Felix G Mhlanga1,2, Lisa Noguchi3, Jennifer E Balkus4,5,6, Samuel Kabwigu7, Rachel Scheckter8, Jeanna Piper9, Heather Watts10, Colin O'Rourke4, Kristine Torjesen8, Elizabeth R Brown4,11, Sharon L Hillier12, Richard Beigi12. 1. a Department of Obstetrics and Gynaecology , College of Health Sciences, University of Zimbabwe , Harare , Zimbabwe. 2. b UZ-UCSF Women's Collaborative Research Programme , Harare , Zimbabwe. 3. c Department of Epidemiology , Johns Hopkins University , Baltimore , MD , USA. 4. d Vaccine and Infectious Disease Division , Fred Hutchinson Cancer Research Center , Seattle , WA , USA. 5. e Department of Epidemiology , University of Washington , Seattle , WA , USA. 6. f Department of Global Health , University of Washington , Seattle , WA , USA. 7. g Department of Obstetrics and Gynaecology , Makerere University - Johns Hopkins University , Uganda. 8. h FHI 360 , Durham , NC , USA. 9. i Division of AIDS , National Institutes of Health (NIH) , Rockville , MD , USA. 10. j US Department of State , Washington , DC , USA. 11. k Department of Biostatistics , University of Washington , Seattle , WA , USA. 12. l Department of OB/GYN/RS , Magee-Womens Hospital of UPMC , Pittsburgh , PA , USA.
Abstract
BACKGROUND: Safety 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. METHODS: 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. CONCLUSION: 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.
BACKGROUND: Safety 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. METHODS: 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. CONCLUSION: 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.
Authors: Quarraisha Abdool Karim; Salim S Abdool Karim; Janet A Frohlich; Anneke C Grobler; Cheryl Baxter; Leila E Mansoor; Ayesha B M Kharsany; Sengeziwe Sibeko; Koleka P Mlisana; Zaheen Omar; Tanuja N Gengiah; Silvia Maarschalk; Natasha Arulappan; Mukelisiwe Mlotshwa; Lynn Morris; Douglas Taylor Journal: Science Date: 2010-07-19 Impact factor: 47.728
Authors: Jared M Baeten; Thesla Palanee-Phillips; Elizabeth R Brown; Katie Schwartz; Lydia E Soto-Torres; Vaneshree Govender; Nyaradzo M Mgodi; Flavia Matovu Kiweewa; Gonasagrie Nair; Felix Mhlanga; Samantha Siva; Linda-Gail Bekker; Nitesha Jeenarain; Zakir Gaffoor; Francis Martinson; Bonus Makanani; Arendevi Pather; Logashvari Naidoo; Marla Husnik; Barbra A Richardson; Urvi M Parikh; John W Mellors; Mark A Marzinke; Craig W Hendrix; Ariane van der Straten; Gita Ramjee; Zvavahera M Chirenje; Clemensia Nakabiito; Taha E Taha; Judith Jones; Ashley Mayo; Rachel Scheckter; Jennifer Berthiaume; Edward Livant; Cindy Jacobson; Patrick Ndase; Rhonda White; Karen Patterson; Donna Germuga; Beth Galaska; Katherine Bunge; Devika Singh; Daniel W Szydlo; Elizabeth T Montgomery; Barbara S Mensch; Kristine Torjesen; Cynthia I Grossman; Nahida Chakhtoura; Annalene Nel; Zeda Rosenberg; Ian McGowan; Sharon Hillier Journal: N Engl J Med Date: 2016-02-22 Impact factor: 91.245
Authors: S Palmer; V Boltz; N Martinson; F Maldarelli; G Gray; J McIntyre; J Mellors; L Morris; J Coffin Journal: Proc Natl Acad Sci U S A Date: 2006-04-25 Impact factor: 11.205
Authors: Paige L Williams; Marilyn J Crain; Cenk Yildirim; Rohan Hazra; Russell B Van Dyke; Kenneth Rich; Jennifer S Read; Emma Stuard; Mobeen Rathore; Hermann A Mendez; D Heather Watts Journal: JAMA Pediatr Date: 2015-01 Impact factor: 16.193
Authors: Jeanne M Marrazzo; Gita Ramjee; Barbra A Richardson; Kailazarid Gomez; Nyaradzo Mgodi; Gonasagrie Nair; Thesla Palanee; Clemensia Nakabiito; Ariane van der Straten; Lisa Noguchi; Craig W Hendrix; James Y Dai; Shayhana Ganesh; Baningi Mkhize; Marthinette Taljaard; Urvi M Parikh; Jeanna Piper; Benoît Mâsse; Cynthia Grossman; James Rooney; Jill L Schwartz; Heather Watts; Mark A Marzinke; Sharon L Hillier; Ian M McGowan; Z Mike Chirenje Journal: N Engl J Med Date: 2015-02-05 Impact factor: 91.245
Authors: Richard H Beigi; Lisa M Noguchi; Elizabeth Montgomery; Joseph Biggio; Craig W Hendrix; Mark A Marzinke; James Y Dai; Jason Pan; Ratiya Kunjara Na Ayudhya; Jill L Schwartz; Karen Isaacs; Jeanna M Piper; D Heather Watts Journal: J Int AIDS Soc Date: 2016-09-21 Impact factor: 5.396
Authors: Elizabeth T Montgomery; Sarah T Roberts; Annalene Nel; Mariette Malherbe; Kristine Torjesen; Katherine Bunge; Devika Singh; Jared M Baeten; Jeanne Marrazzo; Z Mike Chirenje; Samuel Kabwigu; Richard Beigi; Sharon A Riddler; Zakir Gaffour; Krishnaveni Reddy; Leila E Mansoor; Gonasagrie Nair; Kusbashni Woeber; Jayajothi Moodley; Nitesha Jeenarain; Samantha Siva; Logashvari Naidoo; Vaneshree Govender; Thesla Palanee-Phillips Journal: AIDS Date: 2019-11-15 Impact factor: 4.177