Successful Implementation of HIV Preexposure Prophylaxis: Lessons Learned From Three Clinical Settings
- 1.3k Downloads
The past 3 years have marked a transition from research establishing the safety and efficacy of HIV preexposure prophylaxis (PrEP) to questions about how to optimize its implementation. Until recently, PrEP was primarily offered as part of randomized controlled trials or open-label studies. These studies highlighted the key components of PrEP delivery, including regular testing for HIV and other sexually transmitted infections (STIs), adherence and risk-reduction support, and monitoring for renal toxicity. PrEP is now increasingly provided in routine clinical settings. This review summarizes models for PrEP implementation from screening through initiation and follow-up, focusing on the strengths and weaknesses of three delivery systems: a health maintenance organization, an STI clinic, and a primary care practice. These early implementation experiences demonstrate that PrEP can be successfully delivered across a variety of settings and highlight strategies to streamline PrEP delivery in clinical practice.
KeywordsPreexposure prophylaxis (PrEP) PrEP delivery PrEP implementation Human immunodeficiency virus (HIV) Implementation Sexually transmitted infections Delivery of health care Science of prevention Review
This work was supported by a Kaiser Permanente Northern California Community Benefit research grant to Dr. Julia L. Marcus.
Compliance with Ethical Standards
Conflict of Interest
Julia L. Marcus reports grants from Merck.
Albert Y. Liu reports non-financial support from Gilead and personal fees from IAS-USA.
Stephanie E. Cohen reports non-financial support from Gilead.
Jonathan E. Volk, Jess Pinder, C. Bradley Hare, and Oliver Bacon declare they have no conflict of interest.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance
- 4.Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, et al. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2013;381:2083–90.CrossRefPubMedGoogle Scholar
- 5.Preexposure Prophylaxis for the Prevention of HIV Infection in the United States - 2014: A Clinical Practice Guideline. 2014. Available at: http://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf. Accessed December 30, 2014.
- 6.•Grant RM, Anderson PL, McMahan V, Liu A, Amico KR, Mehrotra M, et al. Uptake of pre-exposure prophylaxis, sexual practices, and HIV incidence in men and transgender women who have sex with men: a cohort study. Lancet. 2014;14:820–9. Uptake of PrEP was high in this open-label extension of randomized PrEP trials, particularly among individuals reporting condomless receptive anal intercourse. PrEP efficacy was highly correlated with drug concentrations in dried blood spots, and there were no HIV seroconversions in participants who had drug levels consistent with having taken four or more doses of TDF/FTC per week.CrossRefPubMedGoogle Scholar
- 7.•Cohen SE, Vittinghoff E, Bacon O, Doblecki-Lewis S, Postle BS, Feaster DJ, et al. High interest in preexposure prophylaxis among men who have sex with men at risk for HIV infection: baseline data from the US PrEP Demonstration Project. J Acquir Immune Defic Syndr. 2015;68:439–48. In this report of baseline data from an open-label demonstration project in STI clinics and a community health center in three US cities (The US Demonstration Project), uptake of PrEP was high in a diverse population of MSM at risk for HIV infection and did not vary by race/ethnicity, age, or education level.CrossRefPubMedPubMedCentralGoogle Scholar
- 8.Hosek S, Rudy B, Landovitz R, Kapogiannis B, Siberry G, Liu N, et al. An HIV pre-exposure prophylaxis (PrEP) demonstration project and safety study for young men who have sex with men in the United States (ATN 110). In: 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention. Vancouver; 2015.Google Scholar
- 10.Grant RM, Liu A, Hecht J, Buchbinder SP, Weber S, Crouch P, et al. Scale-up of preexposure prophylaxis in San Francisco to impact HIV incidence. In: 22nd Conference on Retroviruses and Opportunistic Infections. Seattle; 2015.Google Scholar
- 11.Mayer K, Krakower D, Levine K, Grasso C, Gelman M. Significant increases in HIV pre-exposure prophylaxis (PrEP) uptake in Boston, a Boston Community Health Center in 2014: who are the recent users? In: 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention. Vancouver; 2015.Google Scholar
- 12.Hood J, Buskin S, Barash E, Katz D, Dombrowski J, Golden M. Awareness and utilization of HIV prevention innovations among men who have sex with men in Seattle. In: 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention. Vancouver; 2015.Google Scholar
- 13.•Liu AY, Cohen SE, Vittinghoff E, Anderson PL, Doblecki-Lewis S, Bacon O, et al. Preexposure prophylaxis for HIV infection integrated with municipal- and community-based sexual health services. JAMA Intern Med. 2016;176(1):1–11. In this report from the US Demonstration Project, adherence, as measured in dried blood spots, was higher than that observed in clinical trials of PrEP and was correlated with higher self-reported risk behaviors. HIV incidence was extremely low, despite a high incidence of STIs.Google Scholar
- 20.Liu A, Stojanovski K, Lester RT, Amico KR, McMahan V, Goicochea P, et al. Developing and implementing a mobile health (mHealth) adherence support system for HIV-uninfected men who have sex with men (MSM) taking pre-exposure prophylaxis (PrEP): the iText Study. In: 8th International Conference on HIV Treatment and Prevention. Miami; 2014.Google Scholar
- 21.HPTN 073. Pre-exposure prophylaxis (PrEP) initiation and adherence among black men who have sex with men (BMSM) in three U.S. cities. Available at: http://www.hptn.org/research_studies/hptn073.asp. Accessed September 3, 2015.
- 25.Mulligan K, Glidden DV, Anderson PL, Liu A, McMahan V, Gonzales P, et al. Effects of emtricitabine/tenofovir on bone mineral density in HIV-negative persons in a randomized, double-blind, placebo-controlled trial. Clin Infect Dis. 2015;61(4):572–80.Google Scholar
- 27.Mugwanya KK, Wyatt C, Celum C, Donnell D, Mugo NR, Tappero J, et al. Changes in glomerular kidney function among HIV-1-uninfected men and women receiving emtricitabine-tenofovir disoproxil fumarate preexposure prophylaxis: a randomized clinical trial. JAMA Int Med. 2015;175:246–54.CrossRefGoogle Scholar
- 31.Liu AY, Vittinghoff E, Chillag K, Mayer K, Thompson M, Grohskopf L, et al. Sexual risk behavior among HIV-uninfected men who have sex with men (MSM) participating in a tenofovir pre-exposure prophylaxis (PrEP) randomized trial in the United States. J Acquir Immune Defic Syndr. 2013;64(1):87-94.Google Scholar
- 32.Elsesser S, Biello K, Taylor S, Tomassilli J, Safren SA, Mayer K. Absence of sexual behavioral disinhibition in a PrEP adherence trial: considerations for medical providers who prescribe PrEP for men who have sex with men (MSM). In: 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention. Vancouver; 2015.Google Scholar
- 33.Milam J, Jain S, Moore D, Daar E, Dube M, Young J, et al. Risk compensation among men who have sex with men (MSM) in Southern California following the initiation of pre-exposure prophylaxis (PrEP). In: 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention. Vancouver; 2015.Google Scholar
- 35.••McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, et al. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet. 2016;387(10013):53-60. In this pragmatic open-label trial in the UK, participants at 13 sexual health clinics were randomized to receive immediate or deferred PrEP. HIV incidence was high in the deferred arm, with an 86 % risk reduction in the immediate arm. There was no evidence of an increase in STI incidence.Google Scholar
- 36.•Volk JE, Marcus JL, Phengrasamy T, Blechinger D, Nguyen DP, Follansbee S, et al. No new HIV infections with increasing use of HIV preexposure prophylaxis in a clinical practice setting. Clin Infect Dis. 2015;61(10):1601–3. This real-world evaluation of PrEP in a large clinical practice setting found No new HIV infections in a growing population of PrEP users, despite high STI incidence and a reported decrease in condom use in a subset of patients.Google Scholar
- 37.Volk JE, Marcus JL, Phengrasamy T, Hare CB. Incident hepatitis C virus infections among users of HIV preexposure prophylaxis in a clinical practice setting. Clin Infect Dis. 2015;60(11):1728–9.Google Scholar
- 38.California PrEP Provider Directory. HIVE, San Francisco General Hospital. Available at: http://www.pleaseprepme.org. Accessed July 14, 2015.
- 39.PrEP local medical services. Project Inform, San Francisco, CA. Available at: http://www.projectinform.org/pdf/prepprograms.pdf. Accessed July 14, 2015.
- 40.van der Helm JJ, Hoebe CJ, van Rooijen MS, Brouwers EE, Fennema HS, Thiesbrummel HF, et al. High performance and acceptability of self-collected rectal swabs for diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae in men who have sex with men and women. Sex Transm Dis. 2009;36:493–7.CrossRefPubMedGoogle Scholar
- 41.Freeman AH, Bernstein KT, Kohn RP, Philip S, Rauch LM, Klausner JD. Evaluation of self-collected versus clinician-collected swabs for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae pharyngeal infection among men who have sex with men. Sex Transm Dis. 2011;38:1036–9.CrossRefPubMedGoogle Scholar
- 42.Gilead Sciences, Inc. Truvada for PrEP Medication Assistance Program. Available at: http://www.gilead.com/responsibility/us-patient-access/truvada%20for%20prep%20medication%20assistance%20program. Accessed July 9, 2015.
- 48.San Francisco Department of Public Health. San Francisco Sexually Transmitted Disease Annual Summary, 2013. San Francisco Department of Public Health, San Francisco, California. December 2014. Available at: https://www.sfdph.org/dph/files/reports/StudiesData/STD/SFSTDAnnlSum2013.pdf. Accessed July 27, 2015.
- 51.Pre-Exposure Prophylaxis Drug Assistance Program (PrEP DAP). Washington State Department of Health. Available at: http://www.doh.wa.gov/YouandYourFamily/IllnessandDisease/HIVAIDS/HIVCareClientServices/PrEPDAP. Accessed August 3, 2015.
- 52.Pre-Exposure Prophylaxis Assistance Program (PrEP-AP). New York State Department of Health. Available at: https://www.health.ny.gov/diseases/aids/general/resources/adap/prep.htm. Accessed August 3, 2015.