The Real World of STD Prevention
HIV preexposure prophylaxis (PrEP) is a central component of the US National HIV/AIDS strategy.1 In 2014, the US Public Health Service issued clinical practice guidelines defining how medical providers should prescribe and monitor patients on PrEP.2 Those guidelines include recommendations defining high-risk patients for whom medical providers should consider prescribing PrEP. Among men who have sex with men (MSM), the guidelines specifically suggest that providers consider PrEP in patients who have condomless anal sex outside of long-term mutually monogamous relationships and MSM with a history of any sexually transmitted infection in the prior 6 months.2 The Infectious Diseases Society of America recommends that medical providers consider PrEP in patients with an estimated annual risk of HIV acquisition of 2% of more per year, whereas the World Health Organization recommends consideration of PrEP in populations with an annual risk of HIV of 3% or more.3,4
Existing guidelines are helpful as a starting point in defining candidate populations for PrEP. However, Infectious Diseases Society of America and World Health Organization guidelines require medical providers to know the approximate incidence of HIV in different populations of patients, information that clinicians often lack. Meanwhile, US Public Health Service Guidelines recommend that medical providers consider prescribing PrEP in a diverse population with widely variable levels of HIV risk. In large measure, the lack of specificity in existing guidelines reflects the heterogeneity of the HIV epidemic in the US and globally.
In 2015, Public Health–Seattle & King County (PHSKC) and the Washington State Department of Health developed local PrEP implementation guidelines to help medical providers know when to recommend or discuss PrEP with patients. In developing these guidelines, we were particularly interested in data that related risk factors ascertainable during a clinical encounter to the risk of future HIV acquisition.5–9 We sought to define a high-risk population in which local data suggest that the annual risk of HIV infection is 3% or more, and to advise providers to recommend PrEP to those patients. We also defined a larger population of patients at elevated risk for HIV compared with the general population, but with an estimated annual risk of HIV acquisition less than 3%, with whom medical providers should discuss PrEP. In both instances, we purposefully decided not to advise providers to “consider” PrEP because we wanted to promote a decision-making process that included both providers and patients. In some instances, we did not have data to guide our decision making and did not think that good quality local data would be available in the foreseeable future. In particular, we did not have data on the risk of HIV acquisition in transgender populations or among commercial sex workers. In those instances, we elected to issue guidelines based on expert opinion rather than exclude these populations from the guidelines.
We developed the guidelines as a collaboration between state and local departments of health, local medical providers, social service providers, and populations that might be affected by PrEP. PHSKC and Washington State Department of Health convened a meeting of local King County medical providers with experience providing PrEP or treating HIV to gather suggestions related to draft guidelines. We also sought input from a statewide HIV advisory group that includes medical and social service providers as well as persons living with HIV and persons from populations at elevated risk for HIV infection. The final guidelines reflect input from these groups.
This Washington State PrEP Drug Assistance Program has been instrumental in the scale-up of PrEP delivery in King County and Washington State. The Program provides financial assistance to HIV-negative persons who are in serodiscordant relationships or MSM who meet the criteria for high risk of HIV acquisition based on a previous study that included local data.5,10 Our PrEP implementation guidelines differ somewhat from the criteria for PrEP DAP in that they specifically prioritize MSM with syphilis and rectal gonorrhea, recommend PrEP for some populations based on expert opinion, and include 2 tiers of high-risk persons. However, almost all persons prioritized for PrEP in the implementation guidelines would be eligible for PrEP DAP.
The guidelines are presented below. We believe that these guidelines are applicable to parts of the US with HIV epidemics similar to ours in WA State and King County, where HIV is highly concentrated among MSM and incidence is declining. We do not believe that these guidelines are applicable to all areas of the US In particular, we do not think our guidelines are applicable to much of the southern US, where the HIV epidemic is more heterogeneous and where an explosive epidemic of HIV among young, black MSM may require much broader PrEP recommendations.11 Other health departments should consider developing local or regional guidelines that address their specific epidemiologic circumstances. Also, we anticipate updating our guidelines as new data better define risks associated with HIV acquisition. Updated guidelines will be maintained on the PHSKC Web site (http://www.kingcounty.gov/healthservices/health/communicable/hiv.aspx).
1. White House Office of National AIDS policy. National HIV/AIDS Strategy for the United States: Updated for 2020. 2015.
2. US Public Health Service. Preexposure Prophylaxis for the Prevention of HIV Infection in the United States 2014 A clinical practice guidelines. 2014.
3. World Health Organization. Guideline on When to Start Antiretroviral Therapy and Preexposure Prophylaxis for HIV. Switzerland: World Health Organization; 2015.
4. Marrazzo JM, del Rio C, Holtgrave DR, et al. HIV prevention in clinical care settings: 2014 recommendations of the International Antiviral Society–USA Panel. JAMA 2014; 312: 390–409.
5. Menza TW, Hughes JP, Celum CL, et al. Prediction of HIV acquisition among men who have sex with men. Sex Transm Dis 2009; 36: 547–555.
6. Pathela P, Braunstein SL, Blank S, et al. HIV incidence among men with and those without sexually transmitted rectal infections: Estimates from matching against an HIV case registry. Clin Infect Dis 2013; 57: 1203–1209.
7. Pathela P, Braunstein SL, Blank S, et al. The high risk of an HIV diagnosis following a diagnosis of syphilis: A population-level analysis of New York City men. Clin Infect Dis 2015; 61: 281–287.
8. Katz DA DJ, Bell TR, Kerani RP. Golden MR HIV incidence among men who have sex with men following diagnosis with sexually transmitted infections. Paper presented at: 2014 STD Prevention Conference. Atlanta, GA: 2014.
9. Smith DK, Pals SL, Herbst JH, et al. Development of a clinical screening index predictive of incident HIV infection among men who have sex with men in the United States. J Acquir Immune Defic Syndr 2012; 60: 421–427.
10. Washington State Department of Health. Pre-Exposure Prophylaxis Drug Assistance Program (PrEP DAP). 2015. Accessed November 11, 2015.
11. Sullivan PS, Rosenberg ES, Sanchez TH, et al. Explaining racial disparities in HIV incidence in black and white men who have sex with men in Atlanta, GA: A prospective observational cohort study. Ann Epidemiol 2015; 25: 445–454.
Identifying persons in whom to consider PrEP:
- Public Health recommends that medical providers routinely ask all adolescent and adult patients if they have sex with men, women or both men and women.
- Providers should ensure that all of their patients who are MSM or transgender persons who have sex with men know about PrEP.
Guidelines for initiating PrEP in HIV-uninfected persons:
Medical providers should recommend that patients initiate PrEP if they meet the following criteria:
- MSM or transgender persons who have sex with men if the patient has any of the following risks:
Persons in ongoing sexual relationships with an HIV-infected person who is not on antiretroviral therapy (ART) OR is on ART but is not virologically suppressed OR who is within 6 months of initiating ART.
- Diagnosis of rectal gonorrhea or early syphilis in the prior 12 months
- Methamphetamine or popper (amyl nitrite) use in the prior 12 months
- History of providing sex for money or drugs in the prior 12 months
Medical providers should discuss initiating PrEP with patients who have any of the following risks:
- MSM and transgender persons who have sex with men if the patient has either of the following risks:
Persons in HIV-serodiscordant relationships in which the female partner is trying to get pregnant
Persons in ongoing sexual relationships with HIV infected persons who are on antiretroviral therapy and are virologically suppressed
Women who provide sex for money or drugs
Persons who inject drugs that are not prescribed by a medical provider
Persons seeking a prescription for PrEP
Persons completing a course of antiretrovirals for non-occupational exposure to HIV infection
- Condomless anal sex with a man who is HIV negative when that sex occurs outside of a long-term, mutually monogamous relationship. Condomless receptive anal sex is associated with a higher risk of HIV acquisition than condomless insertive anal sex, and some authorities recommend PrEP to all men who have condomless receptive anal intercourse outside of a mutually monogamous relationship with an HIV-uninfected partner.
- Diagnosis of urethral gonorrhea or rectal chlamydial infection in the prior 12 months