Integration to Improve Adolescent Health and HPV Vaccination in Laos

Trial Title: Integration to Improve Adolescent Health and HPV Vaccination in Laos

NCT ID: NCT06650956

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

Conditions: Keywords:
hpv vaccination
adolescent health
integration
lao pdr
cervical cancer prevention
sexual and reproductive health

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Intervention model description: 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.

Primary purpose: Health Services Research

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Other
Intervention name: Integrated HPV and SRH Service Package
Description: 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.
Arm group label: Intervention district

Intervention type: Biological
Intervention name: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant
Description: 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.
Arm group label: Comparison District
Arm group label: Intervention district

Other name: Gardasil

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.

Detailed description: 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): 1. To determine the extent to which the integration of HPV vaccination with adolescent health services increases HPV vaccine uptake among 10-13-year-old girls in the intervention district compared to the comparison district over 9 months. 2. To assess the impact of the integrated intervention on adolescents' knowledge, attitudes, and practices related to sexual and reproductive health and rights (SRHR) among 10-13-year-old boys and girls, as well as their utilization of other adolescent health services. 3. To identify barriers and facilitators to implementing the integrated intervention in the Laotian context, including its impact on healthcare providers' workload and capacity. 4. To explore the perceptions of adolescents, caregivers, healthcare providers, and other stakeholders regarding integrated intervention, including its perceived benefits and challenges. 5. To determine the costs and effects of integrating HPV vaccination with adolescent health services compared to delivering HPV vaccination alone and assess the cost-effectiveness of the integrated intervention in the Laotian context. [A separate protocol will be developed for full methodology to determine the cost and effects.] 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?

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 10 Years

Maximum age: 13 Years

Healthy volunteers: Accepts Healthy Volunteers

Start date: November 2024

Completion date: May 2025

Lead sponsor:
Agency: Health Poverty Action
Agency class: Other

Collaborator:
Agency: Gavi, The Vaccine Alliance
Agency class: Other

Collaborator:
Agency: University of Health Sciences Laos
Agency class: Other

Source: Health Poverty Action

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06650956
https://population.un.org/wpp/
https://hpvcentre.net/statistics/reports/LAO.pdf?t=1718017698721
http://www.hpvcentre.net/
https://iris.who.int/bitstream/handle/10665/336583/9789240014107-eng.pdf?sequence=1
https://iris.who.int/bitstream/handle/10665/365350/WER9750-eng-fre.pdf?sequence=1