Integration to Improve Adolescent Health and HPV Vaccination in Laos

Health Poverty Action

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06650956

Research Ethics Committee (Registry Identifier)

833/REC

Details and patient eligibility

About

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.

Full 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?

Enrollment: 700 estimated patients

Sex: All

Ages: 10 to 13 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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700 participants in 2 patient groups

Intervention district

Experimental group

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.

Treatment:

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

Other: Integrated HPV and SRH Service Package

Comparison District

Active Comparator group

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.

Treatment:

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