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Human Papillomavirus (HPV) VaccineSHARPNCT07200414

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

A study testing Integrated Adolescent Health Package and Routine Government Health Services in people with Human Papillomavirus (HPV) Vaccine and Human Papillomavirus (HPV) Vaccines, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Nigeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 9 years and olderHealthy volunteers can take part
What is being tested?
Integrated Adolescent Health Package and Routine Government Health Services
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12,654 participants
Where
1 siteNigeria
Study dates
1 Oct 2024to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • Those who lack the capacity to provide consent or assent or participate effectively
  • 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

Trial locations and contacts

1 site in 1 country.

Nigeria1 site

  • Lagos State Ministry of Health/Kebbi State Ministry of Health

    Lagos

Other trials in Nigeria

About this study

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

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?

Read more

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.

Read the 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.

Being tested
Integrated Adolescent Health Package, Routine Government Health Services
Keywords
HPV vaccination uptake, Nigeria, Human Papillomavirus, Vaccination coverage, Adolescents, Adolescent Health Services, Immunization programs, Health Services Accessibility
Medical subject headings
Papillomavirus Infections, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated Adolescent Health PackageBehavioural

    Also called SHARP Integrated Package, Integrated Package of Adolescent Services

    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.

  • Routine Government Health ServicesOther

    Also called Standard 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.

Study groups in NCT07200414
Study groupRoleWhat they receive
Integrated Adolescent Health PackageExperimentalLocal 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.
Receives: Behavioral: Integrated Adolescent Health Package
Standard ServicesActive comparatorLocal 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.
Receives: Other: Routine Government Health Services

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in HPV vaccine coverage among 9-year-old girls from baseline to endline

    Human Papillomavirus Virus (HPV) vaccine coverage will be assessed among 9-year-old girls in intervention and comparison (Local Government Areas (LGAs) using baseline and endline household surveys of mother-daughter dyads, supported by administrative vaccination records from health facilities. Differences between baseline and endline coverage in intervention LGAs will be compared with those in comparison LGAs to estimate the impact of the integrated adolescent health package.

    Measured: Baseline, 14 months

  2. Proportion of 9-year-old girls who received at least one dose of HPV vaccine

    Assessed using baseline and endline household surveys and service delivery data. Coverage will be calculated as the number of eligible girls who received at least one dose divided by the total eligible girls surveyed.

    Measured: Baseline, 14 months

Secondary outcomes (1)

  1. Proportion of adolescents aged 9-15 who report use of at least one adolescent health service

    Services may include Sexual and Reproductive Health (SRH) counseling, nutrition or vision screening, mental health services, deworming, or dental/oral care. Measured using baseline and endline household surveys and service records.

    Measured: Baseline, 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2025
  2. Study start1 Oct 2024
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12,654 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07200414
Sponsor's protocol ID
IRB00030748
Acronym
SHARP
Status last verified
Apr 2026
First submitted
23 Sep 2025
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Adeyanju GC, Essoh TA, Sidibe AR, Kyesi F, Aina M. Human Papillomavirus Vaccination Acceleration and Introduction in Sub-Saharan Africa: A Multi-Country Cohort Analysis. Vaccines (Basel). 2024 May 1;12(5):489. doi: 10.3390/vaccines12050489.

    PubMed 38793741

  • Lawson O, Ameyan L, Tukur Z, Dunu S, Kerry M, Okuyemi OO, Yusuf Z, Fasawe O, Wiwa O, Hebert KS, Joseph JT, Nwokwu UE, Okpako O, Chime CI. Cervical cancer screening outcomes in public health facilities in three states in Nigeria. BMC Public Health. 2023 Sep 1;23(1):1688. doi: 10.1186/s12889-023-16539-1.

    PubMed 37658293

  • Singh D, Vignat J, Lorenzoni V, Eslahi M, Ginsburg O, Lauby-Secretan B, Arbyn M, Basu P, Bray F, Vaccarella S. Global estimates of incidence and mortality of cervical cancer in 2020: a baseline analysis of the WHO Global Cervical Cancer Elimination Initiative. Lancet Glob Health. 2023 Feb;11(2):e197-e206. doi: 10.1016/S2214-109X(22)00501-0. Epub 2022 Dec 14.

    PubMed 36528031

Questions about this trial

What is this clinical trial studying?

A study testing Integrated Adolescent Health Package and Routine Government Health Services in people with Human Papillomavirus (HPV) Vaccine and Human Papillomavirus (HPV) Vaccines, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Nigeria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 42 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HPV vaccine coverage among 9-year-old girls from baseline to endline (time frame: Baseline, 14 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07200414, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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