MATRIX-007 (CARE PrEP)

Title: Safety Evaluation following Exposure to Cabotegravir-, Dapivirine- and Tenofovir-based PrEP during Pregnancy

Brief Description: This prospective observational cohort study will enroll approximately 500 CATALYST study participants with pregnancies who were exposed to an antiretroviral (ARV)-based HIV prevention method at the time of enrollment and their infants. The study will evaluate pregnancy and infant outcomes observed in CATALYST study participants exposed to long-acting injectable cabotegravir (CAB-LA), dapivirine vaginal ring (DVR) or tenofovir-based oral pre-exposure prophylaxis (PrEP) during pregnancy. Enrollment will be favored (3:1) for participant mothers exposed to CAB-LA compared to DVR or oral PrEP.

Protocol Co-Chairs: Katherine Bunge, MD, MPH; Njambi Njuguna, MBChB, MSc, MPH

Study Sites: Up to three CATALYST study sites in each of the following countries: Kenya, Lesotho, Uganda, and Zimbabwe

Email Groups: MATRIX-007 Leadership and Operation Group; MATRIX-007 Management Team; MATRIX-007 Protocol Team; MATRIX-007 Safety Sub-committee