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

March 17, 2025 updated by: Dr. Karen Yeates, Kingston Health Sciences Centre

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

  • 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Moshi, Tanzania
        • Pamoja Tunaweza Women's Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Gender: person with an intact cervix
  • HIV type 1 (HIV-1) positive status and receiving care at one of the study CTC sites randomized for the trial
  • Not pregnant and utilizing contraception if sexually active and willing to undergo a urine pregnancy test prior to enrolment
  • Residence in the study-defined catchment area
  • Willing to consent to receive follow-up phone calls from the health provider to provide reminders and counselling about follow-up visits required for the study procedures
  • Willing to receive HPV Vaccination in a 2-dose strategy
  • Language: able to speak/understand English or Kiswahili (if the participant cannot read, the consent will be read to her, and thumbprint will suffice for consent as per the Tanzanian National Institute for Medical Research Ethical Guidelines for Informed Consent Processes)

Exclusion Criteria:

  • Women will be excluded for a prior history of invasive or microinvasive cervical, vaginal, vulvar, or anal cancer; prior hysterectomy; cervical treatments within 1 year prior to study; cervical, vaginal, or vulvar lesions suspicious for cancer; prior HPV vaccination; receipt of anticoagulants; known sensitivity to vaccine components; hemophilia or bleeding diathesis; use of antineoplastic or immunomodulatory treatment; breastfeeding; and <3 months postpartum. Any potential participant who appears unable to provide informed consent or does not want to participate in the research study will be excluded.

Women that do not want to receive the vaccine will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaccination starting from visit 1
Vaccination will be provided at the first visit and then at 6 months for HPV negative women and 12 months for HPV positive women.
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.
Experimental: Vaccination starting at follow up
Vaccination will be provided after HPV results obtained - immediately for HPV negative women and again after 3 months. For HPV positive women this will be offered at 12 months after testing and again at 15 months.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evidence Generation for use of a 4-step HPV testing, triage and vaccinate strategy
Time Frame: 15 months
The primary endpoint will be a composite of HSIL on cervical histology at 12 months re-screening (follow-up). Secondary endpoints will include CIN3 on cervical histology, and grade 3 or 4 adverse events related to vaccination. Additional secondary endpoints will include participant-level predictors that may act as moderators of participation in cervical cancer screening and/or HPV vaccination. The investigators will also collect qualitative and quantitative data on the feasibility, impact, and cost-effectiveness of the different screening strategies through key informant interviews and focus groups comprised on clinic leadership, health providers and study participants.
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kingston Health Sciences Centre

Collaborators

Merck Canada Inc.

Investigators

  • Principal Investigator: Karen Yeates, MD,MPH, Kingston Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

April 5, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102030

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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