Human Papillomavirus VaccinationNCT07784283
Integrating HPV Education Into School Health Programs in Cambodia and Kenya
A study testing Integrated HPV Education in people with Human Papillomavirus Vaccination and Cervical Cancer Prevention, run by Clinton Health Access Initiative Inc. at 5 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Vaccination, Cervical Cancer Prevention
- What is being tested?
- Integrated HPV Education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,054 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Dec 2024to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Kenya3 sites
Participating primary schools, Kilifi County
Kilifi, Kilifi County
Participating primary schools, Migori County
Migori, Migori County
Participating primary schools, Nairobi County
Nairobi, Nairobi County
Cambodia2 sites
Participating primary schools, Kampong Cham Province
Kampong Cham, Kampong Cham
Participating primary schools, Kratie Province
Kratie, Kratie
About this study
Official title: Evaluating the Impact and Feasibility of Integrating Human Papillomavirus (HPV) Education Into Existing School-Based Health Education Initiatives in Cambodia and Kenya
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.
Read the detailed description
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.
- Being tested
- Integrated HPV Education
- Keywords
- HPV education, HPV vaccine uptake, school health, sexual and reproductive health, implementation research, difference-in-differences, Cambodia, Kenya, quasi-experimental
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated HPV EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Proportion of student KAP respondents who reported having heard of HPV.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Dec 2024
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus VaccinationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 9,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinton Health Access Initiative Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Gavi, The Vaccine Alliance, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Justin Graves, MPH, Principal investigator, Clinton Health Access Initiative Inc.Sonali Patel, MPA, Study director, Clinton Health Access Initiative Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784283
- Sponsor's protocol ID
- GAVI100001391
- Other IDs
- INV-098720, 359NECHR, 492NECHR, P1832/2025, NACOSTI/P/25/416527
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact and Feasibility of Integrating Human Papillomavirus (HPV) Education Into Existing School-Based Health Education Initiatives in Cambodia and Kenya
- ClinicalTrials.gov ID
- NCT07784283
- Acronym / sponsor ID
- GAVI100001391
- Keywords
- HPV education, HPV vaccine uptake, school health, sexual and reproductive health, implementation research, difference-in-differences, Cambodia, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9,054 participants (actual)
- Lead sponsor
- Clinton Health Access Initiative Inc.University, hospital or other
- Collaborators
- Gavi, The Vaccine Alliance, Bill and Melinda Gates Foundation
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Integrated HPV Education | Experimental | Behavioral: Integrated HPV EducationParticipating 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated HPV EducationAge-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. | Behavioural | Integrated HPV Education |
Primary outcome
HPV vaccination coverage among age-eligible girls
Time frame: Baseline and endline (approximately 13 months after baseline in Cambodia and 9-10 months after baseline in Kenya)
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.
HPV, HPV vaccine, and cervical cancer knowledge score among students
Time frame: Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya)
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.
14 secondary outcomes
HPV awareness among students
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Graves, MPH principal investigator
Clinton Health Access Initiative Inc.
Sonali Patel, MPA study director
Clinton Health Access Initiative Inc.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated HPV Education in people with Human Papillomavirus Vaccination and Cervical Cancer Prevention, run by Clinton Health Access Initiative Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Kenya, Cambodia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV vaccination coverage among age-eligible girls (time frame: Baseline and endline (approximately 13 months after baseline in Cambodia and 9-10 months after baseline in Kenya)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.