# Project 1: Urine sampling for HPV infection and methylation testing for cervical cancer screening among women living with HIV in Malawi and South Africa

> **NIH NIH U54** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $241,950

## Abstract

ABSTRACT: PROJECT 1: Urine sampling for HPV infection and methylation testing for cervical cancer
screening among women living with HIV in Malawi and South Africa
Cancer incidence, mortality, and disparities are projected to rise at staggering rates. It is estimated, for
example, that cancer will kill one million Africans each year by 2030, with invasive cervical cancer (ICC)
accounting for the most cancer deaths in African women. Although global policy seeks to rapidly expand
access to human papillomavirus (HPV) vaccination and cervical cancer screening in the coming decade,
practical efforts to eliminate cervical cancer in low- and middle-income countries (LMICs) remain limited. This
gap leaves generations of women needlessly at risk for ICC, with HIV-positive (HIV+) women particularly
vulnerable. The need for cost-effective and scalable screening and treatment strategies to reduce ICC is
therefore substantial. There is also an urgent need for quality evidence directly applicable to HIV+ women in
LMICs, who face the highest risk of HPV infection, cervical precancer (CIN2/3), and ICC.
The central hypothesis of our proposal is that the use of self-collected samples to test for HPV infection has
the potential to increase cervical screening coverage in clinical settings where pelvic examinations are not
routinely performed. We will validate urine-based HPV testing among HIV+ women attending cervical
screening clinics at two strong research sites in Malawi and South Africa. As primary HPV screening is
highly sensitive but only moderately specific for CIN2/3 and ICC, we will also validate a novel S5 methylation
test for triage of women who screen positive for HPV.
In Aim 1, we will enroll 925 HIV+ women and evaluate high-risk HPV testing in urine, self-collected
cervicovaginal, and provider-collected cervical samples for the detection of CIN2/3 and ICC (CIN2+). We will
report HPV positivity in the 3 sample types and compare the sensitivity, specificity, and positive and negative
predictive values (PPV and NPV) for CIN2+ detection between the sample types. In Aim 2, we will evaluate S5
methylation as a triage test for HIV+ women with HPV positive results. For each sample collection method
(urine, self, and provider), we will calculate PPV, NPV, sensitivity, and specificity of S5 triage testing for CIN2+.
We will also report the number of colposcopy referrals per CIN2+ case detected with and without S5 triage.
Our proposed project will be the first to validate urine-based HPV testing among HIV+ women and the first to
compare the clinical performance of S5 triage testing using urine, self, and provider-collected samples in an
LMIC setting. If successful, our findings will have broad relevance for HIV+ women in both resource-rich and
resource-poor regions worldwide, including rural and remote areas of the U.S.

## Key facts

- **NIH application ID:** 10084557
- **Project number:** 1U54CA254564-01
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Carla J Chibwesha
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $241,950
- **Award type:** 1
- **Project period:** 2020-08-13 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10084557

## Citation

> US National Institutes of Health, RePORTER application 10084557, Project 1: Urine sampling for HPV infection and methylation testing for cervical cancer screening among women living with HIV in Malawi and South Africa (1U54CA254564-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10084557. Licensed CC0.

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