Cervical CancerMBMT-3NCT02651883
Effect of Human Papillomavirus Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3
A study testing Screening invitation (with education) and Self-collection for HPV testing in people with Cervical Cancer and Uterine Cervical Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer, Uterine Cervical Neoplasms, Human Papillomavirus
- What is being tested?
- Screening invitation (with education) and Self-collection for HPV testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 665 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 10 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Gillings School of Public Health
Chapel Hill, North Carolina, 27599
About this study
Official title: Effect of HPV Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3
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.
Read the detailed description
Invasive cervical cancer (ICC) is preventable through regular screening and treatment, but one fifth of US women report not receiving Pap testing at recommended intervals. More than half of ICC cases occur in these under-screened women. For women 30 years and older, the US Preventive Services Task Force recommends Pap smears alone every 3 years or physician-collected HPV testing with Pap smear (co-testing) every 5 years. The FDA approved primary HPV physician screening for US women 25 years and older. Self-collection for HPV testing is a valid and well-accepted method for detecting HPV infection with comparable sensitivity and specificity to physician-collection for detecting high-grade cervical lesions.
This 2-arm randomized control trial of 510 women will investigate whether offering HPV testing by mailed at-home self-collection to under-screened women increases their likelihood of completing cervical cancer screening. All participants will received a screening invitation by phone: a phone call providing (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free screening at a study-affiliated clinic, if needed. Those randomized to the intervention arm will first be mailed a kit to self-collect a cervico-vaginal sample, return the sample for oncogenic HPV testing, and receive their results by phone. HPV negative women will be considered screening complete. HPV positive women will be invited to schedule an appointment for free follow-up in-clinic screening in the same call in which their results are delivered. The study endpoint of screening completion will be defined as completing in-clinic screening (control arm participants and HPV positive intervention arm participants) or receiving a negative HPV self-collection result (intervention arm).
Aim 1. Determine whether at-home HPV self-collection increases completion of cervical cancer screening among under-screened women offered enhanced reminders.
Aim 2. Examine possible mechanisms explaining the intervention's effect, or lack of an effect.
Aim 3. Estimate the incremental cost per additional woman completing screening of adding at-home HPV self-collection to enhanced reminders.
- Being tested
- Screening invitation (with education), Self-collection for HPV testing
- Keywords
- Cervical cancer screening, HPV testing, Self-collection
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening invitation (with education)Behavioural
Also called Screening recall, Client reminder
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
Self-collection for HPV testingBehavioural
Also called Self-testing, Self-sampling
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.
| Study group | Role | What they receive |
|---|---|---|
| Screening invitation (with education) | Active comparator | 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. Receives: Behavioral: Screening invitation (with education) |
| Self-collection for HPV testing | Experimental | 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. Receives: Behavioral: Screening invitation (with education); Behavioral: Self-collection for HPV testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months after enrollment
Secondary outcomes (5)
Levels of risk appraisal with regards to cervical cancer and screening
Risk appraisal will include multiple components measured by post-intervention questionnaire: Worry; Likelihood; Severity; Embodiment of risk (2 measures); "Gist" risk; Anticipated regret, action; Anticipated regret, inaction
Measured: 1-5 weeks after completion of self-collection or screening invitation
Costs to payers
Incremental cost to payer (public or private) per additional woman screened
Measured: 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
As measured in post-intervention questionnaire
Measured: 1-5 weeks after completion of self-collection or screening invitation
Level of self-efficacy to complete cervical cancer screening
As measured in post-intervention questionnaire
Measured: 1-5 weeks after completion of self-collection or screening invitation
Percentage of participants who schedule a clinic appointment to get cervical cancer screening
Percent of participants that agree to schedule a clinic appointment to get a Pap smear or Pap/HPV co-testing
Measured: 1-5 weeks after completion of self-collection or screening invitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startApr 2016
- Primary completion10 Apr 2020
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 665 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jennifer S Smith, PhD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651883
- Sponsor's protocol ID
- 14-3042
- Other IDs
- 1R01CA183891-01A1
- Acronym
- MBMT-3
- Status last verified
- Dec 2022
- First submitted
- 4 Jan 2016
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 41505134Broshkevitch 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.
PubMed 41118505Bukowski 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.
PubMed 37327372Pretsch 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.
PubMed 37182529Biddell 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.
PubMed 33851854Spees 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.
PubMed 31881928
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of HPV Self-Collection on Cervical Cancer Screening in High Risk Women: My Body, My Test 3
- ClinicalTrials.gov ID
- NCT02651883
- Acronym / sponsor ID
- MBMT-3 / 14-3042
- Keywords
- Cervical cancer screening, HPV testing, Self-collection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 665 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2016
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Invasive cervical cancer (ICC) is preventable through regular screening and treatment, but one fifth of US women report not receiving Pap testing at recommended intervals. More than half of ICC cases occur in these under-screened women. For women 30 years and older, the US Preventive Services Task Force recommends Pap smears alone every 3 years or physician-collected HPV testing with Pap smear (co-testing) every 5 years. The FDA approved primary HPV physician screening for US women 25 years and older. Self-collection for HPV testing is a valid and well-accepted method for detecting HPV infection with comparable sensitivity and specificity to physician-collection for detecting high-grade cervical lesions.
This 2-arm randomized control trial of 510 women will investigate whether offering HPV testing by mailed at-home self-collection to under-screened women increases their likelihood of completing cervical cancer screening. All participants will received a screening invitation by phone: a phone call providing (i) education on cervical cancer, and (ii) assistance scheduling an appointment for free screening at a study-affiliated clinic, if needed. Those randomized to the intervention arm will first be mailed a kit to self-collect a cervico-vaginal sample, return the sample for oncogenic HPV testing, and receive their results by phone. HPV negative women will be considered screening complete. HPV positive women will be invited to schedule an appointment for free follow-up in-clinic screening in the same call in which their results are delivered. The study endpoint of screening completion will be defined as completing in-clinic screening (control arm participants and HPV positive intervention arm participants) or receiving a negative HPV self-collection result (intervention arm).
Aim 1. Determine whether at-home HPV self-collection increases completion of cervical cancer screening among under-screened women offered enhanced reminders.
Aim 2. Examine possible mechanisms explaining the intervention's effect, or lack of an effect.
Aim 3. Estimate the incremental cost per additional woman completing screening of adding at-home HPV self-collection to enhanced reminders.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening invitation (with education) | Active comparator | Behavioral: Screening invitation (with education)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. |
| Self-collection for HPV testing | Experimental | Behavioral: Screening invitation (with education), Behavioral: Self-collection for HPV testingParticipants 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. |
Who may qualify
- Ages
- 25 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Completion of cervical Pap screening in preceding 4 years
- Completion of HPV testing in preceding 6 years
- Pregnant
- History of hysterectomy
- Private insurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening invitation (with education)Also: Screening recall, Client reminderThe 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 | Behavioural | Screening invitation (with education), Self-collection for HPV testing |
| Self-collection for HPV testingAlso: Self-testing, Self-samplingParticipant 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. | Behavioural | Self-collection for HPV testing |
Primary outcome
Percent of participants that complete cervical cancer screening
Time frame: Six months after enrollment
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.
5 secondary outcomes
Levels of risk appraisal with regards to cervical cancer and screening
Time frame: 1-5 weeks after completion of self-collection or screening invitation
Costs to payers
Time frame: 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
Time frame: 1-5 weeks after completion of self-collection or screening invitation
Level of self-efficacy to complete cervical cancer screening
Time frame: 1-5 weeks after completion of self-collection or screening invitation
Percentage of participants who schedule a clinic appointment to get cervical cancer screening
Time frame: 1-5 weeks after completion of self-collection or screening invitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Derived from this study: PubMed 41505134Ganguly 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.
- Derived from this study: PubMed 41118505Broshkevitch 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.
- Derived from this study: PubMed 37327372Bukowski 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.
- Derived from this study: PubMed 37182529Pretsch 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.
- Derived from this study: PubMed 33851854Biddell 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.
- Derived from this study: PubMed 31881928Spees 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer S Smith, PhD principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening invitation (with education) and Self-collection for HPV testing in people with Cervical Cancer and Uterine Cervical Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants that complete cervical cancer screening (time frame: Six months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02651883, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2022.