Cervical Cancer ScreeningIMPROVENCT06943547
The Effectiveness, Cost-effectiveness, and Budget Impact of Interventions to Improve the Delivery of Cervical Cancer Screening in Puerto Rico.
A study testing Arm 2: Patient Navigator and HPV self-collection kit in people with Cervical Cancer Screening, run by University of Puerto Rico Comprehensive Cancer Center at 1 site in Puerto Rico.
Trial summary
Cervical cancer incidence is increasing dramatically (2.5% per year) in Puerto Rico (PR), with increased occurrence of regional (1.7% per year) and distant (4.7% per year) stage cancer, which reflects a real increase and indicates missed screening opportunities. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Cervical Cancer Screening
- What is being tested?
- Arm 2: Patient Navigator and HPV self-collection kit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 4 Feb 2025to 31 Aug 2028
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25-65 years old
- No history of cervical cancer or hysterectomy
- Have not had a Pap test in the past 3 years or more, an HPV test in the past 5 years or more, or a combination of a Pap test and an HPV test in the past 5 or more years (co-testing).
- Must have a record at the study clinics (at least 2 previous visits).
Who cannot join
- Women with no telephone contact information
- Being pregnant*
- Living with HIV, Lupus, or Crohn's*
- Active on immunotherapy treatment*
- History of organ transplants*
- Will be excluded as cervical cancer screening guidelines differ for them.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effectiveness, Cost-effectiveness, and Budget Impact of Interventions to Improve the Delivery of Cervical Cancer Screening in Puerto Rico
Cervical cancer incidence is increasing dramatically (2.5% per year) in Puerto Rico (PR), with increased occurrence of regional (1.7% per year) and distant (4.7% per year) stage cancer, which reflects a real increase and indicates missed screening opportunities. Unfortunately, 80% of cervical cancer cases diagnosed in PR occur among low-income women covered by Medicaid or Medicare, who also have a 70% greater likelihood of being diagnosed with cervical cancer. Cervical cancer screening uptake continues to decline in PR, particularly among low-income Medicaid enrollees, mainly seen by government clinics. Barriers to cervical cancer screening in PR are mainly due to personal (lack of transportation, obesity-related embarrassment) and environmental (repeated disaster events that hampered screening uptake and made recovery slow) factors. The absence of evidence on the effectiveness, cost-effectiveness, and budget impact of patient navigators has limited its adoption among government clinics in this US territory. Multicomponent interventions that can address common screening barriers and improve screening participation in clinic-based settings or avert the need for a clinical-based visit could help improve screening uptake and follow-up care. Our preliminary work suggests the feasibility and acceptability of Human Papillomavirus (HPV) self-sampling in PR. We now propose a hybrid type 1 effectiveness-implementation study using a four-arm multi-site randomized controlled trial (RCT) conducted within government OBGYN clinics in PR. We will assess the effectiveness of patient reminders plus patient navigation and HPV self-collection (individually and in combination) compared to patient reminders alone in increasing cervical cancer screening, timely colposcopy, and cervical precancer treatment (Aim 1). The secondary aim will evaluate key implementation outcomes, including patient and provider receptivity, reach, level of implementation and fidelity, and sustainment intentions. We will then develop an open-cohort micro-simulation model to evaluate the population impact, cost-effectiveness, and budget impact of alternative strategies (Aim 2) to inform their potential applicability at delivery organization, community, and territory levels. This study will provide much-needed knowledge that is necessary to successfully facilitate the adoption and sustained integration of optimal strategies that will improve cervical cancer screening participation and reduce magnifying disparities in Puerto Rico.
Read the detailed description
Aim 1. Conduct a four-arm multi-site randomized controlled trial to evaluate the effectiveness of three interventions, including patient reminders plus patient navigation and self-collection of HPV test (individually and in combination), compared to patient reminders alone on:
1a. Cervical cancer screening (clinic-based pap test/HPV co-testing) uptake among women and completion of HPV self-collection kit.
- b. Timely colposcopy and high-grade squamous intraepithelial lesion (HSIL) treatment among women with abnormal screening results. Secondary analyses will examine implementation outcomes, including patient and provider receptivity, reach, level of implementation and fidelity, and sustainment intentions. Aim 2. Evaluate the population impact, cost-effectiveness, and budget impact of each intervention strategy compared to patient reminders.
- a. Develop an open-cohort micro-simulation model of cervical cancer natural history, screening, and treatment outcomes among women in PR and evaluate population impact (incidence and mortality trends) and the cost-effectiveness of alternative strategies.
2b. Evaluate the budget impact of implementing an optimal screening strategy compared to the current intervention mix (at a delivery organization, community, and territory levels).
- Conditions
- Cervical Cancer Screening
- Being tested
- Arm 2: Patient Navigator, HPV self-collection kit
- Keywords
- HPV related cancers, Cervical cancer, Puerto Rico, Patient Navigator, Patient Reminder, HPV self-collection, Cervical cancer prevention, cervical cancer screening
- 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.
Arm 2: Patient NavigatorBehavioural
The patient navigation model used in the study is aligned with the conceptual model for cervical cancer screening proposed by the Population-based Research Optimizing Screening Through Personalized Regimens (PROSPR) consortium. The initial contact, as well as most navigation activities, will occur mostly over the phone. In our study, the roles of the patient navigator (Arms 2 and 4) will include: exploring individual barriers to screening, use of motivational interviewing to educate and encourage patients to perform screening, performing reminder calls, and coordinating of referral and clinical services if needed. Also, providing other services to identify and overcome access barriers encountered during the cancer care process, including linkage to community resources. In arm 4, the patient navigator will also facilitate the explanation of the use of the self-collection kits by study participants.
HPV self-collection kitBehavioural
Each HPV testing kit will include an invitation letter, information sheet, one FLOQSwabs552C® and one sealable plastic bag to put the swab. Because home high risk (HR) HPV self-screening is not standard of care in the US, the kit will also include a letter advising women to receive routine Pap tests, regardless of their HR-HPV self-sampling results. Detailed instructions on how to collect the cervical sample and how to mail the kit back to the study site or bring it to the clinical visit (depending on their preference) will be included.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Patient reminder (Control Arm) | No intervention | Participants who are due or past recommended cervical cancer screening will be contacted through a scripted telephone call by trained research staff to remind them to schedule an appointment for screening and to provide them with the contact information of the clinic. |
| Arm 2: Patient reminder and patient navigator | Experimental | A patient navigator will call the participants to remind them of their cervical cancer screening, assess any screening barriers that they may have, explain the importance of cervical cancer screening, and help them schedule their appointment at the study sites. The patient navigator will also coordinate follow-up colposcopy and treatments as needed. Receives: Behavioral: Arm 2: Patient Navigator |
| Arm 3: Patient Reminder and Mailed HPV Test for Self-collection | Experimental | Research staff will contact the participants and remind them to schedule an appointment for cervical cancer screening and will provide them with the contact information of the clinic. She/he will also explain to the participant the role of HPV infection in the development of cervical cancer, provide the participant with information about HPV self-collection, and send them the HPV-self-collection through the mail. The kit will include written instructions on how to collect the cervical sample and mail it back to the study site. Receives: Behavioral: HPV self-collection kit |
| Arm 4: Patient reminder, patient navigator, and mailed HPV test for self-collection | Experimental | A patient navigator will remind the participant that it is time for their cervical cancer screening, assess any screening barriers that they may have, explain the importance of cervical cancer screening, and help them schedule their appointment at study sites. She/he will also explain to the participant the role of HPV infection in the development of cervical cancer, provide the participant with information about HPV self-collection, and send them the HPV-self-collection through the mail. The patient navigator will coordinate cytology visits if it is the preference of the participant and any follow-up appointment for cytology and other triage tests, colposcopy and treatments as needed. Receives: Behavioral: Arm 2: Patient Navigator; Behavioral: HPV self-collection kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Effectiveness
Proportion of women who complete cervical cancer screening (attending in-clinic cervical cancer screening) and the proportion of women who completed/returned HPV self-collection kit (Arms 3 and 4).
Measured: Within 6 months after a patient is recruited
Secondary outcomes (1)
Screening Adherence after abnormal results
Proportion of women who receive a colposcopy after an abnormal Pap Test or positive clinic-based HPV result and the proportion of women who receive treatment after histologically diagnosed HSIL.
Measured: Within 18 months after a patient is recruited.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start4 Feb 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Aug 2028 (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 Cervical Cancer ScreeningStudies 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
- A hybrid type 1 effectiveness-implementation study using a four-arm multi-site randomized controlled trial (RCT) conducted within government OBGYN clinics in Puerto Rico. We will assess the effectiveness of patient reminders plus patient navigation and HPV self-collection (individually and in combination) compared to patient reminders alone in increasing cervical cancer screening, timely colposcopy, and cervical precancer treatment.
- Masking
- None (open label)
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ana P. Ortiz Martinez, University of Puerto Rico Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943547
- Sponsor's protocol ID
- R01CA282424
- Other IDs
- Protocol #: 2411003902
- Acronym
- IMPROVE
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with research collaborators.
Publications
Ortiz AP, Torres-Cintron CR, Santiago-Rodriguez EJ, Ramos-Cartagena JM, Suarez-Ramos T, Damgacioglu H, Colon-Lopez V, Ortiz-Ortiz KJ, Deshmukh AA. Recent cervical cancer incidence, stage at diagnosis, and mortality trends in Puerto Rico, 2001-2019. BMC Med. 2024 Aug 13;22(1):327. doi: 10.1186/s12916-024-03535-4.
PubMed 39135060
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness, Cost-effectiveness, and Budget Impact of Interventions to Improve the Delivery of Cervical Cancer Screening in Puerto Rico
- ClinicalTrials.gov ID
- NCT06943547
- Acronym / sponsor ID
- IMPROVE / R01CA282424
- Conditions
- Cervical Cancer Screening
- Keywords
- HPV related cancers, Cervical cancer, Puerto Rico, Patient Navigator, Patient Reminder, HPV self-collection, Cervical cancer prevention, cervical cancer screening
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- University of Puerto Rico Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 24 Apr 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.
Cervical cancer incidence is increasing dramatically (2.5% per year) in Puerto Rico (PR), with increased occurrence of regional (1.7% per year) and distant (4.7% per year) stage cancer, which reflects a real increase and indicates missed screening opportunities. Unfortunately, 80% of cervical cancer cases diagnosed in PR occur among low-income women covered by Medicaid or Medicare, who also have a 70% greater likelihood of being diagnosed with cervical cancer. Cervical cancer screening uptake continues to decline in PR, particularly among low-income Medicaid enrollees, mainly seen by government clinics. Barriers to cervical cancer screening in PR are mainly due to personal (lack of transportation, obesity-related embarrassment) and environmental (repeated disaster events that hampered screening uptake and made recovery slow) factors. The absence of evidence on the effectiveness, cost-effectiveness, and budget impact of patient navigators has limited its adoption among government clinics in this US territory. Multicomponent interventions that can address common screening barriers and improve screening participation in clinic-based settings or avert the need for a clinical-based visit could help improve screening uptake and follow-up care. Our preliminary work suggests the feasibility and acceptability of Human Papillomavirus (HPV) self-sampling in PR. We now propose a hybrid type 1 effectiveness-implementation study using a four-arm multi-site randomized controlled trial (RCT) conducted within government OBGYN clinics in PR. We will assess the effectiveness of patient reminders plus patient navigation and HPV self-collection (individually and in combination) compared to patient reminders alone in increasing cervical cancer screening, timely colposcopy, and cervical precancer treatment (Aim 1). The secondary aim will evaluate key implementation outcomes, including patient and provider receptivity, reach, level of implementation and fidelity, and sustainment intentions. We will then develop an open-cohort micro-simulation model to evaluate the population impact, cost-effectiveness, and budget impact of alternative strategies (Aim 2) to inform their potential applicability at delivery organization, community, and territory levels. This study will provide much-needed knowledge that is necessary to successfully facilitate the adoption and sustained integration of optimal strategies that will improve cervical cancer screening participation and reduce magnifying disparities in Puerto Rico.
Detailed description
Aim 1. Conduct a four-arm multi-site randomized controlled trial to evaluate the effectiveness of three interventions, including patient reminders plus patient navigation and self-collection of HPV test (individually and in combination), compared to patient reminders alone on:
1a. Cervical cancer screening (clinic-based pap test/HPV co-testing) uptake among women and completion of HPV self-collection kit.
- b. Timely colposcopy and high-grade squamous intraepithelial lesion (HSIL) treatment among women with abnormal screening results. Secondary analyses will examine implementation outcomes, including patient and provider receptivity, reach, level of implementation and fidelity, and sustainment intentions. Aim 2. Evaluate the population impact, cost-effectiveness, and budget impact of each intervention strategy compared to patient reminders.
- a. Develop an open-cohort micro-simulation model of cervical cancer natural history, screening, and treatment outcomes among women in PR and evaluate population impact (incidence and mortality trends) and the cost-effectiveness of alternative strategies.
2b. Evaluate the budget impact of implementing an optimal screening strategy compared to the current intervention mix (at a delivery organization, community, and territory levels).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A hybrid type 1 effectiveness-implementation study using a four-arm multi-site randomized controlled trial (RCT) conducted within government OBGYN clinics in Puerto Rico. We will assess the effectiveness of patient reminders plus patient navigation and HPV self-collection (individually and in combination) compared to patient reminders alone in increasing cervical cancer screening, timely colposcopy, and cervical precancer treatment.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Patient reminder (Control Arm) | No intervention | –Participants who are due or past recommended cervical cancer screening will be contacted through a scripted telephone call by trained research staff to remind them to schedule an appointment for screening and to provide them with the contact information of the clinic. |
| Arm 2: Patient reminder and patient navigator | Experimental | Behavioral: Arm 2: Patient NavigatorA patient navigator will call the participants to remind them of their cervical cancer screening, assess any screening barriers that they may have, explain the importance of cervical cancer screening, and help them schedule their appointment at the study sites. The patient navigator will also coordinate follow-up colposcopy and treatments as needed. |
| Arm 3: Patient Reminder and Mailed HPV Test for Self-collection | Experimental | Behavioral: HPV self-collection kitResearch staff will contact the participants and remind them to schedule an appointment for cervical cancer screening and will provide them with the contact information of the clinic. She/he will also explain to the participant the role of HPV infection in the development of cervical cancer, provide the participant with information about HPV self-collection, and send them the HPV-self-collection through the mail. The kit will include written instructions on how to collect the cervical sample and mail it back to the study site. |
| Arm 4: Patient reminder, patient navigator, and mailed HPV test for self-collection | Experimental | Behavioral: Arm 2: Patient Navigator, Behavioral: HPV self-collection kitA patient navigator will remind the participant that it is time for their cervical cancer screening, assess any screening barriers that they may have, explain the importance of cervical cancer screening, and help them schedule their appointment at study sites. She/he will also explain to the participant the role of HPV infection in the development of cervical cancer, provide the participant with information about HPV self-collection, and send them the HPV-self-collection through the mail. The patient navigator will coordinate cytology visits if it is the preference of the participant and any follow-up appointment for cytology and other triage tests, colposcopy and treatments as needed. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 25-65 years old
- No history of cervical cancer or hysterectomy
- Have not had a Pap test in the past 3 years or more, an HPV test in the past 5 years or more, or a combination of a Pap test and an HPV test in the past 5 or more years (co-testing).
- Must have a record at the study clinics (at least 2 previous visits).
Key exclusion criteria (6 listed)
- Women with no telephone contact information
- Being pregnant*
- Living with HIV, Lupus, or Crohn's*
- Active on immunotherapy treatment*
- History of organ transplants*
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 |
|---|---|---|
| Arm 2: Patient NavigatorThe patient navigation model used in the study is aligned with the conceptual model for cervical cancer screening proposed by the Population-based Research Optimizing Screening Through Personalized Regimens (PROSPR) consortium. The initial contact, as well as most navigation activities, will occur mostly over the phone. In our study, the roles of the patient navigator (Arms 2 and 4) will include: exploring individual barriers to screening, use of motivational interviewing to educate and encourage patients to perform screening, performing reminder calls, and coordinating of referral and clinical services if needed. Also, providing other services to identify and overcome access barriers encountered during the cancer care process, including linkage to community resources. In arm 4, the patient navigator will also facilitate the explanation of the use of the self-collection kits by study participants. | Behavioural | Arm 2: Patient reminder and patient navigator, Arm 4: Patient reminder, patient navigator, and mailed HPV test for self-collection |
| HPV self-collection kitEach HPV testing kit will include an invitation letter, information sheet, one FLOQSwabs552C® and one sealable plastic bag to put the swab. Because home high risk (HR) HPV self-screening is not standard of care in the US, the kit will also include a letter advising women to receive routine Pap tests, regardless of their HR-HPV self-sampling results. Detailed instructions on how to collect the cervical sample and how to mail the kit back to the study site or bring it to the clinical visit (depending on their preference) will be included. | Behavioural | Arm 3: Patient Reminder and Mailed HPV Test for Self-collection, Arm 4: Patient reminder, patient navigator, and mailed HPV test for self-collection |
Primary outcome
Intervention Effectiveness
Time frame: Within 6 months after a patient is recruited
Proportion of women who complete cervical cancer screening (attending in-clinic cervical cancer screening) and the proportion of women who completed/returned HPV self-collection kit (Arms 3 and 4).
1 secondary outcome
Screening Adherence after abnormal results
Time frame: Within 18 months after a patient is recruited.
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 30 Apr 2026.
- Results publication: PubMed 39135060Ortiz AP, Torres-Cintron CR, Santiago-Rodriguez EJ, Ramos-Cartagena JM, Suarez-Ramos T, Damgacioglu H, Colon-Lopez V, Ortiz-Ortiz KJ, Deshmukh AA. Recent cervical cancer incidence, stage at diagnosis, and mortality trends in Puerto Rico, 2001-2019. BMC Med. 2024 Aug 13;22(1):327. doi: 10.1186/s12916-024-03535-4.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with research collaborators.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 2: Patient Navigator and HPV self-collection kit in people with Cervical Cancer Screening, run by University of Puerto Rico Comprehensive Cancer Center at 1 site in Puerto Rico.
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 4 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: enrolling by invitation, as of the sponsor's last update on 30 Apr 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 Puerto Rico. 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?
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?
Intervention Effectiveness (time frame: Within 6 months after a patient is recruited). 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 NCT06943547, 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 30 Apr 2026.