Mail-in self-collection tests for human papillomavirus (HPV) more than doubled cervical cancer screening participation among never- and under-screened U.S. women, according to a first-of-its-kind study from researchers at The University of Texas MD Anderson Cancer Center.
In the real-world, randomized, PRETIS study, published in JAMA Internal Medicine,1 41% of those who received self-collection tests and a telephone reminder participated in cervical cancer screening, compared with 17% of those who received a telephone reminder alone. Adding patient navigation support to self-collection tests and the telephone reminder further increased participation rates to 47%. The next steps for researchers will be studying how to integrate self-collection HPV tests in different primary care settings.
“Too many women, especially those who are uninsured, live in rural areas or come from marginalized and underserved communities, aren’t getting screened for cervical cancer,” said lead study author Jane Montealegre, PhD, MPH, Associate Professor of Behavioral Science at the University of Texas MD Anderson Cancer Center. “These results show that self-collection testing could be a solution to increasing access to screening and, in turn, reducing the burden of cervical cancer in the United States.”
Jane Montealegre, PhD, MPH
In May 2025, the U.S. Food and Drug Administration approved the first at-home screening test for cervical cancer, a disease that affects nearly 13,000 women annually. Although HPV vaccination and in-office screening have driven significant declines in cervical cancer rates, disparities in outcomes continue, specifically for women of color and for those in rural and low-income counties.
Study Details and Results
Between February 2020 and August 2023, the PRETIS study enrolled nearly 2,500 women (aged 30–65) from the Houston area. Most (94%) were from ethnic/racial minoritized populations, and 56% were covered by a publicly funded financial assistance program. Eligibility criteria for women and persons with a cervix included the following: (1) no history of hysterectomy or cervical cancer; (2) two or more ambulatory care visits in the past 5 years; (3) no cytology in the past 3.5 years nor HPV test in the past 5.5 years; and (4) current enrollment in a health-care coverage or financial assistance plan accepted by the health system (ie, Medicaid/Medicare, county publicly funded financial assistance program, state grants, private insurance).
Patients received one of three screening intervention approaches: (1) a telephone reminder for clinic-based screening; (2) a telephone reminder with a mailed self-collection test; and (3) a telephone reminder with a mailed self-collection test and patient navigation. Results on screening participation were collected at 6 months. The researchers also found that more than 80% of the women in the self-collection groups returned their kits.
“As self-collection tests become available in the United States, it’s vital that we gather data to guide how they are rolled out. We want to make sure that they become available in clinics and health centers that care for people who often have the hardest time accessing health care,” Dr. Montealegre said. “By removing barriers, we are hopeful that we can improve the uptake of evidence-based screening tests and make significant progress against this preventable disease.”
Limitations of this study include the effects from the COVID-19 pandemic, unclear reasons for participation refusal, and barriers around mailing the kits to peoples’ homes. The trial also did not evaluate differences in the types of follow-up appointments that patients need if they test positive for HPV.
DISCLOSURE: This study was supported through grants from the National Institutes of Health, including the National Institute for Minority Health and the National Cancer Institute (R01MD30175, P30CA016672, P30CA125123, P30CA138313). A full list of collaborating authors and their disclosures can be found at jamanetwork.com.
REFERENCE
1. Montealegre JR, Hilsenbeck SG, Bulsara S, et al: Self-collection for cervical cancer screening in a safety-net setting: The PRESTIS randomized clinical trial. JAMA Intern Med. June 6, 2025 (early release online).
