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Authors
Kamanga, Funny
Squibb, Madeleine A.
Nyangulu, Watipa
Wu, William
Chen, Jiehua
Ngwira, Chatonda
Drabko, Anna
Garbarek, Wiktor
Pomykala, Maciej
Bilicki, Dominik
Nakanga, Charity
Masiye, Gladwell
Chinula, Lameck
Mvalo, Tisungane
Chagomerana, Maganizo B.
Matoga, Mitch M.
Kumwenda, Wiza
Mkochi, Tawonga
Matola, Ernest
Dias, Peter
Mkochi, Nomthata
Thonyiwa, Virginia
Nyirenda, Rose K.
Chewere, Linley
Ozituosauka, Washington
Jahn, Andreas
Nkhonjera, Joe
Odek, James
Hoege, Deborah
Schwartz, Sheree
Chauwa, Felluna
Dadabhai, Sufia
Phiri, Sam
Rutstein, Sarah E.
Herce, Michael
Hoffman, Irving
Allinder, Sara
Holmes, Charles B.
Hosseinipour, Mina C.
Saidi, Friday
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Funding
Funding for this research was provided by:
Bill and Melinda Gates Foundation (INV-050867)
Fogarty International Center (D43TW010060)
National Institute of Child Health and Human Development (1P01HD112215)
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Article History
Received: 17 March 2026
Accepted: 28 April 2026
First Online: 8 May 2026
Declarations
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: The PrEP Pregnancy Registry was approved as a sub-study under the Path to Scale study protocol by the Malawi National Health Sciences Research Committee (NHSRC), protocol #23/10/4205, and the Georgetown University Institutional Review Board (IRB), protocol #00007311. It is jointly implemented and evaluated alongside the PRI 3 SM-PrIMO study protocol, which also received NHSRC approval under protocol #23/08/4178 and UNC Chapel Hill IRB approval protocol #23-2220. Both studies are conducted in accordance with the ethical principles of the Declaration of Helsinki.Individual consent is not obtained, as the registry is designed to reflect routine programmatic data collection. However, verbal consent is sought for follow-up to document pregnancy outcomes. Additional written consent is obtained for the nested PRI3SM-PrIMO Study safety cohort. All data will be de-identified for analysis. The registry evaluates the safety of only the US. Food and Drug Administration (FDA) approved and WHO-recommended PrEP options; oral TDF/FTC or TDF/3TC and injectable CAB-LA among pregnant women in real-world service delivery settings.
: Not applicable.
: The authors declare no competing interests.
