Integrated CareSHARP-CINCT06997705
Integrated HPV Vaccination and Adolescent Health in Ivory Coast
A study testing Optimized VMS in people with Integrated Care and HPV Vaccination, run by Jhpiego at 1 site in Côte d’Ivoire.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Integrated Care, HPV Vaccination, Adolescent
- What is being tested?
- Optimized VMS
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,384 participants
- Where
- 1 siteCôte d’Ivoire
- Study dates
- 16 Mar 2025to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 110 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pooja Sripad, PhD contact
Côte d’Ivoire1 site, 1 recruiting
- Recruiting
École Nationale Supérieure de Statistique et d'Économie Appliquée (ENSEA)
Abidjan
Rosine Mosso, PhD, DEA, +2250708543592, rosine.mosso@ensea.ed.ci
About this study
Official title: Strengthening HPV Vaccination and Adolescent Health Research Program (SHARP) 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.
- Conditions
- Integrated Care, HPV Vaccination, Adolescent
- Being tested
- Optimized VMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimized VMSBehavioural
Also called SHARP-intervention in Cote d'Ivoire
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (before intervention start) and at endline (6 months after intervention)
Secondary outcomes (2)
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)).
Measured: Baseline (before intervention start) and at endline (6 months after intervention)
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).
Measured: Baseline (before intervention start) and at endline (6 months after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start16 Mar 2025
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Integrated CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jhpiego
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaine Charurat, MBA, MHS, Principal investigator, Jhpiego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997705
- Sponsor's protocol ID
- 30593
- Acronym
- SHARP-CI
- Status last verified
- May 2025
- First submitted
- 31 Mar 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening HPV Vaccination and Adolescent Health Research Program (SHARP) in Ivory Coast
- ClinicalTrials.gov ID
- NCT06997705
- Acronym / sponsor ID
- SHARP-CI / 30593
- Conditions
- Integrated Care, HPV Vaccination, Adolescent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,384 participants (estimated)
- Lead sponsor
- JhpiegoUniversity, hospital or other
- Study start
- 16 Mar 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimized VMS | Experimental | Behavioral: Optimized VMSThe 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. |
| 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). |
Who may qualify
- Ages
- 9 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimized VMSAlso: SHARP-intervention in Cote d'IvoireBuilding 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. | Behavioural | Optimized VMS |
Primary outcome
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.
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.
2 secondary outcomes
Number/proportion of participants with HPV knowledge
Time frame: Baseline (before intervention start) and at endline (6 months after intervention)
Number/proportion of participants with positive attitudes towards integrated services
Time frame: Baseline (before intervention start) and at endline (6 months after intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pooja Sripad, PhD contact
Elaine Charurat, MBA, MHS principal investigator
Jhpiego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimized VMS in people with Integrated Care and HPV Vaccination, run by Jhpiego at 1 site in Côte d’Ivoire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Côte d’Ivoire. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shana Kagan, MN, MSc (9523807839, Shana.kagan@jhpiego.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.