Rectal Microbicide Acceptability, Tolerability and Adherence

NACompletedINTERVENTIONAL
Enrollment

217

Participants

Timeline

Start Date

April 26, 2019

Primary Completion Date

July 27, 2020

Study Completion Date

July 27, 2020

Conditions
HIV Prevention
Interventions
BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Trial Locations (7)

2038

Wits Reproductive Health and HIV Institute Clinical Research Site, Johannesburg

15088

San Miguel Clinical Research Site, San Miguel

15216

University of Pittsburgh Clinical Research Site, Pittsburgh

35294

Alabama Clinical Research Site, Birmingham

50202

Chiang Mai University HIV Prevention Clinical Research Site, Chiang Mai

94102

Bridge HIV Clinical Research Site, San Francisco

Unknown

Blantyre Clinical Research Site, Blantyre

Sponsors
All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Microbicide Trials Network

NETWORK