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NCT Number: NCT05458869

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

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Key information

Conditions

Cervical Carcinoma Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Human Papillomavirus Infection Infections Neoplasms Neoplasms by Site Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

25 year and older

Sex eligibility

Female

Study type

Observational

Primary location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HPV Self-Collection

Procedure

Use HPV self-collection kit

Other names: At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-Collection

interview

Other

Attend interview

Survey Administration

Other

Complete surveys

Primary outcomes

  1. Experience of cervical cancer screening in patients with a history of sexual trauma

    Time frame: Up to 12 months

    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.

  2. Utility of HPV self-collection among patients with a history of sexual trauma

    Time frame: Up to 12 months

    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.

Sponsors and collaborators

Lead sponsor

OHSU Knight Cancer Institute

Other

Collaborators

  • Oregon Health and Science University
  • Robert Wood Johnson Foundation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 14, 2022
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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