Browsing by Author "Noguchi, Lisa"
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Item Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials(HIV Clinical Trials, 2018) Mhlanga, Felix G.; Noguchi, Lisa; Balkus, Jennifer E.; Kabwigu, Samuel; Scheckter, Rachel; Piper, Jeanna; Watts, Heather; O’Rourke, Colin; Torjesen, Kristine; Brown, Elizabeth R.; Hillier, Sharon L.; Beigi, RichardSafety data on pregnancy and fetal outcomes among women in HIV prevention trials are urgently needed to inform use of effective antiretroviral agents for HIV prevention. We describe an effective, efficient, and novel method to prospectively collect perinatal safety data concurrent with on-going parent clinical trials. The Microbicide Trials Network (MTN)-016 study is a multinational prospective pregnancy exposure registry designed to capture pregnancy and neonatal outcomes. Studies currently contributing data to this registry included phase I and II safety trials with planned exposures to candidate HIV prevention agents, as well as phase IIB and III efficacy trials capturing data on pregnancy and infant outcomes following inadvertent fetal exposure during study participation. Results: To date, participants from two phase I studies and two effectiveness trials have participated in MTN- 016, resulting in 420 pregnant women and 381 infants enrolled. Infant retention has been high, with 329 of 381 (86%) infants completing the 12-month follow-up visit. In a research setting context, it is feasible to establish and implement a prospective, multinational HIV chemoprophylaxis pregnancy registry that will generate pregnancy exposure data in a robust fashion.Item The MTN-016 Pregnancy Registry: Baseline Characteristics of Enrollees from the VOICE Study and Reasons for Non-enrollment of Eligible Women(AIDS Research and Human Retroviruses, 2014) Kabwigu, Samuel; Noguchi, Lisa; Moodley, Jothi; Palanee, Thes; Kintu, Kenneth; Nair, Lulu; Panchia, R.; Selepe, Pearl; Balkus, Jennifer E.; Torjesen, Kristine; Piper, Jeanna; Scheckter, Rachel; Hazra, Rohan; Beigi, RichardAs pregnant women are at risk for HIV and women at risk of HIV may become pregnant, it is important to assess the safety of candidate HIV prevention products in both non-pregnant and pregnant women. The MTN-016 pregnancy registry is a prospective observational cohort in which participants who became pregnant during MTN effectiveness studies or those with planned exposures in pregnancy safety studies are monitored for adverse obstetric outcomes; infants from these pregnancies are followed through the first year of life. Registry enrollment systematically excludes termination of pregnancy and early pregnancy loss, including early non-viable pregnancies with a transient positive test at a monthly visit, as these data are captured in parent protocols. For VOICE participants enrolled into the registry from Uganda, Zimbabwe and South Africa, we describe baseline demographic characteristics and key reasons for non-enrollment as reported by site investigators.