Clinical trial · Interventional
Effect of Human Papillomavirus Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3
Effect of HPV Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3
NCT02651883CI-TRIAL-00062456MBMT-3completedN/AClinicalTrials.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)
This study will investigate whether cervical cancer screening completion among under-screened women could be improved by offering HPV (human papillomavirus) testing by at-home self-collection followed by screening invitation compared to screening invitation alone.
Conditions
Conditions (3)
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 | — | UNRESOLVED | — |
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Screening invitation (with education) | Behavioral | — | UNRESOLVED |
| Self-collection for HPV testing | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Screening invitation (with education)
- description
- Participants will receive a phone call providing (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free cervical cancer screening at a study-affiliated clinic.
- interventionNames
- Behavioral: Screening invitation (with education)
- type
- EXPERIMENTAL
- label
- Self-collection for HPV testing
- description
- Participants in the intervention arm will receive a kit to self-collect a sample and return it for HPV testing. Participants will then receive a phone call providing their HPV results plus (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free cervical cancer screening at a study-affiliated clinic, if desired.
- interventionNames
- Behavioral: Screening invitation (with education)
- Behavioral: Self-collection for HPV testing
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Aged 25 to 64 years old * Living at ≤250% of the federal poverty line * Eligible to receive cervical cancer screening from a study-associated clinic * Resides within the same or bordering county of a study-associated clinic Exclusion Criteria: * Completion of cervical Pap screening in preceding 4 years * Completion of HPV testing in preceding 6 years * Pregnant * History of hysterectomy * Private insurance * Unable to provide informed consent
References
Publications (6)
- DERIVEDGanguly AP, Pretsch PK, Brewer NT, Spees LP, Hudgens MG, Sanusi B, Barclay L, Carter A, Wheeler SB, Smith JS. Streamlined Self-Collection Screening for Sexually Transmitted Infections and Human Papillomavirus: A Single-Group Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2026 Jan 2;9(1):e2551345. doi: 10.1001/jamanetworkopen.2025.51345. PMID 41505134
- DERIVEDBroshkevitch CJ, Pretsch PK, Spees LP, Wheeler SB, Sanusi B, Des Marais A, Barclay L, Carter A, Hudgens MG, Brewer NT, Smith JS. Underscreened Women's Reactions to At-Home Self-Collected Human Papillomavirus Test Result Delivery. Sex Transm Dis. 2026 Feb 1;53(2):109-115. doi: 10.1097/OLQ.0000000000002256. Epub 2025 Oct 21. PMID 41118505
- DERIVEDBukowski A, Smith JS, Wheeler SB, Sanusi B, McGuire FH, Zeno E, Des Marais AC, Barclay L, Hudgens MG, Jackson S, Brewer NT. Cervical Cancer Screening Knowledge, Perceptions, and Behaviors in a Multiracial Cohort of Low-Income, Underscreened Women in North Carolina. J Womens Health (Larchmt). 2023 Sep;32(9):970-981. doi: 10.1089/jwh.2022.0412. Epub 2023 Jun 16. PMID 37327372
- DERIVEDPretsch PK, Spees LP, Brewer NT, Hudgens MG, Sanusi B, Rohner E, Miller E, Jackson SL, Barclay L, Carter A, Wheeler SB, Smith JS. Effect of HPV self-collection kits on cervical cancer screening uptake among under-screened women from low-income US backgrounds (MBMT-3): a phase 3, open-label, randomised controlled trial. Lancet Public Health. 2023 Jun;8(6):e411-e421. doi: 10.1016/S2468-2667(23)00076-2. Epub 2023 May 11. PMID 37182529
- DERIVEDBiddell CB, Spees LP, Smith JS, Brewer NT, Des Marais AC, Sanusi BO, Hudgens MG, Barclay L, Jackson S, Kent EE, Wheeler SB. Perceived Financial Barriers to Cervical Cancer Screening and Associated Cost Burden Among Low-Income, Under-Screened Women. J Womens Health (Larchmt). 2021 Sep;30(9):1243-1252. doi: 10.1089/jwh.2020.8807. Epub 2021 Apr 13. PMID 33851854
- DERIVEDSpees LP, Des Marais AC, Wheeler SB, Hudgens MG, Doughty S, Brewer NT, Smith JS. Impact of human papillomavirus (HPV) self-collection on subsequent cervical cancer screening completion among under-screened US women: MyBodyMyTest-3 protocol for a randomized controlled trial. Trials. 2019 Dec 27;20(1):788. doi: 10.1186/s13063-019-3959-2.