# A novel cervical cancer screen-and-treat demonstration project with HPV self-testing and thermocoagulation for HIV-infected women in Malawi

> **NIH NIH R21** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $137,025

## Abstract

ABSTRACT
Invasive cervical cancer (ICC) kills 270,000 women/year, and 445,000 new cases are diagnosed annually. ICC
is preventable with human papillomavirus (HPV) vaccination, cervical screening, and treatment of cervical
dysplasia. However, 84% of new ICC cases occur in low-and-middle income countries (LMICs) such as Malawi,
due to poor access to all three prevention strategies. This challenge is compounded in Sub-Saharan Africa
(SSA), the epicenter of the HIV epidemic, because HIV-infected women are at increased risk for developing
cervical dysplasia and have a >20-fold increased risk for ICC than HIV-uninfected women. In SSA, women
comprise 59% of adults infected with HIV, and ICC is the most common cancer among women. The World Health
Organization (WHO) recommends screening with high-risk (hr)-HPV testing/visual inspection with acetic acid
(VIA) and treatment with cryotherapy as the preferred approach to prevent ICC in LMICs. Malawi has attempted
to implement VIA and cryotherapy since 2004, but both screening and treatment rates remain abysmal.
Furthermore, the HPV vaccine is not yet available in Malawi, and even when it does roll out in 2019, the vast
majority of Malawian women will remain unvaccinated or age ineligible since, similar to other resource-limited
SSA countries, only adolescent girls will be eligible for it. Even if widespread vaccination of adolescent girls is
achieved, the consequent decline in ICC incidence is not anticipated for decades, and millions of African women
will be missed. Therefore, an improved and scalable ICC prevention approach is urgently needed. We plan to
evaluate a novel ICC screen-and-treat algorithm among HIV-infected women in Malawi with the following
strategy: self-collected vaginal swabs for hr-HPV testing, followed by same-day VIA and cervical
thermocoagulation for those who are VIA positive and eligible for ablation. This strategy has not yet been robustly
evaluated, utilizes new technologies developed specifically for low-resource settings (rapid Xpert HPV testing,
thermocoagulation), and can be completed in a single day. These attributes are likely to address the coverage
and attrition problems that have limited current approaches. Specifically, Aim 1 will assess same-day
completion of this novel ICC screen-and-treat strategy among 625 HIV-infected women in Malawi, enrolled over
12 months from antiretroviral therapy clinics in the capital city of Lilongwe. Aim 2 will evaluate the performance
of the proposed screen-and-treat strategy among HIV-infected women, by estimating the overtreatment rate for
women who are hr-HPV positive/VIA positive and the undertreatment rate among HIV-infected women who are
hr-HPV positive/VIA negative. Aim 3 will determine the 24-week efficacy of thermocoagulation among HIV-
infected women with high-grade cervical dysplasia (CIN2/3). This study will provide essential data to inform
national policy in Malawi and other countries where both HIV and ICC prevalence are high, ...

## Key facts

- **NIH application ID:** 10020969
- **Project number:** 5R21CA236770-02
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Lameck Chinula
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $137,025
- **Award type:** 5
- **Project period:** 2019-09-19 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10020969

## Citation

> US National Institutes of Health, RePORTER application 10020969, A novel cervical cancer screen-and-treat demonstration project with HPV self-testing and thermocoagulation for HIV-infected women in Malawi (5R21CA236770-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10020969. Licensed CC0.

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