Clinical trial NCT06943547: The Effectiveness, Cost-effectiveness, and Budget Impact of Interventions to Improve the Delivery of Cervical Cancer Screening in Puerto Rico.
Official title: The Effectiveness, Cost-effectiveness, and Budget Impact of Interventions to Improve the Delivery of Cervical Cancer Screening in Puerto Rico
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
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
Lead sponsor: University of Puerto Rico Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-04-24
Enrollment: 1400
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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. 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.

1. 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.
2. 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).

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Intervention Effectiveness
timeFrame: Within 6 months after a patient is recruited
Secondary outcomes:
measure: Screening Adherence after abnormal results
timeFrame: Within 18 months after a patient is recruited.
Other outcomes:
measure: Other tertiary outcomes
timeFrame: Within 18 months after a patient is recruited.
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
References:
citation: 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.