agreed that WHO Geneva was the best base initially for the network.

A small secretariat would be necessary to maintain the momentum generated by the meeting, housed by the SRM team (who had called for and organized the meeting) in the HIV department. This would comprise one professional staff member supported by the SRM administration team, with additional help as required. To fund this post, additional external resources would need to be mobilized.

It was not possible to develop during the two day meting a more structured view of the secretariat nor the precise funding needed to take the network forward. There was however general agreement on the objectives of the network: to provide evidence of the impact of the introduction of ART programmes in communities and to inform the development of ART programmes on a wide range of health systems, programme (including prevention) and clinical issues in low resource settings. Impact is broadly defined to include effects on HIV incidence, stigma and discrimination, sexual behaviour, prevention programmes (testing and counselling, PMTCT etc.), mortality, morbidity, socio-economic, mobility, and health services/health service utilization.

There was agreement on the overall functions of a secretariat of a network. These would include activities to assist ART programme development (development and sharing of training materials, tools, logistics and drug supply, negotiations with ministries and government, link with global fund etc.), activities to assist impact assessment (sharing information, sharing issues, data analysis, data sharing, proposal development, joint publications) , facilitating the handling of ethical issues, and linking with other networks (ARV drug resistance monitoring, ART cohort collaboration, CASCADE, IN-DEPTH, vaccine network).

4. a timetable for future activities and an activity plan

A proposal would be developed by WHO, in consultation with the groups, for circulation in April to all funders who had participated in the meeting.

An activity plan would be developed in this proposal which would meet the needs and expectations that emerged during the meeting. Activities will include: - Naming and defining the goals and structure of the network
- Consolidating the different groups in the network
- Widening the groups involved with less stringent criteria
- Developing a web-based communications strategy
- Technical assistance with development of ARV package etc
- Defining the common protocols and activity areas
- Brokering bridging funding if necessary
- Planning future meetings

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Agenda

>>The care and prevention interface

a) lack of data and unique opportunity afforded by longitudinal community cohort studies – Ties Boerma
b) where we are in scaling up public health sector delivery of ART- Charles Gilks

>>The cohorts and communities

All sites give a selective and themed presentation to cover:
- brief background to project, site location, organisation
- main science and current objectives
- future directions, funding issues and long-term sustainability
- what HIV prevention activities are promoted and implemented
- where ART is – community perspective, availability, interest

  • Masaka/Chambuliwa, Uganda
  • Hlabisa, South Africa
  • Mbeya, Tanzania
  • Karonga, Malawi
  • Rakai, Uganda
  • Addis Ababa, Ethiopia
  • Kisesa, Tanzania
  • Manicaland study, Zimbabwe

>>Opportunities and drawbacks in expanded delivery of ART to communities in which cohorts are based

Two breakout groups with one representative from the different sites in each group WHO and other participants spread equally around – about twelve in each group.

Focused discussion to explore the perceived opportunities but also the concerns and possible drawbacks with becoming involved in delivery of ART. The groups could also consider community expectations, knowledge and attitudes to ART, as far as they are recognized or understood.

>>A public health approach to ART

a) Two rapporteurs from each group summarize discussions
b) Could a standard ART package be implemented in each site? By whom?

Discussion led by Charles Gilks – covering core issues:
- What service infrastructure and human resources are available in each site?
- What constraints exist in setting up/scaling up capacity to deliver ART?
- What additional inputs may be necessary to implement a standard ART package?
- What are possible roles of Ministry of Health and the research teams?

>>The impact of ART on communities

Discussion led by Ties Boerma - what impacts could and should be captured if a standard ART package was implemented (what is already collected and what could be added)
- changes in sexual risky behaviour; reported STIs and syndromes treated
- in migration from districts with no services
- change in HIV incidence over time
- change in mortality over time
- other potential important impacts and externalities

>>Working together and sharing data

Lessons from existing collaborations (15 minute presentations then discussion):
a) Cascade and sero-incident cases for natural history – Kholoud Porter
b) Meta-analysis of ART survival – Francois Dabis or Matthias Egger
c) Co-operation across vaccine site – Jose Esparza
d) IN-DEPTH network

Discussion - issues with setting up a new collaborative initiative - What sort of network is required to coordinate such an initiative?
- Are data sets and methodologies compatible, or can they be made so?
- How would analysis be organized and where would it be carried out?
- What are the resource and time implications?

>>The next steps

What needs to be done to take this initiative forward?
roles and responsibilities
who should do what?
what can WHO do to facilitate coordination?
what are the likely funding needs?
which donors may be interested in supporting further developments? timetable for next steps

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List of Participants

Dr Michael Bennish
Africa Centre for Health and Population studies
Mtubatuba, South Africa

Mr John Changalucha
TANESA/National Institute for Medical Research
Mwanza, Tanzania

Dr François Dabis
Institute of Public Health
University Victor Segalen
Bordeaux, France

Professor Paul Fine
London School of Hygiene and Tropical Medicine
London, UK

Professor Geoff Garnett
Imperial College of Science, Technology and Medicine
London, UK

Dr Judith Glynn
London School of Hygiene and Tropical Medicine
London, UK

Dr Ron Gray
Bloomberg School of Public Health
Baltimore, USA

Dr Simon Gregson
Biomedical Research and Training Institute
Harare, Zimbabwe

Dr Anatoli Kamali
Medical Research Council
Entebbe, Uganda

Mr Godfrey Kigozi
Rakai Project, UVRI
Kalisizo, Uganda

Dr Nigel Livesley
Africa Centre for Health and Population Studies
Mtubatuba, South Africa

Dr Gabriel Mwaluko
TANESA/National Institute for Medical Research
Mwanza, Tanzania

Ms Constance Nyamukapa
Biomedical Research and Training Institute
Harare, Zimbabwe

Dr Kholoud Porter
Medical Research Council
London, UK

Dr Eduard Sanders
Ethiopian Health and Nutrition Research Institute
Addis Ababa, Ethiopia

Dr Osman A. Sankoh
INDEPTH Network
Accra, Ghana

Mr James Todd
London School of Hygiene and Tropical Medicine
London, UK

Dr Mark Urassa
TANESA/National Institute for Medical Research
Mwanza, Tanzania

Dr Lieve Vanderpaal
Medical Research Council
Entebbe, Uganda

Dr Dawit Wolday
Ethiopian Health and Nutrition Research Institute
Addis Ababa, Ethiopia

Dr Basia Zaba
London School of Hygiene and Tropical Medicine
London, UK

WHO/UNAIDS Secretariat

Dr Charlene Brown
USAID
Washington, DC, USA

Dr Janet Darbyshire
Medical Research Council
London, UK

Dr Wendy Ewart
The Wellcome Trust
London, UK

Dr Richard P. Lane
The Wellcome Trust
London, UK

Dr Paolo Miotti
NIH, Bethesda
USA

Dr Luke M. Nkinsi
Bill & Melinda Gates Foundation
Seattle, USA

Dr Alastair Robb
Department for International Development
London, UK

Mr Manuel Romaris
European Commission
Brussels, Belgium

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