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| ID | Type | Description | Link |
|---|---|---|---|
| Research Ethics Committee | Other Identifier | University of Health Sciences Laos |
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| Name | Class |
|---|---|
| Gavi, The Vaccine Alliance | OTHER |
| Health Sciences University, Laos | UNKNOWN |
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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:
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:
Participants in the comparison group will receive standard HPV vaccination services, including:
• HPV vaccination given at schools, health facilities, and through community outreach.
Objectives: The overall objective of the study is to determine how integrating HPV vaccination services with adolescent health services could increase HPV vaccine coverage equitably and sustainability, as well as contribute to selected adolescent health outcomes in Lao.
Specific Objectives (SO):
Research Questions:
SO-1: 1.1) What is the difference-in-differences (DID) of change in the HPV vaccine uptake in the 10-13-year-old girls' population between the intervention and comparison districts over 9 months? 1.2) What factors contribute to the differences - if any - in HPV vaccine uptake as such between the intervention and comparison districts?;
SO-2: 2.1) How does the integrated intervention affect 10-13-year-old adolescents' knowledge, and attitudes related to SRHR in the intervention district compared to the comparison district over 9 months?, 2.2) What changes in the utilization of adolescent health services among 10-13-year-olds are observed in the intervention district compared to the comparison district?;
SO-3: 3.1) What are the main barriers and facilitators to implementing the integrated intervention in the Lao context?, 3.2 How does the integrated intervention impact healthcare providers' workload and capacity in the intervention district?;
SO-4: 4.1) What are the perceptions of adolescents, caregivers, healthcare providers, educators and other key stakeholders regarding the benefits and challenges of the integrated intervention?, 4.2) How do the perceived benefits and challenges of the integrated intervention vary among different stakeholder groups?;
SO-5: 5.1) What are the costs and effects of integrating HPV vaccination with adolescent health services compared to delivering HPV vaccination alone?, 5.2) How does the cost-effectiveness of the integrated intervention compare to that of delivering HPV vaccination alone in the Lao context?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention district | Experimental | The intervention provides HPV vaccinations to girls aged 10-13 and sexual and reproductive health (SRH) services to boys and girls aged 10-13 through three service delivery touch points: schools, health facilities, and community outreach. The vaccine in the intervention is a single dose of recombinant Human Papilloma virus quadrivalent types, 6, 11, 16, and 18. Schools will provide vaccinations and comprehensive sexuality education (CSE) sessions. Health facilities offer vaccinations and SRH education service. Community outreach delivers the integrated package to out-of-school girls and boys. |
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| Comparison District | Active Comparator | Standard HPV Vaccination (Comparison District) - In the comparison district, routine HPV vaccination services will be provided to girls aged 10-13 years. The vaccine is a single dose of recombinant Human Papilloma virus quadrivalent types, 6, 11, 16, and 18.; A school-based vaccination campaign will be conducted in 2024 November to promote and administer the HPV vaccine. Additionally, the vaccine will be available at health facilities starting in the same month. Outreach activities will also be conducted to ensure access to the vaccine for hard-to-reach populations and out-of-school girls. - Unlike the intervention district, there will be no additional training for nor service by healthcare providers on comprehensive sexuality education (CSE) or other sexual and reproductive health (SRH) services, and there will be no dedicated community outreach sessions on SRH topics. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Integrated HPV and SRH Service Package | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline: Assessment at the start of the study (Month 0). Mid-Intervention: Assessment 3 months after the intervention begins (Month 3). End-of-Intervention: Assessment 7 months after the intervention begins (Month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kongmany Chaleunvong, MD, PhD | Contact | +8562022200650 | kchaluenvong@gmail.com | |
| Viengnakhone Vongxay, MD, PhD | Contact | +856 20 95 665 699 | viengnakhone_poom@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Thet Lynn, MD, MMedSc Global Health | Health Poverty Action | Principal Investigator |
| Vanphanom Sychareun, MD, PhD | Health Sciences University, Laos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sing District, Luang Namtha Province | Recruiting | Muang Sing | Province | Laos |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23199957 | Background | Markowitz LE, Tsu V, Deeks SL, Cubie H, Wang SA, Vicari AS, Brotherton JM. Human papillomavirus vaccine introduction--the first five years. Vaccine. 2012 Nov 20;30 Suppl 5:F139-48. doi: 10.1016/j.vaccine.2012.05.039. | |
| 34844819 | Background | Engel D, Afeli ADJ, Morgan C, Zeck W, Ross DA, Vyankandondera J, Bloem P, Adjeoda KR. Promoting adolescent health through integrated human papillomavirus vaccination programs: The experience of Togo. Vaccine. 2022 Mar 31;40 Suppl 1:A100-A106. doi: 10.1016/j.vaccine.2021.11.021. Epub 2021 Nov 26. |
| Label | URL |
|---|---|
| United Nations, Department of Economic and Social Affairs, Population Division. World Population Prospects: The 2022 Revision | View source |
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Only IPD used in the results publication
October, 2025 - Jun,2026
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The study population includes girls aged 10-13 years for HPV vaccination and boys and girls aged 10-13 years for other adolescent health services. The intervention district will receive an integrated service package comprising HPV vaccination and adolescent health services delivered through school-based, facility-based, and outreach approaches. The comparison district will continue with its standard HPV vaccination and routine adolescent health service delivery. The intervention will be for 7 months from 2024 November to 2025 May.
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| Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant | Biological | The 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. |
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| Baseline: Assessment at the start of the study (Month 0). Mid-Intervention: Assessment 3 months after the intervention begins (Month 3). End-of-Intervention: Assessment 7 months after the intervention begins (Month 7) |
| 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. | End-of-Intervention: Assessment 7 months after the intervention begins (Month 7) |
| 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. | End-of-Intervention: Assessment 7 months after the intervention begins (Month 7). |
| 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:
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. | End-of-Intervention: Assessment 7 months after the intervention begins (Month 7). |
| Cost per unit delivery of integrated intervention package to the adolescents | To get the cost per unit delivery of integrated intervention package, the total cost will be divided by the total number of adolescents reached. The total cost of the intervention will be calculated by summing up all the costs collected across different cost components. All relevant cost components will be identified, including direct costs (i.e., vaccine procurement, personnel, training, materials) and indirect costs (i.e., overhead and transportation). The total number of adolescents reached will be calculated by the number of adolescents reached through different delivery channels (school-based, facility-based and community outreach). | End-of-Intervention: Assessment 7 months after the intervention begins (Month 7). |
| Themes on Facilitators to Integrated HPV Vaccination and Adolescent Health Services in Lao PDR | Focus group discussions (FGDs) will be used to explore the consolidated themes on facilitators 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 facilitators to implementing the integrated intervention. The information gathered from different groups will be aggregated by identifying common themes and patterns across the different groups, and these consolidated thematic facilitators will be reported as the key findings for this outcome measure. | End-of-Intervention: Assessment 7 months after the intervention begins (Month 7) |
| 30650100 | Background | Vongxay V, Albers F, Thongmixay S, Thongsombath M, Broerse JEW, Sychareun V, Essink DR. Sexual and reproductive health literacy of school adolescents in Lao PDR. PLoS One. 2019 Jan 16;14(1):e0209675. doi: 10.1371/journal.pone.0209675. eCollection 2019. |
| 38685885 | Background | Aryal A, Clarke-Deelder E, Phommalangsy S, Kounnavong S, Fink G. Health system inequities in Lao People's Democratic Republic: Evidence from a nationally representative phone survey. Trop Med Int Health. 2024 Jun;29(6):518-525. doi: 10.1111/tmi.13997. Epub 2024 Apr 30. |
| 29753597 | Background | Starrs AM, Ezeh AC, Barker G, Basu A, Bertrand JT, Blum R, Coll-Seck AM, Grover A, Laski L, Roa M, Sathar ZA, Say L, Serour GI, Singh S, Stenberg K, Temmerman M, Biddlecom A, Popinchalk A, Summers C, Ashford LS. Accelerate progress-sexual and reproductive health and rights for all: report of the Guttmacher-Lancet Commission. Lancet. 2018 Jun 30;391(10140):2642-2692. doi: 10.1016/S0140-6736(18)30293-9. Epub 2018 May 9. No abstract available. |
| GBD Compare. Seattle, WA: IHME, University of Washington: Institute for Health Metrics and Evaluation (IHME).; 2023 | View source |
| Bruni L, Albero G, Serrano B, Mena M, Collado J, Gómez D, et al. Human Papillomavirus and Related Diseases in Laos. Summary Report 2023. ICO/IARC Information Centre on HPV and Cancer (HPV Information Centre) | View source |
| Human papillomavirus and related cancers in Laos. Summary report 2010. WHO/ICO Information Centre on HPV and Cervical Cancer (HPV Information Centre) | View source |
| Global strategy to accelerate the elimination of cervical cancer as a public health problem | View source |
| Human papillomavirus vaccines: WHO position paper (2022 update). Weekly Epidemiological Record, 2022, vol 97, 50. 2022 Dec 16;97(50):645-72 | View source |
| ID | Term |
|---|---|
| D003075 | Coitus |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D012725 | Sexual Behavior |
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| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D053918 | Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
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