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

NCT05458869 | Completed

• 2 other identifiers: STUDY00024429NCI-2022-05454
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Carcinoma; Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Observational (survey, HPV self-collection, interview)

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

Procedure: HPV Self-Collection; Other: Interview; Other: Survey Administration

Interventions

HPV Self-Collection PROCEDURE

Use HPV self-collection kit

Also known as: At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-Collection

Observational (survey, HPV self-collection, interview)

Interview OTHER

Attend interview

Observational (survey, HPV self-collection, interview)

Survey Administration OTHER

Complete surveys

Observational (survey, HPV self-collection, interview)

Eligibility Criteria

• Age: 25 Years+
• Gender Eligibility Details: Females are individuals with a cervix including women, gender non-forming, non-binary and transgender (trans) persons
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

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; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Amanda S Bruegl

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 14, 2022
• Study Start: September 6, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

US (1)