Status:
ACTIVE_NOT_RECRUITING
Strengthening HPV Vaccination and Adolescent Health Research Program in Nigeria (SHARP)
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Collaborating Sponsors:
Direct Consulting and Logistics
Jhpiego
Conditions:
Human Papillomavirus (HPV) Vaccine
Human Papillomavirus (HPV) Vaccines
Eligibility:
All Genders
9+ years
Phase:
NA
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-ol...
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...
Eligibility Criteria
Inclusion
- 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
- 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:
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
14768 Patients enrolled
Trial Details
Trial ID
NCT07200414
Start Date
October 1 2024
End Date
March 31 2026
Last Update
January 7 2026
Active Locations (1)
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1
Lagos State Ministry of Health/Kebbi State Ministry of Health
Lagos, Nigeria