IMPAACT 2009
Infectious Diseases
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
Rationale
Feasibility, Acceptability and Safety of pre-exposure prophylaxis during Pregnancy and Breast Feeding to establish drug thresholds for optimal adherence when FTC/TDF is administered daily under direct observation during pregnancy and in the postpartum period.
Primary Objectives
- To characterize PrEP adherence among HIV-uninfected adolescent and young adult women (aged 16-24 years) who initiate once-daily emtricitabine-tenofovir disoproxil fumarate (FTC/TDF) in pregnancy and are followed through 6 months postpartum, when offered adherence support through mobile technology and drug level-directed counseling.
- To compare maternal and infant adverse events (including pregnancy outcomes) between women who initiate PrEP and women who decline PrEP over the observation period.
Investigators
- Dr Elizea Horne (Principal Investigator)
- Dr Faeezah Patel (Sub-Investigator)
- Dr Mrinmayee Dhar (Sub-Investigator)
- Muneerah Khan (Sub-Investigator)
- Jeanne Coetzee (Sub-Investigator)
- Tiffany Seef (Clinical Associate)
- Othusitse Segalo (Clinical Associate)
Latest Update:
March 2024
For more about IMPAACT 2009 please email EHorne@wrhi.ac.za
