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

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 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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Populations involved in the research are:

1. stakeholder advisory board members;
2. patients 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:

Patients 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

Patients 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:

Patients 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 it's running

• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Jane R Montealegre, PHD
• Email: jrmontealegre@mdanderson.org
• Phone: 713- 745-5008

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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.