# CAMPO Clinical Trials Program

> **NIH NIH U54** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2023 · $867,605

## Abstract

The California-Mexico-Puerto Rico (CAMPO) Consortium will perform three clinical research studies
focused on the prevention of cervical cancer among HIV-positive women in Mexico and Puerto Rico. Study 1
will examine new screening algorithms for cervical high-grade squamous intraepithelial lesions (HSIL) in 4000
HIV-positive women in Mexico and Puerto Rico. Study 2 will evaluate the impact of anogenital probiotic use on
anal and cervical microbiota profiles and the relationship to anal and cervical HSIL regression in 600 HIVpositive women and men as well as reduction of high-risk HPV DNA persistence among those with no lesions.
Study 3 will evaluate the safety and efficacy of a multivalent replication-defective adenovirus-based
therapeutic HPV vaccine to treat cervical and anal HSIL in 300 HIV-positive women and men and identify
immune response correlates of HSIL regression. The CAMPO Clinical Trials Program has the following aims:
(1) To identify optimal screening strategies among HIV-positive women in Mexico and Puerto Rico for cervical
HSIL detection, including cytology, HPV extended-typing, oncoprotein E6/E7 testing and methylation markers;
(2) To determine the safety and efficacy of Visbiome™ probiotic on cervical and anal HSIL regression and
reduced persistence of high-risk HPV infection in HIV-positive women and men in Mexico and Puerto Rico; and
(3) To determine the safety and efficacy of a novel therapeutic vaccine on cervical and anal HSIL regression in
HIV-positive women and men in Mexico and Puerto Rico. The Clinical Trials Program will be led by Dr. Joel
Palefsky (Contact MPI) and co-led by Dr. Jorge Salmerón (MPI) of the INSP. The Protocol Chairs of the three
studies are Dr. Jorge Salmerón (Study 1), Dr. Josefina Romaguera of UPR (Study 2), and Dr. George Sawaya
of UCSF (Study 3). Protocol Teams for each study will be comprised of the Protocol Chair, representatives of
each CAMPO Core, a representative from Emmes, and investigators from all three sites with relevant expertise
and interest. Each of the studies is highly innovative. Study 1 uses new approaches for recruitment and
performance of cervical screening in HIV-positive women and will include cost-effectiveness and quality of life
analyses. Study 2 will test the safety of a probiotic for treatment of HSIL in HIV-positive women and men and
its ability to reduce the risk of persistent hrHPV infection among those without disease. Study 3 will test a novel
therapeutic vaccine for treatment of HSIL that covers multiple hrHPV types and HPV proteins. We expect the
results of the three studies to change the paradigm of both screening and treatment of HSIL, with the potential
to substantially reduce the incidence of cervical and anal cancers in HIV-positive women and men in Mexico
and Puerto Rico. Our results will be broadly applicable to other populations in the Latin America and Caribbean
region, and to a large extent, to Hispanic and other women in the U.S.

## Key facts

- **NIH application ID:** 10690031
- **Project number:** 5U54CA242646-05
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** JOEL Michael PALEFSKY
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $867,605
- **Award type:** 5
- **Project period:** 2019-09-12 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10690031

## Citation

> US National Institutes of Health, RePORTER application 10690031, CAMPO Clinical Trials Program (5U54CA242646-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10690031. Licensed CC0.

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