The IMPAACT Network has released a response to the COVID-19 pandemic. Read more from IMPAACT Leadership and see guidance from the CDC, DAIDS, EMA, FDA, WHO, and more.
The IMPAACT Network is closely monitoring the ongoing COVID-19 pandemic. The safety and well-being of IMPAACT study participants, community members, clinical research site staff, and laboratory staff are of utmost importance and the highest priority for our Network. We are tracking all updates and heeding recommendations from national and international health organizations, including the US Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) regarding the disease.
Consistent with guidance from DAIDS, and in consultation with our NIH partners, action steps are as follows (updated 1 September 2020):
- IMPAACT P1108, IMPAACT P1115, and IMPAACT 2005 were permitted to resume accrual as of 19 July 2020; IMPAACT 2019 was opened to accrual. Sites will need to confirm contingency planning for COVID-19 concerns prior to enrolling into any of these studies.
- Accrual is only open for studies listed above, once site receives study-specific approvals.
- For most IMPAACT studies, follow-up of participants continued, and should continue — to the extent possible and in accordance with relevant government and site-specific institutional policies — with emphasis on safety monitoring and ensuring access to treatment regimens for participants living with HIV.
- Shipments of study specimens to the IMPAACT repositories and designated testing laboratories have resumed
We will continue to provide updates as needed via email and our website. Please stay safe and be well.
Resources and Guidance
- Supporting mom and baby to breastfeed during COVID-19 (January 2021)
- Job aids on maintaining essential maternal and newborn care during the COVID-19 pandemic (January 2021)
Guidance for Re-Opening
- IMPAACT Network Guidance for Resuming Accrual in Select Studies during the COVID-19 Pandemic (21 July 2020)
- IMPAACT Specimen Shipping Memo (15 July 2020)
- IMPAACT / NIAID US Domestic Specimen Shipments to BRI (4 June 2020)
- Resuming Operations at Sites (DAIDS) (21 May 2020)
- Letter from IMPAACT Network Leadership (18 March 2020)
- U.S. Pediatric COVID-19 Registry
- DAIDS COVID-19 Guidance
- Extended Suspension of Monitoring Visits - DAIDS OCSO Monitoring Operations Branch (6 April 2020)
- Alternative Remote Informed Consent Process Memo (8 April 2020)
- COVID-19 Virtual Visits and Data Management Guidance for Sites (April 2020)
- COVID-19: What people with HIV should know (CDC)
- COVID-19 Guidance for People Living with HIV (Infographic)
- WHO Risk Communication Package For Healthcare Facilities
- EMA Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) Pandemic
- Protocol Deviation Reporting System: Guidance for IMPAACT Clinical Research Sites (30 April 2020)
- Guidelines for Network Lab Operations Recovery (1 May 2020)
- Phased Approach to Resumption of On-Site Monitoring Visits (11 May 2020)
- Brazil: ANVISA Issues Updated Guidelines Related to COVID-19 and Clinical Trials (15 June 2020)
- Brazil: ANVISA Issues Notice for Clinical Trials Impacted by COVID-19 (23 March 2020)
- Brazil: ANVISA and CONEP Issue Updated Requirements Related to COVID-19 and Clinical Trials (5 May 2020)
- India: ICMR Issues Guidelines for EC Review during COVID-19 Pandemic (6 May 2020)
- Kenya PPB Issues Guidance for Clinical Trials Impacted by COVID-19 (Effective 20 April 2020)
- Peru: INS Issues Communications for Clinical Trials Impacted by COVID-19
- SAHPRA Policy on Conduct of Clincial Trials of Health Products During the Current COVID-19 Pandemic
- SAHPRA Revises GCP Training Requirements and Issues Clinic Clinical Trial Application Guidance for Public Health Emergencies (13 April 2020)
- Thailand FDA Issues Guidelines for Clinical Trials During COVID-19 Outbreak (26 May 2020)
- Uganda: UNCST Issues Guidelines for Research during COVID-19 Pandemic (28 August 2020)
- U.S. FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic
- U.S. FDA Guidance on Developing COVID-19 Drugs and Biological Products for Treatment or Prevention