Uterine Cervical Neoplasms* / diagnosis

The incidence and mortality of cervical cancer have fallen since the adoption of widespread screening, but it still disproportionately affects underserved populations in the US. Expanding access to screening, especially in primary care settings, may reduce these disparities and improve women’s health. This Clinical Insights article summarizes cervical cancer screening recommendations for patients with average and higher than average risk, including recommendations for self-collected human papillomavirus (HPV) testing. It highlights statements by the US National Cancer Institute–sponsored Enduring Guidelines Committee, which was established to continuously evaluate new technologies for cervical cancer screening, management, and surveillance.

Author/s:

Hunter K. Holt, MD, MAS, Yasaswi Kislovskiy, MSc, George F Sawaya

Self-Collection for Cervical Cancer Screening in a Safety-Net Setting: The PRESTIS Randomized Clinical Trial

Megan George — Thu, 04 Sep 2025 19:41:24 +0000

Date Added:

September 4, 2025

Journal/Publication:

JAMA Internal Medicine

Publication Date:

June 6, 2025

URL:

Self-Collection for Cervical Cancer Screening in a Safety-Net Setting: The PRESTIS Randomized Clinical Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jamainternmed.2025.2971

Keywords

PMID (1):

40478588

MeSH

Uterine Cervical Neoplasms* / diagnosis

Single-Blind Method

Safety-net Providers*

Early Detection of Cancer* / methods

In community health centers, use of self-collection of specimens for cervical cancer screening was significantly more effective than telephonic reminders. James W. Mold, MD, MPH

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Importance There are limited data on the effectiveness of mailed self-collection to increase cervical cancer screening (CCS) participation in underresourced health care settings.

Objective To compare the effectiveness of mailed self-collection kits, with and without patient navigation, to telephone reminders to increase CCS in a safety-net health system.

Design, Setting, and Participants This pragmatic, parallel, single-blinded, randomized clinical trial within a publicly funded safety-net health system in Houston, Texas, compared (1) telephone reminder (TR) for clinic-based screening, (2) TR with mailed self-collection (SC), and (3) TR with mailed SC and patient navigation among a random sample of CCS-eligible patients not up to date with CCS, including those with no CCS on record. The trial was conducted from February 20, 2020, to August 31, 2023.

Interventions All groups received a TR by a patient navigator to attend clinic-based CCS. In the SC and SC with patient navigation groups, participants were additionally mailed a self-collection kit to their home as an alternative to clinic-based CCS. In the SC with patient navigation group, the mailed kit was followed by a patient navigation telephone call.

Main Outcomes and Measures CCS participation was defined as attendance for clinic-based screening or return of a mailed self-collection kit within 6 months of randomization and determined through electronic health record review.

Results Of the 2474 participants in the intent-to-screen analyses (median [IQR] age, 49 [39-57] years), 2325 (94.0%) were from racial or ethnic minoritized populations (1655 [66.9%] identifying as Hispanic or Latino, 82 [3.3%] as non-Hispanic Asian, 535 [21.6%] as non-Hispanic Black or African American, and 53 [2.1%] as other or unknown race, including American Indian or Alaska Native and Native Hawaiian or Other Pacific Islander), and 1388 (56.1%) were covered by the county’s publicly funded financial assistance program. At 6 months, 144 of 828 participants (17.4%) in the TR group, 340 of 828 (41.1%) in the SC group, and 381 of 818 (46.6%) in the SC with patient navigation group had participated in CCS. Compared to TR, relative participation was 2.36 (95% CI, 1.99-2.80) times higher for SC and 2.68 (95% CI, 2.27-3.16) times higher for SC with patient navigation; screening difference was 23.7% (95% CI, 19.4%-27.9%) for SC and 29.2% (95% CI, 24.9%-33.5%) for SC with patient navigation.

Conclusions and Relevance In this randomized clinical trial in a safety-net health system, SC was effective for increasing CCS participation among underscreened patients; there were modest additional gains from SC with patient navigation. The large increase in CCS participation using SC compared to TR suggest that SC should be considered in safety-net settings with suboptimal CCS coverage.

Trial Registration ClinicalTrials.gov Identifier: NCT03898167

Author/s:

Jane R. Montealegre, Susan G. Hilsenbeck, Shaun Bulsara

Self-Collection for Cervical Cancer Screening in a Safety-Net Setting: The PRESTIS Randomized Clinical Trial

Megan George — Thu, 04 Sep 2025 19:41:13 +0000

Date Added:

September 4, 2025

Journal/Publication:

JAMA Internal Medicine

Publication Date:

June 6, 2025

URL:

Self-Collection for Cervical Cancer Screening in a Safety-Net Setting: The PRESTIS Randomized Clinical Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jamainternmed.2025.2971

Keywords

PMID (1):

40478588

MeSH

Uterine Cervical Neoplasms* / diagnosis

Single-Blind Method

Safety-net Providers*

Early Detection of Cancer* / methods

In community health centers, use of self-collection of specimens for cervical cancer screening was significantly more effective than telephonic reminders. James W. Mold, MD, MPH

Free full text

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Importance There are limited data on the effectiveness of mailed self-collection to increase cervical cancer screening (CCS) participation in underresourced health care settings.

Objective To compare the effectiveness of mailed self-collection kits, with and without patient navigation, to telephone reminders to increase CCS in a safety-net health system.

Trial Registration ClinicalTrials.gov Identifier: NCT03898167

Author/s:

Jane R. Montealegre, Susan G. Hilsenbeck, Shaun Bulsara

Clinical Validation of a Vaginal Cervical Cancer Screening Self-Collection Method for At-Home Use: A Nonrandomized Clinical Trial

Alex Haga — Tue, 27 May 2025 13:21:18 +0000

Date Added:

May 27, 2025

Journal/Publication:

JAMA

Publication Date:

May 1, 2025

URL:

Clinical Validation of a Vaginal Cervical Cancer Screening Self-Collection Method for At-Home Use: A Nonrandomized Clinical Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jamanetworkopen.2025.11081

Keywords

Vaginal Cervical Cancer

Self-Collection

At-Home

screening

PMID (1):

40388167

MeSH

Early Detection of Cancer* / methods

Mass Screening* / methods

Papillomavirus Infections

Uterine Cervical Neoplasms* / diagnosis

An in-home, patient administered screening test for cervical cancer was highly accurate when compared with usual in-office testing. James W. Mold, MD, MPH

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Importance: One-quarter of US women who are at risk for cervical cancer delay screening. Self-collected (SC) cervical screening was recently US Food and Drug Administration (FDA)-approved in the US for use in a health care setting only; an at-home SC option is crucial to address clinic-related barriers to screening.

Objective: To clinically validate the use of an SC device that was designed for optimal at-home performance, safety, ease-of-use, and dry storage and transport.

Design, setting, and participants: This nonrandomized clinical trial used a prospective method comparison study design. Participants aged 25 to 65 years were recruited from 16 clinical sites in the US including community and academic practices from November 20, 2023, to April 5, 2024. Data analysis was conducted from April to August 2024.

Intervention: Eligible participants collected a sample with the SC method, followed by a clinician-collected (CC) sample. The SC sample was eluted into PreservCyt at the laboratory and both samples were tested on an FDA-approved high risk human papillomavirus (hrHPV) test approved for primary screening. Participants were followed up for safety and completed usability and screening preference surveys.

Main outcome and measures: The primary outcome measures were positive percentage agreement (PPA) and negative percentage agreement for detection of hrHPV between the SC and CC samples. Other study measures included clinical sensitivity for high grade cervical dysplasia and usability.

Results: Of 609 screening-eligible participants, 599 (262 aged 30-39 years [43.7%]; 583 identified as female [97.3%]) had paired SC-CC samples, of which 582 had valid paired samples included in the end point analysis. Among the 582 evaluable paired samples, the PPA between SC compared with paired CC samples for detection of hrHPV was 95.2% (95% CI, 92.1%-97.1%; 278 of 292 participants). The absolute clinical sensitivity for detection of high-grade cervical dysplasia was 95.8% (95% CI, 86.0%-98.8%; 46 of 48 participants), equivalent to the CC (relative sensitivity, 1.00). Nearly all participants (555 of 601 participants [92.3%]) reported that the device instructions were easy or very easy to understand and also that they would choose SC if they knew the results were comparable to CC results (560 of 602 participants [93.0%]).

Conclusions and relevance: In this nonrandomized clinical trial, SC samples collected with the device showed equivalent clinical sensitivity and exceeded the PPA end point for cervical screening. This SC method was found to be easy to use and to be a preferred option with high clinical performance intended for use in an at-home setting.

Author/s:

Megan B Fitzpatrick, Catherine M Behrens, Karl Hibler, Courtney Parsons