Last reviewed · How we verify
NCT06402383
Supporting the National Expansion of HPV-based Cervical Cancer Screening in Tanzania Among Women Living with HIV: NECST-HIV
NA trial testing Vaccination Provision in Cervical Cancer in 2,000 participants. Participants enrolled and being followed up; not accepting new ones.
1 January 2026
Quick facts
| Lead sponsor | Queen's University |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | screening |
| Enrollment | 2,000 |
| Start date | 25 May 2024 |
| Primary completion | 1 January 2026 |
| Estimated completion | 1 April 2026 |
| Sites | 1 location across Tanzania |
Drugs / interventions tested
- Vaccination Provision — full drug profile →
- Vaccination Provision 2 — full drug profile →
Conditions studied
- Cervical Cancer — all drugs for Cervical Cancer →
Sponsor
Queen's University
Who can join
Adults 25 to 40, female only, with Cervical Cancer. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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
Sponsor's own description
* 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06402383
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cervical Cancer
Currently open trials in the same condition.
- NCT07276360 — Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda · Phase 2 · recruiting
- NCT05570422 — A Study to Evaluate the Safety, Tolerability, Preliminary Efficacy of KRC-01 · Phase 1 · recruiting
- NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
- NCT07209917 — Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India · NA · recruiting
- NCT07256236 — SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer · Phase 2 · recruiting
Other Queen's University trials
Trials by the same sponsor.
- NCT07526103 — Developing a Colonoscopy Preparation Protocol for Patients With Diabetes · NA · not yet recruiting
- NCT07456670 — Caffeine for Infants Born at 28 to 34 Weeks Receiving Respiratory Support · Phase 2 · not yet recruiting
- NCT06794723 — A Probiotic Based Intervention in Pregnancies Complicated by GDM · Phase 2 · not yet recruiting
- NCT07030426 — Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery · Phase 3 · not yet recruiting
- NCT07036653 — Bone Enhanced Ultrasound (BEUS) Data Library Development Project · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06402383 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Queen's University
- Last refreshed: 17 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06402383.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing