title: Implementation science of pre-exposure prophylaxis: preparing for public use.
abstract: As efficacy trials of antiretroviral pre-exposure prophylaxis (PrEP) continue, a growing literature has begun anticipating the potential challenges of implementing PrEP for HIV prevention. These efforts coincide with a shift toward combination interventions for preventing HIV, which integrate biomedical, behavioral, and structural components. The optimal implementation of PrEP would exemplify this combination model, incorporating not only PrEP drugs, but also HIV testing, safety screening, behavioral interventions addressing adherence and risk behavior, and long-term monitoring. Efforts to plan for PrEP implementation therefore present an opportunity to advance the science of implementation and delivery in HIV prevention, in order to better address the challenges of scaling up combination approaches. We review the published and unpublished literature on PrEP implementation, organizing themes into five categories: scientific groundwork, regulatory and policy groundwork, stakeholder and infrastructure groundwork, delivery, and long-term monitoring. The lessons from PrEP planning can benefit the scale-up of future combination interventions.
authors.affiliation: Department of Community Health, Brown University, Providence, RI 02912, USA. kristen_underhill@brown.edu
authors.forename: Kristen
authors.initials: K
authors.lastname: Underhill
authors.forename: Don
authors.initials: D
authors.lastname: Operario
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Mimiaga
authors.forename: Margie R
authors.initials: MR
authors.lastname: Skeer
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Mayer
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use*; D001294:Attitude to Health; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence; D033161:Government Regulation; D017408:Guidelines as Topic; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control*; D058015:Health Communication; D007722:Health Knowledge, Attitudes, Practice; D006285:Health Planning / Q000331:legislation & jurisprudence; D006287:Health Planning Guidelines; D006291:Health Policy; D006293:Health Promotion; D006301:Health Services Needs and Demand; D006801:Humans; D010349:Patient Compliance; D040242:Risk Reduction Behavior; D012309:Risk-Taking; D012725:Sexual Behavior
chemical_list: D019380:Anti-HIV Agents
references.citation: JAMA. 2008 Aug 27;300(8):945-51
references.pmid: 18728268
references.citation: J Acquir Immune Defic Syndr. 2010 Sep;55(1):8-13
references.pmid: 21423876
references.citation: Cochrane Database Syst Rev. 2010 Jul 07;(7):CD006493
references.pmid: 20614446
references.citation: PLoS One. 2010 Mar 10;5(3):e9626
references.pmid: 20224782
references.citation: J Womens Health (Larchmt). 2010 Apr;19(4):791-8
references.pmid: 20210540
references.citation: Science. 2005 Aug 12;309(5737):1002-5
references.pmid: 16099959
references.citation: Clin Infect Dis. 2007 Dec 15;45 Suppl 4:S255-60
references.pmid: 18190296
references.citation: Curr HIV/AIDS Rep. 2009 Nov;6(4):217-23
references.pmid: 19849965
references.citation: PLoS One. 2008 May 07;3(5):e2077
references.pmid: 18461185
references.citation: J Acquir Immune Defic Syndr. 2008 Feb 1;47(2):241-7
references.pmid: 18340656
references.citation: AIDS. 2008 Sep 12;22(14):1829-39
references.pmid: 18753932
references.citation: PLoS Clin Trials. 2007 May 25;2(5):e27
references.pmid: 17525796
references.citation: AIDS Care. 2008 Jan;20(1):106-15
references.pmid: 18278621
references.citation: Lancet. 2008 Aug 23;372(9639):669-84
references.pmid: 18687459
references.citation: AIDS. 2008 Jul;22 Suppl 1:S75-85
references.pmid: 18664958
references.citation: N Engl J Med. 2008 Apr 10;358(15):1543-5
references.pmid: 18403764
references.citation: PLoS One. 2007 Sep 19;2(9):e875
references.pmid: 17878928
references.citation: Public Health Rep. 2007;122 Suppl 1:32-8
references.pmid: 17354525
references.citation: Lancet. 2007 Jul 7;370(9581):89-93
references.pmid: 17617276
references.citation: Clin Infect Dis. 2010 May 15;50 Suppl 3:S96-101
references.pmid: 20397962
references.citation: AIDS Patient Care STDS. 2010 Jul;24(7):409-13
references.pmid: 20578906
references.citation: Clin Infect Dis. 2009 Mar 15;48(6):806-15
references.pmid: 19193111
references.citation: J Acquir Immune Defic Syndr. 2009 Jan 1;50(1):77-83
references.pmid: 19295337
references.citation: Ann Intern Med. 2007 Apr 17;146(8):591-601
references.pmid: 17438318
references.citation: J Acquir Immune Defic Syndr. 2009 Dec;52 Suppl 2:S87-96
references.pmid: 19901631
references.citation: Lancet. 2008 Aug 16;372(9638):585-99
references.pmid: 18687456
references.citation: Sex Transm Dis. 2008 Dec;35(12):1002-8
references.pmid: 19051397
references.citation: J Int Assoc Physicians AIDS Care (Chic). 2010 Jan-Feb;9(1):23-9
references.pmid: 20071594
references.citation: J Acquir Immune Defic Syndr. 2006 Nov 1;43(3):376-7
references.pmid: 17079995
references.citation: J Acquir Immune Defic Syndr. 2000 Dec 15;25 Suppl 2:S94-6
references.pmid: 11256739
references.citation: Annu Rev Clin Psychol. 2009;5:143-67
references.pmid: 19327028
references.citation: JAMA. 2006 Aug 16;296(7):863-5
references.pmid: 16905792
references.citation: Science. 2010 Sep 3;329(5996):1168-74
references.pmid: 20643915
references.citation: J Acquir Immune Defic Syndr. 2007 Nov 1;46(3):378-80
references.pmid: 18090305
references.citation: Lancet. 2007 Jul 7;370(9581):10-1
references.pmid: 17617254
references.citation: BMJ. 2005 Dec 10;331(7529):1403-6
references.pmid: 16339256