Evaluating the Human Papillomavirus Self-Collection Experience in Individuals Who Have Experienced Sexual Trauma

NCT ID: NCT05458869

Last Updated: 2023-06-27

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

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-06

Study Completion Date

2023-05-30

Brief Summary

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This study explores the human papillomavirus (HPV) self-collection experience among individuals with a history of sexual trauma. Cervical cancer is the fourth most common cancer in women worldwide and is the second leading cause of cancer-related death in women ages 29-39. Despite programs to improve accessibility of cervical cancer screening and overall high screening rates, disparities in routine surveillance have been demonstrated in certain populations, such as victims of intimate partner violence and sexual trauma. One barrier to participating in cervical cancer screening for this population is the office-based visit which necessitates the individual to undress, sit with their legs in stirrups, and undergo speculum examination for specimen collection. This type of visit may cause distress for participants who have experienced sexual violence. HPV self-collection has been studied with favorable outcomes in effectiveness and ease of use. This study evaluates the experience of HPV self-collection among individuals who have experienced sexual trauma.

Detailed Description

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PRIMARY OBJECTIVE:

I. To explore the HPV self-collection experience among individuals with a history of sexual trauma.

OUTLINE:

Participants complete a survey, use an HPV self-collection kit, and attend an interview over 30 minutes.

Conditions

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Cervical Carcinoma Human Papillomavirus Infection

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational (survey, HPV self-collection, interview)

Participants complete a survey, use an HPV self-collection kit, and attend an interview over 30 minutes.

HPV Self-Collection

Intervention Type PROCEDURE

Use HPV self-collection kit

Interview

Intervention Type OTHER

Attend interview

Survey Administration

Intervention Type OTHER

Complete surveys

Interventions

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HPV Self-Collection

Use HPV self-collection kit

Intervention Type PROCEDURE

Interview

Attend interview

Intervention Type OTHER

Survey Administration

Complete surveys

Intervention Type OTHER

Other Intervention Names

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At-home HPV Self Collection HPV Self Collection Human Papillomavirus Self-Collection

Eligibility Criteria

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Inclusion Criteria

* Individuals with a cervix who are eligible for primary HPV testing (age 25 and older) according to national cervical cancer screening guidelines
* Identify themselves as having a history of IPV, sexual abuse, or sexual trauma
* Participants will also need to have access to a smartphone, tablet, or computer with video capability
* English speaking
* Reside in the State of Oregon
* Patients who have participated in prior HPV self-collection study (reference Institutional Review Board \[IRB\] number- IRB# 23478) will also be eligible to participate in the interview if they meet the remaining eligibility requirements (i.e. history of IPV, sexual abuse, sexual trauma)

Exclusion Criteria

* Individuals who are not English speaking
* Individuals \< 25 years old or no longer eligible/recommended to undergo cervical cancer screening
* Resides outside the state of Oregon
* Adults who are unable to consent or are decisionally impaired
* Individuals without a cervix (i.e. prior hysterectomy)
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role collaborator

Robert Wood Johnson Foundation

OTHER

Sponsor Role collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Amanda Bruegl, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amanda S Bruegl

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

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OHSU Knight Cancer Institute

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2022-05454

Identifier Type: REGISTRY

Identifier Source: secondary_id

STUDY00024429

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00024429

Identifier Type: -

Identifier Source: org_study_id

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