Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

COMPLETED

NCT07784283

Integrating HPV Education Into School Health Programs in Cambodia and Kenya

Sponsor: Clinton Health Access Initiative Inc.

View on ClinicalTrials.gov

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.

Official title: Evaluating the Impact and Feasibility of Integrating Human Papillomavirus (HPV) Education Into Existing School-Based Health Education Initiatives in Cambodia and Kenya

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

9054

Start Date

2024-12-01

Completion Date

2026-01-31

Last Updated

2026-08-25

Healthy Volunteers

Yes

Conditions

Human Papillomavirus Vaccination Cervical Cancer Prevention

Interventions

BEHAVIORAL

Integrated HPV Education

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.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (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