Recruiting

HPV Screening

Sponsor:

University of Hawaii

Code:

NCT05989464

Conditions

HPV

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

Interventions

Self-swab for genital HPV

Study Details

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

Study ID

NCT05989464

Start date

Aug 8, 2023

Status verified date

Aug, 2023

Completion date

Feb 1, 2025

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

84 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Self-swab for genital HPV

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

Primary outcome measure

  • Percentage of swabs with result [ Time Frame: Within 1 week of swab collection ]
  • Percentage of participants with abnormal result [ Time Frame: Within 1 week of swab collection ]

Central Contacts and Locations

Central contacts

Jonathan Riel

(808) 203-6502jriel@hawaii.edu

Paris Stowers, MD

stowersp@hawaii.edu

Locations

Kalihi Palama

Recruiting

Honolulu, Hawaii, United States, 17460

Contacts

Ann Chang, MD

808-222-9305annchang@hawaii.edu

More Information

Sponsor

University of Hawaii

Last update posted

Aug 25, 2023

Last verified

Aug, 2023

Keywords

  • hpv
  • self swab
  • cervical cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Hawaii on 2023-08-25.