Evaluating the Impact and Feasibility of Integrating Human Papillomavirus (HPV) Education Into Existing School-Based Health Education Initiatives in Cambodia and Kenya
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9,054
- 试验地点
- 5
- 主要终点
- HPV vaccination coverage among age-eligible girls
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
No masking was used. Participants, teachers/implementers, investigators, and outcome assessors were not masked to study-arm assignment.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
HPV vaccination coverage among age-eligible girls
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Confidence in HPV vaccine benefits among students(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(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(Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya))
- Caregiver confidence in HPV vaccination(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(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(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(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(Single post-intervention assessment, approximately 9 months after baseline in Cambodia and 5-6 months after baseline in Kenya)
- Cervical cancer awareness among students(Baseline and endline (approximately 9 months after baseline in Cambodia and 9-10 months after baseline in Kenya))
