Box 4.8

Sample e-mail alerting stakeholders to upcoming DSMB meeting

Dear Colleagues,

The independent Data and Safety Monitoring Board (DSMB) for the Bangkok Tenofovir Study will meet October 26 and 27 in Atlanta, GA, for its planned interim review of trial data. This clinical trial is a joint collaboration of the U.S. Centers for Disease Control and Prevention, the Bangkok Metropolitan Administration, and the Thailand Ministry of Public Health, and is examining the safety and efficacy of once-daily tenofovir as pre-exposure prophylaxis (PrEP) for HIV prevention among injection drug users in Thailand.

At the upcoming meeting, the DSMB will conduct a regular review of the safety data and will review the HIV infection rate in both arms of the trial for the first time to determine if there is enough evidence to determine efficacy at this point. While the most likely outcome of the meeting is that the DSMB will recommend the trial continue to its planned completion, it is possible that the panel could recommend that the trial be stopped. CDC and our Thai colleagues are therefore preparing for all possible outcomes.

The DSMB could make four possible recommendations:

  1. That the study continue as planned.
  2. That the study be stopped early because data show strong evidence that once-daily use of tenofovir significantly reduces the risk of HIV infection among injection drug users.
  3. That the study be stopped because the data suggest that once-daily tenofovir will not prove effective in reducing the risk of HIV infection among injection drug users and continued study is not warranted.
  4. That the study be stopped due to concerns about participant safety.

We hope this information is helpful to you in your own planning and will continue to keep you abreast of developments in this trial, including the outcome of the DSMB meeting.