HPV Vaccine Recommendations Including Guidance for Ages 27 to 45

SUMMARY:

Previously, US guidelines called for two doses when vaccination began before age 15, and three doses for those starting at age 15 or older or for individuals who were immunocompromised. The Department of Health and Human Services (HHS) supports a one‑dose recommendation based on international alignment with other high‑income countries and emerging scientific evidence indicating that one dose provides protection comparable to two doses. This directive has been published by the CDC. However, it is important to note that the US does not yet have a single‑dose HPV vaccine licensed for use. Furthermore, ACOG and AAP, based on current evidence, do not support this change in dosing. 

HHS/CDC Recommendations

• Routine vaccination
  • Age 11 to 12 years
  • Can be started at age 9 years
• Catch-up vaccination
  • Age 13 to 26 years
  • If not adequately vaccinated
• Shared clinical decision-making
  • Some adults ages 27 to 45 years
  • If not adequately vaccinated

Dosing Schedule 

• HHS/CDC
  • Change to 1-dose regimen for children and adolescents 
• AAP and ACOG
  • <15 years: 2 doses spaced 6 to 12 months apart
  • ≥15 years: 3-dose schedule
    • Initial dose | Second dose at 1 to 2 months | Third dose at 6 months  

ACOG HPV vaccine recommendations 

• Routine HPV vaccination is recommended for females and males 
• Target age is 11 to 12 years but can be given through age 26
  • Can be given from age of 9 
• Do not test for HPV DNA prior to vaccination
  • Vaccinate even if patient was tested and is HPV DNA positive
•  If not vaccinated between 11 to 12 years
  • Vaccinate between 13 to 26 years (catch up period)
  • Offer regardless of sexual activity, prior exposure to HPV, or sexual orientation 
• Women 27 to 45 years and previously unvaccinated
  • Use shared clinical decision making
• ACOG “does not recommend that an individual who received the quadrivalent HPV vaccine be revaccinated with 9-valent HPV vaccine, including those aged 27 to 45 years who previously completed some, but not all, of the vaccine series when they were younger”
• Pregnancy
  • HPV vaccine is not recommended during pregnancy
  • Pregnancy testing prior to HPV vaccination not recommended
  • If vaccination schedule is interrupted by pregnancy, resume postpartum with the next dose
  • HPV vaccine can and should be given to breastfeeding women ≤26 who have not been vaccinated
  • The CDC encourages pregnant patients and healthcare professionals to report to the manufacturer and VAERS system if vaccine was administered during pregnancy | How and where to report is described in “CDC: HPV Vaccine Safety” in Learn More-Primary Sources below  
• Counsel to expect mild local discomfort and that this is not a cause for concern
  • Watch adolescents for at least 15 minutes following vaccination due to risk of fainting in this population

ACS

• The ACS overall endorses national guidance except for the approach to take with individuals who are 27 to 45 years and not adequately vaccinated

The ACS does not endorse the 2019 Advisory Committee on Immunization Practices recommendation for shared clinical decision making for some adults aged 27 through 45 years who are not adequately vaccinated because of the low effectiveness and low cancer prevention potential of vaccination in this age group, the burden of decision making on patients and clinicians, and the lack of sufficient guidance on the selection of individuals who might benefit

Adjuvant HPV Vaccine to Prevent CIN Recurrence 

• ACOG recommends considering adjuvant HPV vaccine for unvaccinated individuals 27 to 45 years who are undergoing treatment for CIN 2+

Learn More – Primary Sources:

HHS: Childhood Immunization Schedule by Recommendation Group

NIH: One dose of HPV vaccine as effective as two | National Institutes of Health

Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices (MMWR) 

CDC: Clinical Overview of HPV 

ACOG Committee Opinion 809: Human Papillomavirus Vaccination 

ACOG Practice Advisory: Adjuvant Human Papillomavirus Vaccination for Patients Undergoing Treatment for Cervical Intraepithelial Neoplasia 2+ 

AAP: How Pediatricians Can Recommend HPV Vaccination to Parents and Caregivers 

CDC HPV Vaccine Safety 

CDC: HPV Educational Materials For Clinicians 

ACS: Human Papillomavirus Vaccination 2020 Guideline Update 

AAP’s 2026 immunization schedule keeps routine recommendations intact after overhaul of federal schedule

SGO: The New U.S. Childhood Vaccine Schedule: A Key Change for HPV Immunization

ASCCP-Practice-Advisory-Childhood-Immunization-Recommends-Single-Dose-HPV-Vaccine

Key Highlights from the ASCCP Management Consensus Guidelines for Abnormal Cervical Cancer Screening Results

SUMMARY:

ASCCP guidance informs the assessment and treatment of abnormal cervical cancer screening results. The overarching theme of the recommendations reflects a ‘risk-based’ strategy, rather than rigid focus on a particular result. Risk tables have been generated to assist the clinician and guide practice. This is a consensus document with input from ACOG, ACS, SGO and multiple other professional organizations, including those affiliated with laboratory medicine.

The executive summary states

New data indicate that a patient’s risk of developing cervical precancer or cancer can be estimated using current screening test results and previous screening test and biopsy results, while considering personal factors such as age and immunosuppression

For a given current results and history combination, the immediate CIN 3+ risk is examined

If this risk is 4% or greater, immediate management via colposcopy or treatment is indicated

If the immediate risk is less than 4%, the 5-year CIN 3+ risk is examined to determine whether patients should return in 1, 3, or 5 years

Routine screening applies only to asymptomatic individuals who do not require surveillance for prior abnormal screening results

KEY POINTS:

• Recommendations (colposcopy and treatment vs surveillance) are based on risk for CIN 3+
  • Risk determined by prior history as well as screen results
  • Risk tables also address ‘unknown history’ scenario
• Deferral of colposcopy: Low risk for CIN 3+ (risk defined by tables)
  • Repeat HPV testing or cotesting at 1 year
  • At the 1-year follow-up test, referral to colposcopy if still abnormal
• Expansion of expedited treatment category (biopsy not needed prior to therapy), for example, in nonpregnant patients ≥25 years, expedited treatment is
  • Preferred: CIN 3+ risk is ≥60%
  • Preferred: HPV 16–positive HSIL cytology and never or rarely screened patients with HPV-positive HSIL regardless of HPV genotype
  • Acceptable: CIN 3+ risk is between 25% and 60%
  • Shared decision making is important in the context of “impact on pregnancy outcomes”
• Excisional treatment
  • Preferred over ablation for HSIL (CIN 2 or CIN 3) in the US
  • Recommended for AIS
• CIN 1
  • Observation is preferred vs treatment
  • Treatment acceptable with persistent CIN 1 results >2 years
• Lower Anogenital Squamous Terminology (LAST)/World Health Organization (WHO) recommendations for reporting histologic HSIL
  • Include HSIL (CIN 2) and HSIL (CIN 3) (i.e., include CIN 2 and 3 qualifiers)
• Reflex cytology
  • Should be performed on all positive HPV tests, regardless of genotype
  • If HPV 16 and 18 testing is positive but additional laboratory testing of the same sample is not feasible, proceed directly to colposcopy
• Surveillance recommendations following histologic HSIL, CIN 2, CIN 3, or AIS
  • Continue surveillance with HPV testing or cotesting at 3-year intervals for at least 25 years (recommended)
  • >25 years is acceptable “for as long as the patient’s life expectancy and ability to be screened are not significantly compromised by serious health issues”
• HPV assays
  • The ASCCP consensus document states the following in reference to HPV tests

Human papilloma virus assays that are Food and Drug Administration (FDA)-approved for screening should be used for management according to their regulatory approval in the United States

Note: All HPV testing in this document refers to testing for high-risk HPV types only

For all management indications, HPV mRNA and HPV DNA tests without FDA approval for primary screening alone should only be used as a cotest with cytology, unless sufficient, exceptionally rigorous data are available to support primary HPV testing in management

Learn More – Primary Sources:

2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors

Risk Estimates Supporting the 2019 ASCCP Risk-Based Management Consensus Guidelines

ACOG Practice Advisory: Updated Guidelines for Management of Cervical Cancer Screening Abnormalities

ASCCP Management Web App (free but requires sign in)

HPV Vaccine and Maternal and Infant Outcomes

BACKGROUND AND PURPOSE:

• Lipkind et al. (Obstet Gynecol., 2017) evaluated the impact of administering quadrivalent human papillomavirus vaccine (4vHPV) during the periconception and perinatal time periods on maternal and fetal outcomes

METHODS:

• Retrospective, observational cohort study (2007-2013)
• Pregnancy Cohort
  • Periconception (2 weeks before and 2 weeks after after LMP)
  • During pregnancy
  • Both of the above
• Control Cohort
  • 4-18 months before their last menstrual period
• Outcomes were
  • Gestational diabetes
  • Hypertensive disorders of pregnancy
  • Chorioamnionitis
  • Preterm birth
  • Small-for-gestational-age birth
  • Major structural birth defects in offspring

RESULTS:

• 720 received vaccine during periconceptional period, 698 received vaccine during pregnancy and 8196 controls received vaccine
• 4vHPV administered during pregnancy was not associated with increased risk for adverse obstetric events or birth outcomes
• When comparing vaccine exposure during pregnancy to controls
  • There was no evidence of increased preterm birth (adjusted relative risk [aRR] 0.97; 95% CI 0.72-1.3)
  • There was no evidence of increased major structural birth defects (2.0% vs 1.8%)
• Results were similar for 4vHPV exposure during periconceptional period

CONCLUSION:

• Administering 4vHPV during pregnancy or periconceptional period was not associated with adverse pregnancy or birth outcomes

Learn More – Primary Sources:

Maternal and Infant Outcomes After Human Papillomavirus Vaccination in the Periconceptional Period or During Pregnancy

Sex Education and the ObGyn: the ACOG Committee Opinion

CLINICAL ACTIONS

Comprehensive sexuality education should be medically accurate, evidence-based, and age-appropriate. Obstetrician-gynecologists can take part in this by addressing issues directly with adolescent patients in the following ways:

• Participate locally in development of community programs on sexuality utilizing evidence-based curricula that focus on clear health goals (e.g. the prevention of pregnancy and STDs, including HIV)
• Provide health care that focuses on optimizing sexual and reproductive health and development
• Aid in designing programs that cover the variations in sexual expression, including vaginal intercourse, oral sex, anal sex, mutual masturbation, as well as texting and virtual sex

SYNOPSIS:

Community and school-based programs are an important facet of sexuality education. However, a preponderance of evidence suggests that when a responsible adult talks about sexual topics with adolescents, there is delayed sexual initiation and increased birth control and condom use. Although many parents talk with their adolescents about risks and responsibilities of sexual activity, one-third to one-half of females aged 15–19 years report never having talked with a parent about contraception, STDs, or “how to say no to sex.” The gynecologist can also play an important supporting role in this dialogue by open discussions with parents, guardians and adolescents.

KEY POINTS:

• Sexuality education should be evidence-based and should include the benefits of delaying sexual intercourse, while also providing information about normal reproductive development, contraception (including long-acting reversible contraception methods) to prevent unintended pregnancies, as well as barrier protection to prevent STDs
• Sex education should be tailored to specific ethnicities and cultural groups and should be inclusive of those with physical, and cognitive disabilities
• Sex education should not marginalize lesbian, gay, bisexual, questioning, and transgender individuals and those that have variations in sexual development
• Studies have demonstrated that comprehensive sexuality education programs reduce the rates of sexual activity, sexual risk behaviors (e.g. number of partners and unprotected intercourse, STDs, and adolescent pregnancy)
• Obstetrician–gynecologists have the unique opportunity to act “bi-generationally” by asking their patients about their adolescents’ reproductive development and sexual education, human papillomavirus vaccination status, and contraceptive needs

Learn More – Primary Sources:

ACOG Committee Opinion 678: Comprehensive Sexuality Education

STI Screening in Pregnancy: CDC Recommendations

CLINICAL ACTIONS:  

Pregnant women are considered a ‘special population’ by the CDC. Due to the potential burden to pregnant women, offspring and partners, providers should ask all pregnant women and their partners about STIs, and ensure counseling, screening and treatment are available.

SPECIFIC STIs: 
HIV
SYPHILIS
HEPATITIS B
HEPATITIS C
CHLAMYDIA
GONORRHEA
BACTERIAL VAGINOSIS
TRICHOMONAS
HSV-2

Recommended Screening Tests for ALL Pregnant Women

HIV

• ‘Opt-out screening’ – screen at first prenatal visit after notifying patient of the need to be screened, unless patient declines
  • Screen in prepregnancy or as early as possible in pregnancy
• If patient declines, address concerns and discuss the following
  • A previous negative HIV test does not mean patient is still negative
  • Health benefit not only to patient but to fetus/offspring as treatment available to reduce perinatal transmission
• Retest in the 3rd trimester (before 36 weeks, if possible) if at high risk
  • Illicit drug use
  • STI during pregnancy
  • Multiple sex partners during pregnancy
  • Live in areas of high HIV incidence
  • Receiving care in facilities with an HIV incidence in pregnant women ≥1/1,000 per year
  • Partner has HIV
  • Signs or symptoms of acute HIV infection
    • Fever | Lymphadenopathy | Skin rash | Myalgias | Arthralgias | Headache | Oral Ulcers | Leukopenia | Thrombocytopenia | Elevated transaminase
• Rapid HIV testing should be performed on any woman in labor who has not been screened during pregnancy, unless she declines
  • If rapid HIV test positive, antiretroviral prophylaxis should be administered prior to receiving confirmatory test results
  • AAP recommends expedited HIV testing as soon as possible after birth for infants born to women with unknown HIV status
• NOTE: The USPSTF (June 2019) continues to recommend screening for HIV infection in all pregnant persons, including those who present in labor or at delivery whose HIV status is unknown. (A recommendation)

SYPHILIS

• Cases of congenital syphilis have increased 10 fold in the past decade
• Syphilis during pregnancy can lead to
  • Stillbirth | Miscarriage | Infant death | Maternal and infant morbidity
• Serologic tests should be performed at first prenatal visit
• Screening for syphilis infection is a 2-step process | Antepartum screening can be performed by manual nontreponemal antibody testing (e.g., RPR) by using the traditional syphilis screening algorithm or by treponemal antibody testing (e.g., immunoassays)
  • Traditional screening
    • Initial “nontreponemal” antibody test (ie, Venereal Disease Research Laboratory test or rapid plasma reagin [RPR] test) to detect biomarkers released from damage caused by syphilis infection
    • Followed by a confirmatory “treponemal” antibody detection test (ie, fluorescent treponemal antibody absorption [FTA-ABS] or T pallidum particle agglutination test [TP-PA])
  • Reverse sequence screening algorithm
    • Initial automated treponemal test (such as an enzyme-linked [EIA], chemiluminescence [CIA], or multiplex flow immunoassay [immunoblot])
    • Followed by a nontreponemal test
    • NOTE: If the test results of the reverse sequence algorithm are discordant, a second treponemal test (preferably using a different treponemal antibody) is performed
• Pregnant women with positive treponemal screening tests (e.g., EIA, CIA, or immunoblot) should have additional quantitative nontreponemal testing because titers are essential for monitoring treatment response
• If access to prenatal care is suboptimal, RPR test and treatment should be performed at time of pregnancy confirmation
• Serologic retesting in the 3rd trimester (28 weeks) and at delivery if the patient for patients at high risk including
  • Sex with multiple partners | Sex in conjunction with drug use or transactional sex
  • Late entry to prenatal care (i.e., first visit during the second trimester or later) or no prenatal care
  • Methamphetamine or heroin use
  • Incarceration of the woman or her partner
  • Unstable housing or homelessness
• Test any woman who delivers a stillborn or in the case of infant death
  • Untreated syphilis has a 40% infant death rate
• Do NOT discharge neonate if serologic status is unknown
  • Newborn infection may not be immediately obvious
  • Within a few weeks may develop
    • Developmental delay
    • Seizures
    • Birth defects such as bone deformation, blindness and deafness

Note: In September 2018, the USPSTF reaffirmed previous guidance and “recommends early screening for syphilis infection in all pregnant women.” (Grade A – Offer or Provide this Service)

HEPATITIS B (HBV)

• Screen during each pregnancy, preferably in the first trimester, regardless of vaccination status or history of testing
  • Use ‘triple panel’: Hepatitis B surface antigen (HBsAg), antibody to HBsAg, and total antibody to HBcAg (total anti-HBc)
• If patient underwent appropriately timed triple panel screening and has not had any new HBV exposures since triple panel screening, only HBsAg screening is required
• At time of admission for delivery, retest if patient
  • Is at high risk – more than one sex partner in previous 6 months, evaluation or treatment for STI, injection-drug use, HBsAG-positive sex partner
  • Was not screened prenatally
  • Has clinical hepatitis
• Always do HBsAg testing prior to giving the HBV vaccine to avoid misinterpretation
• Report HBsAg positive women to local or state health departments to ensure they are entered into a case management program to arrange access to appropriate vaccinations for contacts and prophylaxis for infants
  • If HBsAg positive, test for hepatitis B virus deoxyribonucleic acid (HBV DNA) to guide the use of antiviral medication to prevent perinatal transmission
  • If HBV DNA >200,000 IU/mL (7.6 log10 IU/mL): The American Association for the Study of Liver Diseases suggests antiviral therapy during pregnancy to further reduce perinatal HBV transmission

HEPATITIS C (HCV) 

• The CDC has updated HepC guidelines (2020)
  • Hepatitis C screening at least once in a lifetime for all adults aged ≥18 years, except in settings where the prevalence of HCV infection (HCV RNA-positivity) is <0.1%
  • Hepatitis C screening for all pregnant women during each pregnancy, except in settings where the prevalence of HCV infection (HCV RNA-positivity) is <0.1%
• USPSTF also calls for universal screening for HCV infection, including pregnancy

Recommended Screening Tests for Pregnant Women at Risk

CHLAMYDIA 

• Test all pregnant women who are <25 years old for Chlamydia trachomatis at the first prenatal visit
• Test all older women if at high risk:
  • More than one sex partner
  • A sex partner with concurrent partners or has an STI
• Retest in the 3rd trimester to prevent maternal postnatal complications and chlamydia infection in the neonate
• Test of cure by NAAT 3 to 4 weeks after treatment and retest within 3 months

GONORRHEA 

• Test all pregnant women who are <25 years old for N. gonorrhoeae at the first prenatal visit
• Test all older women if at high risk:
  • More than one sex partner
  • A sex partner with concurrent partners or has an STI
  • Inconsistent condom use in non-monogamous relationships
  • Previous or co-existing sexually transmitted infections
  • Exchanging sex for money or drugs
  • Consider consulting local public health authorities for further guidance on identifying those at high risk related to geographic location 
• Treat all positive patients immediately and retest in 3 months
• Retest in the 3rd trimester to prevent maternal postnatal complications and chlamydia infection in the neonate

Screen Only if Symptomatic

Bacterial Vaginosis (BV)

• Evidence does not support routine screening
• Evaluate and screen symptomatic women
• The USPSTF addresses BV screening during pregnancy and states the following

The USPSTF addresses BV screening during pregnancy and states the following
The USPSTF recommends against screening for bacterial vaginosis in pregnant persons not at increased risk for preterm delivery. (D recommendation)

The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for bacterial vaginosis in pregnant persons at increased risk for preterm delivery. (I statement)

Trichomonas

• Evidence does not support routine screening 
• Evaluate and screen symptomatic women

HSV-2

• Evidence does not support routine screening
• In the absence of lesions during the 3rd trimester, routine cultures for HSV are not indicated for women in the 3rd trimester who have a history of recurrent genital herpes
• Type-specific serologic tests may help identify pregnant women at risk for HSV and to help guide counseling regarding the risk of acquiring herpes during pregnancy

SYNOPSIS:

Recommendations for STI testing can vary based on certain considerations, including state laws. The CDC recommendations are considered broader, such that more women will potentially be screened, but are consistent with other CDC guidance with the intention of preventing adverse outcomes for pregnant women, partners and fetuses.

KEY POINTS:

• All pregnant women and their partners should be asked about STIs and counseled regarding personal risks as well as pregnancy and outcomes
• Pap Smears should be performed in pregnancy at the same frequency as nonpregnant women
  • Management of abnormal Pap tests differ in pregnancy

Screening at Delivery

SYPHILIS 

• Select groups of pregnant women, including women who are at high risk for syphilis or live in areas of high syphilis morbidity
• Pregnant women with no previously established status
• Pregnant women who deliver a stillborn infant

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HIV

• Pregnant women not screened during pregnancy

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HBV

• Women admitted for delivery at a health care facility without documentation of HBsAg test results should have blood drawn and tested as soon as possible after admission
• Women at high risk
  • Having had more than one sex partner during the previous 6 months, an HBsAg-positive sex partner, evaluation or treatment for a sexually transmitted disease, or recent or current injection-drug use
• Women with signs or symptoms of hepatitis

Note: CDC recommends universal hepatitis B vaccination within 24 hours of birth for medically stable infants >2000 grams

• Permissive language that allowed the vaccine to be delayed until after hospital discharge has been removed
• Administer hepatitis B vaccination and hepatitis immune globulin regardless of birth weight within 12 hours of birth for infants born to hepatitis b-infected mothers

---

CHLAMYDIA

• Pregnant women less than 25 years of age
• Continued high risk
  • New or multiple sex partners, sex partner with concurrent partners, sex partners who have a sexually transmitted disease

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GONORRHEA 

• Continued high risk
  • Past or current injection-drug use, having had a blood transfusion before July 1992, receipt of an unregulated tattoo, having been on long-term hemodialysis, intranasal drug use, and other percutaneous exposures

Learn More – Primary Sources:

CDC: Sexually Transmitted Infections Treatment Guidelines 2021

Current Perspectives on Prevention of Mother-to-Child Transmission of Syphilis

ACOG Committee Opinion 752: Prenatal and Perinatal Human Immunodeficiency Virus Testing: Expanded Recommendations

CDC: A Guide to Taking a Sexual History

CDC: Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices

ACOG Clinical Practice Guideline 6: Viral Hepatitis in Pregnancy

CDC Recommendations for Hepatitis C Screening Among Adults — United States, 2020

Screening for Syphilis Infection in Pregnant Women: US Preventive Services Task Force Reaffirmation Recommendation Statement

Screening for HIV Infection: US Preventive Services Task Force Recommendation Statement

Screening for Hepatitis B Virus Infection in Pregnant Women: US Preventive Services Task Force Reaffirmation Recommendation Statement

USPSTF: Screening for Bacterial Vaginosis in Pregnant Persons to Prevent Preterm Delivery

Screening and Testing for Hepatitis B Virus Infection: CDC Recommendations — United States, 2023

Vital Signs: Missed Opportunities for Preventing Congenital Syphilis — United States, 2022

Guidance Update: Cervical Cancer Screening

SUMMARY:

The Health Resources and Services Administration (HRSA) has released cervical cancer screening guidelines. The guidance addresses screening modalities such as cytology and high-risk human papillomavirus (hrHPV) testing as well as the role of patient self-collection and insurance coverage related to any additional follow-up testing.

CLINICAL ACTIONS:

HRSA Cervical Cancer Screening Guidelines

Screening Approach Based on Age

• 21 to 29 years
  • Screen with cervical cytology (Pap test) every 3 years
  • Co-testing with cytology and hrHPV testing is not recommended
• 30 to 65 years
  • Preferred: primary hrHPV testing every 5 years
  • Acceptable alternative: cytology and hrHPV co-testing every 5 years
  • If hrHPV testing is unavailable: cytology alone every 3 years
  • Patient-collected hrHPV testing is an appropriate option if follow-up systems are in place

Screening Frequency and Follow-Up

• Screening interval
  • Average-risk women should not be screened more than once every 3 years
• Additional testing and evaluation
  • May include
    • Cytology | Biopsy | Colposcopy | Extended genotyping | Dual stain testing
  • Pathologic evaluation and follow-up testing are recommended when indicated to complete the screening process for malignancies

Insurance Coverage Requirements

• Applicable plans
  • Non-grandfathered group health plans
  • Health insurance issuers offering group or individual health insurance coverage
• Cost-sharing
  • Required to cover listed services and screenings without cost-sharing
• Plan and policy years
  • Update for most plans will take effect in 2027

Self-Collection for Cervical Cancer Screening

• The ACS recommends the following regarding self-collection
  • Preferred: Clinician-collected cervical specimens
  • Acceptable: Self-collected vaginal specimens
• Repeat testing in 3 years when self-collected vaginal specimens are HPV-negative
• Only use tests kits with FDA indication for primary HPV screening using self-collection
• Only use in settings for which there is FDA approval (clinic or at home)

Note: The ASC provides the following reasoning as to why clinician collection remains preferred at this time

• Provides direct access to the cervical transformation zone (primary site of HPV-related precancerous lesions)
• Allows the same sample to be used for both HPV testing and cytologic evaluation if HPV-positive
• Can be used to screen all patients
• Self-collected vaginal samples
  • Do not directly capture cervical cells
  • A positive HPV result typically requires a follow-up speculum exam for clinician-collected cervical cytology
  • Critical to assess eligibility (e.g., HIV/immunosuppression, exposure to DES in utero or history of cervical cancer must receive appropriate testing)
• The ASC states that “Recommendations are intentionally conservative to provide a margin of safety during implementation” and may be changed to every 5 years once there is sufficient reassuring data (i.e., incidence of CIN3+ is sufficiently low)
• ACOG has responded to the HRSA guidelines and notes potential benefit of self-collection but also risks in the absence of suitable infrastructure

Increasing screening access without established systems to provide follow-up testing and treatment could delay diagnosis and treatment and prove detrimental to patients

SYNOPSIS:

Cervical cancer rates in the United States are low due largely to access to effective screening.  Cervical cancer is believed with a high degree of certainty, to be the delayed consequence of infection with high risk or oncogenic human papillomavirus (HPV).  The majority of HPV infections are transient and do not progress to cervical cancer.  However, the consequences of missing precancerous or early cancerous lesions are potentially lethal and should be avoidable with appropriate screening.

KEY POINTS:

• The goal of cervical cancer screening is to minimize harm and maximize benefit
• The above clinical action items refer to average risk women
• Women at increased risk for cervical cancer require a higher level of surveillance and include those who are
  • Immunocompromised (HIV positive, organ transplant recipient, chronic steroid use)
  • Women with multiple partners or high risk partners
  • Women with a history of abnormal Pap smear or precancerous genital conditions
  • Smokers

Learn More – Primary Sources:

HRSA Cervical Cancer Guidelines

ACOG Committee Statement: Screening for Cervical Cancer

Cervical cancer screening for individuals at average risk: 2020 guideline update from the American Cancer Society

ASC: Self‐collected vaginal specimens for human papillomavirus testing and guidance on screening exit: An update to the American Cancer Society cervical cancer screening guideline

Human papillomavirus self-collection: The long road from scientific evaluation to implementation in screening programs

ACOG Responds to Updated HRSA Women’s Preventive Services Initiative Guidelines on Cervical Cancer Screening