IMPAACT 2009 (DAIDS ID 30020): Feasibility, Acceptability and Safety of Oral Pre-Exposure Prophylaxis for Primary HIV Prevention during Pregnancy and Breast Feeding in Adolescents and Young Women

Study Status Study Restriction

In Development

Non-US

What is IMPAACT 2009?

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.

Sites where the study is implemented:

CRS ID Site Name City Country

30301

College of Medicine JHU CRS

Blantyre

Malawi

30300

CAPRISA Umlazi Clinical Research Site (UKZN)

Umlazi, KwaZulu-Natal

South Africa

30293

Makerere University - Johns Hopkins University (MU-JHU) Research Collaboration

Kampala

Uganda

31798

Baylor-Uganda CRS

Kampala

Uganda

30303

St. Mary's CRS (Zimbabwe)

Chitungwiza

Zimbabwe

30306

Seke North CRS (Zimbabwe)

Harare

Zimbabwe

31890

Harare Family Care CRS

Harare

Zimbabwe

Study contacts:

Study Co-Chair: Benjamin Chi

Study Co-Chair: Lynda Stranix-Chibanda

Study Vice-Chair: Sybil Hosek

DAIDS Medical Officer: Hans Spiegel

NICHD Medical Officer: Nahida Chakhtoura

NICHD Medical Officer: Jack Moye

NIMH Medical Officer: Susannah Allison

Clinical Trials Specialist: Kathleen George

Clinical Trials Specialist: Kathryn Lypen

Community Program Manager: Cheryl Cokley

DAIDS Protocol Pharmacist: Nayri  Khairalla

Data Manager: Benjamin Johnston

Data Manager: Elise Tjaden

Investigator: Rivet Amico

Investigator: Geri Donenberg

Investigator: Lisa Frenkel

Investigator: Lisa Hightow-Weidman

Laboratory Data Manager (LDM): Katelyn Hergott

Laboratory Specialist: Carolyn Yanavich

Laboratory Technologist: Dean Soko

Pharmaceutical Company Representative: James Rooney

Pharmacologist: Peter Anderson

Pharmacologist: Jennifer Kiser

Proposal Statistician: Deborah Kacanek

Statistician: Sharon Huang

 

Funded by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health of the US National Institutes of Health, US Department of Health and Human Services.