Mail-in HPV self-collection tests more than doubled cervical cancer screening participation rates among never- and under-screened U.S. women, according to a new real-world clinical trial led by researchers at The University of Texas MD Anderson Cancer Center. Published in JAMA Internal Medicine, the PRESTIS trial (Prospective Evaluation of Self-Testing to Increase Screening) was conducted between February 2020 and August 2023 in Houston’s publicly funded safety-net health system and is the first trial to study the effectiveness of mailed self-collection kits for HPV testing in a safety-net population.
“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 the study’s first author Jane Montealegre, PhD, associate professor of Behavioral Science at MD Anderson. “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 U.S.”
The MD Anderson team designed the trial to address a continuing decline in cervical cancer screening in the U.S., particularly among underserved populations. According to national data, screening rates dropped to 75.2% in 2021, below the target of 79.2% set by Healthy People 2030, an effort by U.S. Department of Health and Human Services (HHS) that provides science-based, 10-year national objectives for improving the health and well-being of Americans. Groups that show significantly lower HPV screening rates included those women who are uninsured, publicly insured, live in rural areas, or are part of minoritized racial and ethnic groups.
For this study, PRESTIS enrolled 2,474 women aged 30–65 who were not up-to-date with cervical cancer screening. Of these, 94% identified as members of racial or ethnic minoritized populations and 56% were covered by the county’s public assistance program. Participants were randomly assigned to one of three interventions: a telephone reminder (TR) for in-clinic screening; a TR plus a mailed self-collection kit; or a TR plus self-collection kit and a follow-up call from a patient navigator. Screening participation was measured within six months via review of the participant’s electronic health record.
The resulted showed that participation in screening was 17.4% for those who received only a TR, compared with 41.1% for those who received a TR and a self-collection kit, and 46.6% for those who received a TR, self-collection kit, and patient navigation.
“This pragmatic randomized clinical trial is, to our knowledge, the first to evaluate self-collection in a U.S. public safety-net health system,” the researchers wrote. “The results demonstrate that mailing self-collection kits to the homes of underscreened individuals following TR is effective for increasing CCS (cervical cancer screening) participation in safety-net settings.”
The study affirms prior international trials showing self-collection can significantly increase participation, particularly in countries with organized screening programs and universal healthcare. In a recent meta-analysis of 28 trials, mailed self-collection was associated with a 2.5-fold relative increase in screening rates. The PRESTIS trial found similar relative participation gains but with higher absolute screening rates—41.1% and 46.6% compared to a global average of 24%.
The researchers said that the higher uptake in the PRESTIS study may reflect the acute barriers faced by participants, such as poverty, lack of transportation, and low access to healthcare. A nested survey within the study found that more than 80% of the trial participants had household incomes below the federal poverty level.
The TR was an important feature in this trial that to boost engagement. All participants received a call from a bilingual patient navigator to confirm eligibility and explain the importance of screening. While adding a second call from a patient navigator provided incremental gains, the difference between self-collection kit alone and self-collection with navigation was modest—41.1% versus 46.6%. Fewer than 70% of those in the navigation group could be reached for the follow-up call, suggesting this additional effort may not be a cost-effective method to further boost screening rates.
The authors acknowledged some potential limitations of the study including the possible influence from the COVID-19 pandemic, which may have temporarily limited in-person care and inflated interest in mail-in options. They also noted that refusal of participation in the self-collection kit groups were not systematically documented, and the trial did not evaluate follow-up care for patients testing positive.
Furthering this line of inquiry the MD Anderson team will explore implementation strategies for integrating mailed self-collection into a variety of primary care settings. Plans also include studying automated alternatives to patient navigation and evaluating adherence to follow-up care among those who test positive.
