Clinical trial · Interventional
Integration to Improve Adolescent Health and HPV Vaccination in Laos
Integrated Service Delivery to Improve Adolescent Health and HPV Vaccination in Lao PDR: a Quasi-Experimental Mixed-Methods Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adolescents | — | UNRESOLVED | — |
| Attitude | — | UNRESOLVED | — |
| Health Workers | — | UNRESOLVED | — |
| Healthy | — | UNRESOLVED | — |
| HPV Vaccines | — | UNRESOLVED | — |
| Integrated, Community-Health Systems | — | UNRESOLVED | — |
| Knowledge | — | UNRESOLVED | — |
| Sexual and Reproductive Health | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant | Biological | — | UNRESOLVED |
| Integrated HPV and SRH Service Package | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention district
- description
- 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.
- interventionNames
- Other: Integrated HPV and SRH Service Package
- Biological: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
- type
- ACTIVE_COMPARATOR
- label
- Comparison District
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 13 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * males and females younger than 10 years or older than 13 years
References
Publications (6)
- BACKGROUNDMarkowitz 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. PMID 23199957
- BACKGROUNDEngel 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. PMID 34844819
- BACKGROUNDVongxay 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. PMID 30650100
- BACKGROUNDAryal 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. PMID 38685885
- BACKGROUNDStarrs 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. PMID 29753597
- DERIVEDLynn T, Sychareun V, Chaleunvong K, Vongxay V, Thongmixay S, Phimmavong C, Taikeophithoun C, Van Der Kooij J. Integrated service delivery to improve adolescent health and human papillomavirus (HPV) vaccination in Lao PDR: a quasi-experimental mixed-methods study - study protocol. BMJ Open. 2026 Aug 3;16(8):e098836. doi: 10.1136/bmjopen-2025-098836.