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RecruitingNCT06997705SHARP-CIUpdated May 30, 2025

Integrated HPV Vaccination and Adolescent Health in Ivory Coast

An interventional study of Optimized VMS in Integrated Care, HPV Vaccination and Adolescent, sponsored by Jhpiego. Recruiting at 1 site in Côte D'Ivoire. Open to participants aged 9 Years to 110 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.

Sponsored by Jhpiego · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
3,384
Allocation
Non-randomized
Ages
9 Years to 110 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Integrated Care
  • HPV Vaccination
  • Adolescent
03

Who can participate

Ages eligible
9 Years to 110 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
3,384 participants (estimated)

Study arms

  • Experimental
    Optimized VMS

    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

  • No intervention
    VMS (comparison)

    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

  • BehavioralOptimized VMS

    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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

  2. 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.

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

Secondary outcomes

  1. Number/proportion of participants with HPV knowledge

    This measure will be captured through a survey by several knowledge related items, including an adapted composite measure (standardized scale: Human Papillomavirus Knowledge Questionnaire (PHV-KQ)).

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

  2. Number/proportion of participants with positive attitudes towards integrated services

    This outcome reflects several indicators related to attitudes related to accessing integrated adolescent health services, including HPV vaccination assessed through several items on a questionnaire (not a validated scale).

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

06

Study locations

1 of 1 sites recruiting
  • École Nationale Supérieure de Statistique et d'Économie Appliquée (ENSEA)
    Abidjan, Côte D'Ivoire
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06997705
Lead sponsor
Jhpiego
Responsible party
Sponsor
First posted
May 30, 2025
Start date
Mar 16, 2025
Primary completion
Sep 2025 (estimated)
Completion
Sep 2025 (estimated)
Last update
May 30, 2025

Study contacts

Shana Kagan, MN, MSc
Contact
Shana.kagan@jhpiego.org
9523807839
Pooja Sripad, PhD
Contact
Pooja.Sripad@jhpiego.org
Elaine Charurat, MBA, MHS
principal investigator · Jhpiego

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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