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Resources and Links

Home 14 What led to the cancellation of PrEP trials in Cambodia and Cameroon and what can we learn? Read our latest case studies!


 

Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site 2009 (54 pages) GCM

Preventing Prevention Trial Failures: A Case Study and Lessons Learned for Future Trials from the 2004 Tenofovir Trial in Cambodia 2009 (36 pages) GCM



Many organisations and networks are working to articulate and resolve ethical issues of HIV prevention trials, and to develop models for community involvement and mobilisation.

Factsheets

1 Ethics of Clinical Trials Factsheet (4 pages) word pdf
2 Consensus Points on Access to Treatment and Standards of Care Microbicides Trials (3 pages)   pdf
3 Resources and Links on Ethics   link

In Depth Resources

   
1

Mapping the Standards of Care at Microbicide Clinical Trial Sites
Feb 09 - Full Report (77 pages)

  pdf
2

Mapping the Standards of Care at Microbicide Clinical Trial Sites
Feb 09 - Executive Summary (22 pages)

  pdf
3

Overcoming Key Obstacles to adolescent involvement in HIV Vaccine and Microbicides Trials: A Roadmap for Stakeholders
2008 (15 pages) HIV AIDS Vaccines Ethics Group & GCM

  pdf
4 Rethinking the Ethical Roadmap for Clinical Testing of Microbicides: Report on an International Consultation
March 2005 (link - per chapter) (zip - full report 75 pages)
zip link
5 Research Rashomon: Lessons from the Cameroon Pre-exposure Prophylaxis Trial Site 2009 (54 pages) GCM   pdf
6 Preventing Prevention Trial Failures: A Case Study and Lessons Learned for Future Trials from the 2004 Tenofovir Trial in Cambodia 2009 (36 pages) GCM   pdf

The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that develops and tests the safety and efficacy of primarily non-vaccine interventions designed to prevent the transmission of HIV. HPTN has both an Ethics Working Group and a Community Working Group, and members of these groups and the Global Campaign often work in collaboration on cross-cutting issues and activities.

The HPTN has produced a document that provides guidance for ethical decision-making and practice in HPTN-sponsored clinical trials.

On May 30-31st 2005 the Steering Committee of the Global Campaign for Microbicides (GCM) met for two days in Barcelona to discuss issues of access to treatment and standard of care in microbicide trials.  The recommendations in this statement represent the points of consensus that emerged from this dialogue.

The Community Working Group advises and advocates for community participation at all levels of the research process and ensures community participation is adequately addressed at the sites and in the management of the HPTN.

The World Health Organization has a resource for guidelines on ethical research, including issues of gender, adolescents, and partner consent, as well as the establishment of national ethical review bodies.

Microbicide and vaccine research share many issues in ethics and community involvement, and there are several resources within the vaccine world that have insight for microbicides. Some of these include:

UNAIDS Guidance Document "Ethical Considerations in HIV Preventive Vaccine Research"

HIV Vaccine Trials Network Community

South Africa AIDS Vaccine Initiative (SAAVI) HIV/AIDS Vaccine Ethics Group.