ArticleTrials2021
Single-dose HPV vaccination efficacy among adolescent girls and young women in Kenya (the KEN SHE Study): study protocol for a randomized controlled trial.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 34 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Dose Reduction Immunobridging and Safety Study of Two HPV Vaccines in Tanzanian Girls
KENya Single-dose HPV-vaccine Efficacy - The KEN-SHE Study
Who cites it
34 citing papers in PubMed, 43 citations in OpenAlex.
- Efficacy and durability of immediate versus delayed single-dose HPV vaccination for persistent infection among young women in Kenya: a randomized, blinded, cross-over clinical trial.Nature communications · 2026Trial
- Individual-level HPV vaccination verification in Botswana: lessons learned from implementation of the HOPE II trial.Frontiers in public health · 2026Trial
- Comparing one dose of HPV vaccine in girls aged 9-14 years in Tanzania (DoRIS) with one dose in young women aged 15-20 years in Kenya (KEN SHE): an immunobridging analysis of randomised controlled trials.The Lancet. Global health · 2024Trial
- Durability of single-dose HPV vaccination in young Kenyan women: randomized controlled trial 3-year results.Nature medicine · 2023Trial
- Efficacy of single-dose HPV vaccination among young African women.NEJM evidence · 2022Trial
- Analyzing and forecasting global cervical cancer burden based on WHO's elimination strategy: insights and projections from a 1990-2021 global burden of disease (GBD) study covering 204 countries and territories.Journal of advanced research · 2026Article
- High-risk human papillomavirus genotypes in cervical squamous cell carcinomas diagnosed in Rwanda.Infectious agents and cancer · 2026Article
- Towards Global HPV Eradication: Single-Dose HPV Vaccination vs. Pseudoscience.Pathophysiology : the official journal of the International Society for Pathophysiology · 2026Article
- Multiple-level stakeholders' perspectives on barriers and facilitators of HPV vaccination delivery in Western and Central Kenya: a qualitative study.BMJ public health · 2026Article
- Modelling the time to cervical cancer elimination in England: strategies for achieving elimination by 2040.BMJ public health · 2026Article
- Public Health Impact and Cost-Effectiveness of 2-Dose vs 1-Dose Human Papillomavirus Vaccination Regimen in Saudi Arabia.Journal of health economics and outcomes research · 2026Article
- Initial Coverage and Regional Disparities of the National HPV Vaccination Program in Poland: A Cross-Sectional Analysis.Healthcare (Basel, Switzerland) · 2025Article
- Memory B-cells elicited by different HPV vaccine regimens in the DoRIS randomised controlled trial.NPJ vaccines · 2025Article
- Observational
- Review
- Review
- Exploring Adolescents' Contraceptive Preferences and Trade-Offs: Findings From a Discrete Choice Experiment in Kenya.Studies in family planning · 2025Article
- Article
- Acceptability of single-dose HPV vaccination schedule among health-care professionals in Kenya: a mixed-methods study.Journal of the National Cancer Institute. Monographs · 2024Article
- Incidence, Clearance, and Persistence of Penile High-Risk Human Papillomavirus Among Rwandan Men Who Have Sex With Men.The Journal of infectious diseases · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 2 institutions in 2 countries.
Funding
Abstract
backgroundHPV infection is the primary cause of cervical cancer, a leading cause of cancer among women in Kenya and many sub-Saharan African countries. High coverage of HPV vaccination is a World Health Organization priority to eliminate cervical cancer globally, but vaccine supply and logistics limit widespread implementation of the current two or three dose HPV vaccine schedule.
methodsWe are conducting an individual randomized controlled trial to evaluate whether a single dose of the bivalent (HPV 16/18) or nonavalent (HPV 16/18/31/33/45/52/58/6/11) HPV vaccine prevents persistent HPV infection, a surrogate marker for precancerous lesions and cervical cancer. The primary objective is to compare the efficacy of immediate, single-dose bivalent or nonavalent vaccination with delayed HPV vaccination. Kenyan women age 15-20 years old are randomized to immediate bivalent HPV and delayed meningococcal vaccine (group 1), immediate nonavalent HPV vaccine and delayed meningococcal vaccine (group 2), or immediate meningococcal vaccine and delayed HPV vaccine (group 3) with 36 months of follow-up. The primary outcome is persistent vaccine-type HPV infection by month 18 and by month 36 for the final durability outcome. The secondary objectives include to (1) evaluate non-inferiority of antibody titers among girls and adolescents (age 9 to 14 years) from another Tanzanian study, the DoRIS Study (NCT02834637), compared to KEN SHE Study participants; (2) assess the memory B cell immune response at months 36 and 37; and (3) estimate cost-effectiveness using the trial results and health economic models. DISCUSSION: This study will evaluate single-dose HPV vaccine efficacy in Africa and has the potential to guide public health policy and increase HPV vaccine coverage. The secondary aims will assess generalizability of the trial results by evaluating immunobridging from younger ages, durability of the immune response, and the long-term health benefits and cost of single-dose HPV vaccine delivery.
trial registrationClinicalTrials.gov NCT03675256 . Registered on September 18, 2018.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.