JMIR Publications

ABSTRACT

Background:

Cervical cancer risk is shaped by interacting psychosocial, biologic, microbial, and clinical processes, yet few prospective studies integrate repeated biospecimens, ecological momentary assessment (EMA), wearable data, and electronic health record (EHR) information within the same cohort. This gap is especially important in populations disproportionately affected by cervical cancer inequities.

Objective:

This paper describes the protocol and current implementation of Sacred WOMB, a digitally enabled prospective cohort study designed to examine how psychosocial stress, cortisol regulation, vaginal microbiome dynamics, HPV-related factors, and clinical follow-up jointly influence the resolution or persistence of abnormal cervical cancer screening findings at diagnostic evaluation.

Methods:

Sacred WOMB is recruiting women aged 21 to 65 years after an abnormal cervical cancer screening result and before diagnostic colposcopy. The target sample is 270 women (90 Latina, 90 non-Latina Black, and 90 non-Latina White). Study procedures include EHR-based prescreening, in-person consent and onboarding, baseline surveys, twice-daily EMA for 14 days, home salivary cortisol collection, passive Fitbit monitoring, retrieval of residual Pap material from the index abnormal screen (T0), blood, urine, saliva, vaginal pH, and a self-collected vaginal swab at baseline, and provider-collected vaginal and cervical sampling at follow-up colposcopy (T2). Data are integrated across EPIC, REDCap, participant-facing digital tools, biospecimen workflows, and pathology-linked outcomes.

Results:

Recruitment began in September 2025. As of March 2026, 118 women had been prescreened, 19 met eligibility criteria, 17 had been contacted, 10 completed direct screening, 6 declined participation, and 1 participant enrolled. Recruitment and longitudinal data collection are expected to continue through December 2028, after which primary analyses will evaluate multilevel associations among stress, cortisol, vaginal microbiome features, HPV-related factors, and screening outcome resolution or persistence at diagnostic follow-up.

Conclusions:

Sacred WOMB provides a protocol model for equity-focused, prospective cohort research to examine multilevel drivers of women's health. By integrating psychosocial, biologic, digital, and clinical data across multiple timepoints, the study is positioned to inform both mechanistic research on pathways underlying the resolution or persistence of abnormal cervical cancer screening results and implementation strategies for complex, participant-centered longitudinal studies.