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Search / Trial NCT06536855

Faster Elimination of HPV Infection and Cervical Cancer Using Concomitant HPV Vaccination and HPV Screening: A Demonstration Project in Rwanda

Launched by RWANDA BIOMEDICAL CENTRE · Jul 31, 2024

Trial Information

Current as of May 12, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial, taking place in Rwanda, is studying a new approach to prevent cervical cancer by combining HPV vaccination and screening for women aged 23 to 29. Cervical cancer is a major health issue in Rwanda, but it can be mostly prevented with the right measures. The goal of this study is to see if giving the HPV vaccine and conducting screening tests at the same time helps to eliminate HPV infections more quickly than if they were done separately. By doing this, the researchers aim to reduce the number of new cervical cancer cases and related deaths in the targeted areas.

To participate in the trial, women must be between 23 and 29 years old and willing to take part in the screening program. They should not have severe allergies to the vaccine components, certain immune disorders, or be currently pregnant. Participants can expect to receive the Gardasil 9 vaccine and undergo HPV screening, with follow-ups every two years to monitor the effectiveness of this combined approach. This study is important as it could lead to more efficient and sustainable ways to prevent cervical cancer in Rwanda.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Eligible women will include women within the age range of 23-29, who have not opted out of the screening program and who consent to participate in the study
  • Exclusion Criteria:
  • Known history of severe allergic reaction or hypersensitivity to any of the components of the HPV vaccine. (For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80, or Sodium borate)
  • Known history of immune-related disorders
  • Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection, or low-grade fever.
  • Administration of immunoglobulin or blood-derived products within 6 months prior to the scheduled HPV vaccine first dose
  • Current pregnancy (reported)
  • Women with a total hysterectomy

About Rwanda Biomedical Centre

The Rwanda Biomedical Centre (RBC) is a leading governmental institution dedicated to advancing health and biomedical research in Rwanda. As a clinical trial sponsor, the RBC plays a pivotal role in promoting evidence-based health interventions, facilitating innovative research, and enhancing the nation's capacity for scientific inquiry. With a commitment to improving public health outcomes, the RBC collaborates with local and international partners to conduct rigorous clinical trials that address pressing health challenges, including infectious diseases and non-communicable conditions. Through its comprehensive approach, the RBC aims to foster a robust research environment that contributes to the global body of knowledge while ensuring the highest ethical standards and participant safety.

Locations

Patients applied

0 patients applied

Trial Officials

Francois Uwinkindi, MD, Msc Epi

Principal Investigator

Rwanda Biomedical Centre

Claude Mambo Muvunyi, MD, PhD

Study Chair

Rwanda Biomedical Centre

Joachim Dillner, MD, PhD

Study Director

Karolinska Institutet

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported