Integration to Improve Adolescent Health and HPV Vaccination in Laos

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. 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

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

Interventions

OTHER

Integrated HPV and SRH Service Package

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.

BIOLOGICAL

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

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.

Sponsors & Collaborators

• Gavi, The Vaccine Alliance

  collaborator OTHER

• University of Health Sciences Laos

  collaborator UNKNOWN

• Health Poverty Action

  lead OTHER

Principal Investigators

• Thet Lynn, MD, MMedSc Global Health · Health Poverty Action

• Vanphanom Sychareun, MD, PhD · University of Health Sciences Laos

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

10 Years

Max Age

13 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-01

Primary Completion

2025-05-31

Completion

2025-05-31

Countries

• Laos

Study Locations