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

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

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-18

Study Completion Date

2022-10-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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HPV self-sampling

Participants will be offered self-collection kits for HPV-based cervical cancer screening.

Group Type EXPERIMENTAL

Flocked swab paired with Roche Cobas 4800

Intervention Type DEVICE

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.

Interventions

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Flocked swab paired with Roche Cobas 4800

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.

Intervention Type DEVICE

Other Intervention Names

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COPAN 552c FLOQSwabs

Eligibility Criteria

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Inclusion Criteria

* 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