aDepartment of Infectious Diseases, Copenhagen University Hospital, Hvidovre, Hvidovre, Denmark;

bDepartment of Public Health, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark;

cMixed Methods Program and Department of Family Medicine, University of Michigan, Ann Arbor, MI;

dDepartment of Infectious Diseases, Helsinki University Hospital, Helsinki, Finland;

eDepartment of Infectious Diseases, Region Västra Götaland, Sahlgrenska University Hospital, Gothenburg, Sweden;

fDepartment of Infectious Diseases, Institute of Biomedicine, Sahlgrenska Academy, University of Gothenburg, Sweden;

gDepartment of Infectious Diseases, Odense University Hospital, Odense, Denmark;

hDepartment of Infectious Diseases, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark;

iDepartment of Infectious Diseases, Aalborg University Hospital, Aalborg, Denmark;

jDepartment of Infectious Diseases, Aarhus University Hospital, Aarhus, Denmark; and

kDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.

Correspondence to: Ellen Moseholm, PhD, Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre Kettegaard Alle 30 2650 Hvidovre, Denmark (e-mail: [email protected]).

The 2BMOM study was funded by The Novo Nordisk Foundation (Grant Number: NNF17OC0029508 and NNF18OC0052512), Gilead Sciences (Grant Number: 220002078), and a research grant from Copenhagen University Hospital, Hvidovre. The funders had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Presented at a poster presentation at The International HIV & Women Workshop, February 17–18, 2023, Seattle, WA.

E.M. reports personal fees from Gilead and Merck Sharp Dohme, outside the submitted work and honorarium paid to her institution. I.A. reports personal fees from AbbVie, Merck Sharp Dohme, Gilead, and GlaxoSmithKline and a grant from Gilead, outside the submitted work. Å.M. reports personal fees from Gilead and ViiV/GSK, outside the submitted work. T.L.K. reports personal fees and grants from ViiV/GlaxoSmithKline, Gilead, CLS Behring, and Baxalta, outside of the submitted work. N.W. reports personal fees from Novo Nordisk and honorarium paid to her institution from AbbVie and Merck Sharp Dohme, outside the submitted work. The remaining authors (M.D.F., G.P., I.S.J., D.B., and M.S.) declare no conflicts of interest.

The data presented in this study are available upon reasonable request from the corresponding author and with approval from the relevant regulatory agencies. The data are not publicly available as restrictions apply to the availability of these data, which were used under license for the current study.

E.M., M.D.F., and N.W. had the original concept for the study. All authors contributed to study design, data interpretation, writing the report, and approved the final version. E.M., I.A., Å.M., I.S.J., T.L.K., G.P., M.S., and N.W. contributed to the data collection. E.M. had full access to the data and completed the analysis together with M.D.F. and N.W.

†Deceased (July 2023).