Clinical trial NCT06997705: Integrated HPV Vaccination and Adolescent Health in Ivory Coast
Official title: Strengthening HPV Vaccination and Adolescent Health Research Program (SHARP) in Ivory Coast
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Integrated Care
HPV Vaccination
Adolescent
Lead sponsor: Jhpiego
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 3384
Sex: ALL
Minimum age (years): 9
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background: Cervical cancer is a serious global public health problem, particularly in sub-Saharan Africa, where it is the leading cause of cancer in women, with around 70,722 new cases each year. Vaccination against human papillomavirus (HPV) prevents cervical cancer and is usually given to children around 9 to 15 years of age. HPV vaccination has been incorporated into many countries' Expanded Programs on Immunization, but often faces optimization and uptake challenges. SHARP is an implementation research initiative in Tanzania, Nigeria, and Côte d'Ivoire that is looking at the potential of combining HPV vaccination with with adolescent primary care/preventive health services - how this might work and its effect on the uptake of the HPV vaccine and other services.

Objective: To describe the feasibility, acceptability, effectiveness and sustainability of a locally-designed integrated adolescent health service package, including HPV vaccination in Cote d'Ivoire. Specifically, this study aims to optimize existing primary health care approaches, making service delivery not only more convenient but also more effective in addressing the specific needs of adolescents-both in school and out of school-across schools, communities, and health facilities.

Methods: This is a quasi-experimental research study using the difference-in-difference method between an intervention group and a comparison group over time. It will use mixed methods drawing on quantitative surveys, qualitative interviews, service time motion assessment, and administrative data. The study will be conducted in two regions, each with an intervention and comparison district. The optimized adolescent integrated health intervention will be implemented in the intervention districts with routine service provision in comparison areas. Monthly administrative service coverage data and baseline and endline surveys will be conducted in up to 3502 households with 1626 parents/caregivers and 1626 adolescents will assess effectiveness by looking at changes in service uptake and coverage, as well in knowledge, attitudes, and practices towards HPV vaccination and integrated services. At endline, up to 132 in-depth interviews will be conducted with program managers, health officials, service providers, school authorities, community influencers and leaders, and adolescents and parents/caregivers will assess feasibility, acceptability and sustainability.


Eligibility criteria: Inclusion Criteria for adolescents:

* Age: 9 to 15;
* Residence in the study regions;
* Parental or guardian permission is required;
* Provides assent and agrees to participate in the study.

Inclusion criteria for Parents/caregivers:

* Be the parent or legal guardian of an adolescent aged 9 to 15 years;
* Residence in the study regions;
* Provides informed consent and agrees to participate in the study.

Exclusion Criteria:

* People who have time constraints;
* those who do not speak French or the prominent dialects in study regions;
* those unable to participate because ill, intoxicated or appearing psychologically impaired;
* those residing outside study health regions;
* those who do not provide consent/assent to participate.

Primary outcomes:
measure: Number/proportion of adolescent girls vaccinated for HPV
timeFrame: Baseline (before intervention start) and at endline (up to 8 months after intervention); regularly collected information from registers will be collected by study team members on a montly basis during interverntion
measure: Number/proportion of adolescent girls intending to get HPV vaccine
timeFrame: Baseline (before intervention start) and at endline (6 months after intervention)
Secondary outcomes:
measure: Number/proportion of participants with HPV knowledge
timeFrame: Baseline (before intervention start) and at endline (6 months after intervention)
measure: Number/proportion of participants with positive attitudes towards integrated services
timeFrame: Baseline (before intervention start) and at endline (6 months after intervention)
Other outcomes:
Locations:
city: Abidjan
country: Côte D'Ivoire
facility: École Nationale Supérieure de Statistique et d'Économie Appliquée (ENSEA)
Study officials:
affiliation: Jhpiego
name: Elaine Charurat, MBA, MHS
role: PRINCIPAL_INVESTIGATOR
References: