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Project Gel

Status
Completed
Phase
I
Principal Investigator(s)
Ian McGowan
Objective

1) To find out more about the sexual health of young men who have sex with men, including how common sexually transmitted infections are among this group of men. 2) To find out how young men feel about using a gel in their rectum prior to anal sex and whether or not they actually use it prior to anal sex.

Prevention Option(s)
Microbicides
Study Design
Controlled
Placebo
Randomized
Double-blind
Arms and Assigned Interventions
Description
Receive a single dose of gel (4 mL). If not adverse events, will begin self-administration of once-daily doses of gel for 7 days.
Mode of Delivery
Gel
Products
1% tenofovir gel
ARMs
Experimental
Description
Receive a single dose of gel (4 mL). If not adverse events, will begin self-administration of once-daily doses of gel for 7 days.
Mode of Delivery
Gel
Products
HEC gel
ARMs
Placebo Comparator
Trial Sponsors
CONRAD, NICHD, NIMH
March 2014
March 2014
18
Years
30
Years
Population
MSM
Sites

Fenway Community Health Clinical Research Site (FCHCRS)

Boston, Massachusetts
United States of America

University of Pittsburgh School of Medicine, Center for Family Planning Research

Pittsburgh, Pennsylvania
United States of America

University of Puerto Rico Medical Sciences Campus

San Juan
Puerto Rico