Trials / Completed

CompletedNCT07200414

Strengthening HPV Vaccination and Adolescent Health Research Program in Nigeria (SHARP)

Strengthening HPV Vaccination and Adolescent Health Research Program in Nigeria (SHARP in Nigeria)

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 12,654 (actual)

Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
Sex: All
Age: 9 Years
Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn whether adding adolescent health services to routine government health programs can increase Human Papillomavirus (HPV) vaccination coverage among 9-year-old girls and improve use of other health services by adolescents in Nigeria. The main questions it aims to answer are: Does offering an integrated package of adolescent health services increase the proportion of 9-year-old girls who receive the HPV vaccine? Does this package increase use of other services such as reproductive health counseling, nutrition and vision screening, mental health services, and deworming among girls and boys ages 9-15 years? Researchers will compare areas that receive the integrated package to areas that continue with the standard government services to see if the intervention improves vaccination and health service use. Participants will: Be surveyed about HPV vaccination and health service use before and after the program is offered. Take part in interviews or focus groups about experiences with adolescent health services. Be offered HPV vaccination and other adolescent health services through local health facilities.

Detailed description

This is a mixed-methods, quasi-experimental implementation science study to evaluate the integration of adolescent health services with routine HPV vaccination in Nigeria. The study is being conducted in Lagos and Kebbi States between October 2024 and December 2025. The intervention will leverage the routine government health system to deliver an integrated package of adolescent health services that includes HPV vaccination and additional services such as sexual and reproductive health counseling, general health check-ups, nutrition and vision screening, mental health services, deworming, and dental and oral health care. The primary objective is to determine the effect of the integrated package on HPV vaccine coverage among 9-year-old girls. Secondary objectives include: (1) assessing changes in uptake of other adolescent health services among girls and boys aged 9-15 years, (2) examining feasibility, acceptability, and fidelity of the intervention from the perspective of adolescents, parents, providers, and policymakers, and (3) estimating incremental costs of delivering the integrated package. The study design includes three phases: formative research, implementation, and evaluation. Baseline and endline household surveys will be conducted with parents and adolescents, supplemented by qualitative data collection (in-depth interviews (IDI), focus groups, key informant interviews (KII), and multi-informant interviews (MII)). Service delivery records and costing data from 30 health facilities will also be analyzed. Comparison will be made between intervention and comparison local government areas to assess differences in HPV vaccine uptake and adolescent health service utilization. The study will generate evidence on strategies to improve HPV vaccination coverage and strengthen adolescent health service delivery in Nigeria.

Conditions

Interventions

Type	Name	Description
BEHAVIORAL	Integrated Adolescent Health Package	Delivery of an integrated package of adolescent health services through government health facilities. The package includes HPV vaccination, sexual and reproductive health counseling, general health check-ups, nutrition and vision screening, mental health support, deworming, and dental and oral health services. Implemented in intervention LGAs in Lagos and Kebbi States.
OTHER	Routine Government Health Services	Routine government health services provided in comparison LGAs. Services may include HPV vaccination as per national immunization schedules and other adolescent health services delivered under existing programs, but without the integrated package.

Timeline

Start date: 2024-10-01
Primary completion: 2025-12-31
Completion: 2025-12-31
First posted: 2025-10-01
Last updated: 2026-04-13

Locations

1 site across 1 country: Nigeria

Source: ClinicalTrials.gov record NCT07200414. Inclusion in this directory is not an endorsement.