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Outcome Measures

Primary Outcomes (2)

HPV vaccination coverage among age-eligible girls
Proportion of age-eligible girls in participating schools with documented receipt of the HPV vaccine. Primary coverage analyses used school-based immunization records, supplemented by linked health-facility records in Kenya where school registers were unavailable; routine EPI/KHIS data were used for validation and sensitivity analyses. In Cambodia, coverage reflected receipt of the first dose under the national single-dose schedule among 9-year-old girls. In Kenya, the prespecified primary indicator was HPV vaccine dose 1 coverage among girls aged 10-14 years. Country-specific changes were compared between intervention and control schools using difference-in-differences analyses.
Baseline and endline (approximately 13 months after baseline in Cambodia and 9-10 months after baseline in Kenya)
HPV, HPV vaccine, and cervical cancer knowledge score among students
Mean composite knowledge score, expressed as a percentage, based on student KAP questionnaire items assessing cervical cancer, HPV, and HPV vaccination knowledge. Independent cross-sectional student samples were assessed at baseline and endline. Cambodia included Grades 3-5 at both rounds. Kenya included Grades 4-8 at baseline and Grades 5-9 at endline to reflect progression of the targeted grade cohorts. Country-specific changes were compared between intervention and control schools.

Study Arms (2)

Integrated HPV Education

EXPERIMENTAL

Participating schools received the existing school health/SRH curriculum plus integrated age-appropriate education on cervical cancer, HPV, and HPV vaccination delivered through routine school education activities. Cambodia implemented the integrated package in Grades 3-5 and Kenya in Grades 4-8.

Behavioral: Integrated HPV Education

Status Quo School Health Education

NO INTERVENTION

Participating control schools continued the existing school health or sexual and reproductive health curriculum without the study-added integrated HPV education package. Routine HPV vaccination services continued according to existing national and local arrangements.

Interventions

Integrated HPV EducationBehavioral

Age-appropriate cervical cancer, HPV, and HPV vaccination education was integrated into existing school health/SRH education and delivered by trained teachers. In Cambodia, the package comprised six approximately 45-minute sessions (three HPV-focused and three SRH-focused) for Grades 3-5. In Kenya, 25-35-minute health education sessions were delivered approximately 1-2 times per week over about 4.5 months to Grades 4-8, with HPV/SRH content prioritised and completed in approximately four sessions early in implementation. The study did not alter routine HPV vaccine products, eligibility, schedules, supply, or delivery arrangements.

Integrated HPV Education

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Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Student educational intervention population: Girls and boys enrolled in the country-specific target grades at participating schools (Cambodia: Grades 3-5; Kenya: Grades 4-8 during intervention implementation). In Kenya, the targeted cohorts progressed to Grades 5-9 by the January 2026 endline. Student eligibility for the educational intervention was primarily grade-based rather than based on a single numerical age restriction.
Student KAP questionnaire participants: Students in the relevant study grades at selected KAP schools who met country-specific consent/assent and literacy requirements. KAP recruitment used independent repeated cross-sectional samples at baseline and endline; individual students were not longitudinally linked across rounds.

Study Sites (5)

Participating primary schools, Kampong Cham Province

Kampong Cham, Kampong Cham, Cambodia

Participating primary schools, Kratie Province

Kratie, Kratie, Cambodia

Participating primary schools, Kilifi County

Kilifi, Kilifi County, Kenya

Participating primary schools, Migori County

Migori, Migori County, Kenya

Participating primary schools, Nairobi County

Nairobi, Nairobi County, Kenya

Study Design

Study Type

interventional

Phase

not applicable

Allocation

NON RANDOMIZED

Masking

NONE

Masking Details

No masking was used. Participants, teachers/implementers, investigators, and outcome assessors were not masked to study-arm assignment.

Purpose

PREVENTION

Intervention Model

PARALLEL

Model Details: Two-arm, school-cluster parallel design. Procedures varied by setting. In Cambodia, 46 larger schools were purposively selected and allocated 1:1 using operational district, urbanicity, and random-number ordering. In Kenya, 160 schools were initially randomly sampled from an operational school-health facility mapping list. In Nairobi and Kilifi, schools were grouped by ward and the resulting groups randomly assigned to intervention or control; 25 Nairobi and 6 Kilifi schools were replaced before baseline, retaining the original arm. In Migori, 18 of 52 schools were replaced after county validation, then the corrected roster was randomized 1:1 at school level without ward grouping. Schools were assessed at baseline and endline, with effects estimated separately by country using difference-in-differences analyses.

Sponsor Type

OTHER

Responsible Party

SPONSOR

Integrating HPV Education Into School Health Programs in Cambodia and Kenya

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Integrated HPV Education

Status Quo School Health Education

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (14)

Other Outcomes (3)

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Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Integrated HPV Education

Status Quo School Health Education

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Secondary Outcomes (14)

Other Outcomes (3)

You may not qualify if:

Data Sharing

Source record

Locations