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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

14768 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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

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Human Papillomavirus (HPV) Vaccine Human Papillomavirus (HPV) Vaccines Human Papillomavirus (HPV) Infections Adolescent Health Services

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Integrated Adolescent Health Package

Local government areas (LGAs) where the routine government health system delivers an integrated package of adolescent health services. 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.

Group Type EXPERIMENTAL

Integrated Adolescent Health Package

Intervention Type BEHAVIORAL

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.

Standard Services

Local government areas (LGAs) where only standard government health services are provided. HPV vaccination and other adolescent health services are delivered according to routine practice without the additional integrated package.

Group Type ACTIVE_COMPARATOR

Routine Government Health Services

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Other Intervention Names

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SHARP Integrated Package Integrated Package of Adolescent Services Standard Services

Eligibility Criteria

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Inclusion Criteria

* Immunization program managers from National Primary Health Care Development Agency of Nigeria (NPHCDA), state and Local Government Area (LGA) must:
* Have at least one year of experience in current position
* Be part of the HPV vaccine working group and be engaged in discussions around the HPV routinization plan.
* Be involved in the Routine Immunization (RI) working group at the national or state level, or be part of the local government (LG) RI team, and participate in regular discussions about the HPV vaccination program
* Have been involved in the HPV vaccine rollout, including planning, training, deployment, fieldwork, or assessment activities.
* Must be knowledgeable about vaccination programs in the country and able to provide valuable insights into service delivery practices at different levels.

Program managers from the Ministries of Health, and Education must:

* Have at least one year of experience in current position
* Be knowledgeable about adolescent health programs or policies as it relates to the Ministry and its engagements with Ministry of Health and NPHCDA

Health service providers must:

* Have at least one year of experience in current position
* Provide immunization services at the facility, school or community levels
* Have been involved in the HPV vaccine rollout, including planning, training, deployment, fieldwork, or assessment activities.
* Must be knowledgeable about vaccination programs in the country and able to provide valuable insights into service delivery practices at different levels.

School-based service providers such as principals, teachers and school nurses must:

* Have at least one year of experience in current or similar roles within the educational system.
* Have previous involvement or interest in school health initiatives, adolescent health issues, including sexual health education, vaccination programs etc.
* Be employed in schools located within Lagos or Kebbi states where adolescent girls (9-15 years) attend
* Be a representative from public, private, urban or rural schools, including those serving underprivileged students.
* Be willing to participate in interviews and share experiences and opinions.
* Be proficient in English or Yoruba for Lagos, or English or Hausa for Kebbi

Civil Society Organization (CSO) partner in the state must:

* Be engaged in any of the following cervical cancer elimination, HPV vaccination, girl-child education, internally displaced persons rehabilitation, and youth empowerment within the last 2 years in the intervention LGAs
* Have working relationship with the immunization program at the national, state, local or ward level

Adolescent male and female respondents:

* Must be aged between 9-19 years for the HCD workshop, (In-Depth Interview) IDIs and FGDs, and aged between 9-15 years for the household surveys
* Must reside in the study states (Lagos or Kebbi and in the study LGAs) to be considered for all data collection activities,
* Must have parental or guardian consent to participate in all data collection activities unless classified as emancipated minors.
* In addition to having parental or guardian consent, adolescents must be willing to participate in the data collection activities.
* Adolescents aged 9 to 17, who are legally considered emancipated (e.g. married) can provide consent for participation in all data collection activities without requiring parental or guardian consent
* Must not have participated in any other data collection activity in the study, since distinct adolescents will be enrolled for each data collection activity.

Parents must:

* Be parents or legal guardians of adolescents aged 9-19 years.
* Reside in Lagos or Kebbi states.
* Be willing to participate in the interview process and share experiences, concerns, and suggestions.
* Be proficient in English or Yoruba for Lagos, or English or Hausa for Kebbi.

Community leaders:

* Have at least one year of experience in current role
* Reside in Lagos or Kebbi states
* Must be residing in the community for more than 1 year
* Be willing to participate in the interview process and share experiences, concerns, and suggestions.
* Be proficient in English or Yoruba for Lagos, or English or Hausa for Kebbi.

Exclusion Criteria

1. For all participants

* Individuals unable to participate due to time constraints or conflicting responsibilities.
* Those not proficient in the necessary languages (English or Yoruba for Lagos, English or Hausa for Kebbi).
* For the Key Informant Interviews (KIIs), Multi-Informant Interviews (MIIs), Focus Group Discussions (FGDs) and Household Surveys (HHS): sub-national level individuals not residing in the respective study states (Lagos and Kebbi)
* For the Human-Centered Design Workshop (HCD) workshop: LGA, ward, facility, community, school-level participants who are not from the intervention LGA
* Those who do not provide consent or assent.
* Those who lack the capacity to provide consent or assent or participate effectively
2. For specific participant types

* Immunization program managers from NPHCDA, state and LGA levels
* Individuals with less than one year experience in current position and in immunization programs.
* Those who have not been involved in HPV vaccination program operations or lack a comprehensive view of potential service delivery options.
* Program managers who do not belong to the National or state or LGA or Ward HPV Technical Working Group
* Program managers from the Ministry of Health, Women affairs and Education
* Individuals with less than one year experience in current position.

Health service providers:

* Healthcare workers who didn't participate in the HPV vaccine introduction and has less than 1 year working in routine immunization.
* School-based service providers such as principals, teachers and school nurses
* Individuals without experience teaching adolescents 9-15 years or lacking familiarity with the educational system.
* Teachers or principals from institutions not relevant to the study, such as boys-only school, or universities.

Adolescents:

* Adolescents outside the specified age range of 9-19 years.
* Those unable to communicate effectively, even with interpreters or accommodation.
* Adolescents with medical conditions preventing participation in discussions about vaccination or health.
* Those whose parents or guardians do not provide consent or who do not assent to participate.
* Wards of the state or adolescent under government supervision

Parents:

* Individuals who are not parents or guardians of adolescents aged 9-15 years.
* Parents with extreme beliefs or conspiracy theories about vaccinations that may not contribute constructively to the program design process (For HCD only)
* School teachers in only boys' school or girls outside the age range of 9-15 years.
* Community influencers that have resided in the community for less than one year

Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes