Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer Trial — STEP  

Cervical Cancer Clinical Trial

Official title: Self-Testing Options in the Era of Primary HPV Screening for Cervical Cancer: the STEP Trial

Status Completed

Clinical Trial Summary

The Self-Testing options in the Era of Primary HPV screening for cervical cancer (STEP) trial will evaluate effectiveness of home-based HPV kits for improving cervical cancer screening uptake and its cost-effectiveness. The investigators will compare cervical cancer screening uptake within six months among women randomized to different outreach approaches based on prior screening behavior: A) Adherent and coming due: direct mail HPV kit vs. opt-in HPV kit vs. education; B) Overdue: direct mail HPV kit vs. education; C) Unknown: opt-in HPV kit vs. education.

Clinical Trial Description

The scientific objective of the proposed research is to study whether an in-home programmatic HPV screening outreach strategy improves cervical cancer screening initiation and uptake. Identifying new, patient-centered options that motivate continued screening initiation and uptake is essential now and in the future.

In August 2018, the US Preventive Services Task Force released updated cervical cancer screening guidelines that include human papillomavirus (HPV) testing alone (ie, primary HPV screening) as a newly recommended strategy for women aged 30-65 years. With primary HPV screening, home-based screening is an emerging option, because HPV tests (unlike Pap tests) can be performed on clinician- or self-collected samples. Self-collected samples are as sensitive as clinician-collected samples in detecting HPV and mailing HPV self-sampling kits increases screening participation. As US healthcare systems prepare to implement primary HPV screening, they will need to consider a variety of strategies. To date, HPV self-sampling randomized clinical trials have included only overdue women; no study has evaluated uptake and acceptance of HPV self-sampling kits as an alternative to in-clinic screening in a screening-adherent population.

Based on our Home-based Options to Make cervical cancer screening Easy (HOME) trial (ClinicalTrials.gov, NCT02005510), most women will test negative (88%) and can continue routine screening; 11% will require in-clinic follow-up: 3% directly to colposcopy (HPV-16/18+ results) and 8% to Pap because of "HPV+ other" results or an unsatisfactory result (<1%). For home-based HPV screening strategies to be successful, ensuring high follow-up compliance in the minority of women who test positive is critical. ;

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Dysplasia
• Genital Neoplasms, Female
• HPV Infection
• HPV-Related Cervical Carcinoma
• HPV-Related Malignancy
• Human Papilloma Virus
• Neoplasms
• Neoplasms by Site
• Papilloma
• Papillomavirus Infections
• Urogenital Neoplasms
• Uterine Cervical Diseases
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasm
• Uterine Cervical Neoplasms
• Uterine Diseases
• Uterine Neoplasms

• NCT number: NCT04679675
• Study type: Interventional
• Source: Kaiser Permanente
• Status: Completed
• Phase: N/A
• Start date: November 20, 2020
• Completion date: July 29, 2023