Prospective Evaluation of Self-Testing to Increase Screening

NCT03898167CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Baylor College of Medicine

Enrollment

2474

Start Date

2020-02-13

Completion Date

2024-03-01

Study Type

INTERVENTIONAL

Official Title

A Randomized Controlled Trial of Mailed Self-Sample HPV Testing to Increase Cervical Cancer Screening Participation Among Minority/Underserved Women in an Integrated Safety Net Healthcare System

Interventions

Telephone RecallMailed HPV Self-Sampling KitPatient Navigation

Conditions

Cervical CancerHuman Papillomavirus Infection

Eligibility

Age Range

30 Years – 65 Years

Sex

FEMALE

Inclusion Criteria:

* no history of hysterectomy or cervical cancer
* no Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years
* patient of Harris Health System in Harris County (Houston), Texas
* have at least 2 visits to ambulatory care within Harris Health System in the past 5 years
* be currently enrolled in a healthcare coverage or financial assistance plan accepted by Harris Health System or have been enrolled in a Harris Health coverage plan in the past 12 months

Exclusion Criteria:

* no valid telephone contact information
* unable to communicate in English or Spanish\*
* currently pregnant
* history of cervical dysplasia in the past 3.5 years

Outcome Measures

Primary Outcomes

Primary Screening Participation

cervical cancer screening participation within 6 months, defined as return of a mailed HPV self-collection kit or attendance for clinic-based screening.

Time frame: within 6 months of randomization

Secondary Outcomes

Screening Tests Results

Results of HPV test using self-collected samples (positive, negative, or inadequate)

Time frame: within 6 months of randomization

Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result

Electronic medical record (EMR)-confirmed attendance for colposcopy among participants who had a positive test by clinic-based screening; EMR- confirmed attendance for colposcopy or subsequent clinic-based screening among those who had a positive test by self-sampling

Time frame: Attendance to clinical follow up was assessed within 12 months of screening test result, up to 18 months post randomization.

Locations

Harris Health System, Houston, United States

Linked Papers

2023-05-26

Perceived barriers to cervical cancer screening and motivators for at-home human papillomavirus self-sampling during the COVID-19 pandemic: Results from a telephone survey

Background: Home-based self-sampling for human papillomavirus (HPV) testing may be an alternative for women not attending clinic-based cervical cancer screening. Methods: We assessed barriers to care and motivators to use at-home HPV self-sampling kits during the COVID-19 pandemic as part of a randomized controlled trial evaluating kit effectiveness. Participants were women aged 30–65 and under-screened for cervical cancer in a safety-net healthcare system. We conducted telephone surveys in English/Spanish among a subgroup of trial participants, assessed differences between groups, and determined statistical significance at p<0.05. Results: Over half of 233 survey participants reported that clinic-based screening (Pap) is uncomfortable (67.8%), embarrassing (52.4%), and discomfort seeing male providers (63.1%). The last two factors were significantly more prevalent among Spanish vs English speakers (66.4% vs 30% (p=0.000) and 69.9 vs 52.2% (p=0.006), respectively). Most women who completed the kit found Pap more embarrassing (69.3%), stressful (55.6%), and less convenient (55.6%) than the kit. The first factor was more prevalent among Spanish vs English speakers (79.6% vs 53.38%, p=0.001) and among patients with elementary education or below. Conclusions: The COVID-19 pandemic influenced most (59.5%) to participate in the trial due to fear of COVID, difficulty making appointments, and ease of using kits. HPV self-sampling kits may reduce barriers among under-screened women in a safety-net system. Funding: This study is supported by a grant from the National Institute for Minority Health and Health Disparitie s (NIMHD, R01MD013715, PI: JR Montealegre). Clinical trial number: NCT03898167 .

Self-Collection for Cervical Cancer Screening in a Safety-Net Setting

ImportanceThere are limited data on the effectiveness of mailed self-collection to increase cervical cancer screening (CCS) participation in underresourced health care settings.ObjectiveTo 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 ParticipantsThis 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.InterventionsAll 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 MeasuresCCS 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.ResultsOf 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 RelevanceIn 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 RegistrationClinicalTrials.gov Identifier: NCT03898167

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