Self-collection of vaginal samples for HPV testing to enhance cervical cancer prevention

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of self-collected vaginal samples for HPV testing in patients referred for colposcopy and cervical excisional procedures. The study aims to compare the clinical accuracy of self-collected samples against clinician-collected samples in detecting cervical precancer and cancer. Participants will undergo both self-collection and clinician collection, followed by standard care procedures such as colposcopy and potential biopsies. The trial also explores factors affecting the usability and acceptability of self-collection methods.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Willingness and ability to provide a documented informed consent
* Is 25 years or older
* Has an intact cervix
* Has had a referral for colposcopy and/or cervical excisional procedure in which routine cervical cancer screening has included HPV testing (HPV primary screening, co-testing, or atypical squamous cell of undetermined significance \[ASC-US\] cytology triage) or abnormal cytology performed within the past 12 months preceding the referral visit
* Willing and able to undergo colposcopy, and if clinically indicated for standard of care (SOC) purposes, a biopsy, endocervical curettage, and/or a cervical excisional procedure, as applicable

Exclusion Criteria:

* Is pregnant when presenting for the referral visit or gave birth within the past 3 months
* Has a known history of excisional or ablative therapy to the cervix (e.g., loop electrosurgical excision procedure \[LEEP\], cone biopsy, cervical laser surgery, cryotherapy, thermal ablation) in the last 12 months prior to the referral visit
* Has had a complete or partial hysterectomy, either supracervical or involving removal of the cervix, via self-report or confirmation via medical records
* Known medical conditions that, in the opinion of the investigator, preclude study participation
* Previous participation in the SHIP Trial. Participation is defined as completing the self-collection
* Is experiencing unusual bleeding or pelvic pain

Where it's running

• Yale University
  New Haven, Connecticut, United States Recruiting
• University of Miami Miller School of Medicine-Sylvester Cancer Center
  Miami, Florida, United States Recruiting
• Johns Hopkins University/Sidney Kimmel Cancer Center
  Baltimore, Maryland, United States Recruiting
• University of Mississippi Medical Center
  Jackson, Mississippi, United States Recruiting
• UNC Lineberger Comprehensive Cancer Center
  Chapel Hill, North Carolina, United States Recruiting
• Virginia Commonwealth University/Massey Cancer Center
  Richmond, Virginia, United States Recruiting

Study contacts

• Principal investigator: Vikrant V Sahasrabuddhe — National Cancer Institute Division of Cancer Prevention

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Self-collected HPV testing to help prevent cervical cancer

  This trial tests whether people referred for colposcopy can collect their own vaginal sample for HPV testing and whether those self-samples match clinician-collected cervical samples.

  Recruiting at 18 sites National Cancer Institute (NCI) · Birmingham, Alabama and 17 other locations · NCT07281430

• Lived experiences of women with HPV infection

  This study talks with women who have HPV to hear in their own words how the infection affects daily life, relationships, and what information or support they wish they had.

  Recruiting Bilecik Seyh Edebali Universitesi · Bilecik, Bilecik · NCT07920666

• A Community Approach to Boost Cervical Cancer Screening for Hispanic and East African Immigrant Women

  The study tests a community-based program that offers self-collection HPV tests and information to Hispanic and East African immigrant women to see if screening rates improve.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07890402

• Flyte device to help urinary incontinence after pelvic radiation for endometrial or cervical cancer

  This study tests whether a home-use Flyte device, used during guided pelvic floor exercises, can improve urinary incontinence in women who had pelvic radiation for endometrial or cervical cancer.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07662824

• Neoadjuvant nivolumab for cervical cancer using tumor-draining lymph nodes

  This study tests different doses of nivolumab injected near the tumor to see if the treatment is safe and feasible before standard surgery in newly diagnosed cervical cancer.

  Recruiting Phase 1 University Medical Center Groningen · Groningen · NCT07653503

• Same-day HPV self-testing with digital cytology triage in Cameroon

  This project will test whether HPV self-sampling followed by same-day digital telecytology can quickly find which HPV-positive women aged 30–49 (25–49 if HIV-positive) in Cameroon need treatment.

  Recruiting at 2 sites University Hospital, Geneva · Yaoundé and 1 other locations · NCT07550010

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.