How the KEN SHE Study Informed WHO’s Global HPV Vaccine Guidance with Support from DFnet
Transforming Access to Cervical Cancer Prevention
In Kenya, cervical cancer remains a leading cause of death among women, claiming more than 2,500 lives each year¹. The disease is largely preventable through vaccination against human papillomavirus (HPV), yet many girls and young women face barriers to completing multi-dose vaccine schedules because of distance, cost, and access.
The KEN SHE study set out to answer a question that could transform global prevention efforts: Could one dose of the HPV vaccine offer lasting protection?
Launched in 2018 and led by Dr. Ruanne Barnabas, KEN SHE followed more than 2,200 young women aged 15 to 20 across three Kenyan sites, Thika, Nairobi, and Kisumu.
From the beginning, DFnet worked alongside the study team to design and manage a data system capable of supporting a study of this scale. Our goal was simple: to ensure every data point collected could be trusted and every insight accurately reflected the work being done in the field.
Findings from KEN SHE, published in The Lancet Global Health and presented to the World Health Organization (WHO), helped shape WHO’s 2022 guidance recommending one- or two-dose HPV schedules for adolescent girls².
Study Design and Results
The KEN SHE study, short for KENya Single-dose HPV-vaccine Efficacy, was a randomized, single-blind, three-arm clinical trial evaluating whether a single dose could provide protection comparable to a multi-dose regimen.
Participants were randomized to receive: Bivalent HPV vaccine (Cervarix, HPV 16/18), Nonavalent HPV vaccine (Gardasil 9, HPV 6/11/16/18/31/33/45/52/58), or Control vaccine (meningococcal), followed by delayed HPV vaccination.
All participants were HIV-negative, had not been previously vaccinated for HPV, and underwent routine cervical swabs to assess protection against persistent HPV infection, the key indicator of vaccine efficacy.
After 36 months, results showed: 98% efficacy against HPV 16/18 infection (bivalent arm), 96% efficacy against HPV 16/18 infection (nonavalent arm), and no evidence of waning protection over time³.
Follow-up through 54 months confirmed durable single-dose protection⁴.
These findings became the scientific foundation for WHO’s updated HPV vaccination policy, paving the way for more accessible and equitable vaccine programs around the world.
Study Snapshot
| Category | Details |
|---|---|
|
Study Name |
KEN SHE (KENya Single-dose HPV-vaccine Efficacy) |
|
Principal Investigator |
Dr. Ruanne Barnabas |
|
Launch Year |
2018 |
|
Sites |
Thika, Nairobi, Kisumu (Kenya) |
|
Participants |
~2,275 women aged 15–20 |
|
Design |
Randomized, single-blind, three-arm trial |
|
Follow-up |
54 months |
|
Retention |
>95% through 36 months |
|
Primary Endpoint |
Persistent HPV 16/18 infection |
|
Efficacy |
98% (bivalent), 96% (nonavalent) |
|
Outcome |
WHO guideline change: one- or two-dose schedule |
Building the Data Foundation
Early Planning and System Design
DFnet joined KEN SHE at the planning stage, working closely with the study statistician, project managers, and site coordinators to translate the protocol into a clear data strategy. This included developing a data flow plan to define how information moved from site to central database, designing case report forms (CRFs) aligned with workflow and language needs, establishing version control and audit trails, and creating edit checks to flag discrepancies in real time.
These foundational elements ensured the system was robust enough to adapt as the protocol evolved and new extensions were introduced.
Flexible Electronic Data Capture with DFdiscover
DFdiscover, DFnet’s EDC, was chosen as the data collection platform. It was configured to enable direct electronic entry with minimal paper, support participant transfers between sites without data loss, incorporate multi-language forms, identify sub-cohorts using color-coded CRFs, and adapt quickly to COVID-19 protocol changes, including self-swab data capture.
This flexibility helped ensure that data collection continued smoothly, even during pandemic restrictions and staffing changes.
Reliable Reporting and Continuity
Over multiple study phases, DFnet maintained validated reporting programs and produced enrollment, retention, and safety summaries for DSMB reviews, publication development, and policy briefings. Even as the study evolved, DFnet’s reporting remained consistent, transparent, and responsive, helping the KEN SHE team make timely, informed decisions.
DFnet’s Role at a Glance
- Configured and managed DFdiscover (EDC)
- Supported CRF setup and updates as the protocol evolved
- Conducted daily data cleaning and query resolution
- Delivered regular study reports for DSMB meetings and publications
- Provided training and responsive support for site teams
- Adapted systems for COVID-19 protocol changes and extensions
Global Collaboration, Local Partnership
The success of KEN SHE reflects the strength of local leadership supported by a responsive, global partner. DFnet worked side by side with Kenyan study teams, offering hands-on training, mentorship, and real-time support to ensure data systems were both useful and empowering for the people collecting them.
With additional assistance from DFnet’s South Africa office, site teams had near-continuous coverage, ensuring timely troubleshooting and smooth operations.
Lasting Impact
KEN SHE’s findings are already shaping national vaccination programs and global policy. By proving that one dose can offer lasting protection, the study has helped countries plan simpler, more affordable HPV vaccine rollouts, expanding access and reducing inequities in women’s health.
We’re deeply proud to have supported the KEN SHE team in their work to make prevention more accessible for women everywhere.
Study Collaborators:
University of Washington | Kenya Medical Research Institute (KEMRI) | DFnet
About DFnet
DFnet is a global data management and eClinical solutions partner trusted by research organizations conducting complex vaccine, infectious disease, and public health studies.
We help research teams stay flexible as their studies grow and change.
DFnet combines flexible software with experienced clinical data experts who co-design solutions alongside sponsors. Together, we help PIs and research leaders:
- Design flexible EDC systems that evolve with their protocols
- Implement eClinical tools that simplify oversight and improve data visibility
- Maintain high-quality data across diverse geographies
- Navigate regulatory compliance with confidence
- Build local capacity through training and collaboration
- Transform data into evidence ready for publication or policy
With offices in North America and South Africa and partners worldwide, DFnet brings global reach and local understanding to every study.
Ask How DFnet Can Simplify Your Vaccine Trial. Contact us today to discuss a solution tailored to your study.
Footnotes
¹ KEN SHE Study (2024). Study Background. https://www.kenshestudy.org/about/study-background/
² World Health Organization (2022). WHO recommends one-dose human papillomavirus (HPV) vaccine. https://www.who.int/news/item/11-04-2022-who-recommends-one-dose-hpv-vaccine-for-protection-against-cervical-cancer
³ Centers for Disease Control and Prevention (CDC) ACIP Presentation – Barnabas, April 2025. https://www.cdc.gov/acip/downloads/slides-2025-04-15-16/03-Barnabas-HPV-508.pdf
⁴ Nature Medicine (2023). Efficacy of Single-Dose HPV Vaccine. https://www.nature.com/articles/s41591-023-02658-0.pdf
