Global Campaign for Microbicides

Home

Home » Trial Ethics » Activities & Workshops » Consultation on Standards of Prevention March 09

Consultation on Standards of Prevention March 09


Consultation on Standards of Prevention in HIV Prevention Trials
Speke Resort Munyonyo, Kampala, Uganda
March 26-28, 2009

 

Day 1: Thursday, March 26, 2009

Session I: Setting the Stage

Scientific and Ethical Challenges in HIV Prevention Trials
Lori Heise, Global Campaign for Microbicides

Genesis and Evolution of the UNAIDS/WHO Ethics Guidance on Biomedical Prevention Trials
Ruth Macklin, Albert Einstein College of Medicine

Session II: Prevention Trial Realities

Walking in My Shoes
Lynn Paxton, Centers for Disease Control and Prevention

Session III: Participatory Exercise (No slides available)

Session IV: Ethical Frameworks

Overview of Bioethical Frameworks
Sean Philpott, Global Campaign for Microbicides

Panel Discussion
Ethics, Standards of Prevention, and HIV Prevention Trials, Jeremy Sugarman, Johns Hopkins University

Male circumcision as a (compulsary) component of a HIV prevention package in a HIV vaccine trial, Jerome Singh, CAPRISA, University of KwaZulu Natal

Ethical Assessment of Standard of Prevention, Joseph Mfutso Bengo, University of Malawi

 

Day 2: Friday, March 27, 2009

Review of Key Issues
Elizabeth McGrory, Consultant

Session V: Where Are We Now?

Current Practice
Samu Dube, Global Campaign for Microbicides

Standards of Prevention and Sample Size
Doug Taylor, Family Health International

Session VI: Considering New Prevention Modalities

Interpreting What Works: An Epidemiologist's and Trialist's Perspective
Janneke van de Wijgert, Center for Poverty-Related Communicable Diseases

Session VII: Thresholds of Evidence for New Methods

What is the Threshold of Evidence for New Prevention Tools?
Normative Agencies, Catherine Hankins, UNAIDS
National Regulatory Agencies, Rajen Misra, Medicines Regulatory Authority, South Africa
Data and Safety Monitoring Boards, Timothy Farley, World Health Organization
Investigators, Guy de Bruyn, Perinatal HIV Research Unit
Community Advisory Boards, Marie-Michelle Umulisa, Project Ubuzima
Advocates, Pauline Irungu, Global Campaign for Microbicides

* Institutional Review Boards/Ethics Committees, Tom Lutalo, Uganda Virus Research Institute
(No slides available)

Session VIII: Providing Access to New HIV Prevention Methods in the Research Setting

Facilitated Exercise (No slides available)

Session IX: Implications for Real Life HIV Prevention Trials

Investigator's Perspective, Helen Rees, Reproductive Health and HIV Research Unit

Community's Perspective, Morenike Ukpong, Nigerian HIV Vaccine and Microbicides Advocacy Society

 


Day 3: Saturday, March 29, 2009


Session X: Prevention Methods in the Research Setting

Examples from Related Prevention Fields
Liza Dawson, National Institutes of Health

Session XI: Process and Decision Making

How Do We Decide?
Sheena McCormack, Microbicides Development Programme, Medical Research Council

Session XII: Implications of Adding New Prevention Tools for Trial Feasibility

Testing Superiority, Equivalence, and Non-Inferiority
Benoit Masse, Fred Hutchinson Cancer Research Institute

Overview of Trial Feasibility
Lynn Paxton, Centers for Disease Control and Prevention

Session XIII: Recommendations and Next Steps

 

Additional Meeting Documents

Concept Note

Welcome & Logistics Letter

Agenda

Participant List



Highlighted Publications

Mapping the Standards of Care at Microbicide Clinical Trial Sites (Full Report)
Global Campaign for Microbicides

Mapping the Standards of Care at Microbicide Clinical Trial Sites (Executive Summary)
Global Campaign for Microbicides

Good participatory practice guidelines for biomedical prevention trials
UNAIDS/Aids Vaccine Advocacy Coalition

Ethical considerations in biomedical HIV prevention trials
UNAIDS/WHO