Clinical trial NCT05458869: Evaluating the Human Papillomavirus Self-Collection Experience in Individuals Who Have Experienced Sexual Trauma
Official title: Qualitative Study of HPV Self-Collection Experience and Cervical Cancer Screening in Patients With a History of Sexual Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Carcinoma
Human Papillomavirus Infection
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: Robert Wood Johnson Foundation
First posted: 2022-07-14
Enrollment: 16
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with a history of intimate partner violence (IPV), sexual abuse, or sexual trauma and who are eligible for primary HPV based cervical cancer screening.

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Experience of cervical cancer screening in patients with a history of sexual trauma
timeFrame: Up to 12 months
measure: Utility of HPV self-collection among patients with a history of sexual trauma
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Amanda S Bruegl
role: PRINCIPAL_INVESTIGATOR
References: