Trials
Search / Trial NCT06436274

Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living With HIV.

Launched by MASSACHUSETTS GENERAL HOSPITAL · May 30, 2024

Trial Information

Current as of February 12, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of the HPV vaccine in preventing infections among women who are living with HIV. Specifically, it looks at whether giving a single dose of the nonavalent HPV vaccine right away, or delaying it, is more beneficial for participants who have already received one dose of the HPV vaccine before they were diagnosed with HIV. The trial aims to help improve health outcomes for women who are at risk of HPV-related diseases.

To be eligible for the study, participants must be assigned female at birth, at least 16 years old, and currently living with HIV. They should have received one dose of the HPV vaccine prior to their HIV diagnosis and must be sexually active in the last six months. Participants should not have certain health conditions or be enrolled in other specific medical studies. Those who join the trial will receive either the vaccine immediately or after a delay and will be asked to provide updates about their contact information throughout the study. This research could help pave the way for better prevention methods for women with HIV.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. Assigned female at birth
  • 2. Age 16 years and above on the day of signing the informed consent form
  • 3. Living with HIV with confirmed test results or clinic records
  • 4. History of receiving a single dose of an HPV vaccine before HIV diagnosis
  • 5. Self-reported sexually active in the last six months
  • 6. Lives within the study area and willing to provide updated locator information over the course of the study
  • 7. Does not have an autoimmune, degenerative, or genetic disease
  • 8. Does not have known advanced HIV (as per stage IV World Health Organization clinical staging criteria for HIV)
  • 9. No other Investigator-determined factor would limit participation in the trial
  • 10. Has not and is not enrolled in a monoclonal, investigational vaccine, or a large quantity blood draw study
  • 11. The participant has a cervix
  • Exclusion Criteria:
  • 1. Anyone with cervical abnormality on examination
  • 2. Anyone with an allergy to vaccine components or yeast

Trial Officials

Ruanne Barnabas, MBChB, MSc, DPhil

Principal Investigator

Mass General Brigham

Sinead Delany-Moretlwe, MBBCh, PhD, DTM&H

Principal Investigator

Wits RHI, University of The Witwatersrand

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Gaborone, , Botswana

Kigali, , Rwanda

Johannesburg, Gauteng, South Africa

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0