Effect of Human Papillomavirus Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

665 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-04-10

Brief Summary

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This study will investigate whether cervical cancer screening completion among under-screened women could be improved by offering HPV (human papillomavirus) testing by at-home self-collection followed by screening invitation compared to screening invitation alone.

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Detailed Description

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Invasive cervical cancer (ICC) is preventable through regular screening and treatment, but one fifth of US women report not receiving Pap testing at recommended intervals. More than half of ICC cases occur in these under-screened women. For women 30 years and older, the US Preventive Services Task Force recommends Pap smears alone every 3 years or physician-collected HPV testing with Pap smear (co-testing) every 5 years. The FDA approved primary HPV physician screening for US women 25 years and older. Self-collection for HPV testing is a valid and well-accepted method for detecting HPV infection with comparable sensitivity and specificity to physician-collection for detecting high-grade cervical lesions.

This 2-arm randomized control trial of 510 women will investigate whether offering HPV testing by mailed at-home self-collection to under-screened women increases their likelihood of completing cervical cancer screening. All participants will received a screening invitation by phone: a phone call providing (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free screening at a study-affiliated clinic, if needed. Those randomized to the intervention arm will first be mailed a kit to self-collect a cervico-vaginal sample, return the sample for oncogenic HPV testing, and receive their results by phone. HPV negative women will be considered screening complete. HPV positive women will be invited to schedule an appointment for free follow-up in-clinic screening in the same call in which their results are delivered. The study endpoint of screening completion will be defined as completing in-clinic screening (control arm participants and HPV positive intervention arm participants) or receiving a negative HPV self-collection result (intervention arm).

Aim 1. Determine whether at-home HPV self-collection increases completion of cervical cancer screening among under-screened women offered enhanced reminders.

Aim 2. Examine possible mechanisms explaining the intervention's effect, or lack of an effect.

Aim 3. Estimate the incremental cost per additional woman completing screening of adding at-home HPV self-collection to enhanced reminders.

Conditions

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Cervical Cancer Uterine Cervical Neoplasms Human Papillomavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Screening invitation (with education)

Participants will receive a phone call providing (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free cervical cancer screening at a study-affiliated clinic.

Group Type ACTIVE_COMPARATOR

Screening invitation (with education)

Intervention Type BEHAVIORAL

The participant will be provided with brief education about the importance and effectiveness of cervical cancer screening, and invited to schedule an appointment for a free in-clinic screening

Self-collection for HPV testing

Participants in the intervention arm will receive a kit to self-collect a sample and return it for HPV testing. Participants will then receive a phone call providing their HPV results plus (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free cervical cancer screening at a study-affiliated clinic, if desired.

Group Type EXPERIMENTAL

Screening invitation (with education)

Intervention Type BEHAVIORAL

The participant will be provided with brief education about the importance and effectiveness of cervical cancer screening, and invited to schedule an appointment for a free in-clinic screening

Self-collection for HPV testing

Intervention Type BEHAVIORAL

Participant is provided with a kit to take a self-collected sample at home and return it by mail for HPV testing. Results are provided to participant by phone.

Interventions

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Screening invitation (with education)

The participant will be provided with brief education about the importance and effectiveness of cervical cancer screening, and invited to schedule an appointment for a free in-clinic screening

Intervention Type BEHAVIORAL

Self-collection for HPV testing

Participant is provided with a kit to take a self-collected sample at home and return it by mail for HPV testing. Results are provided to participant by phone.

Intervention Type BEHAVIORAL

Other Intervention Names

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Screening recall Client reminder Self-testing Self-sampling

Eligibility Criteria

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Inclusion Criteria

* Female
* Aged 25 to 64 years old
* Living at ≤250% of the federal poverty line
* Eligible to receive cervical cancer screening from a study-associated clinic
* Resides within the same or bordering county of a study-associated clinic

Exclusion Criteria

* Completion of cervical Pap screening in preceding 4 years
* Completion of HPV testing in preceding 6 years
* Pregnant
* History of hysterectomy
* Private insurance
* Unable to provide informed consent

Minimum Eligible Age

25 Years

Maximum Eligible Age

64 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes