An innovative communications strategy helps improve efficiencies in a clinical trial
Getting lifesaving medicines to patients around the world is a complex process — from drug discovery and clinical trials to licensure and rollout. Believing communication is a critical component for any clinical trial, FHI 360 developed an innovative communications strategy for the ASPIRE study, which was a landmark phase III study that demonstrated the safety and efficacy of a monthly vaginal ring containing the antiretroviral drug dapivirine for HIV prevention among women.
Recognizing the importance and complexity of communications in a multisite international clinical trial, the study’s management team wanted to create a clear plan pre-study. Early on, realizing a one-size-fits-all approach to communications would not be effective, the team designed unique strategies to meet each newly emerging challenge. In creating the strategies, FHI 360 set specific goals and defined roles and responsibilities between network partners, study management teams and site staff.
Throughout, the focus of the strategies was on encouraging open communication across the full protocol team, including the sharing of innovative, site-driven approaches as well as early identification and quick resolution of issues. FHI 360 put into place activities that ranged from study implementation tracking spreadsheets to phone calls and visits with site teams to cadre-specific listservs for site-to-site sharing of ideas. In addition, FHI 360 sent to the management team and sites weekly priority e-mails with important study updates and action items.
One example of site-to-site communication came from the study site in Cape Town, South Africa, to other research centers, sharing “retention checks around holidays are really important as a large number of our participants travel back to the Eastern Cape. This helps to plan visits and the number of rings for us to dispense.” This type of communication allowed other sites to also manage schedules and product dispensation efficiently and proactively around holidays.
The ASPIRE team is sharing their innovative strategy with teams working on other clinical trials managed by FHI 360.
FHI 360 participates in clinical trials through our work with:
- Global Research Services
- Contraceptive Technology Initiative
- Sexually Transmitted Infections Clinical Trials Group
- HIV Prevention Trials Network
- International Maternal Pediatric Adolescent AIDS Clinical Trials Network
- International Clinical Studies Support Center
- Microbicide Trials Network
FHI 360 serves as part of the Leadership and Operations Center for the Microbicide Trials Network (MTN), a worldwide collaborative clinical trials network focused on preventing the sexual transmission of HIV. MTN-020/ASPIRE was a study conducted through the network from August 2012 to June 2015. It was a complex, multisite, multi-country study that had 15 clinical research sites and team members from Malawi, South Africa, Uganda, the United States and Zimbabwe.