# Clinical Trials Program

> **NIH NIH U54** · FRED HUTCHINSON CANCER CENTER · 2024 · $337,247

## Abstract

PROJECT SUMMARY – CLINICAL TRIALS PROGRAM 
The goal of the Clinical Trials Program is to address the dual burden of HIV infection and HPV-associated 
cervical cancer in Latin America and the Caribbean (LAC). Over 270,000 women die every year of cervical 
cancer, and it disproportionately affects women in low- and middle-income countries (LMICs) where 
approximately 90% of cervical cancer deaths occur. Peru and the Dominican Republic experience a 3-fold 
higher incidence of cervical cancer than the US, as well as high rates of HIV infection, especially in vulnerable 
key populations. Women and children living with HIV (WLWH and CLWH) are more likely to have persistent 
HPV and high-grade lesions, and they are at higher risk of progression to cancer than HIV-uninfected women. 
Addressing the needs of HIV-infected persons at risk for HPV-associated cancers in LMICs involves improving 
access to HPV vaccines and more effective screening for and treatment of cervical high-grade lesions. Instead 
of replicating the infrastructure needed for screening used in high-resource settings, the clinical trials proposed 
here seek to use a new combination of prevention and treatment methods aimed at point-of-care with low-infrastructure support. We will leverage and strengthen existing research capacity in Seattle and the LAC sites 
to explore sustainable solutions that are acceptable to local providers and patients. This includes investigating 
optimal HPV vaccine schedules for HIV+ children, assessing new HPV tests and visual imaging technologies 
to help clinicians to perform high-quality screening and triage, and testing non-surgical approaches to improve 
outcomes of cervical cancer precursors among WLWH. Toward this goal we will conduct three clinical trials: 
Trial 1: HPV immunoprevention by vaccination of unexposed children is not optimized for children living with 
HIV (CLWH). We will compare longer-term immune (anamnestic) responses among HIV-infected youth (ages 
9-13 at the time of enrollment) after 1, 2, or 3 doses of 9-valent HPV vaccine. 
Trial 2: Cervical cancer screening and triage among WLWH needs to be optimized to improve detection of 
precancerous lesions, reduce overtreatment and facilitate implementation. We will develop a more efficient 
algorithm to detect high-grade lesions (CIN2/3) by assessing standard of care (Pap test and visual inspection 
with acetic acid), HPV testing, and newer technologies including HPV E6/E7 expression and enhanced visual 
inspection (EVA) with automated visual evaluation (AVE), comparable to colposcopy. 
Trial 3: Evaluating non-surgical strategies for treatment of high-grade lesions (CIN2/3) diagnosed in 
WLWH from Trial 2 in a 2x2 factorial trial of 9-valent HPV vaccine and sirolimus initiated before surgery. 
These trials will be framed by the Cervical Cancer Prevention Partnership (C2P2) Center, that brings 
together collaborators in Peru, the Dominican Republic, Seattle, with international external scient...

## Key facts

- **NIH application ID:** 11183112
- **Project number:** 5U54CA242977-07
- **Recipient organization:** FRED HUTCHINSON CANCER CENTER
- **Principal Investigator:** MARGARET M MADELEINE
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $337,247
- **Award type:** 5
- **Project period:** 2019-09-18 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11183112

## Citation

> US National Institutes of Health, RePORTER application 11183112, Clinical Trials Program (5U54CA242977-07). Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/grant/nih/11183112. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*