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Consultation Access to Care June 08

Consultation on Operationalizing Access to HIV Treatment and Care
19th and 20th June, 2008
9:00 – 9:30 Welcome and Participant Introductions
9:30 – 11:00

Background and meeting objectives

Evolution of Ethical & Political Dialogue around HIV Treatment and Care for Seroconverters (2.4MB)

 Lori Heise, Global Campaign for Microbicides (USA)

Access to Care in Microbicide Trials: Findings from the Standard of Care Mapping Exercise (1.5MB)

 Sean Philpott, Global Campaign for Microbicides (USA)
11:00 – 11:30 Coffee Break
11:30 – 12:30

Panel: Policies and Practice of Current HIV Prevention Trials

 Chair: Sean Philpott, Global Campaign for Microbicides (USA)
Each speaker presented a brief 7 minute overview of the policies and approaches being used by their organization or network to provide long-term care and treatment for HIV infected trial participants. This included if and how they have addressed implementation issues, and what challenges they have experienced or anticipate.
Speakers: Treatment & Care of HIV-Infected volunteers in IAVI sponsored Clinical Trials (592KB) Prince Bahati, International AIDS Vaccine Initiative (USA and Kenya)
Art Program of the HIV Vaccine Trials Network (1.3MB) Margaret Wecker, HIV Vaccine Trials Network (USA)
Approach to HIV Treatment & Care in Future IPM Microbicides Trials (6MB) Pam Norick, International Partnership for Microbicides (USA)
MTN's approach to Care & Treatment of Sero-Converters (380KB) Patrick Ndase, Microbicide Trials Network (Uganda)
The Methods for Improving Reproductive Health in Africa (850KB) Elizabeth Montgomery, Research Triangle Institute (USA and Zimbabwe)
12:30 – 1:30 Lunch
1:30 – 3:30

Tools and Approaches for Ensuring Care: Insurance, employer-based programs and approaches for long-term follow up of trial participants

 Chair: Elizabeth McGrory, Consultant (USA)
This session explored tools and approaches for ensuring long-tern access to treatment and care for trial participant. Each speaker presented for 20 minutes. The first two speakers focused on health insurance schemes developed for low income people in Africa, including approaches being used by Discovery Health, PharmAccess and the Health Insurance Fund; each described these programs and reflecting on their potential to provide long-term access to care and treatment for trial participants. The third speaker described different employer based health schemes operating in Africa, and the fourth speaker discussed practical tools and approaches for long-term follow up of trial participants.
Speakers: Insurance Funds as options to operationalise access to ART (680KB) Elaine McKay, Discovery Health (South Africa)
Subsidized Private Health Insurance in Africa (1.6MB) Emily Gustafsson-Wright, Brookings Institution and Amsterdam Institute for International Development (USA and Netherlands)
Business and HIV/AIDS, TB & Malaria (2.8MB) Neeraj Mistry, Global Business Coalition on HIV/AIDS, TB and Malaria (USA and South Africa)

Mechanisms for long-term follow-up of trial participants (4MB)

 Joshua Kimani, University of Nairobi (Kenya)
3:30 – 4:00 Coffee Break
4:00 – 5:00

Case Study: The Cellulose Sulfate Trial

Chair: Lori Heise, Global Campaign for Microbicides (USA

Each speaker presented a 15 minute overview of the international or site level perspectives on providing treatment for participants who seroconverted while enrolled in the Cellulose Sulfate microbicide trial. The international PI described the impetus and process for securing funding and institutional agreement from the sponsoring agency. Each of the trial site PIs described the process of developing agreements to provide care at these sites, the agreements that were put in place and how the process evolved, and the experience of the sites and participants as they tried to access care and treatment.

Speakers:
 Care for seroconverters in CONRAD's Cellulose Sulfate HIV Prevention Trial (179KB) Lut Van Damme, Family Health International (USA)

Providing care and treatment for HIV seroconvertors in the Cellulose Sulfate trial (Uganda)

 Florence Mirembe, Makerere University (Uganda) (Apologies)

Securing care for seroconverters of an HIV prevention trial: Benin experience with the CONRAD Cellulose Sulfate (CS) Phase III Trial (178KB)

 Fernand Guedou, Ministry of Health (Benin)

Friday June 20, 2008

9:00 – 9:30 Key issues and questions from Day 1 Elizabeth McGrory, Consultant (USA)
9:30 – 11:00

Trial Sites: Perspectives and challenges in referrals and services

Chair: Elizabeth McGrory, Consultant (USA)
Putting Policy into Practice (351KB) Patrick Ndase, Microbicide Trials Network (Uganda)
How Do Participants Access Referrals? (347KB) Hlengiwe Ndlovu, Microbicides Development Programme (South Africa)
Impact of the MIRA Trial on Referral Services (2.4MB) Elizabeth Montgomery, Research Triangle Institute (USA and Zimbabwe)
Providing HIV Care and Treatment in a Referral Center (5MB) Ian Sanne, Right to Care (South Africa)
11:00 – 11:30 Coffee Break
11:30 – 12:00

Trial Networks: Policies of Current HIV Prevention Trials (Continued)

Chair: Sean Philpott, Global Campaign for Microbicides (USA)
Each speaker presented a brief minute overview of the policies and approaches being used by their organization or network to provide long-term care and treatment for HIV infected trial participants. This included if and how they have addressed implementation issues, and what challenges they have experienced or anticipate.
Speaker: HIV Follow-up, Treatment & Care of HIV-Trial Participants: The Carraguard Phase III experience (6MB) Nelson Michael, US Military HIV Research Program (USA)
Linkage to HIV Care & Treatment via Clinical Research (116KB) Louise Pedneault, Population Council (USA)
12:00 – 1:00

Case Study: Managing Continuity of Care – Lessons from NIH- Supported Treatment Trials


Chair: Sean Philpott, Global Campaign for Microbicides (USA)
During this session, each speaker spent 20 minutes reviewing the US National Institutes of Health’s current policies, past practices, and future plans for providing long-term access to HIV-related care for participants enrolled in NIH-sponsored treatment trials.
Speakers:

NIH guidelines on post-trial access to antiretroviral treatment

 Liza Dawson, National Institutes of Health (USA)
1:00 – 1:45 Lunch
1:45 – 3:00

Looking Ahead

 Chair: Lori Heise, Global Campaign for Microbicides (USA)

Meeting participants engaged in a facilitated discussion to:

  • Outline existing and anticipated challenges in delivering care and treatment to trial participants;
  • Highlight creative approaches to overcoming these challenges;
  • Prioritize outstanding issues such as:

- Identify additional technical approaches to be explored;

- Reconcile donor practices, national policies, researcher capacity, and other factors with the responsibility to ensure long-term access to care and treatment;

- Define the scope and duration of researcher’s responsibilities to participants;

- Determine if additional international guidance is needed; and

- Identify additional stakeholders to engage.

3:30 – 4:00

Wrap Up and Conclusion