title: Project Gel a Randomized Rectal Microbicide Safety and Acceptability Study in Young Men and Transgender Women.
abstract: OBJECTIVE
  The purpose of Project Gel was to determine the safety and acceptability of rectal microbicides in young men who have sex with men (MSM) and transgender women (TGW) at risk of HIV infection.
  
  
  METHODS
  MSM and TGW aged 18-30 years were enrolled at three sites; Pittsburgh, PA; Boston, MA; and San Juan, PR. Stage 1A was a cross-sectional assessment of sexual health and behavior in MSM and TGW. A subset of participants from Stage 1A were then enrolled in Stage 1B, a 12-week evaluation of the safety and acceptability of a placebo rectal gel. This was followed by the final phase of the study (Stage 2) in which a subset of participants from Stage 1B were enrolled into a Phase 1 rectal safety and acceptability evaluation of tenofovir (TFV) 1% gel.
  
  
  RESULTS
  248 participants were enrolled into Stage 1A. Participants' average age was 23.3 years. The most common sexually transmitted infection (STIs) at baseline were Herpes simplex (HSV)-2 (16.1% by serology) and rectal Chlamydia trachomatis (CT) (10.1% by NAAT). 134 participants were enrolled into Stage 1B. During the 12 week period of follow-up 2 HIV, 5 rectal CT, and 5 rectal Neisseria gonorrhea infections were detected. The majority of adverse events (AEs) were infections (N = 56) or gastrointestinal (N = 46) and were mild (69.6%) or moderate (28.0%). Of the participants who completed Stage 1B, 24 were enrolled into Stage 2 and randomized (1:1) to receive TFV or placebo gel. All participants completed Stage 2. The majority of AEs were gastrointestinal (N = 10) and of mild (87.2%) or moderate (10.3%) severity.
  
  
  CONCLUSIONS
  In this study we were able to enroll a sexually active population of young MSM and TGW who were willing to use rectal microbicides. TFV gel was safe and acceptable and should be further developed as an alternative HIV prevention intervention for this population.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01283360.
authors.affiliation: University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.|Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America.
authors.forename: Ian
authors.identifier: http://orcid.org/0000-0002-6470-8476
authors.initials: I
authors.lastname: McGowan
authors.affiliation: University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.
authors.forename: Ross D
authors.initials: RD
authors.lastname: Cranston
authors.affiliation: Fenway Institute, Fenway Health, Boston, Massachusetts, United States of America.|Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Mayer
authors.affiliation: University of Puerto Rico Medical Sciences Campus, Department of Pediatrics, Gama Project, San Juan, Puerto Rico.
authors.forename: Irma
authors.initials: I
authors.lastname: Febo
authors.affiliation: Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Duffill
authors.affiliation: Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America.
authors.forename: Aaron
authors.initials: A
authors.lastname: Siegel
authors.affiliation: Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America.
authors.forename: Jarret C
authors.initials: JC
authors.lastname: Engstrom
authors.affiliation: Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America.
authors.forename: Alexyi
authors.initials: A
authors.lastname: Nikiforov
authors.affiliation: University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.
authors.forename: Seo-Young
authors.initials: SY
authors.lastname: Park
authors.affiliation: University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America.|Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America.
authors.forename: Rhonda M
authors.initials: RM
authors.lastname: Brand
authors.affiliation: Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America.
authors.forename: Cindy
authors.initials: C
authors.lastname: Jacobson
authors.affiliation: Columbia University and NY State Psychiatric Institute, HIV Center for Clinical and Behavioral Studies, New York, New York, United States of America.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Giguere
authors.affiliation: Columbia University and NY State Psychiatric Institute, HIV Center for Clinical and Behavioral Studies, New York, New York, United States of America.
authors.forename: Curtis
authors.initials: C
authors.lastname: Dolezal
authors.affiliation: Columbia University and NY State Psychiatric Institute, HIV Center for Clinical and Behavioral Studies, New York, New York, United States of America.
authors.forename: Timothy
authors.initials: T
authors.lastname: Frasca
authors.affiliation: Columbia University and NY State Psychiatric Institute, HIV Center for Clinical and Behavioral Studies, New York, New York, United States of America.
authors.forename: Cheng-Shiun
authors.initials: CS
authors.lastname: Leu
authors.affiliation: CONRAD, Arlington, Virginia, United States of America.
authors.forename: Jill L
authors.initials: JL
authors.lastname: Schwartz
authors.affiliation: Columbia University and NY State Psychiatric Institute, HIV Center for Clinical and Behavioral Studies, New York, New York, United States of America.
authors.forename: Alex
authors.initials: A
authors.lastname: Carballo-Diéguez
mesh_terms: D000285:Administration, Rectal; D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002690:Chlamydia Infections / Q000150:complications / Q000453:epidemiology; D003430:Cross-Sectional Studies; D005260:Female; D005782:Gels; D015658:HIV Infections / Q000453:epidemiology / Q000517:prevention & control*; D006558:Herpes Genitalis / Q000150:complications / Q000453:epidemiology; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D012749:Sexually Transmitted Diseases / Q000150:complications / Q000453:epidemiology*; D000068698:Tenofovir / Q000008:administration & dosage* / Q000009:adverse effects; D063106:Transgender Persons; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D005782:Gels; D000068698:Tenofovir