A Patient-Centered, Combination Intervention to Support Adherence to HIV Pre-exposure Prophylaxis During Pregnancy and Breastfeeding: A Randomized Pilot Study in Malawi

aDepartment of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC;

bUNC Project Malawi, Lilongwe, Malawi;

cDepartment of Epidemiology, University of North Carolina at Chapel Hill, Chapel Hill, NC;

dUNC Center for AIDS Research, University of North Carolina at Chapel Hill, Chapel Hill, NC;

eDepartment of Health Behavior and Health Education, University of Michigan, Ann Arbor, MI;

fDepartment of Health Behavior, University of North Carolina at Chapel Hill, Chapel Hill, NC;

gDepartment of Population Studies and Global Health, University of Zambia, Lusaka, Zambia;

hCenter for International Health, Education, and Biosecurity, Lilongwe, Malawi;

iPartners in Hope, Lilongwe, Malawi; and

jDepartment of Health Policy and Systems, University of Zambia, Lusaka, Zambia.

Correspondence to: Benjamin H. Chi, MD, MSc, University of North Carolina at Chapel Hill, 335 S. Columbia St. CB #7577 Chapel Hill, NC 27599 (e-mail: [email protected]).

This study was funded by the National Institute of Allergy and Infectious Disease (NIAID) and the National Institute of Mental Health (NIMH) through Award R01 AI131060. Investigator and trainee support was provided by NIAID (K24 AI120796), NIMH (R00 MH104154, K01 MH121186), and the Fogarty International Center (D43 TW009340, D43 TW010558, D43 TW010060). Administrative and laboratory support was further provided by NIAID (P30 AI050410) and National Center for Advancing Translational Sciences (UL1TR002489).

B.H.C. and L.A.G. report consultancies for the United Nations Children's Fund (UNICEF). L.M.H. reports grant support from Gilead Sciences. The authors otherwise declare no competing interests.

B.H.C. and W.M. developed the study concept. L.A.G., K.R.M., N.E.R., and L.M.H. participated in the study design. F.S. and T.P. led overall study implementation while K.R.A., K.F., and T.P. oversaw training and monitoring for the study intervention. L.A.G., K.R.M., and B.R. managed and analyzed the study data. B.H.C. wrote the paper. F.S., L.A.G., T.P., K.R.M., K.R.A., K.F., N.E.R., L.M.H., T.H., B.R., T.K., S.P., and W.M. helped to interpret study findings and revised manuscript drafts. All authors reviewed and approved the submitted version of the paper.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.jaids.com).

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