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MTN-016

Details
Protocol Title: 
HIV Prevention Agent Pregnancy Exposure Registry
DAIDS Protocol ID: 
10737
Status: 
Enrolling

Protocol Chair(s)

Richard Beigi [1] (Protocol Co-Chair)
Samuel Kabwigu [2] (Protocol Co-Chair)

Email Groups

MTN-016 Management Group Team [3]
MTN-016 Protocol Deviations [4]
MTN-016 Protocol Team [5]
MTN-016 Site Team [6]
Sites
Pitt CRS [7]
University of Alabama at Birmingham [8]
Bothas Hill Clinical Research Site [9]
Umkomaas Clinical Research Site [10]
Chatsworth CRS [11]
Isipingo CRS [12]
Overport CRS [13]
CAPRISA Aurum CRS [14]
Wits Reproductive Health and HIV Institute (WRHI) [15]
CAPRISA eThekwini CRS [16]
Tongaat CRS [17]
Verulam CRS [18]
Soweto MTN CRS [19]
Makerere University - Johns Hopkins University Research Collaboration [20]
Seke South Clinical Research Site [21]
Spilhaus Clinical Research Site [22]
Zengeza 3 Clinic [23]
Countries
South Africa [24]
United States [25]
Uganda [26]
Zimbabwe [27]
Description
EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure)

Sponsors:

Division of AIDS, US National Institute of Allergy and Infectious Diseases

US National Institutes of Health

Study design:

Prospective observational cohort investigation of prevention agent and control group exposures in pregnancy

Other Study Info

EMBRACE is a prospective observational cohort investigation of exposures to study agents under investigation for HIV prevention. Participants will be offered enrollment in the Registry after it is determined that there has been an exposure to a study agent during pregnancy. Participants will be enrolled as early in pregnancy as possible to maximize the validity of the data. The study population will consist of female participants who are identified as becoming pregnant during microbicide or PrEP trials, or who have had planned exposures in pregnancy safety studies as well as their babies resulting from these pregnancies. This study will only enroll babies who have not yet reached their 1 year birth date.

Printer-friendly version [28]
Source URL: http://www.mtnstopshiv.org/studies/695

Links:
[1] http://www.mtnstopshiv.org/users/rbeigi
[2] http://www.mtnstopshiv.org/users/skabwigu
[3] http://www.mtnstopshiv.org/people/emailgroups/109
[4] http://www.mtnstopshiv.org/people/emailgroups/155
[5] http://www.mtnstopshiv.org/people/emailgroups/93
[6] http://www.mtnstopshiv.org/people/emailgroups/147
[7] http://www.mtnstopshiv.org/sites/51
[8] http://www.mtnstopshiv.org/sites/53
[9] http://www.mtnstopshiv.org/sites/50
[10] http://www.mtnstopshiv.org/sites/52
[11] http://www.mtnstopshiv.org/sites/76
[12] http://www.mtnstopshiv.org/sites/908
[13] http://www.mtnstopshiv.org/sites/909
[14] http://www.mtnstopshiv.org/sites/1071
[15] http://www.mtnstopshiv.org/sites/1073
[16] http://www.mtnstopshiv.org/sites/1327
[17] http://www.mtnstopshiv.org/sites/1419
[18] http://www.mtnstopshiv.org/sites/1420
[19] http://www.mtnstopshiv.org/sites/1602
[20] http://www.mtnstopshiv.org/sites/60
[21] http://www.mtnstopshiv.org/sites/73
[22] http://www.mtnstopshiv.org/sites/74
[23] http://www.mtnstopshiv.org/sites/739
[24] http://www.mtnstopshiv.org/node/3558
[25] http://www.mtnstopshiv.org/countries/united-states
[26] http://www.mtnstopshiv.org/countries/uganda
[27] http://www.mtnstopshiv.org/countries/zimbabwe
[28] http://www.mtnstopshiv.org/print/695

Media Contacts:

Lisa Rossi -- Office: +1 412 641-8940 -- Mobile: +1 412 916-3315 -- Email: rossil@upmc.edu

Clare Collins -- Office: +1 412 641-7299 -- Mobile: +1 412 770-8643 -- Email: collcx@upmc.edu