Easier cervical cancer screening with self-collected HPV tests at safety-net clinics

Expanding Access to Cervical Cancer Screening Through Primary HR-HPV Testing and Self-sampling: a Multicomponent Intervention for Safety Net Health Systems

This project will test whether offering primary high-risk HPV testing with self-collected samples increases cervical cancer screening for people aged 25–65 who get care at participating Texas safety-net clinics.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 7100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: M.D. Anderson Cancer Center (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06843720 on ClinicalTrials.gov

What this trial studies

This multicomponent implementation program uses a cluster randomized stepped-wedge design across partner safety-net clinics to offer primary HR-HPV testing with optional self-collection to underscreened patients. The project combines formative research with patients, providers, and stakeholders, a stakeholder advisory board, and provider training and patient education materials to support rollout. Implementation outcomes will be measured using CFIR and RE-AIM frameworks while tracking screening uptake, follow-up of abnormal results, and clinic-level adoption. The program aims to increase screening coverage and opportunistic screening encounters and to ensure navigation to diagnostic testing for abnormal results.

Who should consider this trial

Good fit: People aged 25–65 with a cervix who live in Texas, receive care at a participating partner clinic, and are due or past due for cervical cancer screening are ideal candidates.

Not a fit: People already up-to-date with screening, those younger than 25 or older than 65, individuals without a cervix, or people who do not receive care at participating clinics are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, more people in underserved clinics may complete cervical cancer screening earlier via convenient self-collection, improving early detection and timely treatment.

How similar studies have performed: Prior studies, including international and some U.S. work, have shown that self-collected HPV testing increases screening participation, but large-scale implementation across U.S. safety-net health systems remains relatively untested.

Eligibility criteria

Inclusion Criteria:

Populations involved in the research are: 1) stakeholder advisory board members; 2) Participants eligible for cervical cancer screening participating in the cluster randomized stepped-wedge trial; 3) Patients and community members participating in formative research activities; 4) Providers, clinic staff, and other health system stakeholders from partnering health systems; 5) Project ECHO Participants (providers, clinic staff, and other health system stakeholders from partner and non-partner institutions).

6\) Other Clinical Networks (providers, clinic staff and other health system stakeholders from partner and non-partner institutions)

The eligibility criteria for each are:

Participants eligible for cervical cancer screening:

* Currently a resident in the state of Texas
* Attend for care at a partner clinic enrolled in the study
* Women and persons with a cervix
* Age 25-65
* Due or past due for cervical cancer screening

Participants and community members participating in formative research activities:

• Purposively identified as a stakeholder for formative research by research staff

Providers, clinic staff, and other health system stakeholders from partnering health systems:

* Employed at least part-time by a partnering health system
* Age 18+

Project ECHO Participants:

* Participate in at least one Project ECHO session
* Age 18+

Other Clinical Networks:

* Participate in at least one clinical network session
* Age 18+

Exclusion Criteria:

Participants eligible for cervical cancer screening:

* Report being currently pregnant
* History of total hysterectomy
* History of cervical cancer

Other study populations:

• Unable to communicate in English or Spanish

Vulnerable Populations Participants/samples belonging to vulnerable populations (children, pregnant women, cognitively impaired adults, or prisoners) will be prohibited from participation.

Where this trial is running

Houston, Texas

• MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Jane R Montealegre, PHD

Conditions: HR-HPV Testing