Communications Handbook for Clinical Trials: Strategies, tips, and tools to manage controversy, convey your message, and disseminate results

The Communications Handbook for Clinical Trials grew out of the collective experience of scores of individuals* who have dedicated themselves to demystifying science and ensuring that both the process and the outcomes of clinical research are communicated clearly. From the beginning, the process of creating the handbook has been a collaborative effort, and the final product reflects the wealth of this input.

The authors would especially like to thank the members of the Microbicides Media and Communications Initiative (MMCI), an ongoing “community of practice” that meets regularly to share strategies for handling the complex communications challenges posed by the conduct of large-scale effectiveness trials of HIV prevention technologies in Africa and other resource-limited settings. Many of the stories and insights contained herein derive from the experiences of MMCI members, who have been incredibly generous in sharing their knowledge, materials, and hard-won wisdom about clinical trial communication. We particularly thank all MMCI Steering Committee members (former and current): Quarraisha Abdool Karim, Centre for the AIDS Programme of Research in South Africa (CAPRISA); Manju Chatani-Gada, AVAC: Global Advocacy for Prevention; Mitzy Gafos, Microbicides Development Programme (MDP), Africa Centre; Yasmin Halima, Global Campaign for Microbicides (GCM); Polly Harrison, AVAC; Lori Heise, London School of Hygiene and Tropical Medicine (LSHTM) (co-author); Neetha Morar, South African Medical Research Council (MRC); Oliver Mweemba, University of Zambia; Patrick Ndase, Microbicide Trials Network (MTN); Pamela Norick, International Partnership for Microbicides (IPM); Elizabeth T. Robinson, Family Health International (FHI) (co-author); Lisa Rossi, MTN; and Deborah Baron, MMCI coordinator, GCM (co-author).

A rich source of learning came from an in-person consultation that we held in March 2009, co-sponsored by the MMCI and CAPRISA. This meeting brought together 45 investigators, trial staff, and community advocates in Durban, South Africa, to solicit feedback on early drafts of the handbook and to collect examples and lessons learned from the lived experience of those working on the frontlines of communicating about HIV prevention trials in Africa. These individuals included:

We are particularly grateful to the many individuals who authored case studies, shared materials, and reviewed earlier drafts of the publication. Chapters of the handbook were shared with over 80 individuals in 13 countries, and we are deeply indebted to the many individuals who provided detailed comments, research examples, and additional field experiences. This input was invaluable in making the document relevant and true to life. We would also like to thank the many individuals in Africa, Asia, Europe, North America, and South America who contributed their time and insights by agreeing to be interviewed by the authors. These interviews helped us to better understand the needs and experiences of the field and shaped both the content and structure of the final publication.

The individuals who contributed substantially to this handbook through time, materials, expert review, interviews, or authored contributions include:

We extend special thanks to Sten Vermund, principal investigator of the HPTN, and Quarraisha Abdool Karim, chair of HPTN’s Information and Communication Committee, for having facilitated the review of the handbook by so many HPTN research sites.

In addition, we would like to thank the following people for their support: Sarah Alexander, HIV Vaccine Trials Network (HVTN); Lillian Anomnachi, FHI-Nigeria; Mark Aurigemma, i-PrEx; Luann Tia Blount, IPM; Allison Burns, FHI; Terry Butler, CDC; Mialy Clark, GCM; Lavinia Crawford-Browne, Desmond Tutu HIV Foundation; Alex Maiolo; Carol Manion, FHI; Carrin Martin, MRC; Timothy Mastro, FHI; Tom Milroy, consultant; Vivienne Naidoo, GCM; Patsy Norman, FHI; Bindya Patel, GCM; Scott Rose, FHI; Kenneth Schulz, FHI; Holly Seltzer, IPM; Margie Shiels, FHI; Stephanie Stuart, PATH; Monica Wanjiru, Population Council.

This handbook was produced with the generous financial support of the U.S. Agency for International Development (USAID), via dual grants to MMCI, a project of the Global Campaign for Microbicides at PATH, and to Family Health International. Additional financial support for printing was provided by the International Partnership for Microbicides.

Finally, the authors offer a special thanks to Kathleen MacQueen for graciously opening her home in Chapel Hill, NC, to the writing team for a week-long writing retreat in 2009.

*The contributors and others acknowledged or cited in the handbook are identified by the titles they held at the time of publication in May 2010.

Credits

We acknowledge the services and creative input of the following individuals in the production of the print and online versions of the handbook:

Design and production of the online version: Deanna Ledet Saab and Jacob Reid of Design Lab 360
Editing: Michael Szpir
Additional data collection and interviewing: Mialy Clark
Writing, filming, editing and production of the video: Kim Best
Additional filming and assistance with production: Sarah Harlan
Graphic design and layout of the print version: Richard Hill/HillStudio
Production management and copyediting: Karen Dickerson
Proofreading: Kerry Aradhya
Printing: Harperprints
Administrative support: Falesha Houston, Kathy Tomasik, Vivienne Naidoo