IAVI and partners worked to develop a way to enhance the assessment of volunteer understanding of informed consent for HIV vaccine clinical trials.

HIV vaccine trials are complex undertakings that necessitate clear communication between the clinical staff at trial sites and the trial volunteers themselves. Before initiating a clinical trial, staff must assess each volunteer's understanding of the informed consent document which contains the information needed for a volunteer to be fully aware of the potential risks and benefits of the trial. But determining genuine informed consent in low-resource settings can be challenging. IAVI and partners have developed an assessment tool and training course to identify the more complex and critical concepts of informed consent for trial volunteers to understand before they participate in HIV vaccine trials.

This toolkit is made possible by the support of the American People through the United States Agency for International Development (USAID). The contents of this toolkit are the sole responsibility of USAID and do not necessarily reflect the views of USAID or the United States Government.

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AcknowledgmentsWellsense logo

This toolkit was developed and compiled by Monique Oliff, RN, FNP, DrPH, Wellsense, International Public Health Consultants, Kilifi, Kenya.

Many collaborators contributed to the development of the core content of the Mixed-Method AOU.

AOU pilot studies:

  • Medical Research Council/Uganda Virus Research Institute (MRC/UVRI),
  • Uganda Research Unit on AIDS, Masaka, Uganda
  • Projet San Francisco (PSF), Kigali, Rwanda
  • Zambia Emory HIV Research Project (ZEHRP), Lusaka, Zambia
  • Desmond Tutu HIV Foundation (DTHF), Emavundleni Research Center, Cape Town,
  • South Africa
  • CRCs implementing AOU:
  • Uganda Virus Research Institute-International AIDS Vaccine Initiative – HIV Vaccine
  • Program, Entebbe, Uganda
  • Kenya AIDS Vaccine Initiative, Nairobi, Kenya
  • Projet San Francisco, Kigali
  • St Stephen’s Centre, London, UK
  • Surrey Clinical Research Centre, Guildford, UK

AOU co-collaborators:

  • Graham Lindegger, Cathy Slack, and Michael Quayle (HAVEG - University of
  • KwaZulu-Natal, Pietermaritzburg, South Africa)
  • Sagri Singh (GHAR Consulting, Inc)
  • Judie Mbogua (WITS Reproductive Health and HIV Institute)
  • Tsedal Mebrahtu (US Military HIV Research Program, Henry M Jackson Foundation.)

IAVI staff:

  • Pat Fast
  • Fran Priddy
  • Sabrina Welsh
  • Bonnie Bender
  • Prince Bahati

Special thanks to the study volunteers and clinical research center teams who participated in this research!