# Natural History of CIN and HPV in HPV Vaccinated Youth with PHIV

> **NIH NIH P01** · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · 2020 · $70,792

## Abstract

Project Summary/Abstract
 Worldwide, over 300,000 women die each year from squamous cell cancers (SCC) of the cervix caused
by the high risk human papillomavirus (hrHPV). The development of the HPV vaccine has been a transforming
event, capable of preventing cervical cancer globally. HIV infection is an established risk factor for HPV
persistence, progression to CIN2+, and HPV-associated cancers. The majority of perinatal HPV appears to
be transient. However, the ability of infants with perinatal HIV infection (PHIV) to clear this infection is
unknown. What is known is that abnormal cytology is one of the more common diagnosed morbidities in PHIV
women. One of the pressing questions worldwide is “what is the efficacy in vaccinating PHIV children?”
 In a recent study within PHACS of HPV-vaccinated youth, we found that those with PHIV had HPV
antibody titers lower than uninfected youth and most disturbingly, their rate of abnormal cytology was
exceedingly high: the incidence of abnormal cytology was 15.0 and 2.9 /100 person-years for PHIV and
uninfected, respectively. It remains unclear whether this reflects vaccine failure or disease due to non-vaccine
HPV types. Our findings led to a sub-study within PHACS supported by the NCI to screen women with
abnormal cytology with colposcopy and perform HPV genotyping on cervical lesions. This proposal plans to
take advantage of women in this sub-study to understand the natural history of CIN 1 or 2. We are proposing
the following Aims:
Among YAPHIV women who have been vaccinated against HPV, we will examine:
1. the rate of and risk factors for regression and persistence/progression of HPV-associated CIN1 or 2.
 YAPHIV found to have CIN 1 or 2 will be followed prospectively by colposcopy, cytology and HPV
genotyping.
2. the prevalence of CIN 2+ in those testing positive for hrHPV with/without p16-Ki67 dual staining.
3. the rate of and risk factors for regression and persistence/progression of hrHPV infections. Women in aim 2
 with normal cytology and no CIN will be followed prospectively by annual cytology and HPV genotyping.
Among PHIV Men, we will examine:
4. the prevalence of and natural history of oral HPV in HPV-vaccinated and unvaccinated PHIV men. Oral
rinses obtained for PHACS bio-repository in men every three years will be tested for HPV genotyping.
 In summary, PHACS AMP-Up, a prospective cohort study, is an exceptional opportunity to understand the
natural history of hrHPV and CIN 1 or 2 in PHIV women and oral HPV in PHIV men. The results of this study
will be critical for developing clinical and policy guidelines for HPV vaccination strategies and cervical cancer
screening among young men and women in resourced and resource poor settings.

## Key facts

- **NIH application ID:** 10065445
- **Project number:** 1P01HD103133-01
- **Recipient organization:** HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH
- **Principal Investigator:** ANNA-BARBARA MOSCICKI
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $70,792
- **Award type:** 1
- **Project period:** 2020-09-18 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10065445

## Citation

> US National Institutes of Health, RePORTER application 10065445, Natural History of CIN and HPV in HPV Vaccinated Youth with PHIV (1P01HD103133-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10065445. Licensed CC0.

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