The COVID-19 pandemic is evolving rapidly and impacting each country and community differently. The leadership of the HVTN, in consideration of the impact of COVID-19, is committed to ensuring the safety and welfare of all study participants and study teams making the early phase and large-scale clinical trials coordinated by the Network possible. The HVTN is also focused on preserving the scientific integrity of HIV prevention clinical trials it coordinates.
What measures are underway?
In consideration of the impact of COVID-19, the leadership of the HVTN has empowered study teams at each trial site to implement measures necessary to preserve the safety and wellbeing of study participants and their study teams. This includes aligning with recommendations and guidance from local public health authorities, Institutional Review Boards (IRBs)/Ethics Committees (ECs) and Community Advisory Boards (CABs).
Decision making at each trial site is done in collaboration with Protocol Leadership teams who ensure that each HVTN trial is conducted with scientific integrity. This approach ensures that the clinical trials are conducted in the context of the respective communities and helps to reduce the possible exposure of study participants and study teams to COVID-19.
As a general approach, study teams are encouraged to:
- Schedule telephone or virtual study participant visits
- Postpone all screening and enrollments visits
- Encourage physical distancing to minimize potential exposures in the waiting area or while visits are being conducted
- Monitor the temperatures of the clinic staff and participants on entering the clinic
- Frequently clean and disinfect all surfaces
- Frequently hand wash with soap at least for 20 seconds.
The HVTN recognizes that measures to manage the possible impact of COVID-19 on each HVTN clinical trial and at the many trial sites will vary.
Protocol Leadership and trial site study teams may decide to take additional measures specific to a particular clinical trial, such as temporarily halting the screening and enrollment of study participants or pausing vaccinations. Such decisions will be regularly reviewed as the situation in each country and community evolves, and study participants will be regularly updated by the trial site study teams.
Our mission remains the pursuit of a safe and globally effective preventive HIV vaccine to help end HIV. The scientific journey is made possible by our study participants and communities who are on the frontline working with the HVTN and its partners to fulfil this global need.
HVTN Director of Communications