THE LANCET PUB. HEALTH: Mailing at-home HPV sampling kits nearly doubles cervical screening uptake among hard-to-reach populations, US clinical trial suggests
Peer-reviewed / Randomised Controlled Trial / People
- Clinical trial with 665 under-screened women in North Carolina (USA) investigated use of high-risk human papillomavirus (hrHPV) self-collection kits to increase cervical cancer screening uptake.
- Screening uptake among participants sent self-collection kits and given support to attend an in-person appointment was almost double (72%) the cervical cancer screening uptake in those only given appointment support alone (37%).
- More than three quarters (78%) of these underserved participants who were mailed a hrHPV kit returned a sample, suggesting effective community outreach plays a key role in increasing screening uptake among women at highest risk of cervical cancer.
- The authors say their findings, together with those from previous studies, provide evidence that HPV self-collection kits have the potential to increase uptake of cervical cancer screening in under-screened women.
At-home high-risk human papillomavirus (hrHPV) sampling kits can help increase cervical cancer screening among under-screened women from low-income backgrounds, according to findings from a US-based clinical trial published in The Lancet Public Health journal.
The trial shows mailing kits to low-income, under-screened women and helping them book an in-person clinic appointment led to a two-fold increase in screening uptake compared to only offering assistance making an appointment.
The main cause of cervical cancer is persistent infection with a hrHPV, which puts women at risk of developing precancerous cervical lesions. Cervical cancer disproportionately affects Black and Hispanic women in the USA, with the highest incidence among Hispanic women and the highest mortality among Black women. Regular hrHPV testing in accordance with national screening guidelines reduces the risk of women developing the disease.
Current US guidelines on cervical cancer screening have several options. For women 21 years and over, a Papanicolaou (Pap) test every three years is recommended. For those 30 years and older, additional options include HPV cytology co-testing every five years or primary hrHPV testing every five years.
While previous studies have shown hrHPV self-collection kits can help increase cervical cancer screening, little research has involved under-screened women in the USA. Limited data is available on the combined effectiveness of using hrHPV self-collection kits and offering help scheduling in-person screening appointments.
Lead author Professor Jennifer S. Smith, University of North Carolina at Chapel Hill, US, said: “Until now, most studies of whether HPV self-collection increases cervical cancer screening have been outside the USA, in countries with national screening registries and universal health care. Our findings suggest programmes that use mailed HPV kits with effective community outreach can greatly improve screening uptake among underserved, at-risk women in the USA.” [1]
The authors conducted a randomised clinical trial involving 665 under-screened women in 22 counties in North Carolina, USA. Intensive community outreach campaigns – including printed and radio advertisements, online postings, community events and organisations and via a social assistance helpline – were used to recruit participants from underserved, under-screened groups and of racial and ethnic diversity.
The average age of participants in the trial – called My Body My Test-3 – which ran from 2016 to 2019, was 42 years, and more than half self-reported as Black or Hispanic (55%, 365/664 participants), uninsured (78%, 518/663), or unemployed (57%, 373/660). Women were only eligible for the trial if they had not received a Pap test in four years or more, or an hrHPV test in six years or more.
Participants were either sent hrHPV self-collection kits and given help booking an in-person appointment, or only given help making an appointment. The main outcome was cervical cancer screening uptake within 6 months of enrolment, defined as a negative hrHPV test result or attending an in-person screening appointment. Participants who tested positive for hrHPV by self-collection were referred to in-clinic appointment for further tests.
For participants who received mailed kits and help scheduling an appointment, cervical cancer screening uptake was almost double (72%, 317/438 participants) compared to those who received scheduling assistance only (37%, 85/227 participants). The benefits of home testing were similar regardless of participants’ age, time since last screening, race/ethnicity, insurance coverage, or level of education.
Among participants sent hrHPV kits, more than three quarters (78%, 341/438 participants) returned a sample. Valid hrHPV results were obtained for 329 participants, of whom 52 (16%) tested positive for hrHPV and were referred for follow-up appointments that 22 (42%) attended. Further tests detected CIN2+ lesions – which can progress to cervical cancer – in two (<1%) participants, who then received treatment.
Second author Dr Noel Brewer, of the University of North Carolina at Chapel Hill, said: “Government approval of at-home HPV tests would have a huge impact. We could better reach those in rural areas where cervical cancer screening is hard to come by. Also, only the people who self-test positive would need to go to a clinic for screening. For the many Americans without reliable access, cervical cancer screening from home would ensure they can get life-saving preventive care.” [1]
The authors acknowledge some limitations to their study. While the outreach approach used may oversample more motivated women and somewhat limit the study’s generalisability, it enabled recruitment of large numbers of at-risk women from the general population who do not regularly use clinic services. Mailed hrHPV kits do not meet the needs of all under-screened, hard-to-reach women. Consistent with other studies, less than half of participants with positive hrHPV results attended an in-clinic appointment, highlighting the need for further efforts to ensure continuity to care among those with positive self-test results. The trial was also conducted prior to the COVID-19 pandemic, so effects on screening uptake in the post-pandemic era could not be determined.
Writing in a linked Comment, Runzhi Wang, MD, and Jenell Coleman, MD, of Johns Hopkins University School of Medicine, who were not involved in the study, said: “This study provides the required evidence that high-risk HPV testing on self-collected samples can be an effective strategy for hard-to-reach populations.” They also call for developments to optimise the entire cervical cancer prevention process in the USA, saying: “Optimisation includes policy reforms to remove financial barriers to diagnostic tests and treatment; community outreach and education campaigns; and improved access to quality care through transportation services, expanded Medicaid eligibility, and skilled clinicians.”
NOTES TO EDITORS
This study was funded by the US National Institutes of Health. It was conducted by researchers from the University of North Carolina at Chapel Hill.
[1] Quote direct from author and cannot be found in the text of the Article.
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JOURNAL
The Lancet Public Health
METHOD OF RESEARCH
Randomized controlled/clinical trial
SUBJECT OF RESEARCH
People
ARTICLE TITLE
Effect of HPV self-collection kits on cervical cancer screening uptake among under-screened women from low-income US backgrounds (MBMT-3): a phase 3, open-label, randomised controlled trial
ARTICLE PUBLICATION DATE
11-May-2023
COI STATEMENT
Investigators interested in accessing these data for the purposes of future studies can do so under the following conditions: Institutional Review Board approval has been obtained from the University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, the institution covering the investigator; data security procedures ensuring patient privacy have been shown by the investigator; and a Data Use Agreement has been filled. Final datasets for analysis will not include any identifying information.
Cervical cancer screening doubles when under-screened women are mailed testing kits
Peer-Reviewed PublicationIMAGE: “MY HOPE GOING INTO THIS STUDY WAS THAT MAILING KITS FOR HOME-BASED COLLECTION MIGHT INCREASE CERVICAL CANCER SCREENING, BUT WE WERE THRILLED TO FIND A NEARLY TWO-FOLD INCREASE IN SCREENING UPTAKE,” SAID UNC LINEBERGER’S JENNIFER S. SMITH, PHD, MPH, PROFESSOR OF EPIDEMIOLOGY AT UNC’S GILLINGS AND CORRESPONDING AUTHOR OF THIS STUDY. “MANY HADN’T ENGAGED IN THE SCREENING SYSTEM FOR A WHILE AND GETTING THE KIT TO THEIR HOMES HELPED BREAK DOWN A FUNDAMENTAL BARRIER.” view more
CREDIT: UNC LINEBERGER COMPREHENSIVE CANCER CENTER
CHAPEL HILL, NC -- Researchers at the UNC Gillings School of Global Public Health and UNC Lineberger Comprehensive Cancer Center found mailing human papillomavirus (HPV) self-collection tests and offering assistance to book in-clinic screening appointments to under-screened, low-income women improved cervical cancer screening nearly two-fold compared to scheduling assistance alone. Scheduling assistance primarily consisted of helping to book an appointment for in-person screening at a clinic, regardless of whether an at-home test was offered or returned, or whether the HPV test was negative or positive.
The findings from the randomized trial appeared May 11, 2023, in Lancet Public Health.
“My hope going into this study was that mailing kits for home-based collection might increase cervical cancer screening, but we were thrilled to find a nearly two-fold increase in screening uptake,” said UNC Lineberger’s Jennifer S. Smith, PhD, MPH, professor of epidemiology at UNC’s Gillings and corresponding author of this study. “Many hadn’t engaged in the screening system for a while and getting the kit to their homes helped break down a fundamental barrier.”
An estimated 14,000 women will be diagnosed with cervical cancer in the United States this year, according to the National Cancer Institute, and the cancer will lead to more than 4,300 deaths. Cervical cancer disproportionately affects Black and Hispanic women, with Hispanic women having the highest incidence rates, and Black women having the highest mortality rates for the disease in North Carolina and in the United States. Most cervical cancers occur among under-screened women. The Centers for Disease Control and Prevention estimate 22% of eligible adults in the U.S. are overdue for screening.
The My Body, My Test-3 study recruited 665 women, ages 25 to 64, who were uninsured or enrolled in Medicaid or Medicare, from 22 counties across North Carolina. The women had low incomes and most of them lived in urban areas. None had a pap test in four years or a high-risk HPV test in six years, making them overdue for screening.
Two-thirds of the women received mailed HPV self-collection kits followed by assistance with scheduling a screening appointment at a clinic. The other third received screening scheduling assistance alone. The primary outcome was attending an in-clinic screening appointment or testing HPV-negative with self-collected samples within six months of enrollment in the trial.
Screening uptake was 72% among women who received mailed HPV kits compared to 37% for the other group of women. The investigators found that the effect of self-collection outreach on screening uptake didn’t vary across age, race/ethnicity, time since last screening, Medicaid or Medicare insurance coverage, or education.
“Home screening for cervical cancer puts women in control. Most can avoid having to go to a doctor’s appointment. These at-home kits can better reach people without access to screening, who are embarrassed by a cervical exam, or whose religious beliefs include modesty,” said study co-author Noel T. Brewer, PhD, Gillings Distinguished Professor in Public Health and UNC Lineberger member.
“We believe our results are applicable to low-income, under-screened women across the United States,” Smith said. “We’re now working with clinical partners to identify women who might be overdue for screening through electronic medical records. We hope to provide the option of either mailing them a self-collection kit to use at-home to mail back to us or hand a kit directly to them when they come into clinics for other services with the vision to eventually make self-collection a regular clinical provision.”
The UNC researchers also hope their findings, together with previous research findings, will spur the Food and Drug Administration to consider approving HPV self-collection as a primary screening test for cervical cancer in the U.S.
Authors and Disclosures
In addition to Smith and Brewer, the other authors are Peyton K. Pretsch, MPH, Lisa P. Spees, PhD, Michael G. Hudgens, PhD, Busola Sanusi, MA, Eliane Rohner, PhD, Elyse Miller, MPH, Sarah L. Jackson, MPH, and Stephanie B. Wheeler, PhD, MPH, UNC; Lynn Barclay, American Sexual Health Association, Research Triangle Park, NC; and Alicia Carter, MD, Laboratory Corporation of America Holdings, Burlington, NC.
The My Body My Test-3 trial was funded by the R01CA183891 grant from the National Cancer Institute. HPV testing reagents, media for self-collected sample preservation and liquid-based cytology media and cervical sample collection brushes were donated by Hologic, Inc. Self-collection brushes were donated by Rovers Medical Devices.
Smith has received research grants, supply donations and consultancies for Hologic, Inc., BD Diagnostics and Rovers Medical Devices in the past five years. Barclay works for the American Sexual Health Association which receives funding from Hologic. Neither Hologic, BD nor Rovers had input into the research design, analysis or interpretation of results. Wheeler receives grant support from Pfizer for unrelated projects. The other authors declared no conflicts of interest.
JOURNAL
The Lancet Public Health
METHOD OF RESEARCH
Randomized controlled/clinical trial
SUBJECT OF RESEARCH
People
ARTICLE PUBLICATION DATE
11-May-2023
COI STATEMENT
Jennifer Smith, Phd, has received research grants, supply donations and consultancies for Hologic, Inc., BD Diagnostics and Rovers Medical Devices in the past five years. Lynn Barclay works for the American Sexual Health Association which receives funding from Hologic. Neither Hologic, BD nor Rovers had input into the research design, analysis or interpretation of results. Stephanie Wheeler, PhD, MPH, receives grant support from Pfizer for unrelated projects. The other authors declared no conflicts of interest.
HPV self-collection kits increase screening among under-screened, under-served women in North Carolina
Jennifer S. Smith, Ph.D., led the Phase 3 controlled trial, which showed that self-collection kits and scheduling assistance are key for reaching these populations and preventing cervical cancer.
Peer-Reviewed PublicationIMAGE: JENNIFER SMITH, PHD view more
CREDIT: UNC GILLINGS SCHOOL OF PUBLIC HEALTH
CHAPEL HILL, N.C. – Five years ago, the World Health Organization (WHO) announced a global call to eliminate cervical cancer. Because nearly all cervical cancers are caused by an initial infection with oncogenic types of human papillomavirus (HPV), screening for the virus is critical to preventing and treating the disease. However, providing HPV screening only within clinical settings may limit access to screening for many under-served women across the United States and here, in North Carolina.
Jennifer S. Smith, PhD, and other researchers in the Gillings School of Global Public Health and UNC’s School of Medicine, conducted an open-label, two-arm randomized controlled trial called “My Body, My Test-3” to see if under-screened, under-served women across North Carolina were more likely to undergo cervical cancer when mailed HPV self-collection kits and offered scheduling assistance.
Researchers found mailed HPV self-collection with scheduling assistance led to more cervical cancer screenings than scheduling assistance alone. The results from the “My Body, My Test-3” study were published in Lancet Public Health.
“We showed that under-screened women were able to take the time to complete an HPV self-collection kit, return it successfully, and found the process acceptable enough that it actually led to their re-engagement in cervical cancer screening,” said Smith, who is a professor in the Department of Epidemiology. “Our study was particularly unique because we used two levels of intervention to increase screening uptake.”
HPV is the most common sexually transmitted infection. In most cases, HPV goes away on its own in a few years and does not cause health problems. But for some, the infection can spur precancerous lesions, or abnormal cell development in the cervix. If doctors know that a patient has HPV-associated cervical lesions, they can act fast to remove the lesions and decrease one’s risk of developing cervical cancer.
The biggest risk factor for cervical cancer, according to Smith, is being overdue for cervical cancer screening, which is higher among those without medical insurance or the financial stability to cover tests or in-person clinical visit costs.
“Many of the cervical cancer cases in the United States are occurring among women who haven't been screened regularly, or at all, because of lack of insurance, barriers to transportation, or a lack of knowledge about state-wide screening programs that offer screening free of charge or at a sliding scale,” said Smith.
Mailing self-collection kits helps to break down these access barriers. The technique uses a simple collection device, such as a brush, to obtain cervico-vaginal cell samples to test for HPV infection. The HPV test itself has comparable performance to physician-collection for the detection of high-grade cervical precancerous lesions or cancer.
One of the advantages of self-collection is that it eliminates the need for an initial in-clinic pelvic examination and can be performed at home, or another location that is convenient for the patient. Those with positive HPV results are then referred to follow-up care at the clinic.
As part of the trial, 665 women were contacted and helped with booking a screening appointment at a nearby clinic. One group of the women were only offered scheduling assistance, so researchers could determine if the intervention was successful on its own.
The remaining group of the women also received an HPV self-collection kit with illustrated instructions and a self-collection brush. They were given a pre-stamped envelope to send back their samples for laboratory testing.
The idea of self-collection is not a new one. Self-collection is being used in national programs throughout the globe already, such as in Denmark and the Netherlands. But self-collection in the United States is still in under review with the Food and Drug Administration (FDA).
The researchers hope the evidence from the trial will help provide some extra momentum for the FDA’s approval of HPV self-collection. If self-collection is approved by national screening bodies, programs, and community organizations such as Medicaid, Federally Qualified Health Centers, or the Breast and Cervical Cancer Control Program, it could be used to identify under-screened people and implement HPV self-collection by mail or within the clinical setting.
For Smith, the trial was incredibly valuable in that it served as a challenging learning experience on ways to reach women overdue for cervical cancer screening. They used a variety of community-outreach methods to recruit women for the screening trial, including through social media, radio, and flyers on local buses.
Inevitably, Smith says that it is important for doctors, researchers, and programs to find interventions and screening strategies that cater to the women who need to be screened.
“We won't make an impact on reducing cervical cancer in North Carolina, or globally, until we are able to find the women who aren't being screened and ensure that they get screening," said Smith. “We need to work together with them. Our results showed that mailing HPV self-collection kits to women who had not been screened regularly doubled cervical cancer screening uptake.”
Moving forward, the researchers will be thinking about the best approaches to providing HPV self-collection outreach. For example, patients could be flagging through medical records as being overdue for screening, and kits could be delivered through the mail or offered in person as they come into the clinic for other services.
Smith believes that as more programs consider integrated self-collection as part of patient care, it is critical to consider the entire cervical cancer cascade, from increasing screening access to providing the needed follow-up care if a self-test result is positive.
“It is important to ensure that women can have access to providers if they have questions about the self-collection process or their results,” said Smith. “If they have a positive result, they need to be ensured the appropriate follow-up care for good patient care.”
Other authors on the Lancet Public Health paper are Peyton K. Pretsch, MPH, Lisa P. Spees, PhD, Noel Brewer, PhD, Michael G. Hudgens, PhD, Busola Sanusi, MA, Eliane Rohner, PhD, Elyse Miller, MPH, Sarah L. Jackson, MPH, and Stephanie B. Wheeler, PhD, MPH, UNC; Lynn Barclay, American Sexual Health Association, Research Triangle Park, NC; and Alicia Carter, MD, Laboratory Corporation of America Holdings, Burlington, NC.
JOURNAL
The Lancet Public Health
METHOD OF RESEARCH
Randomized controlled/clinical trial
SUBJECT OF RESEARCH
People
ARTICLE TITLE
Effect of HPV self-collection kits on cervical cancer screening uptake among under-screened women from low-income US backgrounds (MBMT-3): a phase 3, open-label, randomised controlled trial
ARTICLE PUBLICATION DATE
11-May-2023
