Clinical trial · Interventional
Prospective Evaluation of Self-Testing to Increase Screening
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
NCT03898167CI-TRIAL-00094509PRESTIScompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mailed HPV Self-Sampling Kit | Behavioral | — | UNRESOLVED |
| Patient Navigation | Behavioral | — | UNRESOLVED |
| Telephone Recall | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Telephone Recall
- description
- Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System.
- interventionNames
- Behavioral: Telephone Recall
- type
- EXPERIMENTAL
- label
- Mailed HPV Self-Sampling Kit
- description
- 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.
- interventionNames
- Behavioral: Telephone Recall
- Behavioral: Mailed HPV Self-Sampling Kit
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDMontealegre 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. PMID 33087164
- BACKGROUNDAmboree TL, Parker SL, Bulsara S, Anderson ML, Schmeler KM, Chiao EY, Montealegre JR. Cervical cancer screening among English- and Spanish-speaking Hispanic women in an urban safety net health system, 2015-2020. BMC Womens Health. 2023 Jun 15;23(1):309. doi: 10.1186/s12905-023-02448-3. PMID 37316815
- RESULTParker S, Deshmukh AA, Chen B, Lairson DR, Daheri M, Vernon SW, Montealegre JR. Perceived barriers to cervical cancer screening and motivators for at-home human papillomavirus self-sampling during the COVID-19 pandemic: Results from a telephone survey. Elife. 2023 May 26;12:e84664. doi: 10.7554/eLife.84664. PMID 37232493
- RESULTParker SL, Amboree TL, Bulsara S, Daheri M, Anderson ML, Hilsenbeck SG, Jibaja-Weiss ML, Zare M, Schmeler KM, Deshmukh AA, Chiao EY, Scheurer ME, Montealegre JR. Self-Sampling for Human Papillomavirus Testing: Acceptability in a U.S. Safety Net Health System. Am J Prev Med. 2024 Mar;66(3):540-547. doi: 10.1016/j.amepre.2023.10.020. Epub 2023 Nov 5. PMID 37935320
- DERIVEDMontealegre JR, Hilsenbeck SG, Bulsara S, Parker SL, Amboree TL, Anderson ML, Daheri M, Jibaja-Weiss ML, Schmeler KM, Deshmukh AA, Chiao EY, Scheurer ME. Self-Collection for Cervical Cancer Screening in a Safety-Net Setting: The PRESTIS Randomized Clinical Trial. JAMA Intern Med. 2025 Sep 1;185(9):1119-1127. doi: 10.1001/jamainternmed.2025.2971. PMID 40478588