HPVNCT06109870
Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening
A study testing PRECEDE-PROCEED in people with HPV, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
Cervical cancer is a disease that is preventable through vaccination against the virus that causes it, human papillomavirus (HPV), and through screening and treatment of cervical disease before it becomes cancet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV
- What is being tested?
- PRECEDE-PROCEED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 920 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2023to 31 Aug 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Currently resident in RGV or other low-resource community in Texas
- Stated willingness to comply with all study procedures
- Females; Age ≥25 years
- Have no history of hysterectomy with removal of the cervix
- Have no history of cervical cancer or high-grade dysplasia
- Have not had a Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unable to communicate in English or Spanish
- Lack valid telephone contact information
- Report being currently pregnant.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Texas at Austin
Austin, Texas, 78712
Marian Williams-Brown, MD, 512-324-7036, yvette.brown@austin.utexas.edu
Marian Williams-Brown, MD
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Jane Montealegre, M. D., 281-814-7118, jrmontealegre@mdanderson.org
Jane Montealegre, M. D.
About this study
Cervical cancer is a disease that is preventable through vaccination against the virus that causes it, human papillomavirus (HPV), and through screening and treatment of cervical disease before it becomes cancet.
Read the detailed description
Primary Objectives:
The overall purpose of this protocol is to evaluate the feasibility and acceptability of CHW-delivered selfsample HPV testing (CHW-SS) to increase cervical cancer screening among women in RGV and other low- resource communities in Texas.
The specific aims of this protocol are to:
Specific Aim 1: Determine the feasibility of CHW-SS in the RGV and other low-resource communities in Texas (i.e., reach, screening uptake, notification of test results).
Specific Aim 2: Assess the acceptability and experiences of CHW-SS among under screened persons in rural, persistent poverty communities in the RGV and other low-resource communities in Texas.
Secondary Objectives:
Exploratory Aim 3: Assess attendance for clinical follow-up among individuals who participate in CHW-SS and test positive for HR-HPV.
Exploratory Aim 4: Evaluate contextual fit of the intervention.
- Conditions
- HPV
- Being tested
- PRECEDE-PROCEED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRECEDE-PROCEEDBehavioural
delivered self-sampling (CHWSS) to increase screening participation.
| Study group | Role | What they receive |
|---|---|---|
| PRECEDE-PROCEED | Experimental | To identify predisposing, enabling, and reinforcing factors that could influence women's decision to participate in self-sample HPV testing and diagnostic follow-up. Receives: Behavioral: PRECEDE-PROCEED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start30 Oct 2023
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPVStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 920 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jane Montealegre, M D, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109870
- Sponsor's protocol ID
- 2023-0529
- Other IDs
- NCI-2023-09607
- Status last verified
- Aug 2026
- First submitted
- 25 Oct 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fallah PN, Bowman P, Tran C, Chen V, Pippin M, Varon ML, Baker E, Milan J, Parker SL, Lezama-Sierra J, Munsell MF, Desravines N, Lavie I, Batman S, Montealegre J, Schmeler KM, Williams-Brown MY, Salcedo MP. Implementation of Human Papillomavirus Self-Collection and Barriers to Follow-Up Among Unhoused Individuals in Texas: The EMPOWER Study. Obstet Gynecol. 2025 Nov 1;146(5):710-717. doi: 10.1097/AOG.0000000000006003. Epub 2025 Jul 17.
PubMed 40674748
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT06109870
- Acronym / sponsor ID
- 2023-0529
- Conditions
- HPV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 920 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 31 Oct 2023 (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.
Cervical cancer is a disease that is preventable through vaccination against the virus that causes it, human papillomavirus (HPV), and through screening and treatment of cervical disease before it becomes cancet.
Detailed description
Primary Objectives:
The overall purpose of this protocol is to evaluate the feasibility and acceptability of CHW-delivered selfsample HPV testing (CHW-SS) to increase cervical cancer screening among women in RGV and other low- resource communities in Texas.
The specific aims of this protocol are to:
Specific Aim 1: Determine the feasibility of CHW-SS in the RGV and other low-resource communities in Texas (i.e., reach, screening uptake, notification of test results).
Specific Aim 2: Assess the acceptability and experiences of CHW-SS among under screened persons in rural, persistent poverty communities in the RGV and other low-resource communities in Texas.
Secondary Objectives:
Exploratory Aim 3: Assess attendance for clinical follow-up among individuals who participate in CHW-SS and test positive for HR-HPV.
Exploratory Aim 4: Evaluate contextual fit of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRECEDE-PROCEED | Experimental | Behavioral: PRECEDE-PROCEEDTo identify predisposing, enabling, and reinforcing factors that could influence women's decision to participate in self-sample HPV testing and diagnostic follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Currently resident in RGV or other low-resource community in Texas
- Stated willingness to comply with all study procedures
- Females; Age ≥25 years
Key exclusion criteria (4 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unable to communicate in English or Spanish
- Lack valid telephone contact information
- Report being currently pregnant.
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 |
|---|---|---|
| PRECEDE-PROCEEDdelivered self-sampling (CHWSS) to increase screening participation. | Behavioural | PRECEDE-PROCEED |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion; an average 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 14 Aug 2026.
- Derived from this study: PubMed 40674748Fallah PN, Bowman P, Tran C, Chen V, Pippin M, Varon ML, Baker E, Milan J, Parker SL, Lezama-Sierra J, Munsell MF, Desravines N, Lavie I, Batman S, Montealegre J, Schmeler KM, Williams-Brown MY, Salcedo MP. Implementation of Human Papillomavirus Self-Collection and Barriers to Follow-Up Among Unhoused Individuals in Texas: The EMPOWER Study. Obstet Gynecol. 2025 Nov 1;146(5):710-717. doi: 10.1097/AOG.0000000000006003. Epub 2025 Jul 17.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Jane Montealegre, M D principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRECEDE-PROCEED in people with HPV, run by M.D. Anderson Cancer Center at 2 sites 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 8 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Montealegre, M D ((281) 814-7118, jrmontealegre@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average 1 year.). 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 NCT06109870, which also lists 1 linked publication.
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 14 Aug 2026.