Integrating HPV Education Into School Health Programs in Cambodia and Kenya

NCT07784283 | Completed

• 6 other identifiers: GAVI100001391INV-098720359NECHR492NECHRP1832/2025NACOSTI/P/25/416527
• Study Type: interventional
• Target: 9,054
• Locations: 2 countries
• Sites: 5

Brief Summary

The Clinton Health Access Initiative conducted a mixed-methods, school-based interventional study in Cambodia and Kenya to evaluate whether integrating age-appropriate human papillomavirus (HPV) education into existing school health education improves HPV vaccination coverage and students' knowledge and awareness of HPV, HPV vaccination, and cervical cancer. The study also assessed HPV vaccine-related attitudes and the feasibility, acceptability, and cost of the integrated education model. Schools were assigned to intervention or control using setting-specific procedures that combined geographic structuring and random elements rather than uniform school-level randomization. Intervention schools received integrated HPV education, while control schools continued existing curricula without the study-added package. Routine HPV vaccination eligibility, products, schedules, supply, and delivery arrangements were unchanged. Quantitative outcomes were assessed at baseline and endline using school immunization records and repeated cross-sectional student knowledge, attitudes, and practices questionnaires. Qualitative interviews with caregivers, teachers, and healthcare workers examined HPV-related knowledge, vaccination perceptions, accessibility, and implementation feasibility and acceptability. A costing analysis estimated intervention cost per immunization administered. The study included 46 schools in Cambodia and 160 in Kenya.

Conditions

Human Papillomavirus Vaccination; Cervical Cancer Prevention

Keywords

HPV education; HPV vaccine uptake; school health; sexual and reproductive health; implementation research; difference-in-differences; Cambodia; Kenya; quasi-experimental

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.

  Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya)

Secondary Outcomes (14)

• HPV awareness among students

  Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya)

• HPV vaccine awareness among students

  Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya)

• Motivation to receive HPV vaccination among girls

  Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya)

• Caregiver motivation to vaccinate an eligible child against HPV

  Single post-intervention assessment, approximately 9 months after baseline in Cambodia and 5-6 months after baseline in Kenya

• Caregiver social norms regarding HPV vaccination

  Single post-intervention assessment, approximately 9 months after baseline in Cambodia and 5-6 months after baseline in Kenya

Other Outcomes (3)

• Perceived accessibility of HPV vaccination

  Single post-intervention assessment, approximately 9 months after baseline in Cambodia and 5-6 months after baseline in Kenya

• Feasibility and acceptability of integrating HPV education into school health education

  Single post-intervention assessment, approximately 9 months after baseline in Cambodia and 5-6 months after baseline in Kenya

• Cost per immunization administered under the intervention ACSM model

  At intervention completion

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 Education BEHAVIORAL

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (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.
• HPV vaccination coverage population: Girls eligible for routine HPV vaccination in participating schools according to country-specific national vaccination policy (9-year-old girls in Cambodia; girls aged 10-14 years in Kenya). These age criteria applied to the vaccination coverage outcome and did not define eligibility for exposure to the educational curriculum.
• Caregivers: Age 18 years or older, caring for an age/grade-eligible student at a participating school, able to provide informed consent, and able to communicate in the applicable study language(s).
• Teachers: Age 18 years or older, involved in relevant school health/SRH education, able to provide informed consent, and able to communicate in the applicable study language(s). Teacher qualitative feasibility interviews were conducted in intervention settings.
• Healthcare workers: Age 18 years or older, working in a health facility serving participating-school catchment areas, involved in HPV immunization and/or education, able to provide informed consent, and able to communicate in the applicable study language(s). Healthcare-worker qualitative feasibility interviews were conducted in intervention settings.

You may not qualify if:

• Students outside the applicable study grades or not attending participating schools; for the KAP questionnaire, students without the required consent/assent or who did not meet country-specific literacy requirements.
• Caregivers, teachers, or healthcare workers younger than 18 years, unable to provide informed consent, unable to communicate in the applicable study language(s), or not meeting the relevant role-based eligibility criteria.

Sponsors & Collaborators

• Clinton Health Access Initiative Inc.: lead
• Bill and Melinda Gates Foundation: collaborator
• Gavi, The Vaccine Alliance: collaborator

Study Sites (5)

Participating primary schools, Kampong Cham Province

Kampong Cham, Kampong Cham, Cambodia

Location

Participating primary schools, Kratie Province

Kratie, Kratie, Cambodia

Location

Participating primary schools, Kilifi County

Kilifi, Kilifi County, Kenya

Location

Participating primary schools, Migori County

Migori, Migori County, Kenya

Location

Participating primary schools, Nairobi County

Nairobi, Nairobi County, Kenya

Location

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Justin Graves, MPH

  Clinton Health Access Initiative Inc.

  PRINCIPAL INVESTIGATOR

• Sonali Patel, MPA

  Clinton Health Access Initiative Inc.

  STUDY DIRECTOR

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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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.

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 25, 2026
• Study Start: December 1, 2024
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning at publication of the primary peer-reviewed manuscript and thereafter while the repository remains available.
• Access Criteria: Open public access through the publication-linked data repository, without an individual data request, subject to applicable ethical and privacy requirements.

Locations

KE (3); CA (2)