Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials

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dc.contributor.authorMhlanga, Felix G.
dc.contributor.authorNoguchi, Lisa
dc.contributor.authorBalkus, Jennifer E.
dc.contributor.authorKabwigu, Samuel
dc.contributor.authorScheckter, Rachel
dc.contributor.authorPiper, Jeanna
dc.contributor.authorWatts, Heather
dc.contributor.authorO’Rourke, Colin
dc.contributor.authorTorjesen, Kristine
dc.contributor.authorBrown, Elizabeth R.
dc.contributor.authorHillier, Sharon L.
dc.contributor.authorBeigi, Richard
dc.date.accessioned2022-01-22T17:14:02Z
dc.date.available2022-01-22T17:14:02Z
dc.date.issued2018
dc.description.abstractSafety 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.en_US
dc.identifier.citationFelix G. Mhlanga, Lisa Noguchi, Jennifer E. Balkus, Samuel Kabwigu, Rachel Scheckter, Jeanna Piper, Heather Watts, Colin O’Rourke, Kristine Torjesen, Elizabeth R. Brown, Sharon L. Hillier & Richard Beigi (2018) Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials, HIV Clinical Trials, 19:1, 8-14, DOI: 10.1080/15284336.2017.1411419en_US
dc.identifier.urihttps://doi.org/10.1080/15284336.2017.1411419
dc.identifier.urihttps://nru.uncst.go.ug/xmlui/handle/123456789/1432
dc.language.isoenen_US
dc.publisherHIV Clinical Trialsen_US
dc.subjectHIVen_US
dc.subjectARV-chemoprophylaxis agentsen_US
dc.subjectRegistryen_US
dc.subjectCongenital malformationen_US
dc.subjectPregnancyen_US
dc.titleImplementation of a prospective pregnancy registry for antiretroviral based HIV prevention trialsen_US
dc.typeArticleen_US
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