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IMPAACT 2009

Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention during Pregnancy and Postpartum in Adolescents and Young Women and their Infants

Study Status

Closed to Accrual

DAIDS Number

30020

IND Number

136735

Clinical Trials Link

Summary

IMPAACT 2009 is a parallel, observational cohort study of HIV-uninfected pregnant adolescents and young women (aged 16-24). The study is designed to characterize adherence over time among women who initiate once daily oral PrEP during pregnancy and continue in the first 6 months following delivery, and to compare pregnancy outcomes among women who take PrEP and women who decline PrEP during the antenatal period.

Study Vice-Chair

DAIDS Medical Officer

Community Program Manager

DAIDS Protocol Pharmacist

Epidemiologist

Laboratory Data Manager (LDM)

Laboratory Specialist

Laboratory Technologist

NIMH Medical Officer

Pharmaceutical Company Representative

Pharmacologist

Statistician

Westat Representative

Abstracts

Directly Observed Therapy (DOT) can be Implemented Successfully in Research Settings to Evaluate PrEP PK among Pregnant and Postpartum Adolescents and Young Women in Africa

Conference

HIV R4P 2021

Study

IMPAACT 2009

Authors

E. Brown, L. Stranix-Chibanda, B. Johnston, S. Huang, D. Kacanek, L. Mungate, A. Sango, S. Mambiya, W. Longwe Mwenda, V. Korutaro, S. Nanyunja, P. Kibalama Ssemambo, A. Ssekasi Miwanda, H. Kowo, S. Nelwamondo, H. Spiegel, P. Anderson, B. Chi, K. Lypen