Prospective Evaluation of Self-Testing to Increase Screening

Study Overview
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Brief Summary
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Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women. This study evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (HPV) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.

Detailed Description
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Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women. Using mailed self-sampling kits to test for high-risk human papillomavirus (HPV), the virus that causes cervical cancer, may overcome multiple barriers to clinic-based screening. This study is a randomized controlled trial to compare the effectiveness of three outreach interventions to increase primary screening participation and clinical follow-up among underscreened women a in a safety net health system. The three strategies that will be evaluated are: 1) telephone recall; 2) telephone recall with mailed self-sample HPV testing kits; and 3) telephone recall with mailed self-sample HPV testing kits and patient navigation.

Official Title
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A Randomized Controlled Trial of Mailed Self-Sample HPV Testing to Increase Cervical Cancer Screening Participation Among Minority/Underserved Women in an Integrated Safety Net Healthcare System

Conditions
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Cervical Cancer, Human Papillomavirus Infection

Intervention / Treatment
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* Behavioral: Telephone Recall
* Behavioral: Mailed HPV Self-Sampling Kit
* Behavioral: Patient Navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no history of hysterectomy or cervical cancer no Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years patient of Harris Health System in Harris County (Houston), Texas have at least 2 visits to ambulatory care within Harris Health System in the past 5 years be currently enrolled in a healthcare coverage or financial assistance plan accepted by Harris Health System or have been enrolled in a Harris Health coverage plan in the past 12 months Exclusion Criteria: no valid telephone contact information unable to communicate in English or Spanish currently pregnant history of cervical dysplasia in the past 3.5 years

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telephone Recall<br>Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System. | Behavioral: Telephone Recall<br>* Participants receive a scripted telephone recall from a trained patient navigator.<br>|
| Experimental: Mailed HPV Self-Sampling Kit<br>Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a pre-paid return envelope. | Behavioral: Telephone Recall<br>* Participants receive a scripted telephone recall from a trained patient navigator.<br>Behavioral: Mailed HPV Self-Sampling Kit<br>* Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.<br>|
| Experimental: Mailed HPV Self-Sampling Kit + Patient Navigation<br>Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education. | Behavioral: Telephone Recall<br>* Participants receive a scripted telephone recall from a trained patient navigator.<br>Behavioral: Mailed HPV Self-Sampling Kit<br>* Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.<br>Behavioral: Patient Navigation<br>* Participant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary screening participation | completion and return of a mailed self-sample HPV testing kit that is adequate for testing (i.e., does not produce unsatisfactory results) or attendance for clinic-based screening | within 6 months of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| completion of clinical follow-up among women with an abnormal screening test result | Electronic medical record (EMR)-confirmed attendance for colposcopy among participants who had a positive test by clinic-based screening; EMR- confirmed attendance for colposcopy or subsequent clinic-based screening among those who had a positive test by self-sampling | within 12 months of screening test result | 
| Screening tests results | Results of HPV test using self-collected samples (positive, negative, or inadequate) | within 6 months of randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Human Papillomavirus Infection, Self-Testing