Participant Flow Module
The Participant Flow Module provides information about the flow of participants through each stage of the clinical trial. This includes pre-assignment details, recruitment information, and the types of units analyzed, helping researchers understand how participants move through the study.
Participant Flow Module path is as follows:
Study -> Results Section -> Participant Flow Module
Participant Flow Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
NCT ID:
NCT01618305
Pre Assignment Details:
Participants were randomized 1-to-1 to Arm A (efavirenz) or Arm B (raltegravir) with stratification by gestational age at enrollment (20 to \<28 weeks; 28 to \<31 weeks; 31 to \<34 weeks; 34 to \<37 weeks) and NRTI backbone (lamivudine/zidovudine or alternative, locally-supplied NRTI regimen), and dynamic balancing by study site.
Recruitment Details:
IMPAACT P1081 (protocol version 2.0) enrolled participants from September, 2013 through November, 2014. Enrollment under NICHD P1081 (protocol version 3.0) resumed in July 2015 and continued through February, 2018. Participants enrolled at sites in Argentina (2), Brazil (7), South Africa (1), Tanzania (1), Thailand (3), and the United States (5).
Study:
NCT01618305
Study Brief:
Results Section:
NCT01618305