Integrated HPV Vaccination and Adolescent Health in Ivory Coast

NCT06997705 | Recruiting

• 1 other identifier: 30593
• Study Type: interventional
• Target: 3,384
• Locations: 1 country
• Sites: 1

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.

Conditions

Integrated Care; HPV Vaccination; Adolescent

Outcome Measures

Primary Outcomes (2)

• Number/proportion of adolescent girls vaccinated for HPV

  This is an effectiveness measure that captures the HPV coverage among adolescent girls residing in the study areas.

  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

• Number/proportion of adolescent girls intending to get HPV vaccine

  This measure, captured through the survey, aggregates those who have received HPV vaccination in the past 6 months as well as those who express an intention to get vaccinated in the next 6 months.

  Baseline (before intervention start) and at endline (6 months after intervention)

Secondary Outcomes (2)

• Number/proportion of participants with HPV knowledge

  Baseline (before intervention start) and at endline (6 months after intervention)

• Number/proportion of participants with positive attitudes towards integrated services

  Baseline (before intervention start) and at endline (6 months after intervention)

Study Arms (2)

Optimized VMS

EXPERIMENTAL

The intervention arm will receive an optimized integrated adolescent health service package, including HPV vaccination - this will included newly introduced modalities/modifications in school, health facility, and community settings.

Behavioral: Optimized VMS

VMS (comparison)

NO INTERVENTION

The comparison arm will receive routine health services for adolescents with no programmatic changes. Routine health services delivered to school and university adolescent and youth are part of a program called the Systematic Medical Visit (VMS).

Interventions

Optimized VMS BEHAVIORAL

Building on the Systematic Medical Visits (VMS) the Optimized VMS, optimizes these services for in-school and out-of-school adolescents by expanding availability of VMS services through community and facility platforms and building capacity of health workers to provide integrated services. Also the intervention will involve demand generation activities such as community sensitization.

Also known as: SHARP-intervention in Cote d'Ivoire

Optimized VMS

Eligibility Criteria

• Age: 9 Years - 110 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jhpiego: lead

Study Sites (1)

École Nationale Supérieure de Statistique et d'Économie Appliquée (ENSEA)

Abidjan, Côte d’Ivoire

RECRUITING

Study Officials

• Elaine Charurat, MBA, MHS

  Jhpiego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shana Kagan, MN, MSc

CONTACT

9523807839; Shana.kagan@jhpiego.org

Pooja Sripad, PhD

CONTACT

Pooja.Sripad@jhpiego.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: May 30, 2025
• Study Start: March 16, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CÔ (1)