title: An HIV Preexposure Prophylaxis Demonstration Project and Safety Study for Young MSM.
abstract: Young men who have sex with men (YMSM) are a key population for implementation of preexposure prophylaxis (PrEP) interventions. This open-label study examined adherence to PrEP and assessed sexual behavior among a diverse sample of YMSM in 12 US cities.
  
  
  
  Eligible participants were 18- to 22-year-old HIV-uninfected MSM who reported HIV transmission risk behavior in the previous 6 months. Participants were provided daily tenofovir disoproxil fumarate/emtricitabine (Truvada). Study visits occurred at baseline, monthly through week 12, and then quarterly through week 48. Dried blood spots were serially collected for the quantification of tenofovir diphosphate (TFV-DP).
  
  
  
  Between March and September 2013, 2186 individuals were approached and 400 were found to be preliminarily eligible. Of those 400, 277 were scheduled for an in-person screening visit and 200 were enrolled (mean age = 20.2; 54.5% black, 26.5% Latino). Diagnosis of sexually transmitted infections, including urethral and rectal chlamydial/gonococcal infection and syphilis, at baseline was 22% and remained high across visits. At week 4, 56% of participants had TFV-DP levels consistent with ≥4 pills per week. By week 48, 34% of participants had TFV-DP levels consistent with ≥4 pills per week, with a noticeable drop-off occurring at week 24. Four HIV seroconversions occurred on study (3.29/100 person-years). Condomless sex was reported by >80% of participants, and condomless anal sex with last partner was associated with higher TFV-DP levels.
  
  
  
  Acceptability of PrEP was high, and most participants achieved protective drug levels during monthly visits. As visit frequency decreased, so did adherence. YMSM in the United States may need PrEP access in youth-friendly settings with tailored adherence support and potentially augmented visit schedules.
authors.affiliation: *John Stroger Hospital of Cook County, Chicago, IL; †New York University Medical Center, New York, NY; ‡University of California Los Angeles, Los Angeles, CA; §NICHD/MPIDB, Bethesda, MD; ‖Westat, Rockville, MD; ¶University of California San Francisco, San Francisco, CA; #Indiana University, Indianapolis, IN; **Alpert Medical School of Brown University and Lifespan Hospital System, Providence, RI; ††Fenway Health, Boston, MA; ‡‡University of Colorado, Denver, CO; §§Gilead Sciences, Foster City, CA; and ‖‖University of Alabama at Birmingham, Birmingham, AL.
authors.forename: Sybil G
authors.initials: SG
authors.lastname: Hosek
authors.forename: Bret
authors.initials: B
authors.lastname: Rudy
authors.forename: Raphael
authors.initials: R
authors.lastname: Landovitz
authors.forename: Bill
authors.initials: B
authors.lastname: Kapogiannis
authors.forename: George
authors.initials: G
authors.lastname: Siberry
authors.forename: Brandy
authors.initials: B
authors.lastname: Rutledge
authors.forename: Nancy
authors.initials: N
authors.lastname: Liu
authors.forename: Jennifer
authors.initials: J
authors.lastname: Brothers
authors.forename: Kathleen
authors.initials: K
authors.lastname: Mulligan
authors.forename: Gregory
authors.initials: G
authors.lastname: Zimet
authors.forename: Michelle
authors.initials: M
authors.lastname: Lally
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Mayer
authors.forename: Peter
authors.initials: P
authors.lastname: Anderson
authors.forename: Jennifer
authors.initials: J
authors.lastname: Kiser
authors.forename: James F
authors.initials: JF
authors.lastname: Rooney
authors.forename: Craig M
authors.initials: CM
authors.lastname: Wilson
mesh_terms: D000293:Adolescent; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002947:Cities; D018562:Disease Transmission, Infectious / Q000517:prevention & control*; D015658:HIV Infections / Q000517:prevention & control*; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D055118:Medication Adherence; D010342:Patient Acceptance of Health Care; D065129:Pre-Exposure Prophylaxis / Q000706:statistics & numerical data*; D014481:United States; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents