2022 Rome Action Plan on Paediatric HIV & TB
HIV Clinical Trials Research Networks enrolling adults into phase 2/3 clinical trials of new antiretroviral drugs for treatment or prevention, commit to:
1. Implementing the Call to Action principles and advocate for other research networks to do the same including reporting of incident pregnancies occurring during the conduct of such studies; permitting women who become pregnant in trials to consent to stay on study drug; and collecting outcomes of pregnancies as well as pregnancy and breastfeeding PK data in women who become pregnant on study.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development commits to:
2. Continue to co-fund NIAID’s relevant efforts through IMPAACT and HPTN.
3. Provide new funding that leverages their clinical trial networks to which investigators, both within the networks and not within, can apply.
4. Continue to support the Maternal-Fetal Medicine Units (MFMU) Network and the Neonatal Research Network (NRN), also during the new seven-year cycle starting in 20236.
5. Continue to support the Global Network for Women’s and Children’s Health Research in the new seven-year cycle to start in 2023.
6. Continue to support the Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub and Centers of Excellence in Therapeutics
7. Initiate the MPRINT Translational Research Resource Platform in 2023, to support concerted multidisciplinary team science that leverages existing and prospective resources to advance. therapeutic research for maternal and pediatric therapeutics.
8. Renew/extend funding opportunity announcement - Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R01 Clinical Trial Optional)
9. Promote training opportunity - NICHD Research Education Programs (R25 Clinical Trial Not Allowed). Priority areas include virtual skills development courses and supporting resources for researchers on best practice topics such as inclusion and retention of pregnant and lactating
persons and/or pediatric patients and their families in clinical research
10. Supporting a National Academies of Science, Engineering, and Medicine (NASEM) study to conduct an evaluation of real and perceived liability around research conducted in pregnant and lactating persons, and develop a framework for addressing medicolegal and liability issues when planning or conducting research specific to pregnant and lactating persons.
WHO and Research networks commit to:
61. Working together to collaboratively develop standards to strengthen systematic population data collection, registries, and master protocols to promote alignment and harmonization of studies in pregnant women across studies within the work of the WHO HIV, Hepatitis and STIs Pregnancy
and Breastfeeding Therapeutics Working Group (HHS PTWG) .
62. Ensure appropriate consultation and engagement of community members and communitybased organizations through the research cycle for new therapeutics.