{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T18:02:58Z","timestamp":1791396178399,"version":"4.3.3"},"reference-count":32,"publisher":"Oxford University Press (OUP)","issue":"3","license":[{"start":{"date-parts":[[2026,5,17]],"date-time":"2026-05-17T00:00:00Z","timestamp":1778976000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100021930","name":"USAID","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100021930","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,10,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The safety of a 3-month weekly rifapentine-isoniazid (3HP) for tuberculosis prevention in HIV-positive pregnant women on antiretroviral treatment is unknown. As part of the WHIP3TB trial, 3HP administered once or annually for 2 years was compared to 6 months of isoniazid. We report outcomes among women who became pregnant, with drug exposure in early pregnancy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Women were classified as exposed if conception occurred while taking study drug, and unexposed if conception occurred after the last dose. Outcomes included live birth, stillbirth, or abortion. A composite adverse pregnancy outcome was defined as any of the following: stillbirth, spontaneous abortion, low birth weight (&amp;lt;2500 g), preterm delivery (&amp;lt;37 weeks\u2019 gestation), or major congenital anomalies. Outcomes were compared between exposed and unexposed groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 2207 women aged 15\u201349 years enrolled between November 2016 and November 2017, 236 pregnancies occurred in 222 participants. Fifty-seven (24%) were exposed to study drug (51 in 3HP arm, 6 in 6 months of isoniazid arm) and 179 were unexposed. Median age was 32 years, median antiretroviral treatment duration 2.9 years (interquartile range; 1.2\u20134.9 years) and median CD4 count 522 cells\/L; [interquartile range, 345\u2013684). Of 219 pregnancies with known outcomes, 162 (74%) were live births, 51 (23%) abortions, and 6 (3%) stillbirths. Spontaneous abortions occurred at similar frequencies among exposed (12% [7\/57]) and unexposed (14% [22\/162]) groups with comparable rates of composite adverse outcomes (33% [19\/57] vs 35% [56\/162]).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Spontaneous abortion and composite adverse pregnancy outcomes following first-trimester exposure to 3HP were comparable between exposed and unexposed groups, supporting the safety of 3HP in pregnancy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciag315","type":"journal-article","created":{"date-parts":[[2026,5,15]],"date-time":"2026-05-15T11:45:21Z","timestamp":1778845521000},"page":"e550-e558","source":"Crossref","is-referenced-by-count":0,"title":["Safety of Short-course Weekly Rifapentine and Isoniazid (3HP) for TB Preventive Treatment at Conception and During First Trimester in Women With HIV: A Secondary Analysis of the WHIP3TB trial"],"prefix":"10.1093","volume":"83","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1444-9266","authenticated-orcid":false,"given":"Violet","family":"Chihota","sequence":"first","affiliation":[{"name":"The Aurum Institute Research Division, , Johannesburg ,","place":["South Africa"]},{"name":"School of Public Health, University of Witwatersrand , Johannesburg ,","place":["South Africa"]},{"name":"Department of Medicine, Vanderbilt University , Nashville, Tennessee ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zainab","family":"Waggie","sequence":"additional","affiliation":[{"name":"The Aurum Institute Research Division, , Johannesburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-9890-6243","authenticated-orcid":false,"given":"Vicky","family":"Cardenas","sequence":"additional","affiliation":[{"name":"The Aurum Institute Research Division, , Johannesburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7847-3671","authenticated-orcid":false,"given":"Kathy","family":"Mngadi","sequence":"additional","affiliation":[{"name":"The Aurum Institute Research Division, , Johannesburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7499-7486","authenticated-orcid":false,"given":"Felex","family":"Ndebele","sequence":"additional","affiliation":[{"name":"The Aurum Institute Research Division, , Johannesburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1092-9919","authenticated-orcid":false,"given":"William","family":"Brumskine","sequence":"additional","affiliation":[{"name":"The Aurum Institute Research Division, , Johannesburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Modulakgotla","family":"Sebe","sequence":"additional","affiliation":[{"name":"The Aurum Institute Research Division, , Johannesburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0184-5705","authenticated-orcid":false,"given":"Neil","family":"Martinson","sequence":"additional","affiliation":[{"name":"Perinatal HIV Research Unit (PHRU), Faculty of Health Sciences, University of the Witwatersrand , Johannesburg ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8006-2401","authenticated-orcid":false,"given":"Shu-Hua","family":"Wang","sequence":"additional","affiliation":[{"name":"Division of Infectious Disease, Department of Internal Medicine, The Ohio State University Global One Health Initiative, College of Medicine , Columbus, Ohio ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Getnet","family":"Yimer","sequence":"additional","affiliation":[{"name":"Center for Global Genomics and Health Equity, Department of Genetics, Perelman School of Medicine, University of Pennsylvania , Philadelphia, pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9921-2609","authenticated-orcid":false,"given":"Dinis","family":"Nguenha","sequence":"additional","affiliation":[{"name":"Centro de Investiga\u00e7\u00e3o em Sa\u00fade de Manhi\u00e7a (CISM) , Maputo ,","place":["Mozambique"]},{"name":"Department of Global Health and Amsterdam Institute for Global Health and Development, Amsterdam University Medical Centers Location, University of Amsterdam , Amsterdam, The \u00a0","place":["Netherlands"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2038-5505","authenticated-orcid":false,"given":"Alberto L","family":"Garcia-Basteiro","sequence":"additional","affiliation":[{"name":"Centro de Investiga\u00e7\u00e3o em Sa\u00fade de Manhi\u00e7a (CISM) , Maputo ,","place":["Mozambique"]},{"name":"ISGlobal, Hospital Cl\u00ednic, Universitat de Barcelona , Barcelona ,","place":["Spain"]},{"name":"Centro de Investigaci\u00f3n Biom\u00e9dica en Red de Enfermedades Infecciosas (CIBERINFEC) , Barcelona ,","place":["Spain"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2968-9652","authenticated-orcid":false,"given":"Susan","family":"van den Hof","sequence":"additional","affiliation":[{"name":"KNCV Tuberculosis Foundation Technical Division of TB elimination and Health Systems Innovations, , The Hague ,","place":["The Netherlands"]},{"name":"National Institute of Public Health and the Environment, Centre for Infectious Disease Control , Bilthoven ,","place":["The Netherlands"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alison D","family":"Grant","sequence":"additional","affiliation":[{"name":"TB Centre, London School of Hygiene and Tropical Medicine , London ,","place":["United Kingdom"]},{"name":"Africa Health Research Institute, School of Laboratory Medicine & Medical Sciences, College of Health Sciences, University of KwaZulu-Natal , Durban ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7143-1009","authenticated-orcid":false,"given":"Salome","family":"Charalambous","sequence":"additional","affiliation":[{"name":"The Aurum Institute Research Division, , Johannesburg ,","place":["South Africa"]},{"name":"School of Public Health, University of Witwatersrand , Johannesburg ,","place":["South Africa"]},{"name":"Department of Medicine, Vanderbilt University , Nashville, Tennessee ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6524-3754","authenticated-orcid":false,"given":"Katherine L","family":"Fielding","sequence":"additional","affiliation":[{"name":"TB Centre, London School of Hygiene and Tropical Medicine , London ,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard E","family":"Chaisson","sequence":"additional","affiliation":[{"name":"Center for TB Research, Johns Hopkins University School of Medicine , Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4269-3699","authenticated-orcid":false,"given":"Gavin","family":"Churchyard","sequence":"additional","affiliation":[{"name":"The Aurum Institute Research Division, , Johannesburg ,","place":["South Africa"]},{"name":"School of Public Health, University of Witwatersrand , Johannesburg ,","place":["South Africa"]},{"name":"Department of Medicine, Vanderbilt University , Nashville, Tennessee ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the WHIP3TB study team","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Limakatso","family":"Lebina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tumelo","family":"Moloantoa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ebrahim","family":"Variava","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Itumeleng","family":"Holele","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,5,17]]},"reference":[{"key":"2026100713433843900_ciag315-B1","doi-asserted-by":"crossref","first-page":"196","DOI":"10.1097\/QAI.0b013e3181900201","article-title":"Intensified case finding for tuberculosis in prevention of mother-to-child transmission programs: a simple and potentially vital addition for maternal and child health","volume":"50","author":"DeLuca","year":"2009","journal-title":"J Acquir Immune Defic Syndr"},{"key":"2026100713433843900_ciag315-B2","doi-asserted-by":"crossref","first-page":"e0003578","DOI":"10.1371\/journal.pgph.0003578","article-title":"Mycobacterium tuberculosis infection in pregnancy: a systematic review","volume":"4","author":"Morton","year":"2024","journal-title":"PLOS Glob Public Health"},{"key":"2026100713433843900_ciag315-B3","volume-title":"Global tuberculosis report 2025","author":"World Health Organization","year":"2025"},{"key":"2026100713433843900_ciag315-B4","doi-asserted-by":"crossref","first-page":"1532","DOI":"10.1093\/cid\/cis732","article-title":"Tuberculosis in pregnant and postpartum women: epidemiology, management, and research gaps","volume":"55","author":"Mathad","year":"2012","journal-title":"Clin Infect Dis"},{"key":"2026100713433843900_ciag315-B5","doi-asserted-by":"crossref","first-page":"760","DOI":"10.5588\/ijtld.17.0448","article-title":"Burden of tuberculosis in HIV-positive pregnant women in Cape Town, South Africa","volume":"22","author":"Odayar","year":"2018","journal-title":"Int J Tuberc Lung Dis"},{"key":"2026100713433843900_ciag315-B6","doi-asserted-by":"crossref","first-page":"358","DOI":"10.1093\/jinfdis\/jiq064","article-title":"Maternal tuberculosis: a risk factor for mother-to-child transmission of human immunodeficiency virus","volume":"203","author":"Gupta","year":"2011","journal-title":"J Infect Dis"},{"key":"2026100713433843900_ciag315-B7","doi-asserted-by":"crossref","first-page":"e337","DOI":"10.1016\/S2214-109X(25)00431-0","article-title":"Global estimates of tuberculosis incidence during pregnancy and postpartum: a rapid review and modelling analysis","volume":"14","author":"Mafirakureva","year":"2026","journal-title":"Lancet Glob Health"},{"key":"2026100713433843900_ciag315-B8","doi-asserted-by":"crossref","first-page":"241","DOI":"10.1086\/518974","article-title":"Postpartum tuberculosis incidence and mortality among HIV-infected women and their infants in Pune, India, 2002-2005","volume":"45","author":"Gupta","year":"2007","journal-title":"Clin Infect Dis"},{"key":"2026100713433843900_ciag315-B9","volume-title":"Who consolidated guidelines on tuberculosis. Module 1: prevention\u2014tuberculosis preventive treatment","author":"World Health Organization","year":"2020"},{"key":"2026100713433843900_ciag315-B10","doi-asserted-by":"crossref","first-page":"1901967","DOI":"10.1183\/13993003.01967-2019","article-title":"The safety of isoniazid tuberculosis preventive treatment in pregnant and postpartum women: systematic review and meta-analysis","volume":"55","author":"Hamada","year":"2020","journal-title":"Eur Respir J"},{"key":"2026100713433843900_ciag315-B11","doi-asserted-by":"crossref","first-page":"1333","DOI":"10.1056\/NEJMoa1813060","article-title":"Isoniazid preventive therapy in HIV-infected pregnant and postpartum women","volume":"381","author":"Gupta","year":"2019","journal-title":"N Engl J Med"},{"key":"2026100713433843900_ciag315-B12","doi-asserted-by":"crossref","first-page":"708","DOI":"10.1016\/S2352-4642(23)00174-8","article-title":"Timing of maternal isoniazid preventive therapy on tuberculosis infection among infants exposed to HIV in low-income and middle-income settings: a secondary analysis of the TB APPRISE trial","volume":"7","author":"Gupta","year":"2023","journal-title":"Lancet Child Adolesc Health"},{"key":"2026100713433843900_ciag315-B13","doi-asserted-by":"crossref","first-page":"1419","DOI":"10.1093\/cid\/ciz1024","article-title":"Isoniazid preventive therapy and pregnancy outcomes in women living with human immunodeficiency virus in the Tshepiso cohort","volume":"71","author":"Salazar-Austin","year":"2020","journal-title":"Clin Infect Dis"},{"key":"2026100713433843900_ciag315-B14","doi-asserted-by":"crossref","first-page":"667","DOI":"10.1093\/cid\/ciad583","article-title":"Adverse pregnancy outcomes among women with human immunodeficiency virus taking isoniazid preventive therapy during the first trimester","volume":"78","author":"Gupta","year":"2024","journal-title":"Clin Infect Dis"},{"key":"2026100713433843900_ciag315-B15","doi-asserted-by":"crossref","first-page":"e351-e8","DOI":"10.1093\/cid\/ciz1224","article-title":"Safety and effectiveness of isoniazid preventive therapy in pregnant women living with human immunodeficiency virus on antiretroviral therapy: an observational study using linked population data","volume":"71","author":"Kalk","year":"2020","journal-title":"Clin Infect Dis"},{"key":"2026100713433843900_ciag315-B16","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1056\/NEJMoa1005136","article-title":"New regimens to prevent tuberculosis in adults with HIV infection","volume":"365","author":"Martinson","year":"2011","journal-title":"N Engl J Med"},{"key":"2026100713433843900_ciag315-B17","doi-asserted-by":"crossref","first-page":"922","DOI":"10.1164\/rccm.200512-1953OC","article-title":"Weekly rifapentine\/isoniazid or daily rifampin\/pyrazinamide for latent tuberculosis in household contacts","volume":"173","author":"Schechter","year":"2006","journal-title":"Am J Respir Crit Care Med"},{"key":"2026100713433843900_ciag315-B18","doi-asserted-by":"crossref","first-page":"1607","DOI":"10.1097\/QAD.0000000000001098","article-title":"Three months of weekly rifapentine and isoniazid for treatment of Mycobacterium tuberculosis infection in HIV-coinfected persons","volume":"30","author":"Sterling","year":"2016","journal-title":"Aids"},{"key":"2026100713433843900_ciag315-B19","doi-asserted-by":"crossref","first-page":"2155","DOI":"10.1056\/NEJMoa1104875","article-title":"Three months of rifapentine and isoniazid for latent tuberculosis infection","volume":"365","author":"Sterling","year":"2011","journal-title":"N Engl J Med"},{"key":"2026100713433843900_ciag315-B20","doi-asserted-by":"crossref","first-page":"1001","DOI":"10.1056\/NEJMoa1806808","article-title":"One month of rifapentine plus isoniazid to prevent HIV-related tuberculosis","volume":"380","author":"Swindells","year":"2019","journal-title":"N Engl J Med"},{"key":"2026100713433843900_ciag315-B21","doi-asserted-by":"crossref","first-page":"1604","DOI":"10.1093\/cid\/ciab665","article-title":"Pharmacokinetics and safety of 3 months of weekly rifapentine and isoniazid for tuberculosis prevention in pregnant women","volume":"74","author":"Mathad","year":"2022","journal-title":"Clin Infect Dis"},{"key":"2026100713433843900_ciag315-B22","volume-title":"Who consolidated guidelines on tuberculosis. Module 1: prevention\u2014tuberculosis preventive treatment, second edition","author":"World Health Organization","year":"2024"},{"key":"2026100713433843900_ciag315-B23","doi-asserted-by":"crossref","first-page":"570","DOI":"10.1513\/AnnalsATS.201704-326OC","article-title":"Exposure to latent tuberculosis treatment during pregnancy. The PREVENT TB and the iAdhere trials","volume":"15","author":"Moro","year":"2018","journal-title":"Ann Am Thorac Soc"},{"key":"2026100713433843900_ciag315-B24","author":"Mathad"},{"key":"2026100713433843900_ciag315-B25","author":"Mathad"},{"key":"2026100713433843900_ciag315-B26","doi-asserted-by":"crossref","first-page":"1367","DOI":"10.7326\/M20-7577","article-title":"Annual tuberculosis preventive therapy for persons with HIV infection : a randomized trial","volume":"174","author":"Churchyard","year":"2021","journal-title":"Ann Intern Med"},{"key":"2026100713433843900_ciag315-B27","author":"U.S. Department of Health and Human Services National Institute of Allergy and Infectious Diseases Division of AIDS"},{"key":"2026100713433843900_ciag315-B28","volume-title":"Birth defects surveillance: a manual for programme managers","author":"World Health Organization","year":"2020","edition":"2nd ed"},{"key":"2026100713433843900_ciag315-B29","volume-title":"Preterm birth [fact sheet]","author":"World Health Organization","year":"2024"},{"key":"2026100713433843900_ciag315-B30","doi-asserted-by":"crossref","first-page":"e1297-e308","DOI":"10.1016\/S2214-109X(18)30385-1","article-title":"Population-based rates, timing, and causes of maternal deaths, stillbirths, and neonatal deaths in south Asia and sub-Saharan Africa: a multi-country prospective cohort study","volume":"6","author":"Ahmed","year":"2018","journal-title":"Lancet Global Health"},{"key":"2026100713433843900_ciag315-B31","doi-asserted-by":"crossref","first-page":"459","DOI":"10.1186\/s12889-025-21497-x","article-title":"Effect of maternal HIV infection on birth outcomes among HIV positive women in sub Saharan Africa: a systematic review and meta-analysis","volume":"25","author":"Asferie","year":"2025","journal-title":"BMC Public Health"},{"key":"2026100713433843900_ciag315-B32","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1038\/s43856-023-00331-8","article-title":"Adverse perinatal outcomes attributable to HIV in sub-Saharan Africa from 1990 to 2020: systematic review and meta-analyses","volume":"3","author":"Murray","year":"2023","journal-title":"Commun Med (Lond)"}],"container-title":["Clinical Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/cid\/advance-article-pdf\/doi\/10.1093\/cid\/ciag315\/68299520\/ciag315.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/83\/3\/e550\/68299520\/ciag315.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/cid\/article-pdf\/83\/3\/e550\/68299520\/ciag315.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T17:43:47Z","timestamp":1791395027000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/cid\/article\/83\/3\/e550\/8679368"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,17]]},"references-count":32,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2026,5,17]]},"published-print":{"date-parts":[[2026,10,7]]}},"URL":"https:\/\/doi.org\/10.1093\/cid\/ciag315","relation":{},"ISSN":["1058-4838","1537-6591"],"issn-type":[{"value":"1058-4838","type":"print"},{"value":"1537-6591","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,9,15]]},"published":{"date-parts":[[2026,5,17]]}}}