Effect of Human Papillomavirus Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3
MBMT-3
Effect of HPV Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3
2 other identifiers
interventional
665
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2016
CompletedFirst Posted
Study publicly available on registry
January 11, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2020
CompletedDecember 2, 2022
December 1, 2022
4 years
January 4, 2016
December 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of participants that complete cervical cancer screening
Completion of cervical cancer screening is defined as (a) testing HPV negative by self-collection, or (b) completing in-clinic screening by i. HPV/Pap co-testing or ii. Pap smear alone.
Six months after enrollment
Secondary Outcomes (5)
Levels of risk appraisal with regards to cervical cancer and screening
1-5 weeks after completion of self-collection or screening invitation
Costs to payers
Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
Level of intention to complete cervical cancer screening
1-5 weeks after completion of self-collection or screening invitation
Level of self-efficacy to complete cervical cancer screening
1-5 weeks after completion of self-collection or screening invitation
Percentage of participants who schedule a clinic appointment to get cervical cancer screening
1-5 weeks after completion of self-collection or screening invitation
Other Outcomes (7)
Percentage of participants achieving primary outcome in different demographic categories
Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
Prevalence of HPV mRNA (messenger ribonucleic acid) detection in self- and clinic-collected samples, abnormal cytology detected in clinic samples, and high-grade lesions (CIN2+) as detected in follow-up colposcopy screening (as indicated)
Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
Percentage of patients referred to and completing colposcopy
Throughout data collection period (average of 6 months per participant, approximately 3.5 years of study implementation)
- +4 more other outcomes
Study Arms (2)
Screening invitation (with education)
ACTIVE COMPARATORParticipants 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.
Self-collection for HPV testing
EXPERIMENTALParticipants 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.
Interventions
The participant will be provided with brief education about the importance and effectiveness of cervical cancer screening, and invited to schedule an appointment for a free in-clinic screening
Participant is provided with a kit to take a self-collected sample at home and return it by mail for HPV testing. Results are provided to participant by phone.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina Gillings School of Public Health
Chapel Hill, North Carolina, 27599, United States
Related Publications (6)
Ganguly 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: 41505134DERIVEDBroshkevitch 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: 41118505DERIVEDBukowski 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: 37327372DERIVEDPretsch 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: 37182529DERIVEDBiddell 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: 33851854DERIVEDSpees 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.
PMID: 31881928DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer S Smith, PhD
UNC Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2016
First Posted
January 11, 2016
Study Start
April 1, 2016
Primary Completion
April 10, 2020
Study Completion
April 10, 2020
Last Updated
December 2, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share