An interventional study of Integrated HPV Education in Human Papillomavirus Vaccination and Cervical Cancer Prevention, sponsored by Clinton Health Access Initiative Inc.. Completed at 5 sites in 2 countries. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Clinton Health Access Initiative Inc. · Not applicable, Interventional, and Prevention
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.
This implementation research study evaluated the integration of HPV education into existing school-based health education initiatives in Cambodia and Kenya using a mixed-methods, cluster-level difference-in-differences design.
Study setting, school selection, and arm-assignment procedures varied by country. In Cambodia, Kampong Cham and Kratie provinces were purposively selected based on operational feasibility, relatively low HPV vaccination coverage, differing urban-rural and service-access contexts, and support from the School Health Department. From a frame of 730 schools, 46 schools with larger numbers of age-eligible girls were selected and allocated 1:1 using operational district, urbanicity, and random-number ordering. In Kenya, Nairobi, Kilifi, and Migori counties were purposively selected to represent diverse implementation settings. An initial 160 schools were randomly sampled from an operational school-health facility mapping list. In Nairobi and Kilifi, schools were grouped geographically by ward and the resulting groups were randomly assigned to intervention or control. Before baseline, stakeholder validation led to replacement of 25 Nairobi and 6 Kilifi schools, with replacements retaining the original study arm. In Migori, 18 of the original 52 schools were replaced following county validation; the corrected 52-school roster was then randomized 1:1 at school level without ward grouping. The final study included 46 schools in Cambodia (23 intervention, 23 control) and 160 in Kenya (80 intervention, 80 control).
The intervention was educational. In Cambodia, the package targeted Grades 3-5 and integrated HPV content into existing sexual and reproductive health education. In Kenya, it targeted Grades 4-8 during implementation and integrated HPV content into existing school health education; these cohorts progressed to Grades 5-9 by the January 2026 endline assessment. Trained teachers delivered the education during routine school activities. HPV vaccination itself was not assigned or modified by the study; national eligibility, products, schedules, supply, and delivery arrangements remained unchanged.
Quantitative outcomes were assessed at baseline and endline. HPV vaccination coverage among age-eligible girls was assessed primarily from school immunization records, supplemented by linked health-facility records in Kenya where needed; EPI data in Cambodia and KHIS data in Kenya were used for validation and sensitivity analyses. Student knowledge, awareness, attitudes, and sexual and reproductive health knowledge were assessed using independent repeated cross-sectional KAP questionnaires in six schools per country. Country-specific intervention effects were estimated using difference-in-differences analyses.
Qualitative interviews with caregivers, teachers, and healthcare workers assessed HPV-related knowledge and vaccination perceptions, accessibility, and implementation feasibility and acceptability. Cost data were collected to estimate the cost per immunization administered under the intervention model. Actual enrollment comprised participants contributing directly collected KAP or qualitative data; vaccination coverage analyses used de-identified routine records and did not require individual enrollment.
Four Migori schools had intervention exposure that differed from their assigned study arm: two control-assigned schools received the intervention and two intervention-assigned schools did not. All four were retained in their assigned arms for analysis under an intention-to-treat approach.
The study received country-specific ethics approval from the National Ethics Committee for Health Research in Cambodia and the Amref Ethics and Scientific Review Committee in Kenya. Subsequent amendments or continuations were approved before extended study activities, including January 2026 endline data collection.
Exclusion Criteria:
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
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.
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.
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.
Time frame: 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.
Time frame: Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya)
HPV awareness among students
Proportion of student KAP respondents who reported having heard of HPV.
Time frame: Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya)
HPV vaccine awareness among students
Proportion of student KAP respondents who reported knowing that a vaccine against HPV is available.
Time frame: 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
Proportion of female student KAP respondents who reported wanting to receive the HPV vaccine, assessed as an indicator of HPV vaccine acceptance.
Time frame: 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
Qualitative thematic analysis of caregiver perspectives on and motivation to have their eligible child vaccinated against HPV, assessed among caregivers from intervention and control schools.
Time frame: 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
Qualitative thematic analysis of caregiver perceptions of whether close family and friends support HPV vaccination of their child, assessed among caregivers from intervention and control schools.
Time frame: Single post-intervention assessment, approximately 9 months after baseline in Cambodia and 5-6 months after baseline in Kenya
Confidence in HPV vaccine benefits among students
Proportion of student KAP respondents who reported that HPV vaccination is moderately or very important for their health.
Time frame: Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya)
Confidence in HPV vaccine safety among students
Proportion of student KAP respondents who reported that the HPV vaccine is safe.
Time frame: Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya)
Confidence in HPV vaccine effectiveness among students
Proportion of student KAP respondents who reported that the HPV vaccine is effective.
Time frame: Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya)
Caregiver confidence in HPV vaccination
Qualitative thematic analysis of caregiver perceptions of HPV vaccine benefits, safety, and effectiveness, assessed among caregivers from intervention and control schools.
Time frame: Single post-intervention assessment, approximately 9 months after baseline in Cambodia and 5-6 months after baseline in Kenya
Caregiver knowledge of cervical cancer, HPV, and HPV vaccination
Qualitative thematic analysis of caregiver knowledge and awareness of cervical cancer, HPV, and HPV vaccination, assessed among caregivers from intervention and control schools.
Time frame: Single post-intervention assessment, approximately 9 months after baseline in Cambodia and 5-6 months after baseline in Kenya
Age-appropriate sexual and reproductive health knowledge score among students
Mean age-appropriate sexual and reproductive health (SRH) knowledge score among student KAP respondents, compared over time between intervention and control schools.
Time frame: Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya)
Knowledge of where to obtain HPV vaccination among students
Proportion of student KAP respondents who reported knowing where HPV vaccination can be obtained.
Time frame: Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya)
Caregiver knowledge of where to obtain HPV vaccination
Qualitative thematic analysis of caregiver knowledge of where HPV vaccination can be obtained, assessed among caregivers from intervention and control schools.
Time frame: Single post-intervention assessment, approximately 9 months after baseline in Cambodia and 5-6 months after baseline in Kenya
Cervical cancer awareness among students
Proportion of student KAP respondents who reported having heard of cervical cancer.
Time frame: Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya)
Perceived accessibility of HPV vaccination
Qualitative thematic analysis of caregiver and healthcare worker perspectives on the ease of access to routine HPV vaccination services, assessed in intervention and control settings.
Time frame: 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
Qualitative thematic analysis of teacher and healthcare worker perspectives on the successes, challenges, feasibility, and acceptability of integrating HPV education within school-based health/SRH education, assessed in intervention settings.
Time frame: 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
Country-specific intervention cost analysis calculated as total costs of the intervention advocacy, communications, and social mobilization (ACSM) model divided by the total number of HPV immunizations administered in the intervention arm during the study period.
Time frame: At intervention completion
Plan to share: Yes — De-identified individual-level student KAP data used in analyses reported in the primary peer-reviewed publication will be made publicly available in a publication-linked data repository, consistent with applicable ethical and privacy requirements. Direct identifiers and potentially identifying information will not be shared. Qualitative interview transcripts will not be included in the publicly shared IPD dataset.
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Clinton Health Access Initiative Inc.