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Cervical CancerACCESSNCT05528237

HPV Self-sampling to Improve Access to Cervical Cancer Screening for Persons With HIV and/or Underserved Individuals

A study testing Flocked swab paired with Roche Cobas 4800 in people with Cervical Cancer, run by University of Washington at 3 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The objective of this study is to evaluate self-collection of vaginal samples for HPV testing as an alternative cervical cancer screening strategy for persons with HIV and/or limited access to care. Read more about this study

Who is it for?
Ages 25 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Cervical Cancer
What is being tested?
Flocked swab paired with Roche Cobas 4800
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesUnited States
Study dates
18 Aug 2022to 7 Oct 2022
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age >=25 and <65 (individuals without diagnosed HIV) or >=30 years (individuals with diagnosed HIV)
  • Female sex at birth
  • Proficient in English or Spanish
  • Refused a Pap smear or are >=6 months overdue for cervical cancer screening

Who cannot join

  • Current pregnancy
  • Complete hysterectomy
  • History of cervical cancer
  • Unable to provide informed consent

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States3 sites

  • SHE Clinic

    Seattle, Washington, 98103

  • Madison Clinic

    Seattle, Washington, 98104

  • MAX Clinic

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: Advancing Cervical Cancer Screening Through Self-Sampling (ACCESS): A Pilot Study of HPV Self-sampling for Cervical Cancer Prevention in Washington State

The objective of this study is to evaluate self-collection of vaginal samples for HPV testing as an alternative cervical cancer screening strategy for persons with HIV and/or limited access to care. Self-collection kits will be offered to persons who refuse a Pap smear or are overdue (>=6 months) for cervical cancer screening, with screening uptake recorded as a primary outcome. Kits will be offered in-clinic to individuals who refuse a Pap smear, and individuals overdue for screening will have the option to receive and return kits in the mail. The investigators will additionally administer a phone-based survey to evaluate knowledge about HPV and cervical cancer, barriers and facilitators to screening, and attitudes towards screening. Data from medical records will be abstracted to describe the clinical characteristics of the sample and measure receipt of follow-up procedures. Focus groups will be conducted with clinic administrators, staff, and HIV and women's health experts to evaluate clinic and provider barriers and facilitators to cervical cancer screening. The investigators hypothesize that HPV self-sampling will result in favorable patient-centered outcomes and could reduce disparities in access to screening.

Conditions
Cervical Cancer
Being tested
Flocked swab paired with Roche Cobas 4800
Keywords
Screening, Self-collection, Self-sampling, Cervical cancer, HPV, HIV
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flocked swab paired with Roche Cobas 4800Device

    Also called COPAN 552c FLOQSwabs

    Consenting individuals will insert the sterile flocked swab into the vagina, rotate at least once, and store in the provided dry tube. The sample will be stored at ambient temperature and routed to the lab for HPV testing with Roche Cobas 4800.

Study groups in NCT05528237
Study groupRoleWhat they receive
HPV self-samplingExperimentalParticipants will be offered self-collection kits for HPV-based cervical cancer screening.
Receives: Device: Flocked swab paired with Roche Cobas 4800

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of eligible individuals who accept self-sampling kits

    the proportion of eligible individuals due or overdue for screening who agree to collect a vaginal sample for HPV testing.

    Measured: Baseline (during clinical and/or study recruitment encounter)

  2. Proportion of eligible individuals who submit self-sampled specimens

    the proportion of individuals who agree to self-collection who return samples

    Measured: 3 weeks from enrollment

  3. Satisfaction with self-collection

    Participants will use a 5-point Likert scale (strongly agree, agree, neutral, disagree, strongly disagree) to respond to the statement, "I was satisfied with the self-collection experience."

    Measured: Within 2 weeks of sample collection

  4. Confidence with self-collection

    Participants will use a 5-point Likert scale (strongly agree, agree, neutral, disagree, strongly disagree) to respond to the statement, "I am sure I got a good sample using the swab."

    Measured: Within 2 weeks of sample collection

  5. Recommendation of self-collection

    Participants will use a 5-point Likert scale (strongly agree, agree, neutral, disagree, strongly disagree) to respond to the statement, "I would recommend self-collection to a friend."

    Measured: Within 2 weeks of sample collection

  6. Ease of returning home kits

    Participants who collected a sample at home will use a 5-point Likert scale (strongly agree, agree, neutral, disagree, strongly disagree) to respond to the statement, "It was easy to return my sample (by mail or to the clinic)."

    Measured: Within 2 weeks of sample collection

Secondary outcomes (9)

  1. Proportion of eligible individuals who return samples with adequate specimens

    the proportion of returned samples that have valid specimens for HPV testing

    Measured: 3 weeks from enrollment

  2. Knowledge about HPV and cervical cancer screening

    a survey to measure participant's knowledge about HPV and cervical cancer screening

    Measured: Baseline

  3. Perceived risk of cervical cancer

    a survey to measure participant's perceived risk of cervical cancer

    Measured: Baseline

  4. Attitudes and preferences for screening

    a survey to measure participant's attitudes and preferences for cervical cancer screening

    Measured: Baseline

  5. HPV prevalence checklist

    the distribution of HPV results from all individuals who return a self-sampled specimen

    Measured: Baseline

  6. Receipt of follow-up care

    Among participants who screen positive for hrHPV, measure the proportion who receive indicated follow-up care (cytology and/or colposcopy)

    Measured: Up to 6 months after self-sampling

  7. Reflex cytology results checklist

    the results of cytology tests following positive self-sampled HPV results

    Measured: Up to 6 months after self-sampling

  8. Colposcopy results checklist

    the results of colposcopy tests following positive self-sampled HPV results.

    Measured: Up to 6 months after self-sampling

  9. Provider and/or clinic barriers and facilitators to cervical cancer screening survey

    focus group discussions with clinic administrators, staff and other HIV and women's health experts. These discussions will cover: barriers to clinician-administered screening (i.e., Pap screening and clinician-collected HPV samples); perceived patient barriers to clinician-administered screening and follow-up procedures; perceived facilitators to cervical cancer screening and follow-up; and feasibility of offering HPV self-sampling kits as a potential primary screening strategy.

    Measured: During study year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2022
  2. Study start18 Aug 2022
  3. Primary completion30 Sep 2022 (estimated)
  4. Study completion7 Oct 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05528237
Sponsor's protocol ID
STUDY00014442
Other IDs
5KL2TR002317-05
Acronym
ACCESS
Status last verified
Aug 2022
First submitted
29 Aug 2022
Last updated
6 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: De-identified study data will be posted on a repository for use in studies on access to healthcare and sexual and reproductive health, including but not limited to cervical cancer services.

Questions about this trial

What is this clinical trial studying?

A study testing Flocked swab paired with Roche Cobas 4800 in people with Cervical Cancer, run by University of Washington at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of eligible individuals who accept self-sampling kits (time frame: Baseline (during clinical and/or study recruitment encounter)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05528237.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.

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