217
Participants
Start Date
April 26, 2019
Primary Completion Date
July 27, 2020
Study Completion Date
July 27, 2020
Placebo rectal insert
Participants will be instructed to insert in the rectum a placebo insert prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs at all in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.
Placebo rectal suppository
Participants will be instructed to insert in the rectum a placebo suppository prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs at all in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.
Placebo rectal douche
Participants will be instructed to insert in the rectum a placebo douche (enema bottle with approximately 120 mL of clean tap water or bottled water) prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI, or if no other RAI activity occurs in that 7-day period, to take a dose in the absence of RAI. Furthermore, if no RAI activity occurs at all in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.
Wits Reproductive Health and HIV Institute Clinical Research Site, Johannesburg
San Miguel Clinical Research Site, San Miguel
University of Pittsburgh Clinical Research Site, Pittsburgh
Alabama Clinical Research Site, Birmingham
Chiang Mai University HIV Prevention Clinical Research Site, Chiang Mai
Bridge HIV Clinical Research Site, San Francisco
Blantyre Clinical Research Site, Blantyre
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Institute of Mental Health (NIMH)
NIH
Microbicide Trials Network
NETWORK