By Theresa Gamble, PhD, Scientist, Family Health International
Working as a senior clinical research manager in the HIV Prevention Trials Network (HPTN) at Family Health International, I am involved with managing many complicated, multisite studies. In the summer of 2009, a situation arose that made my team realize the importance of having a communications plan.
One of the ongoing HPTN studies is enrolling serodiscordant couples (one person is HIV positive and the other is HIV negative) and has two outcomes. The first outcome is to determine if treating the infected person with antiretroviral therapy (ART) can prevent the spread of HIV to a sexual partner. The second outcome is to identify the best time to start ART with regard to CD4 cell count (early versus late initiation). If successful, the results of this study could have significant impact on the way that ART is used for both treatment and prevention.
A similar study—not part of the HPTN—was being simultaneously conducted in Haiti. The Haitian study divided HIV patients into two groups. The first group started on ART according to the current guidelines of the World Health Organization (WHO), and the second group started treatment earlier. When the Data and Safety Monitoring Board (DSMB) members for the Haitian study did their interim review, they found that more people in the group receiving ART according to WHO guidelines had died or developed tuberculosis. They recommended that the team halt the trial.
Because of the Haitian data, our study’s sponsor, the U.S. National Institutes of Health (NIH), asked that the DSMB for our study convene a special meeting to look at the Haitian data more carefully. The examination of the Haitian data confirmed significant differences between the two studies, such as the participants in the Haitian trial were much sicker than the participants in our study and had higher rates of co-infection of HIV and tuberculosis. The DSMB decided to allow our trial to continue. Because of the importance of these developments, we needed to let all our study sites know about the results of the Haitian study and also inform them about our DSMB’s recommendation. In turn, all of the HPTN sites needed to quickly inform their own Institutional Review Boards (IRBs).
Although we were able to inform everyone who needed to be contacted, we did not have a systematic way of doing so at the time. What would have happened if the recommendation from our DSMB had been different and we had to change our study? That would have involved informing a much wider audience.
Since then, we have developed a communications plan for the trial. It lists the people and organizations that need to be informed of important developments and states how we will contact them. We also developed a sample letter that can be used to share results from other studies or other information the team should disseminate to keep all sites informed. Finally, we created a one-page document with background information on our study that can be used as a stand-alone document or as a supplement to other communications materials.