Uterine Cervical NeoplasmsHOPENCT07214506
Human Papillomavirus (HPV) Self-Sampling Options to Promote Equity
A study testing Human papillomavirus Self-collection in people with Uterine Cervical Neoplasms and HPV Testing, run by University of Arizona at 1 site in United States.
Trial summary
This study is testing a new way to help people who are unhoused get screened for cervical cancer. Cervical cancer can often be prevented if it is found early. Many people who lack stable housing usually do not receive regular screenings. Read more about this study
- Who is it for?
- Ages 30 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Cervical Neoplasms, HPV Testing, Pap Smear
- What is being tested?
- Human papillomavirus Self-collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women or transgender men with a cervix
- Ages 30-64 years
- Due for cervical cancer screening:
- No Pap test in the past 3 years, or
- No human papillomavirus (HPV) test in the past 5 years
- Unhoused or unstably housed
Who cannot join
- History of cervical cancer
- HIV positive
- History of total hysterectomy
- Known pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
El Rio Santa Cruz Neighborhood Health
Tucson, Arizona, 85713
Lisa Soltani, MD, 520 670 3909, lisas@elrio.org
About this study
Official title: Human Papillomavirus Self-Sampling Options to Promote Equity (HOPE)
This study is testing a new way to help people who are unhoused get screened for cervical cancer. Cervical cancer can often be prevented if it is found early. Many people who lack stable housing usually do not receive regular screenings.
Through this project, the investigators will bring screening to community locations in Tucson, Arizona, using a mobile health unit (MHU) from the University of Arizona (UA) and El Rio Health. At these sites, participants will receive easy-to-understand education about cervical cancer, learn how to collect their own sample for human papillomavirus (HPV) testing, and get follow-up care if needed.
Read more
The study has two goals:
- First, the investigators will see if this community-based approach helps more people complete cervical cancer screening.
- Second, the investigators will ask participants, clinicians, and outreach staff for their opinions about the program and its practicality and acceptability.
By testing this approach, the investigators hope to find a way to make cervical cancer screening more accessible and effective for unhoused individuals.
Read the detailed description
Cervical cancer can often be prevented if it is found early, but many unhoused people don't get regular screening. Through this project, the investigators are offering cervical cancer screening in community settings, such as our mobile health units, to make access easier.
Our proposal aims to design and pilot test an human papillomavirus (HPV) self-sampling program run through an MHU (operated by the UA) throughout El Rio's established outreach sites to people who are unhoused and residing in shelters and outdoor encampments. The proposed intervention, delivered through a clinic-community linkage, will include tailored education about the importance of cervical cancer screening, information on how to perform HPV self-collection, and follow-up as needed. The investigators propose the following Aims:
Aim 1. In a pragmatic pilot trial, assess the preliminary effectiveness of a community-driven, resource-efficient MHU-delivered program to distribute HPV DNA self-collection test kits to eligible unhoused individuals in Tucson, Arizona.
The primary outcome will be the completion of screening among eligible individuals. Secondary outcomes will be (1) screening modality selected (self-collected HPV, clinician-collected HPV, Pap smear, or co-test) and (2) follow-up of abnormal initial screening results within 6 months after the initial result.
Aim 2. Evaluate the feasibility and acceptability of the MHU-based HPV self-collection program through in-depth interviews with individuals who completed self-collection, clinicians, and outreach staff in the HOPE program.
Interview domains will be informed by the COM-B (capability, opportunities, motivation - behavior) framework, and outcomes will be analyzed using thematic analysis with a combination of inductive and deductive coding.
- Conditions
- Uterine Cervical Neoplasms, HPV Testing, Pap Smear
- Being tested
- Human papillomavirus Self-collection, Usual Care
- Keywords
- Cervical cancer screening, HPV self-collection, HPV test, Mobile health unit, Unhoused individuals, Community outreach
- 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.
Human papillomavirus Self-collectionOther
Also called HPV self-sampling
The individual will receive both verbal instruction on self-collection from trained health educators in the mobile health unit, as well as adapted educational materials on human papillomavirus self-collection and information about follow-up care in the case of abnormal results. Individuals will be provided with a safe and private space in the Mobile Health Unit to self-collect.
Usual CareOther
Also called Pap smear, HPV/PAP Co-test, Provider Sampling
Usual care, will involve reminders about overdue Cervical Cancer screening and support with scheduling clinic appointments for screening, arranging for transportation, and addressing other barriers to attendance
| Study group | Role | What they receive |
|---|---|---|
| Human papillomavirus self-collection for Cervical Cancer Screening | Experimental | The eight outreach sites will be randomized 1:1 to arm 1 (invitation to human papillomavirus self-collection in the mobile health unit) or arm 2 (usual care), stratifying on type of outreach site to ensure balance between shelter and encampment sites in both arms. Receives: Other: Human papillomavirus Self-collection |
| Usual Care | Active comparator | The eight outreach sites will be randomized 1:1 to arm 1 (invitation to HPV self-collection in the MHU) or arm 2 (usual care), stratifying on type of outreach site to ensure balance between shelter and encampment sites in both arms Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Cancer Screening Completion
Cervical cancer screening completion will be defined as the completion of any form of cervical cancer screening permitted according to the U.S. Preventive Services Task Force (USPSTF) guidelines, including Pap tests, Pap tests with high-risk human papillomavirus tests (cotesting), or high-risk human papillomavirus testing alone. The primary outcome will be assessed within 2 months of the street medicine team's patient contact during the trial period to account for the time required for scheduling a clinic appointment.
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (1)
Follow-up adherence
The secondary outcome will be follow-up adherence for abnormal screening results ascertained via electronic health record review within six months of the abnormal result
Measured: From identification of abnormal results to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed trial will randomize eight of the street medicine team's outreach sites 1:1 to either the intervention (invitation to Human Papillomavirus self-collection for cervical cancer screening in the mobile health unit plus usual care from the street medicine team) or usual care alone
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), El Rio Santa Cruz Neighborhood Health Center
- Responsible party
- Sponsor
- Investigators
- Dan Theodorescu, MD, PhD, Principal investigator, University of ArizonaPurnima Madhivanan, MBBS, MPH, PhD, Study chair, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214506
- Sponsor's protocol ID
- STUDY00007058
- Other IDs
- 5P30CA023074-43
- Acronym
- HOPE
- Status last verified
- May 2026
- First submitted
- 7 Oct 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: HOPE Project Resource and Data Sharing Plan Resource and data sharing are central to the goals of the National Institutes of Health (NIH) and support open science, collaboration, and the translation of research results into improved public health. The HOPE project (HPV Self-Sampling Options to Promote Equity) will follow NIH policies for responsible data sharing, ensuring participant confidentiality and adherence to all Health Insurance Portability and Accountability Act (HIPAA) rules. Commitment to Dissemination The HOPE project team is committed to the timely and open dissemination of study findings. Results will be shared with community partners, policymakers, and the scientific community through peer-reviewed journal publications, conference presentations, newsletters, and community forums. All publications will adhere to the NIH Public Access Policy guidelines, with manuscripts submitted to PubMed Central. Findings will also be presented at relevant national and international con
Publications
Brown AW, Li P, Bohan Brown MM, Kaiser KA, Keith SW, Oakes JM, Allison DB. Best (but oft-forgotten) practices: designing, analyzing, and reporting cluster randomized controlled trials. Am J Clin Nutr. 2015 Aug;102(2):241-8. doi: 10.3945/ajcn.114.105072. Epub 2015 May 27.
PubMed 26016864Li P, Redden DT. Small sample performance of bias-corrected sandwich estimators for cluster-randomized trials with binary outcomes. Stat Med. 2015 Jan 30;34(2):281-96. doi: 10.1002/sim.6344. Epub 2014 Oct 24.
PubMed 25345738Heintzman J, Hatch B, Coronado G, Ezekiel D, Cowburn S, Escamilla-Sanchez O, Marino M. Role of Race/Ethnicity, Language, and Insurance in Use of Cervical Cancer Prevention Services Among Low-Income Hispanic Women, 2009-2013. Prev Chronic Dis. 2018 Feb 22;15:E25. doi: 10.5888/pcd15.170267.
PubMed 29470167US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Kubik M, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Cervical Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018 Aug 21;320(7):674-686. doi: 10.1001/jama.2018.10897.
PubMed 30140884Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
PubMed 21513547Sabatino SA, Thompson TD, White MC, Shapiro JA, Clarke TC, Croswell JM, Richardson LC. Cancer Screening Test Use-U.S., 2019. Am J Prev Med. 2022 Sep;63(3):431-439. doi: 10.1016/j.amepre.2022.02.018. Epub 2022 Apr 22.
PubMed 35469700Christian NJ, Havlik J, Tsai J. The Use of Mobile Medical Units for Populations Experiencing Homelessness in the United States: A Scoping Review. J Gen Intern Med. 2024 Jun;39(8):1474-1487. doi: 10.1007/s11606-024-08731-9. Epub 2024 Mar 25.
PubMed 38528232Degife EA, Oliveira CR, Znamierowski E, Meyer JP, Sheth SS. Uptake of Cervical Cancer Screening Among Female Patients Using a Mobile Medical Clinic. Am J Prev Med. 2023 Nov;65(5):835-843. doi: 10.1016/j.amepre.2023.05.013. Epub 2023 May 21.
PubMed 37220860Greenwald ZR, El-Zein M, Bouten S, Ensha H, Vazquez FL, Franco EL. Mobile Screening Units for the Early Detection of Cancer: A Systematic Review. Cancer Epidemiol Biomarkers Prev. 2017 Dec;26(12):1679-1694. doi: 10.1158/1055-9965.EPI-17-0454. Epub 2017 Oct 4.
PubMed 28978564De Mil R, Guillaume E, Launay L, Guittet L, Dejardin O, Bouvier V, Notari A, Launoy G, Berchi C. Cost-Effectiveness Analysis of a Mobile Mammography Unit for Breast Cancer Screening to Reduce Geographic and Social Health Inequalities. Value Health. 2019 Oct;22(10):1111-1118. doi: 10.1016/j.jval.2019.06.001. Epub 2019 Jul 29.
PubMed 31563253Pretsch 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 37182529Winer RL, Lin J, Anderson ML, Tiro JA, Green BB, Gao H, Meenan RT, Hansen K, Sparks A, Buist DSM. Strategies to Increase Cervical Cancer Screening With Mailed Human Papillomavirus Self-Sampling Kits: A Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1971-1981. doi: 10.1001/jama.2023.21471.
PubMed 38015219Winer RL, Lin J, Tiro JA, Miglioretti DL, Beatty T, Gao H, Kimbel K, Thayer C, Buist DSM. Effect of Mailed Human Papillomavirus Test Kits vs Usual Care Reminders on Cervical Cancer Screening Uptake, Precancer Detection, and Treatment: A Randomized Clinical Trial. JAMA Netw Open. 2019 Nov 1;2(11):e1914729. doi: 10.1001/jamanetworkopen.2019.14729.
PubMed 31693128Bharel M, Casey C, Wittenberg E. Disparities in cancer screening: acceptance of Pap smears among homeless women. J Womens Health (Larchmt). 2009 Dec;18(12):2011-6. doi: 10.1089/jwh.2008.1111.
PubMed 20044864Asgary R. Cancer screening in the homeless population. Lancet Oncol. 2018 Jul;19(7):e344-e350. doi: 10.1016/S1470-2045(18)30200-6. Epub 2018 Jun 29.
PubMed 30084381
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomavirus Self-Sampling Options to Promote Equity (HOPE)
- ClinicalTrials.gov ID
- NCT07214506
- Acronym / sponsor ID
- HOPE / STUDY00007058
- Conditions
- Uterine Cervical Neoplasms, HPV Testing, Pap Smear
- Keywords
- Cervical cancer screening, HPV self-collection, HPV test, Mobile health unit, Unhoused individuals, Community outreach
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), El Rio Santa Cruz Neighborhood Health Center
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 9 Oct 2025 (actual)
- 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 is testing a new way to help people who are unhoused get screened for cervical cancer. Cervical cancer can often be prevented if it is found early. Many people who lack stable housing usually do not receive regular screenings.
Through this project, the investigators will bring screening to community locations in Tucson, Arizona, using a mobile health unit (MHU) from the University of Arizona (UA) and El Rio Health. At these sites, participants will receive easy-to-understand education about cervical cancer, learn how to collect their own sample for human papillomavirus (HPV) testing, and get follow-up care if needed.
The study has two goals:
- First, the investigators will see if this community-based approach helps more people complete cervical cancer screening.
- Second, the investigators will ask participants, clinicians, and outreach staff for their opinions about the program and its practicality and acceptability.
By testing this approach, the investigators hope to find a way to make cervical cancer screening more accessible and effective for unhoused individuals.
Detailed description
Cervical cancer can often be prevented if it is found early, but many unhoused people don't get regular screening. Through this project, the investigators are offering cervical cancer screening in community settings, such as our mobile health units, to make access easier.
Our proposal aims to design and pilot test an human papillomavirus (HPV) self-sampling program run through an MHU (operated by the UA) throughout El Rio's established outreach sites to people who are unhoused and residing in shelters and outdoor encampments. The proposed intervention, delivered through a clinic-community linkage, will include tailored education about the importance of cervical cancer screening, information on how to perform HPV self-collection, and follow-up as needed. The investigators propose the following Aims:
Aim 1. In a pragmatic pilot trial, assess the preliminary effectiveness of a community-driven, resource-efficient MHU-delivered program to distribute HPV DNA self-collection test kits to eligible unhoused individuals in Tucson, Arizona.
The primary outcome will be the completion of screening among eligible individuals. Secondary outcomes will be (1) screening modality selected (self-collected HPV, clinician-collected HPV, Pap smear, or co-test) and (2) follow-up of abnormal initial screening results within 6 months after the initial result.
Aim 2. Evaluate the feasibility and acceptability of the MHU-based HPV self-collection program through in-depth interviews with individuals who completed self-collection, clinicians, and outreach staff in the HOPE program.
Interview domains will be informed by the COM-B (capability, opportunities, motivation - behavior) framework, and outcomes will be analyzed using thematic analysis with a combination of inductive and deductive coding.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The proposed trial will randomize eight of the street medicine team's outreach sites 1:1 to either the intervention (invitation to Human Papillomavirus self-collection for cervical cancer screening in the mobile health unit plus usual care from the street medicine team) or usual care alone
| Arm | Type | Receives |
|---|---|---|
| Human papillomavirus self-collection for Cervical Cancer Screening | Experimental | Other: Human papillomavirus Self-collectionThe eight outreach sites will be randomized 1:1 to arm 1 (invitation to human papillomavirus self-collection in the mobile health unit) or arm 2 (usual care), stratifying on type of outreach site to ensure balance between shelter and encampment sites in both arms. |
| Usual Care | Active comparator | Other: Usual CareThe eight outreach sites will be randomized 1:1 to arm 1 (invitation to HPV self-collection in the MHU) or arm 2 (usual care), stratifying on type of outreach site to ensure balance between shelter and encampment sites in both arms |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women or transgender men with a cervix
- Ages 30-64 years
- Due for cervical cancer screening:
- Unhoused or unstably housed
Key exclusion criteria (4 listed)
- History of cervical cancer
- HIV positive
- History of total hysterectomy
- Known pregnancy
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 |
|---|---|---|
| Human papillomavirus Self-collectionAlso: HPV self-samplingThe individual will receive both verbal instruction on self-collection from trained health educators in the mobile health unit, as well as adapted educational materials on human papillomavirus self-collection and information about follow-up care in the case of abnormal results. Individuals will be provided with a safe and private space in the Mobile Health Unit to self-collect. | Other | Human papillomavirus self-collection for Cervical Cancer Screening |
| Usual CareAlso: Pap smear, HPV/PAP Co-test, Provider SamplingUsual care, will involve reminders about overdue Cervical Cancer screening and support with scheduling clinic appointments for screening, arranging for transportation, and addressing other barriers to attendance | Other | Usual Care |
Primary outcome
Cervical Cancer Screening Completion
Time frame: From enrollment to the end of treatment at 8 weeks
Cervical cancer screening completion will be defined as the completion of any form of cervical cancer screening permitted according to the U.S. Preventive Services Task Force (USPSTF) guidelines, including Pap tests, Pap tests with high-risk human papillomavirus tests (cotesting), or high-risk human papillomavirus testing alone. The primary outcome will be assessed within 2 months of the street medicine team's patient contact during the trial period to account for the time required for scheduling a clinic appointment.
1 secondary outcome
Follow-up adherence
Time frame: From identification of abnormal results to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 26016864Brown AW, Li P, Bohan Brown MM, Kaiser KA, Keith SW, Oakes JM, Allison DB. Best (but oft-forgotten) practices: designing, analyzing, and reporting cluster randomized controlled trials. Am J Clin Nutr. 2015 Aug;102(2):241-8. doi: 10.3945/ajcn.114.105072. Epub 2015 May 27.
- Background: PubMed 25345738Li P, Redden DT. Small sample performance of bias-corrected sandwich estimators for cluster-randomized trials with binary outcomes. Stat Med. 2015 Jan 30;34(2):281-96. doi: 10.1002/sim.6344. Epub 2014 Oct 24.
- Background: PubMed 29470167Heintzman J, Hatch B, Coronado G, Ezekiel D, Cowburn S, Escamilla-Sanchez O, Marino M. Role of Race/Ethnicity, Language, and Insurance in Use of Cervical Cancer Prevention Services Among Low-Income Hispanic Women, 2009-2013. Prev Chronic Dis. 2018 Feb 22;15:E25. doi: 10.5888/pcd15.170267.
- Background: PubMed 30140884US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, Doubeni CA, Epling JW Jr, Kemper AR, Kubik M, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Cervical Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018 Aug 21;320(7):674-686. doi: 10.1001/jama.2018.10897.
- Background: PubMed 21513547Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
- Background: PubMed 35469700Sabatino SA, Thompson TD, White MC, Shapiro JA, Clarke TC, Croswell JM, Richardson LC. Cancer Screening Test Use-U.S., 2019. Am J Prev Med. 2022 Sep;63(3):431-439. doi: 10.1016/j.amepre.2022.02.018. Epub 2022 Apr 22.
- Background: PubMed 38528232Christian NJ, Havlik J, Tsai J. The Use of Mobile Medical Units for Populations Experiencing Homelessness in the United States: A Scoping Review. J Gen Intern Med. 2024 Jun;39(8):1474-1487. doi: 10.1007/s11606-024-08731-9. Epub 2024 Mar 25.
- Background: PubMed 37220860Degife EA, Oliveira CR, Znamierowski E, Meyer JP, Sheth SS. Uptake of Cervical Cancer Screening Among Female Patients Using a Mobile Medical Clinic. Am J Prev Med. 2023 Nov;65(5):835-843. doi: 10.1016/j.amepre.2023.05.013. Epub 2023 May 21.
- Background: PubMed 28978564Greenwald ZR, El-Zein M, Bouten S, Ensha H, Vazquez FL, Franco EL. Mobile Screening Units for the Early Detection of Cancer: A Systematic Review. Cancer Epidemiol Biomarkers Prev. 2017 Dec;26(12):1679-1694. doi: 10.1158/1055-9965.EPI-17-0454. Epub 2017 Oct 4.
- Background: PubMed 31563253De Mil R, Guillaume E, Launay L, Guittet L, Dejardin O, Bouvier V, Notari A, Launoy G, Berchi C. Cost-Effectiveness Analysis of a Mobile Mammography Unit for Breast Cancer Screening to Reduce Geographic and Social Health Inequalities. Value Health. 2019 Oct;22(10):1111-1118. doi: 10.1016/j.jval.2019.06.001. Epub 2019 Jul 29.
- Background: 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.
- Background: PubMed 38015219Winer RL, Lin J, Anderson ML, Tiro JA, Green BB, Gao H, Meenan RT, Hansen K, Sparks A, Buist DSM. Strategies to Increase Cervical Cancer Screening With Mailed Human Papillomavirus Self-Sampling Kits: A Randomized Clinical Trial. JAMA. 2023 Nov 28;330(20):1971-1981. doi: 10.1001/jama.2023.21471.
- Individual participant dataSharing planned: Yes. HOPE Project Resource and Data Sharing Plan Resource and data sharing are central to the goals of the National Institutes of Health (NIH) and support open science, collaboration, and the translation of research results into improved public health. The HOPE project (HPV Self-Sampling Options to Promote Equity) will follow NIH policies for responsible data sharing, ensuring participant confidentiality and adherence to all Health Insurance Portability and Accountability Act (HIPAA) rules. Commitment to Dissemination The HOPE project team is committed to the timely and open dissemination of study findings. Results will be shared with community partners, policymakers, and the scientific community through peer-reviewed journal publications, conference presentations, newsletters, and community forums. All publications will adhere to the NIH Public Access Policy guidelines, with manuscripts submitted to PubMed Central. Findings will also be presented at relevant national and international con
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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.
Dan Theodorescu, MD, PhD principal investigator
University of Arizona
Purnima Madhivanan, MBBS, MPH, PhD study chair
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human papillomavirus Self-collection in people with Uterine Cervical Neoplasms and HPV Testing, run by University of Arizona 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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 29 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Purnima Madhivanan, MBBS, MPH, PhD (520-621-5730, pmadhivanan@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical Cancer Screening Completion (time frame: From enrollment to the end of treatment at 8 weeks). 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 NCT07214506, which also lists 22 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 29 May 2026.