Self-Collected Swabs for Primary Human Papilloma Virus (HPV) Screening

NCT05989464 | Unknown FDA Device

• 1 other identifier: 2022-00672
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will assess whether implementing a self-swab protocol for primary Human Papilloma Virus (HPV) testing is an effective method to increase cervical cancer screening in a sample of unscreened women in Hawaii. The findings of this study may support adoption of HPV self swab protocols both at Kalihi Palama Health Center (KPHC) and other Federally Qualified Health Centers (FQHC) in Hawaii.

Conditions

HPV

Keywords

hpv; self swab; cervical cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of swabs with result

  Percentage of swabs with result

  Within 1 week of swab collection

• Percentage of participants with abnormal result

  Percentage of participants with abnormal result

  Within 1 week of swab collection

Secondary Outcomes (5)

• Self reported ease of collecting the swab

  Immediately after swab is collected

• Willingness to collect this swab again in the future

  Immediately after swab is collected

• Self reported level of worry concerning collecting self swab

  Immediately after swab is collected

• Knowledge of HPV

  Immediately after swab is collected

• Knowledge of cervical cancer

  Immediately after swab is collected

Study Arms (1)

Human Papilloma Virus (HPV) Self swab

Enrolled participants will be instructed to perform a self swab for genital Human Papilloma Virus (HPV) infection. Additionally, a short survey will be administered to collect demographic information, evaluate knowledge of HPV/cervical cancer, and assess acceptability of HPV self swab.

Diagnostic Test: Self-swab for genital HPV

Interventions

Self-swab for genital HPV DIAGNOSTIC_TEST

Participants will insert a swab in the vagina to collect a sample for HPV testing.

Human Papilloma Virus (HPV) Self swab

Eligibility Criteria

• Age: 25 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be identified by their primary care clinician at the Kalihi Palama Health Center.

You may qualify if:

• Age of 25 years or older
• Have a cervix
• Have an indication for cervical cancer screening per Accreditation Council for Continuing Medical Education (ASCCP) guidelines
• Have been previously referred to women's health in the past 5 years or subjects have declined a women's health referral.
• Subjects must not have been seen in women's health clinic since referral was placed

You may not qualify if:

• Subjects unable to consent in one of the following languages: English, Chuukese, or Marshallese
• Subjects with known history of cervical cancer
• Subjects that are currently pregnant or within 3 months of giving birth

Sponsors & Collaborators

• University of Hawaii: lead

Study Sites (1)

Kalihi Palama

Honolulu, Hawaii, 17460, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Self-Collected Vaginal Swabs

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Ann Chang, MD

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Riel

CONTACT

(808) 203-6502; jriel@hawaii.edu

Paris Stowers, MD

CONTACT

stowersp@hawaii.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: August 8, 2023
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: August 25, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)