The goal of this study is to find out if adding HPV vaccination to adolescent health services works to increase HPV vaccine uptake in 10-13-year-old girls in Laos. The study will also look at the effects of adding HPV vaccination on the use of other health services in 10-13-year-old boys and girls.
The main questions the study aims to answer are:
1. Does adding HPV vaccination to adolescent health services increase HPV vaccine uptake in girls aged 10-13 years compared to girls who only receive standard HPV vaccination services? 2. Does adding HPV vaccination to adolescent health services increase the use of other health services in 10-13-year-old adolescent boys and girls compared to adolescents who only receive standard HPV vaccination services? 3. What are the barriers and facilitators to using the combined intervention in Laos? 4. What are the opinions of adolescents, caregivers, healthcare providers, and other stakeholders on the combined intervention? 5. How much does it cost and how well it works to combine HPV vaccination with adolescent health services, as opposed to providing HPV vaccination alone?
Researchers will compare a combined intervention to standard HPV vaccination services to see if the combined intervention works to increase HPV vaccination uptake and the use of other health services. The combined intervention includes HPV vaccination given at schools, health facilities, and through community outreach. It also includes education on sexual and reproductive health, counseling, and other health services. Participants in the combined intervention group will:
1. Receive the HPV vaccine at school or at a health facility. 2. Take part in group discussions about sexual and reproductive health. 3. Take part in individual counseling sessions. 4. Use other health services as needed.
Participants in the comparison group will receive standard HPV vaccination services, including:
• HPV vaccination given at schools, health facilities, and through community outreach.
Female aged 10-13 years for HPV vaccination and SRH education
Male aged 10-13 years for SRH education
10-13-year-old male and female students in randomly selected schools with at least 100 students in target classes (year-5 primary, year-1, 2 and 3 secondary)
10-13-year-old males and females who are out-of-school and living in 2 remote villages each from four randomly selected health centers located around the selected schools
males and females younger than 10 years or older than 13 years
Parallel
Integrated HPV and SRH Service Package
Other intervention1. Integrated Service Package combines HPV vaccination with sexual and reproductive health (SRH) education. The vaccine in the intervention package is a single dose of recombinant Human Papilloma virus quadrivalent types, 6, 11, 16, and 18.; 2. The package will be delivered through multiple touch-points such as school-based programs, health facility services, and community outreach. i) In school, the intervention incorporates Comprehensive Sexuality Education, empowering boys and girls with knowledge about their bodies, health, and rights. This goes beyond simply providing information about HPV and vaccination. ii) At health facilities, the intervention package will also be delivered in adolescent-friendly ways, ensuring that boys and girls feel comfortable accessing SRH information. iii) Since not all boys and girls attend school, the intervention includes community outreach that ensures wider reach and accessibility for adolescents aged 10-13, including those not enrolled in school.
Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
Biological/VaccineThe vaccine itself is not the intervention of interest as this is delivered in both intervention and comparison arms. The vaccine is a single dose of recombinant Human Papilloma Virus Quadrivalent (Types 6, 11, 16, and 18). The administration of the vaccine is an intramuscular injection of 0.5 mili liter of suspension form.
Difference-in-differences of HPV Vaccination Rates
Difference-in-differences (DID) of the HPV vaccination rates in the 10-13-year-old girls' population between the intervention and comparison districts over 7 months
Change in Scores of Knowledge and Attitude (KA) related to Sexual and Reproductive Health among adolescents
This will measure change in scores of 10-13-year-old adolescents' knowledge, and attitude (KA) questionnaire related to SRH in the intervention district compared to the comparison district over 7 months The knowledge and attitude (KA) questionnaire is a structured assessment tool designed to measure participants' knowledge, attitudes, and practices related to sexual and reproductive health. It covers various aspects of SRH, including: 1. Knowledge of HPV, cervical cancer, and prevention methods, and 2. Attitudes towards HPV vaccination and sexual health. The questionnaire employs a variety of question formats, including multiple-choice, true/false, and Likert scales. Knowledge: 40 items (0-40 score range). Higher scores mean better knowledge. Attitude: 20 items (20-100 score range). Higher scores generally indicate more positive attitudes, but some items need reverse-scoring. Higher total scores mean better knowledge and more positive attitudes.
Themes on Barriers to Integrated HPV Vaccination and Adolescent Health Services in Lao PDR
Focus group discussions (FGDs) will be used to explore the consolidated themes on barriers encountered during the intervention. FGDs: Focus group discussions (FGDs) will be conducted with healthcare providers, educators, community leaders, caregivers and policymakers to gather diverse perspectives on the barriers to implementing the integrated intervention. The information from different groups will be aggregated by identifying common themes and patterns across the different groups, and these consolidated themes on barriers will be reported as the key findings for this outcome measure.
Themes on Healthcare Providers' Workload in Delivering Integrated HPV Vaccination and Adolescent Health Services
FGDs will be conducted to explore the themes on healthcare providers' workload for delivering the integrated intervention. FGDs: Focus group discussions (FGDs) will be conducted with healthcare providers to gather diverse perspectives on how the integrated intervention has affected their workload. The discussions will explore the changes in workload associated with the integration of HPV vaccination and SRH services, the adequacy of resources and training, and the overall impact on service delivery.
Themes on Perceptions of Stakeholders on Integrated HPV Vaccination and Adolescent Health Services
This outcome measure will assess consolidated thematic perceptions among various stakeholders regarding the integrated intervention, including its perceived benefits, challenges, acceptability and suggestions for improvement. Information will be gathered through IDIs and analyzed to identify key themes and areas of consensus and disagreement among stakeholders. IDIs: In-depth interviews (IDIs) will be conducted with a range of stakeholders, including: 1. Adolescents who have participated in the intervention 2. Caregivers of adolescents 3. Healthcare providers involved in delivering the integrated services 4. Educators who have participated in CSE 5. Policymakers involved in adolescent health and vaccination programs The information gathered from different stakeholders will be aggregated by identifying common themes and patterns across the different groups, and these consolidated thematic perceptions will be reported as the key findings for this outcome measure.
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Health Poverty Action
Lead sponsor
Gavi, The Vaccine Alliance
Collaborator
Health Sciences University, Laos
Collaborator