Community-clinic partnership to address social needs and improve colorectal cancer screening outcomes: The PRIME stepped-wedge study

Abstract

Background:

US colorectal cancer screening rates are suboptimal, particularly among Latino populations and patients served by federally qualified health centers (FQHCs). PRIME is a two-phased study to test effectiveness of a multi-component program to address patient social needs and improve colorectal cancer screening and follow-up in neighborhoods served by our partnering FQHC.

Methods:

PRIME is a modified stepped-wedge study involving health-center patients in 12 neighborhoods in Southern California, followed by a scale-up study involving four additional health centers/neighborhoods. Eligible adults are ages 45–64, due for colorectal cancer screening, with a health center clinic visit in the previous 6 months. The intervention combines: (1) phone-based advance notification, a mailed FIT, and text messages with links to a short animated instructional video on FIT completion, (2) patient navigation for addressing patients’ social needs, and (3) neighborhood-level events to raise awareness about the need for colorectal cancer screening.

Results:

Recruitment for Phase I began in July 2024. Primary effectiveness outcome is receipt of any colorectal cancer screening within 6 months; primary implementation outcome is clinic-level and organizational-level rates of program delivery, by component (e.g., mailed FIT, social needs navigation, community events). Phase II scale-up activities will: use webinars, train-the-trainer workshops, and collaborative learning activities; and will assess adoption of and adaptations to the multi-component program.

Conclusion:

This study will test the effectiveness, implementation, and scale-up of a multi-component video text message and social needs navigation program to improve colorectal cancer screening uptake in neighborhoods served by our partnering FQHC and community-based organizations.

INTRODUCTION

Colorectal cancer (CRC) is a leading cause of cancer death in the United States.(1, 2) While CRC screening could prevent more than 73% of deaths from CRC, approximately 33% of US adults aged 45–75 (30 million people) are not currently up to date with CRC screening recommendations.(3–5) Screening participation is especially low among individuals younger than 65, among whom 46% of CRCs are found.(6)

Compared to non-Latino White adults, Latino adults have considerably lower uptake of CRC screening (51% vs. 60% for adults ages 45–75).(5) Rates of CRC screening are particularly low in federally qualified health centers (FQHCs; 41.1% in 2023 among adults ages 45–75), where many uninsured, low-income, and members of racial/ethnic population subgroups receive care.(7) Social factors, including lack of health care coverage, lack of transportation, and food insecurity, contribute to low CRC screening uptake.(8, 9) More than 1 in 10 FQHC patients experience major social risk factors.(10) Attending to social factors may boost stool-testing and improve uptake of follow-up colonoscopy among adults with abnormal stool-test results.(8, 9) A 2020 systematic review of studies that intervened on social determinants of health to improve cancer screening in the United States reported that the approach is cost-effective.(11)

Text messages can reach more people than in-person educational sessions or live phone calls and, when combined with patient navigation, could serve as a model for resource-efficient care delivery.(12–16) This approach decreases reliance on clinic-specific patient portals and secure messaging that are unequally used across population subgroups (17) and moves toward approaches that use communication modes (e.g., smartphones) and community resources that people already use. An estimated 97% of US adults have access to smartphones and can view video links sent via text messages.(18) Abundant research demonstrates the feasibility of using text messages for preventive care reminders, with reach exceeding 90% in recent reports.(19–21) Text messaging with linked video content can also deliver accurate health information, motivate individuals to get screened, and instruct them on proper use of at-home and/or clinic-administered tests.(22)

Our study, Community Partnership for Telehealth Solutions to Convey Information and Enhance Care (PRIME), evaluates the effectiveness and implementation of a targeted, multilevel program incorporating tailored video-text reminders, social needs navigation, and neighborhood-level outreach to address CRC screening disparities in Latino populations. PRIME strengthens partnerships between communities and clinics to tackle social barriers while providing text-based CRC screening education that encourages screening participation. As essential bridges between clinical care and community resources, CBOs will facilitate both immediate intervention delivery and sustainable infrastructure for future program sustainment and expansion. This collaborative framework provides a scalable template for replication across diverse healthcare systems and community contexts. Here, we describe the protocol of our pragmatic trial in 12 neighborhoods, plus a scale-up study across 4 neighborhoods, to facilitate PRIME implementation. We will assess adaptations and drivers of program success at the levels of patient, clinic, and neighborhood.

METHODS

PRIME is a large-scale, modified stepped-wedge study involving FQHC patients in 12 neighborhoods in Los Angeles and Orange counties in California. The intervention program was tailored for FQHC patients using learner verification and revision (LVR) (23), with components delivered by the clinic, text message vendor, and local community-based organizations (CBOs). We will evaluate effectiveness by comparing 6-month proportions of any CRC screening in eligible enrollees at pre-and post-intervention timepoints. The study is a collaborative partnership among Kaiser Permanente (KP) Northwest Center for Health Research, the University of Arizona, San Diego State University, our partnering FQHC, and local CBOs. Study activities build on prior mailed FIT and patient navigation implementation research conducted by our team (13, 23–34) and best practices identified in scientific literature.(35)

PRIME was approved by the KP Interregional Institutional Review Board (protocol number: 1941852), which granted a waiver of informed consent and waiver of HIPAA authorization because the study involves minimal risk and the research could not be practicably carried out without these waivers. The waivers cover study activities and data obtained from the study FQHC and partnering CBOs.

Setting Description

The primary analysis uses a modified stepped-wedge design within 12 neighborhoods served by a large FQHC in Southern California. The FQHC operates 25 medical clinics and served more than 245,000 patients in 2022, including 65,692 patients ages 45–64. More than 97% of patients ages 45–64 listed English (33%) or Spanish (65%) as their preferred language. The FQHC uses the InSure^® ONE™ FIT (Clinical Genomics; Bridgewater, NJ), which requires collection of two specimens from a single stool sample. FITs are processed at a reference laboratory. In 2023, 54.8% of eligible patients were up to date with CRC screening.(7) The FQHC promotes CRC screening in a variety of ways, using opportunistic approaches and a centralized outreach team that delivers reminders to return FITs distributed during in-clinic visits.

The PRIME intervention focused on individuals ages 45 to 64 in select neighborhoods with a clinic visit in the past 6 months, were due for CRC screening, and who had no EHR evidence of having received a stool-test order or referral for colonoscopy (i.e., missed opportunity). We focused on this population given that prior research at our partnering FQHC showed lower 6-month FIT completion rates following mailed FIT in those with a prior year visit (+15.0%), compared to those without (+24+).(14) Further, we anticipated that most individuals ages 45 to 49 and some ages 50 to 64 would be naïve to screening (as the 2021 USPSTF guidelines were implemented in 2022), and would benefit from instructions and navigation to support screening completion.

Research Aims

Aim 1: Refine videos and assess social determinants of health.

Aim 2: Conduct a stepped-wedge trial (12 neighborhoods/clinics; 3,000 patients aged 45–64) testing effects of the program adapted in Aim 1.

Aim 3. Assess multi-level moderators of program effectiveness (including ethnicity, preferred language, and neighborhood-level social determinants of health), as well as organizational-level barriers and facilitators to implementation; scale up the evidence-based components to additional neighborhoods/clinics (n = 4) and assess adoption and adaptations to the program.

Study design

For aim 1, we used a Learner Verification and Revision (LVR) approach to refine our FIT and colonoscopy instructional videos.(36) LVR is a participatory approach that engages users in a series of steps to develop and refine materials to make them actionable, and culturally and literacy-appropriate. We conducted one-on-one interviews with patients (n = 24) to obtain feedback on two animated videos: The first [length in minutes: 2:49 in English; 3:04 in Spanish] instructs patients on how to complete the Insure ONE FIT test; the second [length in minutes: 2:56 in English, 2:58 in Spanish] addresses what a colonoscopy is, how it is performed, and what a patient needs to do to complete one (i.e., schedule the procedure, complete bowel prep, arrange for a ride home).(37) Participants were offered a $50 gift card completing the interview. Text messages and videos were revised, based on feedback obtained.(38)

To complete Aim 2, we will assess effectiveness of the video-text message, and of the mailed-FIT- outreach and social-needs-navigation program using a stepped-wedge design conducted over 18 months (three wedges of 3–5 neighborhoods, each separated by 6 months). Our program uses a collaborative clinic-community linkage model, where clinic staff will identify eligible patients and deliver text messages and advance notification live calls (live phone calls) using Interaction Desktop Software (Genesys, Menlo Park, CA), mail FIT kits and deliver reminders, and clinic and CBO staff will work together to deliver navigation to address patients’ social needs and support screening completion (e.g., provide food boxes, transportation, healthcare access, and organize community educational events). Clinic staff will support patients’ enrollment in insurance coverage. The implementation of the multi-component program is supported by formal training and on-going implementation support (weekly collaborative learning meetings with clinic staff; monthly collaborative learning meetings with clinic staff and partnering CBOs) provided by clinic staff and other members of the research team.

For our primary analysis, we will use a modified non-randomized stepped-wedge design (Figure 1).(39) Stepped wedge designs deliver a program to all selected units over time; and thus resemble “real-world” program implementation. The standard stepped-wedge design assumes consistent program maintenance across time, and effectiveness is calculated using pre-intervention and post-intervention data gathered over time intervals that vary by wedge: earlier wedges implement the program first and contribute more post-intervention data than later wedges. This has the effect of more heavily weighting the effectiveness of units in the first wedge, compared to later wedges. In contrast, the modified stepped-wedge design evaluates the intervention effect using post-intervention data for a fixed time interval (in our case 6 months) for each wedge. We are using a non-randomized approach to further resemble ‘real-world’ program implementation, consistent with our clinical partner preferences and a growing body of literature supporting the validity of this approach.(40)

Figure 1.

Modified Stepped Wedge Design

Neighborhood selection.

We used patient home addresses and geographic information system tools to plot the location of all FQHC patients ages 45–64 who had visited a clinic in Los Angeles- or Orange-counties in any of the past year (Figure 2). With input from partnering CBO staff, we initially selected 24 neighborhoods (10 in Orange County and 14 in Los Angeles County); 12 neighborhoods will be used in the stepped-wedge component of the study (5 in Orange County and 7 in Los Angeles County). Neighborhoods were defined as adjacent zip code areas, with CBO staff confirming whether these contiguous zip codes formed cohesive communities. Neighborhoods were comprised of one to three zip codes and had an average of 121 patients ages 45–54 and 105 patients ages 55–64. Data from the remaining 12 neighborhoods were set aside for use in secondary analysis (pre-defined) that will test the same outcomes, using a staggered cluster-randomized design. This will allow the research team to compare the two research designs (stepped-wedge and staggered cluster-randomized) and analytic approaches.

Figure 2.

PRIME Study Neighborhoods

Randomization.

On July 10, 2024, our project statistician randomized the initial set of 24 neighborhoods into either usual care or intervention using three categories based on county and proximity to community resources (Orange County, Los Angeles County closer to community resources [less than 20 minutes of drive-time], and Los Angeles County farther from community resources [20 minutes or more of drive-time]) and generated allocation sequences using SAS version 9.4 (SAS Institute Inc., Cary, NC). Neighborhoods allocated to the intervention were then ordered for the stepped-wedge analysis (non-randomized), with three-to-five neighborhood assigned to each wedge. For the purposes of engaging CBOs over time, wedge assignment was based on county and proximity of neighborhood to partnering CBO (wedge 1 Los Angeles County neighborhoods < 20 minutes of drive-time, wedge 2 Los Angeles County neighborhoods >= 20 minutes of drive-time; wedge 3 Orange County neighborhoods). For practical reasons, the research team and the clinic staff were unblinded to randomization assignment.

Selection of eligible patients:

For each wedge, clinic staff will use electronic health record (EHR) codes to generate a list of eligible patients for each neighborhood assigned to the intervention; eligible patients are aged 45–64 due for CRC screening (14, 32), had a clinic visit in the past 6 months, primarily speakers of English or Spanish, have a cell phone listed in EHR, and no order for a FIT or FIT-DNA placed, and no referral to a colonoscopy made. Clinic staff then upload into a secure, web-based, electronic data capture tool (REDCap)(41, 42) hosted at KP Center for Health Research, the names and contact information of patients in Wedge 1 neighborhoods (3 neighborhoods; July 2024 – January 2025), Wedge 2 neighborhoods (4 neighborhoods; January 2025 – July 2025), and Wedge 3 neighborhoods (5 neighborhoods; July 2025 – January 2026).

Intervention activities

Intervention activities including providing health insurance, food box, and transportation resources are recorded for individual patients in REDCap by Navigators. CBOs report a weekly summary of food boxes shared.. Outcomes from the interventionists’ calls are logged in the EHR. CBOs are sent a weekly email link to record outreach activities.

Advanced notification.

Clinic outreach staff will deliver live phone calls to patients in wedge 1 neighborhoods (3 neighborhoods, estimated 750 patients; Figure 2). The phone call will be preceded (usually within 2 hours) by a text message. The text will include a link to the short, animated video on how to complete a FIT test and will notify the patient that a clinic staff member will call them (pre-call text message). During the live phone call, clinic staff will confirm the patient’s eligibility for stool testing (no recent screening, no disqualifying family history, symptoms, or colon disease). Patients who are ineligible for stool testing will be referred to a provider who will contact the patient and determine whether to place an order for a colonoscopy. Clinic staff also will confirm receipt of the video text-message (and ability to view the linked video), offer to mail a FIT test, and administer a short social needs survey. The survey asks about needs that can be addressed by the program (i.e., food insecurity, lack of transportation, lack of insurance), using questions from the Protocol for Responding to & Assessing Patients’ Assets, Risks & Experiences (PRAPARE Wheel).(43) Patients who are not reached for the advance notification phone call will be mailed an introductory letter that explains the importance of CRC screening, instructs the patient to contact their doctor if they have a family history or are experiencing CRC symptoms. The letter states that additional testing (i.e., a colonoscopy) will be needed if the FIT finds blood in their stool.

Social needs navigation.

Patients who need assistance enrolling in insurance will be referred to an enrollment coordinator at the FQHC. Patients who experience food insecurity will be provided instructions for picking up a food box with a partnering CBO. The CBO may help patients complete an application for the Supplemental Nutrition Assistance Program, or the Women, Infants and Children program, as appropriate. The food boxes will be provided for up to six months, and referrals will be made to food pantries and other resources, as needed. Patients who need transportation assistance will be provided health insurance plan-specific transportation services information and/or a $10 gift card. Patients having social needs not addressed by the program will be referred to Findhelp.org, a national referral service connecting individuals to health, human, and social service organizations integrated to the FQHC’s EHR. Clinic staff will contact the partnering CBOs following the referral to assess if patients followed-through with obtaining services.

Mailed FIT and reminders.

Patients mailed an introductory letter (those not reached by phone) and patients reached by phone who are eligible for stool-based testing will be mailed a FIT test. Patients who prefer non-FIT tests will be referred to the project clinician who will place an order for FIT-DNA or referral for colonoscopy. The FIT kit will include pictorial instructions with a QR code with a link to the animated video that demonstrates how to complete a FIT test. Two- and four-weeks following the FIT mailing, patients who do not return their FIT will be sent text-based reminders with links to videos on how to complete FIT testing.

Follow-up colonoscopy.

Consistent with usual care, adults whose stool-test result is abnormal and who need a colonoscopy are referred to external gastroenterology specialty care facilities (hospital or ambulatory surgical center) in the region of the clinic, and the health center registry team will coordinate follow-up care.

Neighborhood-level events.

In collaboration with CBOs, clinic staff will participate in neighborhood-level events to raise awareness about CRC and the need for screening. These events include health fairs, setting up tables at retail outlets, and events organized by community partners. We will track the number of events and attendees per event. Patients that join community CRC education sessions will be eligible to join a raffle (two $20 gift cards will be raffled per session).

Implementation Support Activities

Study activities will be primarily facilitated by the project manager, clinic staff, and other study team members with relevant expertise (e.g., data analysis, patient navigation). Intervention training addressed 1) steps in the study protocol, 2) how to outreach to patients, including how to use the telephone and texting platform, 3) how to use motivational interviewing to support patients’ decision-making about CRC screening, 4) how to mail FIT kits and deliver reminders, 5) how to address social needs, and 6) data tracking and documentation, including data entry in the EHR and REDCap database. Clinic staff were trained to address crisis situations (including suicidality) and report adverse events consistent with the study’s data safety monitoring plan (and FQHC protocols). The training lasted 40 hours and was delivered by research staff and clinic staff.

Evaluation

Implementation outcomes.

We will evaluate implementation by assessing extent to which clinics and organizations in intervention neighborhoods deliver the program by component (mailed FIT, notifications/reminders, social needs screening and linkages, community events) within 6 months of the date patients are identified as eligible (Table 1). Reach will be measured by the number of individuals who receive a text message, the number who access the video; the number who receive a FIT (mailed minus undeliverable); the number reached for navigation, and the types of resources received. We will track counts of patients who opt out of FIT mailing, unsubscribe to text messaging, or report recent CRC screening.

Table 1.

Effectiveness and Implementation Outcomes for PRIME study

Variable	Definition	Population
Outcomes – Effectiveness (Primary)
Colorectal cancer screening completion – individual-level, adjusted for neighborhood effects	Receipt of any colorectal cancer screening (FIT, sDNA-FIT, colonoscopy, CT-colonography, sigmoidoscopy) within 6 months of the list pull date b (binary)	Patients on eligibility lists a
Outcomes – Effectiveness (Secondary)
FIT completion	FIT completed within 6 months of the claims list pull date b (binary)	Patients on lists (eligible patients) a
Follow-up colonoscopy completion	Receipt of a colonoscopy within 12 months of the patient’s abnormal fecal test date (binary)	Eligible patients with an abnormal stool- test result
Time to follow-up colonoscopy	Time from abnormal FIT test result to completed colonoscopy (time to event), those who do not complete a colonoscopy are censored at 12 months.	Eligible patients with an abnormal stool- test result
Colonoscopy outcomes (track)	Detection of adenomas, advanced adenomas, or cancer (binary)	Eligible patients with a completed colonoscopy
Outcomes – Implementation
Implementation	Neighborhood-level rates of program delivery, by core component (mailed FIT) and non-core components (reminders delivered, social needs addressed); (proportion)	Eligible patients, by core and non-core intervention components, aggregated by neighborhood
Reach (patient-level)	Receipt of the program, by component (live call outreach completed/left message, mailed FIT sent to valid address, reminders delivered, social needs navigation delivered, follow-up colonoscopy navigation delivered)	Eligible patients, by core and non-core intervention components, aggregated by neighborhood
Aim 3: Assess Moderators, Acceptability, Multi-level Barriers and Facilitators; Scale-Up
Moderators of Intervention Effectiveness	Differences in effectiveness by patient characteristics (baseline age [45–49, 50–54, 55–59, 60–64], sex, ethnicity, preferred language, history of stool-based testing [Yes vs No])	Eligible patients with and without characteristic.
Acceptability, multi-level barriers & facilitators	Acceptability, barriers and facilitators to implementation (qualitative)	Clinic staff, community organization staff, program recipients (FQHC patients)
Participation in scale-up	Number of clinic- or community organization staff that participate in scale-up events, by event	Clinics, organizations that were approached for participation
Adoption at the organizational and staff levels	Proportion clinics or community organizations that adopt the program characteristics of adopters and non-adopters	Clinics, organizations that participate in scale-up events
Adaptations	Adaptations made to the program; type, reason, who made decision to adapt, etc.	Clinics, organizations that adopt the program

^aPatients on eligibility lists are ages 45–64, and overdue for colorectal cancer screening, based on HEDIS criteria

Primary effectiveness outcome.

Our primary intention-to-treat analysis (ITT; all clinics and participants evaluated in their assigned wedge) will compare any CRC screening completion across study conditions using the generalized linear mixed model described by Hussey and colleagues.(32) The model includes study condition (pre-intervention vs. post-intervention) and time (categorical: baseline, 6-months, 12 months, 18 months) as fixed effects and neighborhood as a random effect. We will repeat this analysis for our secondary endpoint of FIT completion within 6 months. Because we do not anticipate having auxiliary variables that would allow us to use multiple imputation,(44, 45) we will assume that patients with missing outcome data did not complete any CRC screening.

Additional analyses

Secondary outcomes.

Secondary effectiveness outcomes are completion of FIT within 6 months, follow-up colonoscopy receipt within 12 months, and time to colonoscopy among those with an abnormal stool-test result. We also will track colonoscopy outcomes (e.g. number of adenomas, cancers detected).

Staggered cluster randomized analysis.

Using data from our 12 intervention neighborhoods plus our 12 usual care neighborhoods, we will evaluate intervention effectiveness by assessing intervention vs usual care differences in any CRC screening within 6 months. We will assess our primary outcome (completion of CRC screening within 6 months) and secondary outcome (completion of FIT within 6 months) using multivariable logistic regression, with study condition as the independent variable. All standard errors will be adjusted to account for clustering within neighborhood.

Per-protocol analysis.

We will perform per-protocol (PP) analyses for both screening outcomes (any CRC screening and FIT completion within 6 months) by limiting the sample to patients known to have received core program components; the PP analysis will include those who were successfully mailed a FIT.

Statistical analysis.

Our primary effectiveness analysis will use hierarchical generalized linear modeling to account for clustering of patients within neighborhoods.(46) Because the primary outcome is binary (i.e., any CRC screening, yes/no), we will use a model with a logit link and binomial distribution (i.e., multilevel logistic regression). The independent variable will be arm (dummy-coded) with usual care as the reference group. Neighborhood will be modeled as a random effect. Odds ratios >1 support the hypothesis that the program of video-text messages and patient navigation increases likelihood of a patient obtaining any CRC screening compared to usual care. A similar framework will be used for the other binary outcome variables (e.g. receipt of FIT, receipt of follow-up colonoscopy). To compare time to follow-up colonoscopy, we will use Cox proportional hazards regression and restricted mean survival time.

Sample size and power.

We conducted power analyses for the stepped wedge trial. We assumed 80% power and calculated a sample size of 121 patients aged 45–54 and 105 patients aged 55–64 per neighborhood on average using EHR data for study planning and implementation. We further calculated an intra-class correlation (ICC) of .0164 and a pre-implementation (baseline) CRC screening rate of 16.5% using data from a previous study at the FQHC.(14–16) With these assumptions and inputs, we will be powered to detect differences in screening rates of 6.7% and 7.0% between intervention and control participants in the stepped-wedge component of the study aged 45–54 and 55–64, respectively. As part of the cluster-randomized component of the study, we will be able to detect differences between intervention and control participants greater than or equal to 7.2% and 7.3% for participants aged 45–54 and 55–64, respectively. In analyses including all participants (ages 45–64), we will be able to detect differences greater than or equal to 5.9% in the stepped-wedge component of the study and 6.5% in the cluster-randomized component of the study. Power calculations were determined using PASS 15.(47)

Assess moderators.

We will examine whether baseline age (45 – 49 vs. 50 –64), sex (male vs. female), ethnicity (Hispanic vs. non-Hispanic), preferred language (English vs. Spanish), history of stool-based testing (no prior stool-based test vs. at least 1 prior stool-based test) at baseline modify the treatment effect. We will perform each subgroup analysis using the same stepped-wedge generalized linear mixed model framework for the primary (any CRC screening within 6 months) and secondary (FIT completion within 6 months) outcomes by adding the moderator and product of moderator and arm. We will also test for moderation in our staggered cluster-randomized design.

Acceptability and multi-level barrier and facilitators

In support of Aim 3, 2e will conduct semi-structured qualitative interviews among program recipients and clinic staff (clinic managers, quality improvement staff, physicians, and navigators implementing the program) to understand contextual factors, barriers and facilitators to implementation, program acceptability and adaptations (both desired and executed), and unanticipated consequences (positive or negative). We will conduct approximately 30 patient interviews representative of participating age groups (45–49; 50–64); sexes; language preferences (Spanish and English); and neighborhoods groups into wedges (~10 patients per wedge). Interviews will occur shortly after each wedge, and patients will receive a $40 gift card for participating. We will conduct approximately 15 local partner interviews with staff from partnering CBOs who provide resources for the program and 15 interviews with clinic staff). Interviews will be conducted via videoconference after each wedge, and generally last 30–60 minutes. All qualitative interviews will be digitally recorded, professionally transcribed, , and analyzed by the research team using rapid qualitative analysis and immersion crystallization techniques to identify salient findings.(48) Findings from interviews will inform program scale-up activities and content for dissemination materials.

Scale up the program in four neighborhoods

We will work with our partnering CBOs to develop a plan based on our findings to scale up the program and disseminate training products to additional neighborhoods as part of Aim 3. The plan will likely include training sessions on sending video-text messages, delivering patient navigation, and organizing community events, using webinars, train-the-trainer workshops, and learning collaboratives. The 40-hour multi-component training program developed for the main trial will be adapted, as needed, and delivered to support asynchronous and synchronous learning. Project staff will be available by phone or email for organization staff who need real-time assistance implementing program components.

We will track the number of clinics-/CBO-staff approached and who agree to implement the program. We will track the number who attend our train-the-trainer workshops, patient-navigation workshops, and project-specific training events. Using 6-month follow-up survey data, we will assess the number of CBOs and the number of clinics that have begun to implement each component of the program. Among those who have implemented the program, we will collect and report information about adaptations to the program and reasons adaptations were made.

DISCUSSION

PRIME is a pragmatic implementation study that tests the effectiveness and scalability of a multi-component intervention combining video-text messaging with social needs navigation, delivered through partnerships between FQHCs and CBOs. The study employs a phased approach: initial testing across diverse neighborhoods, followed by systematic scale-up through tailored training programs for health systems and CBOs, with comprehensive assessment of program adoption and adaptation. This research has the potential to raise CRC screening participation among the more than 10 million age-eligible adults served by FQHCs nationwide.

Possible limitations, including unmeasured confounders could influence results. Fluctuations in clinic patient volumes due to policy, systems, and/or environmental-level modifications may affect study participant eligibility. Federal immigration enforcement policies could additionally impact patients’ capacity or willingness to access available community and clinic services. These factors will be tracked during the study.

Conducted in partnership with the nation’s largest FQHC system, the study’s large geographic scope enables robust outcome analysis and direct comparison of two established cluster randomization methodologies. The PRIME study represents a significant methodological advancement by systematically integrating social determinants of health into a CRC screening intervention. Unlike traditional screening approaches, PRIME addresses patients’ structural barriers through evidence-based, patient-centered solutions including food security support, insurance enrollment assistance, and transportation services. This approach recognizes that effective cancer prevention requires addressing the social and economic factors that impede healthcare access. Furthermore, PRIME establishes a scalable framework for community-clinic integration, demonstrating how strategic FQHC-CBO partnerships can enhance the cultural relevance and contextual appropriateness of preventive care delivery.

Figure 3.

PRIME Study Activities

Highlights:

• Our study will collect data on effectiveness and implementation of a program to promote screening for colorectal cancer through video-text messages and social-needs navigation in neighborhoods served by our partnering federally qualified health center.

• We use a collaborative model to partner with clinics and community organizations. Our findings will provide evidence about scalability of this model across similar US settings.

• We will disseminate our findings and products and scale-up the program to four additional neighborhoods and assess program adoptions and adaptations (both planned and executed).

List of abbreviations

CRC

Colorectal cancer

FIT

Fecal Immunochemical test

PRIME

Community Partnership for Telehealth Solutions to Convey Information and Enhance Care

ICC

Intra-class correlation coefficient

MDES

Minimum detectable effect size

Availability of data and materials

Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.