Clinical trial NCT06650956: Integration to Improve Adolescent Health and HPV Vaccination in Laos
Official title: Integrated Service Delivery to Improve Adolescent Health and HPV Vaccination in Lao PDR: a Quasi-Experimental Mixed-Methods Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Health Poverty Action
Sponsor class: OTHER
Collaborators: name: Gavi, The Vaccine Alliance
name: University of Health Sciences Laos
First posted: 2024-10-21
Enrollment: 700
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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

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. 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?

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

Primary outcomes:
measure: Difference-in-differences of HPV Vaccination Rates
timeFrame: 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:
measure: Change in Scores of Knowledge and Attitude (KA) related to Sexual and Reproductive Health among adolescents
timeFrame: 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)
measure: Themes on Barriers to Integrated HPV Vaccination and Adolescent Health Services in Lao PDR
timeFrame: End-of-Intervention: Assessment 7 months after the intervention begins (Month 7)
measure: Themes on Healthcare Providers' Workload in Delivering Integrated HPV Vaccination and Adolescent Health Services
timeFrame: End-of-Intervention: Assessment 7 months after the intervention begins (Month 7).
measure: Themes on Perceptions of Stakeholders on Integrated HPV Vaccination and Adolescent Health Services
timeFrame: End-of-Intervention: Assessment 7 months after the intervention begins (Month 7).
measure: Cost per unit delivery of integrated intervention package to the adolescents
timeFrame: End-of-Intervention: Assessment 7 months after the intervention begins (Month 7).
measure: Themes on Facilitators to Integrated HPV Vaccination and Adolescent Health Services in Lao PDR
timeFrame: End-of-Intervention: Assessment 7 months after the intervention begins (Month 7)
Other outcomes:
Locations:
city: Sing
country: Lao People's Democratic Republic
facility: Sing District, Luang Namtha Province
state: Province
Study officials:
affiliation: Health Poverty Action
name: Thet Lynn, MD, MMedSc Global Health
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Health Sciences Laos
name: Vanphanom Sychareun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
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citation: 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.