title: Preexposure Prophylaxis for HIV Infection Integrated With Municipal- and Community-Based Sexual Health Services.
abstract: OBJECTIVE
  Several randomized clinical trials have demonstrated the efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) acquisition. Little is known about adherence to the regimen, sexual practices, and overall effectiveness when PrEP is implemented in clinics that treat sexually transmitted infections (STIs) and community-based clinics serving men who have sex with men (MSM).
  
  
  OBJECTIVE
  To assess PrEP adherence, sexual behaviors, and the incidence of STIs and HIV infection in a cohort of MSM and transgender women initiating PrEP in the United States.
  
  
  METHODS
  Demonstration project conducted from October 1, 2012, through February 10, 2015 (last date of follow-up), among 557 MSM and transgender women in 2 STI clinics in San Francisco, California, and Miami, Florida, and a community health center in Washington, DC. Data were analyzed from December 18, 2014, through August 8, 2015.
  
  
  METHODS
  A combination of daily, oral tenofovir disoproxil fumarate and emtricitabine was provided free of charge for 48 weeks. All participants received HIV testing, brief client-centered counseling, and clinical monitoring.
  
  
  METHODS
  Concentrations of tenofovir diphosphate in dried blood spot samples, self-reported numbers of anal sex partners and episodes of condomless receptive anal sex, and incidence of STI and HIV acquisition.
  
  
  RESULTS
  Overall, 557 participants initiated PrEP, and 437 of these (78.5%) were retained through 48 weeks. Based on the findings from the 294 participants who underwent measurement of tenofovir diphosphate levels, 80.0% to 85.6% had protective levels (consistent with ≥4 doses/wk) at follow-up visits. African American participants (56.8% of visits; P = .003) and those from the Miami site (65.1% of visits; P < .001) were less likely to have protective levels, whereas those with stable housing (86.8%; P = .02) and those reporting at least 2 condomless anal sex partners in the past 3 months (88.6%; P = .01) were more likely to have protective levels. The mean number of anal sex partners declined during follow-up from 10.9 to 9.3, whereas the proportion engaging in condomless receptive anal sex remained stable at 65.5% to 65.6%. Overall STI incidence was high (90 per 100 person-years) but did not increase over time. Two individuals became HIV infected during follow-up (HIV incidence, 0.43 [95% CI, 0.05-1.54] infections per 100 person-years); both had tenofovir diphosphate levels consistent with fewer than 2 doses/wk at seroconversion.
  
  
  CONCLUSIONS
  The incidence of HIV acquisition was extremely low despite a high incidence of STIs in a large US PrEP demonstration project. Adherence was higher among those participants who reported more risk behaviors. Interventions that address racial and geographic disparities and housing instability may increase the impact of PrEP.
authors.affiliation: San Francisco Department of Public Health, San Francisco, California2Department of Medicine, University of California, San Francisco.
authors.forename: Albert Y
authors.initials: AY
authors.lastname: Liu
authors.affiliation: San Francisco Department of Public Health, San Francisco, California2Department of Medicine, University of California, San Francisco.
authors.forename: Stephanie E
authors.initials: SE
authors.lastname: Cohen
authors.affiliation: Department of Epidemiology and Biostatistics, University of California, San Francisco.
authors.forename: Eric
authors.initials: E
authors.lastname: Vittinghoff
authors.affiliation: Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora.
authors.forename: Peter L
authors.initials: PL
authors.lastname: Anderson
authors.affiliation: Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida.
authors.forename: Susanne
authors.initials: S
authors.lastname: Doblecki-Lewis
authors.affiliation: San Francisco Department of Public Health, San Francisco, California2Department of Medicine, University of California, San Francisco.
authors.forename: Oliver
authors.initials: O
authors.lastname: Bacon
authors.affiliation: Division of AIDS, National Institutes of Health, Bethesda, Maryland.
authors.forename: Wairimu
authors.initials: W
authors.lastname: Chege
authors.affiliation: DF/Net Research, Inc, Seattle, Washington.
authors.forename: Brian S
authors.initials: BS
authors.lastname: Postle
authors.affiliation: San Francisco Department of Public Health, San Francisco, California.
authors.forename: Tim
authors.initials: T
authors.lastname: Matheson
authors.affiliation: Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor.
authors.forename: K Rivet
authors.initials: KR
authors.lastname: Amico
authors.affiliation: Department of Medicine, University of California, San Francisco.
authors.forename: Teri
authors.initials: T
authors.lastname: Liegler
authors.affiliation: Gilead Sciences, Foster City, California.
authors.forename: M Keith
authors.initials: MK
authors.lastname: Rawlings
authors.affiliation: San Francisco Department of Public Health, San Francisco, California.
authors.forename: Nikole
authors.initials: N
authors.lastname: Trainor
authors.affiliation: San Francisco Department of Public Health, San Francisco, California.
authors.forename: Robert Wilder
authors.initials: RW
authors.lastname: Blue
authors.affiliation: Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.
authors.forename: Yannine
authors.initials: Y
authors.lastname: Estrada
authors.affiliation: Whitman-Walker Health, Washington, DC.
authors.forename: Megan E
authors.initials: ME
authors.lastname: Coleman
authors.affiliation: Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Cardenas
authors.affiliation: Division of Biostatistics, Department of Public Health Sciences, Miller School of Medicine, University of Miami, Miami, Florida.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Feaster
authors.affiliation: Gladstone Institutes, San Francisco, California14San Francisco AIDS Foundation, San Francisco, California.
authors.forename: Robert
authors.initials: R
authors.lastname: Grant
authors.affiliation: San Francisco Department of Public Health, San Francisco, California2Department of Medicine, University of California, San Francisco.
authors.forename: Susan S
authors.initials: SS
authors.lastname: Philip
authors.affiliation: Whitman-Walker Health, Washington, DC15Department of Medicine, George Washington University School of Medicine, Washington, DC.
authors.forename: Richard
authors.initials: R
authors.lastname: Elion
authors.affiliation: San Francisco Department of Public Health, San Francisco, California2Department of Medicine, University of California, San Francisco3Department of Epidemiology and Biostatistics, University of California, San Francisco.
authors.forename: Susan
authors.initials: S
authors.lastname: Buchbinder
authors.affiliation: Department of Medicine, Miller School of Medicine, University of Miami, Miami, Florida.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Kolber
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives / Q000097:blood; D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D001727:Bisexuality; D002690:Chlamydia Infections / Q000453:epidemiology; D003153:Community Health Services / Q000379:methods*; D004219:District of Columbia; D005260:Female; D005431:Florida; D006069:Gonorrhea / Q000453:epidemiology; D015658:HIV Infections / Q000517:prevention & control*; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D008875:Middle Aged; D010755:Organophosphates / Q000097:blood; D065129:Pre-Exposure Prophylaxis / Q000379:methods*; D011446:Prospective Studies; D060728:Reproductive Health; D012495:San Francisco; D012725:Sexual Behavior / Q000706:statistics & numerical data; D013587:Syphilis / Q000453:epidemiology; D000068698:Tenofovir / Q000627:therapeutic use*; D063106:Transgender Persons; D047568:Unsafe Sex / Q000706:statistics & numerical data*; D055815:Young Adult; D016903:Drug Monitoring
chemical_list: D019380:Anti-HIV Agents; D010755:Organophosphates; C583447:tenofovir diphosphate; D000068698:Tenofovir; D000225:Adenine