Clemensia Nakabiito, MBChB, MMed and MU-JHU Senior Investigator, is an internationally recognised practicing obstetrician/gynaecologist clinical researcher with wide experience in research involving women, both HIV infected and uninfected and both pregnant and non-pregnant women for over 20 years.
She has been involved in training, clinical management and research in the Department of Obstetrics and Gynecology and has been employed as a researcher and clinician at MU-JHU for the past 20 years. Within IMPAACT (formerly HPTN) trials, she was the Co-Investigator on the HIVNET 012 study, the SWEN/HIVGLOB study and served as a Site Co-Investigator on the HPTN 046 trial and also served as a sub-investigator of the ongoing PROMISE study. She has also served on the Hepatitis subcommittee for the Women health Advocacy Committee of IMPAACT and has experience with Phase 1, 2B and Phase 3 studies.
She served as the site Principal Investigator for the completed NIH/NIAID funded MTN protocols including MTN-001, MTN-003, MTN-015, and MTN-003B study which specifically assessed bone health of HIV uninfected women on TDF based pre-exposure prophylaxis. She was the Co-PI for the completed MTN-020/ASPIRE study and the follow-on trial for ASPIRE Study named MTN-025/HOPE Open-label Study which was recently completed. She is currently the Investigator of Record (IOR) for the HPTN 084(A Phase 3 Double-Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women and 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).
She has been part of the protocol development teams for MTN-042B, MTN-042 (Phase 3b, Randomized, Open-Label Safety Trial of Dapivirine Vaginal Ring and Oral TRUVADA® Use in Pregnancy) and MTN-043. Through these studies, as an IoR and Co-Investigator, she has mentored young investigators who have taken on leadership skills including positions of IORs. Working on these various protocols has given her valuable experience in implementing trials in resource-limited settings including overcoming challenges, and the particular issues that arise in this study population. Her vast knowledge, experiences, training, and longstanding interest in women of reproductive age in resource-limited settings give her a unique perspective on supporting reproductive choices, treatment options among HIV infected and HIV prevention among women.