HR-HPV TestingNCT06843720
Expanding Access to Cervical Cancer Screening Through Primary HR-HPV Testing and Self-sampling: a Multicomponent Intervention for Safety Net Health Systems
A study testing HR-HPV Testing in people with HR-HPV Testing, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn about the attitudes toward implementing self-collection among healthcare providers and staff, participants, and other stakeholders; and to inform the development of patient education and provider training materials to aid in the implementation of self-collection in clinical settings. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HR-HPV Testing
- What is being tested?
- HR-HPV Testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,100 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2025to 31 Mar 2031
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Populations involved in the research are:
- stakeholder advisory board members;
- patients eligible for cervical cancer screening participating in the cluster randomized stepped-wedge trial;
- patients and community members participating in formative research activities;
- providers, clinic staff, and other health system stakeholders from partnering health systems;
- Project ECHO Participants (providers, clinic staff, and other health system stakeholders from partner and non-partner institutions);
Show all 25Show fewer
- Other Clinical Networks (providers, clinic staff and other health system stakeholders from partner and non-partner institutions)
- The eligibility criteria for each are:
- Patients eligible for cervical cancer screening:
- Currently a resident in the state of Texas
- Attend for care at a partner clinic enrolled in the study
- Women and persons with a cervix
- Age 25-65
- Due or past due for cervical cancer screening
- Patients and community members participating in formative research activities:
- Purposively identified as a stakeholder for formative research by research staff
- Providers, clinic staff, and other health system stakeholders from partnering health systems:
- Employed at least part-time by a partnering health system
- Age 18+
- Project ECHO Participants:
- Participate in at least one Project ECHO session
- Age 18+
- Other Clinical Networks:
- Participate in at least one clinical network session
- Age 18+
Who cannot join
- Patients eligible for cervical cancer screening:
- Report being currently pregnant
- History of total hysterectomy
- History of cervical cancer
- Other study populations:
- Unable to communicate in English or Spanish
- Vulnerable Populations Participants/samples belonging to vulnerable populations (children, pregnant women, cognitively impaired adults, or prisoners) will be prohibited from participation.
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, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Jane R Montealegre, PHD, 713-745-5008, jrmontealegre@mdanderson.org
Jane R Montealegre, PHD
About this study
To learn about the attitudes toward implementing self-collection among healthcare providers and staff, participants, and other stakeholders; and to inform the development of patient education and provider training materials to aid in the implementation of self-collection in clinical settings.
Read the detailed description
The overarching goal of the implementation program is to increase cervical cancer screening, early detection, and linkage to treatment in underserved populations that receive care in safety net health systems. Specific goals are:
- To increase up-to-date cervical cancer screening coverage by 10%;
- To increase clinical encounters used for opportunistic cervical cancer screening using primary HR-HPV testing by 5% annually;
- To increase awareness and readiness for implementing primary HR-HPV testing with self-sampling in routine care among clinics in the ECHO Network;
- All patrticipants with abnormal screening results will be navigated to and receive diagnostic testing.
The overarching goal of program evaluation (i.e., research component of this protocol) is to evaluate the progress and achievement of program goals and to evaluate effectiveness and implementation outcomes:
Primary objective 1: Evaluate the effectiveness of primary HPV testing and self-collection to increase participation in cervical cancer screening among underscreened health system participants.
Primary objective 2: Evaluate implementation outcomes of the program across health systems and clinics and explore mechanisms underlying outcomes, guided by the Consolidated Framework for Implementation Research (CFIR)41,42 and RE-AIM (reach, effectiveness, adoption, implementation, maintenance)43.
Secondary Objectives Secondary objective 1: Compare the proportion of clinical encounters used for opportunistic cervical cancer screening across clinics.
Secondary objective 2: Evaluate proportion of participants receiving clinical follow-up after a positive HR-HPV test.
Secondary objective 3: Describe the prevalence of cervical cancer and pre-cancer among participants who self-collected and tested positive for HR-HPV.
Secondary objective 4: Compare the effectiveness of clinic-based primary HPV testing with self-collection with and without preceding telephone-based patient education by a participant navigator.
- Conditions
- HR-HPV Testing
- Being tested
- HR-HPV Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR-HPV TestingBehavioural
Given by Interview and focus groups
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants participate in an interview or a focus group discussion and provide opinions about self-collection and/or education and training materials for participants and providers.
Partipants participation in this study may be limited to a single interview or focus group discussion. Some stakeholders will be asked to participate in additional interviews and/or focus groups. Receives: Behavioral: HR-HPV Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start17 Feb 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR-HPV TestingStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843720
- Sponsor's protocol ID
- 2024-0361
- Other IDs
- NCI-2025-01326
- Status last verified
- Jun 2026
- First submitted
- 19 Feb 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Access to Cervical Cancer Screening Through Primary HR-HPV Testing and Self-sampling: a Multicomponent Intervention for Safety Net Health Systems
- ClinicalTrials.gov ID
- NCT06843720
- Acronym / sponsor ID
- 2024-0361
- Conditions
- HR-HPV Testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7,100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 25 Feb 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.
To learn about the attitudes toward implementing self-collection among healthcare providers and staff, participants, and other stakeholders; and to inform the development of patient education and provider training materials to aid in the implementation of self-collection in clinical settings.
Detailed description
The overarching goal of the implementation program is to increase cervical cancer screening, early detection, and linkage to treatment in underserved populations that receive care in safety net health systems. Specific goals are:
- To increase up-to-date cervical cancer screening coverage by 10%;
- To increase clinical encounters used for opportunistic cervical cancer screening using primary HR-HPV testing by 5% annually;
- To increase awareness and readiness for implementing primary HR-HPV testing with self-sampling in routine care among clinics in the ECHO Network;
- All patrticipants with abnormal screening results will be navigated to and receive diagnostic testing.
The overarching goal of program evaluation (i.e., research component of this protocol) is to evaluate the progress and achievement of program goals and to evaluate effectiveness and implementation outcomes:
Primary objective 1: Evaluate the effectiveness of primary HPV testing and self-collection to increase participation in cervical cancer screening among underscreened health system participants.
Primary objective 2: Evaluate implementation outcomes of the program across health systems and clinics and explore mechanisms underlying outcomes, guided by the Consolidated Framework for Implementation Research (CFIR)41,42 and RE-AIM (reach, effectiveness, adoption, implementation, maintenance)43.
Secondary Objectives Secondary objective 1: Compare the proportion of clinical encounters used for opportunistic cervical cancer screening across clinics.
Secondary objective 2: Evaluate proportion of participants receiving clinical follow-up after a positive HR-HPV test.
Secondary objective 3: Describe the prevalence of cervical cancer and pre-cancer among participants who self-collected and tested positive for HR-HPV.
Secondary objective 4: Compare the effectiveness of clinic-based primary HPV testing with self-collection with and without preceding telephone-based patient education by a participant navigator.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: HR-HPV TestingParticipants participate in an interview or a focus group discussion and provide opinions about self-collection and/or education and training materials for participants and providers. Partipants participation in this study may be limited to a single interview or focus group discussion. Some stakeholders will be asked to participate in additional interviews and/or focus groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- stakeholder advisory board members;
- patients eligible for cervical cancer screening participating in the cluster randomized stepped-wedge trial;
- patients and community members participating in formative research activities;
- providers, clinic staff, and other health system stakeholders from partnering health systems;
- Project ECHO Participants (providers, clinic staff, and other health system stakeholders from partner and non-partner institutions);
Key exclusion criteria (7 listed)
- Report being currently pregnant
- History of total hysterectomy
- History of cervical cancer
- Unable to communicate in English or Spanish
- Vulnerable Populations Participants/samples belonging to vulnerable populations (children, pregnant women, cognitively impaired adults, or prisoners) will be prohibited from participation.
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 |
|---|---|---|
| HR-HPV TestingGiven by Interview and focus groups | Behavioural | Intervention |
Primary outcome
Safety and Adverse Events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
Time frame: Through study completion; an average of 1 year.
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 23 Jun 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for HR-HPV Testing
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Phase II Study of Dysplasix™ Intravaginal Suppositories in Patients Patients With High-Risk HPV and Mild Cervical Cytologic Abnormalities
High-risk HPV (Any Strain), LSIL, Low Grade Squamous Intraepithelial Lesion
Recruiting
Human Papillomavirus Self-sampling for Enhancing Cervical Screening During the War in Ukraine
Cervical Cancer, Cervical Cancer Screening
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HR-HPV Testing in people with HR-HPV Testing, run by M.D. Anderson 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 25 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Jun 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 Jane R Montealegre, PHD (713- 745-5008, jrmontealegre@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03 (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2026.