# Full Project 2: Improving Testing, Triage, and Followup for Cervical Cancer Screening in Medically Underserved Women

> **NIH NIH U54** · NORTH CAROLINA CENTRAL UNIVERSITY · 2020 · $68,746

## Abstract

This NCCU-UNC collaboration seeks to evaluate novel approaches to reduce disparities in and the morbidity
and mortality attributable to high-grade precancerous lesions (CIN2+) and invasive cervical cancer by (1)
improving the accessibility of primary screening by testing urine samples rather than physician-collected
samples, (2) increasing adherence to follow-up of abnormal screening results, and (3) reducing unnecessary
referral to follow-up screening among women with abnormal results. We will evaluate these approaches by
completing the following specific aims:
Aim 1: Assess the validity of testing for oncogenic human papillomavirus (HPV) in urine compared to
physician-collected cervical samples for the detection of high-grade cervical intra-epithelial neoplasia (CIN2+).
We will: (1) Conduct HPV testing in urine and cervical samples from 160 patients attending the UNC
colposcopy clinic and from 250 women with cytology normal/ HPV positive results at UNC primary screening
clinics, followed by colposcopy with directed biopsy, (2) Calculate the validity (sensitivity, specificity, positive
and negative predictive values) of the new urine diagnostic test for detection of biopsy-confirmed CIN-2+.
Aim 2: Examine new approaches to improve patient adherence to follow-up colposcopy screening – needed
for the appropriate referral to treatment and prevention of invasive cancer – by (a) assessing perceptions of
urine HPV-testing versus clinic-based Pap or HPV/Pap co-testing, and (b) developing the content and protocol
for a text-message-based intervention to increase colposcopy attendance, to be tested in a future efficacy trial.
2a. We will conduct semi-structured interviews with 15 women undergoing cervical cancer screening to assess
their understanding of and attitudes towards HPV urine testing compared to in-clinic Pap/HPV co-testing.
2b: We will conduct a target audience assessment of women referred to colposcopy following an abnormal
screening result, then use this assessment and existing evidence to develop and pilot test the content of a
proposed tailored text-message reminder intervention designed to improve patient follow-up to colposcopy.
Aim 3: Investigate the clinical performance of testing for the E6 protein of HPV types 16 and 18 for the
detection of CIN-2+ among HPV-positive women in order to assess its potential for use in triage to colposcopy.
We will (1) Complete HPV E6 test testing on urine and cervical samples collected in Aim 1 from patients with
cytology negative/HPV-positive screening results: 250 primary screening patients and 40 colposcopy patients;
(2) Calculate the validity (sensitivity, specificity, positive and negative predictive values) for biopsy-confirmed
CIN-2+ of HPV E6 triage testing among HPV-positive women with normal cytology.
The successful completion of this project will provide valuable insight into new approaches to improve
effectiveness and reduce the resource burden of cervical cancer screening, as well as develo...

## Key facts

- **NIH application ID:** 10247151
- **Project number:** 3U54CA156735-10S1
- **Recipient organization:** NORTH CAROLINA CENTRAL UNIVERSITY
- **Principal Investigator:** LaHoma Smith Romocki
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $68,746
- **Award type:** 3
- **Project period:** 2010-09-29 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10247151

## Citation

> US National Institutes of Health, RePORTER application 10247151, Full Project 2: Improving Testing, Triage, and Followup for Cervical Cancer Screening in Medically Underserved Women (3U54CA156735-10S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10247151. Licensed CC0.

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