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Supporting the National Expansion of HPV-based Cervical Cancer Screening in Tanzania Among Women Living with HIV

NCT06402383 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2000

Last updated 2025-03-20

No results posted yet for this study

Summary

* Cervical cancer is caused by persistent infections with one of \~13 carcinogenic human papillomavirus (HPV) types and causes substantial morbidity and mortality worldwide.
* Highly effective strategies exist, including HPV vaccination and HPV-based screening for early detection and treatment of precancerous lesions.
* The investigators are proposing an innovative implementation research program and randomized trial evaluating HPV DNA testing as a primary screening tool for cervical cancer screening in HIV Care and Treatment clinics within Tanzania's National Cervical Cancer Prevention (CECAP) program.
* The investigators will combine HPV DNA testing with high quality visual assessment of the cervix for treatment and management of cervical precancerous lesions among HPV+ Women Living with HIV (WLWH).
* At 12-month follow up women will be recalled for repeat screening for HPV and visual assessment of the cervix for treatment combined with a second therapeutic dose of HPV vaccine.
* The investigators propose to recruit 2000 WLWH from 4 HIV Clinics in Kilimanjaro Region. Two clinics will be randomized to the test, treat and vaccinate strategy and two clinics will be randomized to test, treat and re-screen and then vaccinate strategy.
* Currently, there is no Standard of Care (SOC) for vaccination of women who are at risk for HPV in the country. These two arms of the study will allow for treatment and observation to occur that would not be available otherwise.

Conditions

Interventions

BIOLOGICAL

Vaccination Provision

HPV vaccination #1 will be offered by provider at the first visit when the HPV self-sample is collected. HPV Vaccination #2 will be offered at 6 months for HPV negative women and at 12 months for HPV positive women.

BIOLOGICAL

Vaccination Provision 2

HPV vaccination #1 will be offered by the provider after an HPV negative result is received with vaccine #2 given at 3 months after negative test results obtained. For HPV positive women - vaccination #1 will be offered at 12 months and vaccination #2 will be offered at the 15 month mark.

Sponsors & Collaborators

  • Merck Canada Inc.

    collaborator INDUSTRY

  • Queen's University

    lead OTHER

Principal Investigators

  • Karen Yeates, MD,MPH · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-25
Primary Completion
2026-01-31
Completion
2026-04-30

Countries

  • Tanzania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06402383 on ClinicalTrials.gov