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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. This study is a supplement to increase representation of Asian and Asian American women in a pragmatic clinical trial that 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.
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. 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. The parent study (NCT03898167) 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. A supplemental accrual of Asian/Asian American persons (target n=240) was added to increase representation of this subpopulation in the parent trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephone Recall | Active Comparator | Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System |
|
| Mailed HPV Self-Sampling Kit | Experimental | 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 prepaid return envelope |
|
| Mailed HPV Self-Sampling Kit + Patient Navigation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone Recall | Behavioral | Participants receive a scripted telephone recall from a trained patient navigator. |
|
| 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 | [Time Frame: within 6 months of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Screening tests results | Results of HPV test using self-collected samples (positive, negative, or inadequate) | Time Frame: within 6 months of randomization |
| completion of clinical follow-up among women with an abnormal screening test result |
| Measure | Description | Time Frame |
|---|---|---|
| Detection of cervical precancer | Histologically-confirmed cervical intraepithelial neoplasia grade II or greater (CIN2+) | [Time Frame: within 12 months of screening test result] |
| Treatment of cervical precancer |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harris Health System | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33087164 | Background | Montealegre JR, Anderson ML, Hilsenbeck SG, Chiao EY, Cantor SB, Parker SL, Daheri M, Bulsara S, Escobar B, Deshmukh AA, Jibaja-Weiss ML, Zare M, Scheurer ME. Mailed self-sample HPV testing kits to improve cervical cancer screening in a safety net health system: protocol for a hybrid effectiveness-implementation randomized controlled trial. Trials. 2020 Oct 21;21(1):872. doi: 10.1186/s13063-020-04790-5. |
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Within one year of study completion.
Available upon request to Principal Investigator.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 29, 2026 | |
| Reset | Feb 17, 2026 |
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| Mailed HPV Self-Sampling Kit | Behavioral | 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. |
|
| Patient Navigation | Behavioral | 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. |
|
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
| Time Frame: within 12 months of screening test result |
Treatment of histologically-confirmed cervical intraepithelial neoplasia grade II or greater (CIN2+) per American Society for Colposcopy and Cervical Pathology guidelines
| [Time Frame: within 6 months of diagnosis] |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 29, 2026 | Feb 17, 2026 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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