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

Qualitative Study of HPV Self-Collection Experience and Cervical Cancer Screening in Patients With a History of Sexual Trauma

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.

Study Overview

• Status: Completed
• Conditions: Cervical Carcinoma; Human Papillomavirus Infection
• Intervention / Treatment: Other: Survey Administration; Other: Interview; Procedure: HPV Self-Collection

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.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (survey, HPV self-collection, interview); Participants complete a survey, use an HPV self-collection kit, and attend an interview over 30 minutes.	Other: Survey Administration; Complete surveys; Other: Interview; Attend interview; Procedure: HPV Self-Collection; Use HPV self-collection kit; Other Names: At-home HPV Self Collection; HPV Self Collection; Human Papillomavirus Self-Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience of cervical cancer screening in patients with a history of sexual trauma	Data analysis of interview transcripts will occur concurrent with data collection. The transcripts will be analyzed using Taguette, a qualitative software program. The coding scheme to analyze interview transcripts will be developed through an iterative and reflective process using grounded theory. A comparative, iterative, and interactive method, grounded theory follows a cyclical research process of collecting, analyzing and coding data, memo-writing and theoretical sampling to the point of saturation, where no new ideas, theories or constructs emerge. The research team will thoroughly explore the data and develop a comprehensive list of categories. The categories will be used to identify themes and make connections both between and across interview subjects. Thematic analysis will be basis of the study's findings.	Up to 12 months
Utility of HPV self-collection among patients with a history of sexual trauma	Data analysis of interview transcripts will occur concurrent with data collection. The transcripts will be analyzed using Taguette, a qualitative software program. The coding scheme to analyze interview transcripts will be developed through an iterative and reflective process using grounded theory. A comparative, iterative, and interactive method, grounded theory follows a cyclical research process of collecting, analyzing and coding data, memo-writing and theoretical sampling to the point of saturation, where no new ideas, theories or constructs emerge. The research team will thoroughly explore the data and develop a comprehensive list of categories. The categories will be used to identify themes and make connections both between and across interview subjects. Thematic analysis will be basis of the study's findings.	Up to 12 months

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: Oregon Health and Science University; Robert Wood Johnson Foundation
• Investigators: Principal Investigator: Amanda S Bruegl, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Disease Attributes; DNA Virus Infections; Trauma and Stressor Related Disorders; Tumor Virus Infections; Stress Disorders, Traumatic; Urogenital Diseases; Genital Diseases; Papillomavirus Infections; Sexual Trauma
• Other Study ID Numbers: STUDY00024429 (Other Identifier: OHSU Knight Cancer Institute); NCI-2022-05454 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No