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

NCT07200414 | Completed

• 1 other identifier: IRB00030748
• Study Type: interventional
• Target: 12,654
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

HPV vaccination uptake; Nigeria; Human Papillomavirus; Vaccination coverage; Adolescents; Adolescent Health Services; Immunization programs; Health Services Accessibility

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, 14 months

• 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.

  Baseline, 14 months

Secondary Outcomes (1)

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

  Baseline, 14 months

Study Arms (2)

Integrated Adolescent Health Package

EXPERIMENTAL

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.

Behavioral: Integrated Adolescent Health Package

Standard Services

ACTIVE COMPARATOR

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.

Other: Routine Government Health Services

Interventions

Integrated Adolescent Health Package 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.

Also known as: SHARP Integrated Package, Integrated Package of Adolescent Services

Integrated Adolescent Health Package

Routine Government Health Services 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.

Also known as: Standard Services

Standard Services

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• Gavi, The Vaccine Alliance: collaborator
• Johns Hopkins Bloomberg School of Public Health: lead
• Direct Consulting and Logistics: collaborator
• Jhpiego: collaborator

Study Sites (1)

Lagos State Ministry of Health/Kebbi State Ministry of Health

Lagos, Nigeria

Location

Related Publications (3)

• 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.

  PMID: 38793741 BACKGROUND

• 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.

  PMID: 37658293 BACKGROUND

• 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.

  PMID: 36528031 BACKGROUND

MeSH Terms

Conditions

Papillomavirus Infections; Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chizoba Wonodi, MBBS, DrPH, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

NG (1)