“Towards Creating Effective Partnerships for the Conduct of HIV Prevention Trials”
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“Towards Creating Effective Partnerships for the Conduct of HIV Prevention Trials”Summary Feedback of the UNAIDS SEA Regional Consultation held on 24 – 26 April, 2005 in Durban, South AfricaPresented to: The Geneva International Consultation June 20 – 21, 2005SEA Consultation Representatives:Dr. Elizabeth Bukusi, KEMRI, Kenya Mr. Ignatius M Kayawe, SAT, ZambiaMs. Florence Goalape Makgarapa, MCDA, Botswana


Acknowledgements
Acknowledgements: of HIV Prevention Trials”

The presenters wish to thank the following:

  • UNAIDS SEA and sponsors for facilitating the SEA Regional Consultation held in April 2005 - Durban

  • UNAIDS (Geneva) and sponsors for facilitating the International Consultation in June 2005 - Geneva

  • Participants and facilitators of the SEA Regional Consultation for according the presenters the opportunity and responsibility to report to the International Consultation

  • Their employers: KEMRI, SAT and MCDA for releasing and supporting the presenters to participate in the regional and international consultation


Presentation overview
Presentation Overview: of HIV Prevention Trials”

This is a summary feedback from the SEA Regional Consultation, and seeks to:

  • Provide an overview on the process and proceedings of the SEA Regional Consultation held in April 2005; Durban

  • Highlight salient contents/issues that came out from the regional consultation

  • Note: Summary of key challenges and recommendations from the said SEA Regional Consultation shall be included in a later presentation “Key Themes and Challenges” by Shaun Mellors.


Overview of the april 24 26 2005 sea regional consultation
Overview of the April 24 – 26, 2005 SEA Regional Consultation

  • Preparatory workshop for the International Consultation – to bring on board Experiences and perceptions from the SEA Region

  • Supported by an electronic discussion hosted through partnership of the local organising committee and AMAG

  • Participants (selected through consultative process with country key stakeholders) were drawn from Botswana, Kenya, Malawi, South Africa and Zambia, by consensus of the ISC.


Overview of the april 24 26 2005 sea regional consultation continued
Overview of the April 24 – 26, 2005 SEA Regional Consultation… Continued

  • The Consultation was preceded by a half day orientation workshop on key concepts and methodologies relating to randomised trials (to facilitate common understanding among non-biomedical scientists)

  • Day 1 commenced with an overview of the magnitude of HIV pandemic – with particular focus on the sub-Saharan Africa (to contextualize the workshop discussion).

  • The rest of the programme followed and flowed very well. Highlights are on the following slides.


Highlights from the april 24 26 2005 sea regional consultation
Highlights from the April 24 – 26, 2005 SEA Regional Consultation

1.0 HIV Prevention Trials Currently Underway in the region:

  • A data base (though not exhaustive; therefore representing work in progress) was presented

  • Workshop delegates noted and expressed surprise that the region has high volume and multi centres of HIV prevention trials. This signified lack of or limited, awareness/information on trials within the region


Highlights continued
Highlights.. (continued) Consultation

2.0 On Effective Partnerships between Scientists and Civil Society in the region:

2.1 Perceptions & Experiences of Existing partnerships:

  • Success stories do exist

  • Mistrust, misunderstandings and estrangement characterize current relationships

  • Civil Society/community have often been marginalised in research process

  • Community voices are often ignored or dismissed; late and often token engagement


Highlights continued1
Highlights.. (continued) Consultation

2.1 Perceptions & Experiences of Existing partnerships:

  • Issues of threshold of early consultation were brought to the fore by scientists (i.e. pitfalls of prospective Vs retrospective consultation – before Vs after protocol design and approval)

  • Issues of community engagement, i.e. geographically restricted to a specific study/trial Vs wider public engagement process that expanded number of stakeholders with co-ownership of research process


Highlights continued2
Highlights.. (continued) Consultation

2.2 Perceptions & Experiences of Scientists’ Collaboration/co-operation in the region:

  • Limited funding; competition and rivalry: Very little interaction or cooperation among HIV investigators in the region

  • Intellectual Property and Non- Disclosure Agreements: Results in isolationist tendencies and stifles co-operation/co-ordination

  • Externally driven research/trails: Do not promote real (only superficial) partnership


Highlights continued3
Highlights.. (continued) Consultation

2.3 Enhancing communication and co-ordination between scientists and civil Society/Community:

  • The common goal of defeating HIV should drive the HIV research in the region; and research should move away from isolationist mindset

    2.4 What constitutes an Effective partnership between Scientists and Community?

  • Should include mutual trust; common sense of purpose and goals; mutual ownership of research process; varied and differentiated roles based on stakeholder expertise, skills and responsibility; participatory management; development of national/regional research capacity; translation of research findings into policy and practice and engagement and consultation being an on-going process and not one-off event


Highlights continued4
Highlights.. (continued) Consultation

2.5 Who are community Representatives?

  • A number of questions and issues regarding what constitutes community representation, how should that be determined and by who; at what levels, etc were discussed. Participants did not reach consensus and thought to seek wider input at international consultation.

    2.6 Selection of Accountable and Autonomous Community Representatives:

  • A number of questions and issues were raised by community representatives relating to qualities for community representatives, their selection, mandate and conduct, to ensure non-enticement/compromise, independent mindedness but driven by community needs and voices.


Highlights continued5
Highlights.. (continued) Consultation

2.7 Mechanisms for interacting with community/civil society beyond Community Advisory Boards:

  • A number of questions and issues regarding creation of Community Advisory Boards (CAB), composition and mandate; but consensus was not reached. Wider attention at the international consultation was suggested.

    2.8 Adequate Community Consultation

  • Who should be consulted and what constitutes adequate consultation generated a lot of discussion. Consensus was not reached but agreed that context (site and nature of study) is important in this consideration. Further attention at International consultation was recommended

    2.8 Resolution of disputes/conflict between scientists and civil society/community

  • National Policies and legislation, with which research protocols should comply, were recommended.


Highlights continued 3 0 ethical challenges
Highlights.. (continued) Consultation3.0 Ethical Challenges

3.1 Access to, and Availability of, known Prevention Options:

  • Agreed that at the minimum, HIV risk reduction counselling, male condoms and treatment of STIs be provided. Other challenges, such as legal, emerged that needed further attention

    3.2 Access to, and Availability to HAART by study volunteers who screen positive and seroconvert during a trial:

  • Need to provide best available care locally sustainable

  • Care needs to extend beyond just providing HAART during trial

    3.3 Gender Issues relating to the participants in HIV prevention trials:

  • Need to separate out theory and practice – female condom given as example

  • Need for preparatory social science; and need for gender expert panel


Highlights continued 4 0 government as critical stakeholder
Highlights.. (continued) Consultation4.0 Government as Critical Stakeholder

  • Criticality and central role of government in shaping and leading the response to the HIV epidemic (including research interventions) was highlighted throughout the meeting.

  • Issues/challenges of eccentric politics on the part of government that could threaten research process were noted.

  • Issue of whose responsibility (scientist, sponsor, or government) to initiate engagement process and drive the agenda arose; discussed and recommended for further consideration at the international consultation.


Highlights continued 5 0 building capacity to facilitate meaningful partnership
Highlights.. (continued) Consultation5.0 Building Capacity to Facilitate Meaningful Partnership

5.1 Building Capacity of Community/Civil Society: Issues of low knowledge-based capacity on scientific issues, language barriers, etc that present challenges to engagement should be addressed.

5.2 Building Ethics and Regulatory Review Capacity: Capacity of IRBs and regulatory agencies need to be raised. This could be achieved through funded workshops which include investigators and IRB audiences; provision of discussion documents, position papers and networking

5.3 Clinical Trial Infrastructure and Local Scientific Capacity: Local capacity, particularly local scientific leadership development needs further attention and support


Summary recommendations and conclusion
Summary Recommendations and Conclusion Consultation

Specific Summary Recommendations and Conclusion are included in the presentation on “Key Themes and Challenges”

THANK YOU!!


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