Grant Number:	1R01CA312709-01 Interpret this number
Primary Investigator:	Smith, Jennifer
Organization:	Univ Of North Carolina Chapel Hill
Project Title:	Effect of Bundling Home-Based Self-Collection for Cervical and Colorectal Cancer Screening: the My Body, My Test-4 Trial
Fiscal Year:	2026

ABSTRACT This study will investigate whether colorectal (CRC) and cervical cancer (CC) screening programs could be improved by bundling outreach of at-home self-collection kits for CRC and CC screening for under- screened patients. Both CRC and CC are highly preventable through regular screening and treatment, yet more than 50% of cases are attributable to suboptimal screening. More than 40% of U.S. women report not being screened for both cancers at recommended intervals. Self-collected fecal immunochemical testing (FIT) is a widely used test which detects hidden blood in stool for CRC screening. Self-collection of cervico-vaginal cells for human papillomavirus (HPV) testing is a valid and accepted screening method for detecting high-grade cervical lesions and cancer. Although our previous research shows that mailed outreach interventions are effective in increasing CRC and CC screening coverage separately, the effectiveness of a novel 2-for-1 approach that bundles self-collection kits to improve outcomes for both screening programs remains to be seen. This trial will test if the bundled approach improves outcomes for both programs. Aim 1: We will enroll 2,499 women overdue for both CRC and CC screening at a large Federally Qualified Health Center in North Carolina, which serves a community with limited access to care (92% of patients at or below 200% of the Federal Poverty Level; 17% self-pay). Women will be randomly assigned to one of three groups: Arm 1: Receive a FIT kit (for CRC) and an HPV self-collection kit (for CC) at the same time. Arm 2: Receive one kit first, followed by the second kit one month later (either CRC then CC, or vice versa). Arm 3: Receive usual care (no kits sent). All participants will receive a study information letter. Arms 1 and 2 will be mailed the kits for at-home use to return by mail. Arm 3 will continue with the standard of care procedures provided by the clinic. The primary trial outcome will be the completion of both CRC and CC screenings within 9 months, defined as either a negative result from self-collected samples or an in-clinic screening. Secondary trial outcomes include opt-out rates, kit return rates, screening completion by cancer type, and follow-up procedures within 9 months. Aim 2: We will conduct telephone surveys both pre- and post-intervention to assess perceptions of screening efficacy, convenience, and commitment across arms. We hypothesize that these factors will mediate the effect of bundled outreach on screening completion. Aim 3: We will measure cost inputs for each arm and calculate the incremental cost per additional patient completing screening of bundled kit outreach as compared to sequential kit outreach and to usual care. This trial will provide rigorous evidence on whether (Aim 1), why (Aim 2), and at what cost (Aim 3), bundled provision can improve CRC and CC screening programs. If found to be effective, this scalable approach could have a large public health impact by substantially improving early cancer detection and reducing mortality among under-screened populations.





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