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NCT Number: NCT06997705

Integrated HPV Vaccination and Adolescent Health in Ivory Coast

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.

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Key information

Age range

9 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Abidjan, Côte d’Ivoire

Location status: Recruiting

Location contact

Rosine Mosso, PhD, DEA

CONTACT

[email protected]

+2250708543592

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: SHARP-intervention in Cote d'Ivoire

Primary outcomes

  1. Number/proportion of adolescent girls vaccinated for HPV

    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

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

  2. Number/proportion of adolescent girls intending to get HPV vaccine

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

    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.

Secondary outcomes

  1. Number/proportion of participants with HPV knowledge

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

    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)).

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

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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Pooja Sripad, PhD

CONTACT

[email protected]

Shana Kagan, MN, MSc

CONTACT

[email protected]

9523807839

Sponsors and collaborators

Lead sponsor

Jhpiego

Other

Registry information

Official study title

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

Acronym: SHARP-CI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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