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The world is grappling with the far-reaching impacts of the COVID-19 pandemic and the HIV prevention field is no different. Most trials investigating new biomedical HIV prevention products have paused, citing concerns for the safety of trial participants and the study teams. Where possible, participant follow-up is designed in a way to minimize risk and exposure to COVID-19, in line with recommendations from local public health authorities.
How COVID-19 is impacting research varies by trial and site, and efforts are ongoing to minimize impact on trial timelines and data. AVAC will continue to monitor developments—watch this space.
NIH HIV/AIDS Clinical Trials Networks Updates
- AIDS Clinical Trials Group (ACTG) — all screening/enrollment will halt; specimen shipments will cease; site activation to continue; follow-up with participants per study team instructions; all CABs meet virtually (18 March 2020).
- DAIDS suspended on-site monitoring visits through May 15.
- HIV Prevention Trials Network (HPTN) — all screening/enrollment is paused; observational studies paused; no new initiation of studies; participant follow-up to be guided by protocol leadership. Click here for a table of ongoing studies/impact (16 March 2020).
- HIV Vaccine Trials Network (HVTN) — screening/enrollment paused; sites to schedule telephone or virtual visits; those with a scheduled appointment must contact the site beforehand if they feel unwell; physical distancing in the waiting area or while visits are being conducted; monitor temperature of clinic staff and participants upon entering the clinic; wash hands and disinfect surfaces (1 April 2020 statement). Click here for a table of ongoing studies/impact (1 April 2020).
- International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Network — all screening/enrollment is paused; no new studies to be initiated; specimen shipments will cease; follow-up with participants should continue per protocol chair instructions (17 March 2020).
- Microbicide Trials Network (MTN) — all screening/enrollment is paused; participant follow-up to be guided by protocol leadership. Click here for a table of ongoing studies/impact (18 March 2020).
Other Research Sponsor Updates
- IAVI suspended all recruitment activities. Most trials are currently continuing participant follow-up.
- International Partnership for Microbicides provides a message from CEO Dr. Zeda F. Rosenberg.
- Merck temporarily suspended enrollment to all ongoing trials and delayed the start of new studies. Those already enrolled will continue with study visits.
- PrEPVacc paused recruitment of their registration cohort at all sites; follow-ups continue but only where permitted by national guidelines. The potential timing for a start of the vaccine trial will be evaluated in June.
Regulatory Updates
- EMA issued guidance on March 27.
- FDA issued updated guidance on April 16.
- SAHPRA issued guidance on clinical trials March 25.
