Dear U.S. Preventive Services Task Force Members—

Thank you for the opportunity to submit comments regarding the U.S. Preventive Services Task Force’s (USPSTF) Draft Recommendation Statement for Syphilis Infection in Nonpregnant Adults and Adolescents: Screening. The American Sexually Transmitted Diseases Association (ASTDA) is an organization devoted to the control and study of sexually transmitted diseases with membership representing major STD researchers across the country. The National Coalition of STD Directors (NCSD) represents STD programs in every state, territory, and seven large cities and counties directly funded by the Centers for Disease Control and Prevention (CDC). With this combined membership, along with hundreds of additional members from both organizations likewise engaged in sexual health across the country, ASTDA and NCSD have a unique perspective on this draft recommendation, as those we represent are on the front line of STD prevention and control throughout the country.

As the USPSTF is likely aware, we are currently experiencing a raging syphilis epidemic in this country which we have not seen the likes of in over a decade. According to the most recent data released by the CDC, a total of 19,999 primary and secondary (P&S) syphilis cases, the most infectious stages of syphilis, were reported in 2014. The national P&S syphilis rate in 2014 was 6.3 cases per 100,000 population, the highest rate reported since 1994. During 2000–2014, the rise in the P&S syphilis rate was primarily attributable to increased cases among men and, specifically, among gay men and other men who have sex with men (MSM). Given these increasing numbers, NCSD and ASTDA are pleased to see a strong recommendation for syphilis screening for those who are at increased risk for infection, including MSM and those living with
HIV.

The breadth and depth of our syphilis epidemic is not limited to MSM, however. During 2013–2014, the rate of P&S syphilis increased among men (14.4%) but we saw an even higher increase among women (22.7%). As a result, NCSD and ASTDA request that the USPSTF considers expanding its syphilis screening recommendation to include additional populations, to include women and heterosexual men at increased risk for syphilis.

In addition to primary and secondary syphilis, increases have also been seen recently of ocular syphilis. According to the CDC, more than 200 cases reported over the past two years from 20 states. The majority of cases have been among HIV-infected MSM; a few cases have occurred among HIV-uninfected persons including heterosexual men and women. Several of the cases have resulted in significant sequelae including blindness. It is believed that this number could be only the tip of the iceberg, as many providers who see these cases may not be reporting the cases to state and local health departments. This recommendation should also include a strong mention of this new trend.

In addition, NCSD and ASTDA would recommend the USPSTF specifically reference the need for syphilis screening for those on Pre-Exposure Prophylaxis (PrEP). While those on PrEP may be included within other at-risk populations (such as MSM) that this recommendation references, there is new data coming out regarding the importance of syphilis screening for specifically those on PrEP.

How could the USPSTF make this draft Recommendation Statement clearer?
1) This recommendation is for those at “increased risk” for syphilis, and the USPSTF explicitly states that they recommend screening for MSM and persons living with HIV. Whether any populations outside of these are considered “at increased risk” is unclear. Specifically, the additional factors that the USPSTF states for use in consideration for screening (“increase prevalence rates, including male sex combined with age younger than 29 years, race/ethnicity, geography, incarceration, and sex work”) leaves out large at-risk populations, most notably women and heterosexual men. How the USPSTF defines those “at increased risk” should be made clearer, in order for private providers to better implement this recommendation. For example, other USPSTF recommendations, most notably on HIV screening, contain a section regarding an assessment of risk where risk factors are discussed more at length; this recommendation would be improved by such a section. In addition, specific examples of “atrisk,” especially those supported by literature or surveillance data would be helpful.

2) In the “Assessment of Risk” section, NCSD and ASTDA were disappointed that no sub-group of females, other than possibly those included in the “sex work” category was included among those “at increased risk.” The recent increases in syphilis among women due to heterosexual transmission demand an expanded population to include women for syphilis screening in this recommendation. While reference is made to the USPSTF’s separate recommendation on screening for syphilis in pregnant women, surely those women with increased risk of syphilis infection can be identified and included in the recommendation BEFORE they become pregnant. We suggest the addition to the recommendation of: “All sex partners of those persons identified at increased risk of syphilis infection” could be included. This inclusion would encompass additional women and men, those who truly are at risk for syphilis, are also included in this recommendation.

3) The USPSTF should add a statement recommending the pregnancy status of reproductive age women with syphilis be determined in order to better address the recent increases in congenital syphilis.

What information, if any, did you expect to find in this draft Recommendation Statement that was not included?
1) While likely due to the timing of the release of the draft recommendation, this draft includes 2013 data; the final USPSTF recommendation should include the most up-to-date national statistics.

2) As noted above, NCSD and ASTDA expected the USPSTF to react to the recent rise of syphilis through heterosexual transmission and address that in some matter with recommend screening. We also expected to see a clearer definition of “at increased risk” for syphilis containing clear metrics and consideration for association with rectal STDs to make this recommendation easier to implement for all health care providers.

3) As also noted above, we expected to see a specific reference to those on PrEP included in this recommendation. New data is emerging regarding the importance of syphilis screening for these individuals.1, 2 Including a reference to this population group will ensure that the USPSTF recommendation is in line with recommendations from the CDC.

4) Under the section titled, “Importance”, inclusion of the following statement would be most appropriate and timely given the dramatic increases in reported Congenital Syphilis cases per 100,000 live births in the United States from 8.4 in 2012 to 9.1 in 2013 and 11.5 in 2014: “Males infected with syphilis can transmit the infection to pregnant females.”

5) Regarding the “screening tests” section, the RPR serologic test for syphilis is also widely available, provides standardized quantitative results which are needed to determine initial syphilis infection, evaluate response to treatment, and help determine if reinfection has occurred. It is inexpensive and sufficiently sensitive and specific for screening and follow up purposes. A brief discussion or reference to the need for and interpretation of follow up serologies after treatment for syphilis might be appropriate, which would be particularly true in HIV-positive individuals and pregnant females.

6) Additionally, the recent rise of ocular syphilis warrants a mention by the USPSTF in this recommendation. This is a new and emerging trend that has resulted in syphilis-caused irreversible blindness and should be mentioned by the USPSTF. Syphilis is a great imitator, often being mistaken for other conditions, and health care providers who may not often see cases of STDs, such as optometrists or ophthalmologists, may not be aware of this rising trend. The USPSTF should increase awareness of this trend in this draft recommendation. Please see the CDC’s recent Clinical Advisory on this topic.³

7) Finally, there have been new developments in the screening for syphilis in the last five years, with the Food and Drug Administration’s approval of a rapid syphilis test in 2011, the first of its kind approved for us in the United States, and this test receiving a CLIA waiver in 2014. This test can be useful in certain populations, including:

• HIV testing sites where venous blood draws are not performed,
• STD clinics, emergency departments, or urgent care centers after patients are evaluated for signs and symptoms consistent with P&S syphilis,
• Field screening for social contacts of syphilis cases,
• Sexually active gay men and other MSM,
• Pregnant women
• Settings in which patients may not return and immediate treatment is deemed beneficial
• Jails and other correctional settings in high prevalence communities or screening of incarcerated women where congenital syphilis has not been eliminated.

New and emerging test technologies should also be mentioned in the draft recommendation statement.

Based on the evidence presented in this draft Recommendation Statement, do you believe that the USPSTF came to the right conclusions? Please provide additional evidence or viewpoints that you think should have been considered.

While the recommendation includes a discussion of correctional facilities as a risk factor, this recommendation should also include a proactive recommendation for routine STD and HIV screening for those in adult correctional facilities. In addition to being supported by evidence, this recommendation could drive federal and state policy supporting routine screening.

What resources or tools could the USPSTF provide that would make this Recommendation Statement more useful to you in its final form?

If the USPSTF or CDC could maintain a website and reference its address in this recommendation which would be updated with the most current definition of, “Persons who are at increased risk for infection (syphilis)” and include recommendations which are specific for various geographic areas of the country and at-risk populations, syphilis screening could be standardized based on the unique needs of each major city/region and modified as morbidity trends change, perhaps on an annual basis.

The USPSTF is committed to understanding the needs and perspectives of the public it serves. Please share any experiences that you think could further inform the USPSTF on this draft Recommendation Statement.

1) NCSD and ASTDA are aware as a result of its members’ direct expertise that persons diagnosed with syphilis often have a history of infection with another STD. We expected to see an analysis evaluating the need to include at least a sub-group of those with a prior history of an STD among those at increased risk of syphilis infection.

2) We were pleased to see the USPSTF note the important role that public health agencies play in the prevention and treatment of syphilis. Key public health staff trained in STD contact tracing, often called Disease Intervention Specialists, or DIS, are the fundamental public health STD infrastructure and integral to ensuring all of those who may have been exposed to an STD are tested and correctly treated. This role is especially important in the case of syphilis, which is highly contagious within a specific period of time. Highlighting the importance of private providers working with public health in ensuring potential syphilis contacts are identified is key to getting our current syphilis epidemic under control.

3) In addition, this recommendation is also a unique opportunity to strongly emphasis referral of all sexual contacts of syphilis cases to testing or medical evaluation. In many primary care settings, providers may be less likely to request sexual health contacts of their patients and following up with these contacts or to view this as their role. While the recommendation does note the important role of public health agencies in this outreach, resources available to public health do not come close to meeting the need for these functions for the current STD epidemics in the United States. As a result, this recommendation should also reference research showing the importance of screening contacts of those with an STD and encourage all providers to engage in these activities.

Do you have other comments on this draft Recommendation Statement?
We thank the USPSTF for noting that “initial studies suggest that detection of syphilis infection in MSM or persons living with HIV improves when screening is performed every three month compared with annually.” Other STDs play a significant role in the acquisition and transmission of HIV and no STD more so than syphilis. NCSD and ASTDA strongly support the CDC’s STD and HIV screening recommendations which state that those who engage in risky sexual activities and MSM should receive STD and HIV screening every three to six months. We urge a strong support of syphilis screening more frequently than annually in MSM or persons living with HIV in the USPSTF’s final syphilis screening recommendation. In addition, the USPSTF should also add a recommendation to for providers to offer PrEP to all HIV-negative MSM with newly diagnosed syphilis.

Thank you for consideration of these comments. Should you need additional information, please contact NCSD’s Director of Policy and Communications, Stephanie Arnold Pang, at sarnold@ncssdc.org or at 202-715-3865.

Sincerely,
William A. Smith
Executive Director
National Coalition of STD Directors

Kees Rietmeijer, MD, PhD
President
American Sexually Transmitted Diseases Association
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1 Jonathan E. Volk, et. al, “No New HIV Infections with Increasing Use of HIV Preexposure Prophylaxis in a Clinical Practice Setting,” Clinical Infectious Diseases, 2015 Nov 15;61(10):1601-3.
2 Albert Y. Lui, et. al., “Preexposure Prophylaxis for HIV Infection Integrated With Municipal- and Community-Based Sexual Health Services,” JAMA Intern Med, 2016;176 (1):1-11.
3 Available at: http://www.cdc.gov/std/syphilis/clinicaladvisoryos2015.htm