Integration to Improve Adolescent Health and HPV Vaccination in Laos

NCT06650956 | Recruiting

• 2 other identifiers: 833/RECResearch Ethics Committee
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 3.What are the barriers and facilitators to using the combined intervention in Laos?
4. 4.What are the opinions of adolescents, caregivers, healthcare providers, and other stakeholders on the combined intervention?
5. 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?
6. 6.Receive the HPV vaccine at school or at a health facility.
7. 7.Take part in group discussions about sexual and reproductive health.
8. 8.Take part in individual counseling sessions.
9. 9.Use other health services as needed.
10. 10.HPV vaccination given at schools, health facilities, and through community outreach.

Conditions

Healthy; Adolescents; Integrated, Community-Health Systems; HPV Vaccines; Sexual and Reproductive Health; Knowledge; Attitude; Health Workers

Keywords

hpv vaccination; adolescent health; integration; lao pdr; cervical cancer prevention; sexual and reproductive health

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• Change in Scores of Knowledge and Attitude (KA) related to Sexual and Reproductive Health among adolescents

  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

  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

  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

  End-of-Intervention: Assessment 7 months after the intervention begins (Month 7).

• Cost per unit delivery of integrated intervention package to the adolescents

  End-of-Intervention: Assessment 7 months after the intervention begins (Month 7).

Study Arms (2)

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.

Other: Integrated HPV and SRH Service Package; Biological: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant

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.

Biological: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant

Interventions

Integrated HPV and SRH Service Package OTHER

1. 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.

Intervention district

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.

Also known as: Gardasil

Comparison District; Intervention district

Eligibility Criteria

• Age: 10 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Female aged 10-13 years for HPV vaccination and SRH education
• Male aged 10-13 years for SRH education
• 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)
• 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

You may not qualify if:

• males and females younger than 10 years or older than 13 years

Sponsors & Collaborators

• Health Poverty Action: lead
• Gavi, The Vaccine Alliance: collaborator
• University of Health Sciences Laos: collaborator

Study Sites (1)

Sing District, Luang Namtha Province

Muang Sing, Province, Laos

RECRUITING

Related Publications (5)

• 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.

  PMID: 23199957 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.

  PMID: 34844819 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.

  PMID: 30650100 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.

  PMID: 38685885 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.

  PMID: 29753597 BACKGROUND

Related Links

• United Nations, Department of Economic and Social Affairs, Population Division. World Population Prospects: The 2022 Revision
• GBD Compare. Seattle, WA: IHME, University of Washington: Institute for Health Metrics and Evaluation (IHME).; 2023
• 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)
• Human papillomavirus and related cancers in Laos. Summary report 2010. WHO/ICO Information Centre on HPV and Cervical Cancer (HPV Information Centre)
• Global strategy to accelerate the elimination of cervical cancer as a public health problem
• Human papillomavirus vaccines: WHO position paper (2022 update). Weekly Epidemiological Record, 2022, vol 97, 50. 2022 Dec 16;97(50):645-72

MeSH Terms

Conditions

Coitus; Behavior

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Sexual Behavior

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Thet Lynn, MD, MMedSc Global Health

  Health Poverty Action

  PRINCIPAL INVESTIGATOR

• Vanphanom Sychareun, MD, PhD

  University of Health Sciences Laos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kongmany Chaleunvong, MD, PhD

CONTACT

+8562022200650; kchaluenvong@gmail.com

Viengnakhone Vongxay, MD, PhD

CONTACT

+856 20 95 665 699; viengnakhone_poom@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Development and Quality Manager - Asia Region

Model Details: 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.

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 21, 2024
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: October, 2025 - Jun,2026

Locations

LA (1)