Integrated Service Delivery to Improve Adolescent Health and HPV Vaccination in Lao PDR: a Quasi-Experimental Mixed-Methods Study

Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 13
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Lao People's Democratic Republic
Sing District, Luang Namtha Province
RECRUITING
Muang Sing
Contact Information
Primary
Kongmany Chaleunvong, MD, PhD
kchaluenvong@gmail.com
+8562022200650
Backup
Viengnakhone Vongxay, MD, PhD
viengnakhone_poom@yahoo.com
+856 20 95 665 699
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2025-05
Participants
Target number of participants: 700
Treatments
Experimental: Intervention district
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.
Active_comparator: Comparison District
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.
Related Therapeutic Areas
Sponsors
Collaborators: Gavi, The Vaccine Alliance, University of Health Sciences Laos
Leads: Health Poverty Action

This content was sourced from clinicaltrials.gov