Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650956
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
Integration to Improve Adolescent Health and HPV Vaccination in Laos
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Integrated Service Delivery to Improve Adolescent Health and HPV Vaccination in Lao PDR a Quasi-Experimental Mixed-Methods Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11 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 12 What factors contribute to the differences - if any - in HPV vaccine uptake as such between the intervention and comparison districts
SO-2 21 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 22 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 31 What are the main barriers and facilitators to implementing the integrated intervention in the Lao context 32 How does the integrated intervention impact healthcare providers workload and capacity in the intervention district
SO-4 41 What are the perceptions of adolescents caregivers healthcare providers educators and other key stakeholders regarding the benefits and challenges of the integrated intervention 42 How do the perceived benefits and challenges of the integrated intervention vary among different stakeholder groups
SO-5 51 What are the costs and effects of integrating HPV vaccination with adolescent health services compared to delivering HPV vaccination alone 52 How does the cost-effectiveness of the integrated intervention compare to that of delivering HPV vaccination alone in the Lao context
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 11 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 12 What factors contribute to the differences - if any - in HPV vaccine uptake as such between the intervention and comparison districts
SO-2 21 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 22 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 31 What are the main barriers and facilitators to implementing the integrated intervention in the Lao context 32 How does the integrated intervention impact healthcare providers workload and capacity in the intervention district
SO-4 41 What are the perceptions of adolescents caregivers healthcare providers educators and other key stakeholders regarding the benefits and challenges of the integrated intervention 42 How do the perceived benefits and challenges of the integrated intervention vary among different stakeholder groups
SO-5 51 What are the costs and effects of integrating HPV vaccination with adolescent health services compared to delivering HPV vaccination alone 52 How does the cost-effectiveness of the integrated intervention compare to that of delivering HPV vaccination alone in the Lao context
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None