Improving HPV Vaccination Coverage Among Adolescent Girls in Mali and Côte d'Ivoire Through Community Health Worker Follow-up

September 11, 2026 updated by: Arsène Brunelle Sandie

Improving HPV Immunization Coverage Among Adolescent Girls in Mali and Côte d'Ivoire Through an Innovative Community-Based Follow-Up: A Randomized Controlled Trial With a Waitlist Design

The goal of this trial is to learn if a community health worker (CHW) follow-up program can improve HPV vaccination coverage among adolescent girls in Mali and Côte d'Ivoire. The main questions it aims to answer are:

Does the CHW follow-up program increase the number of girls who get vaccinated against HPV? Does the CHW follow-up program help girls get vaccinated sooner?

Researchers will compare girls who receive proactive CHW home visits and digital follow-up reminders to girls who receive standard community outreach, to see if the CHW follow-up program works to increase HPV vaccination.

Participants will:

Be visited at home by a community health worker, who will check their HPV vaccination status Receive an invitation to get vaccinated, and reminders and follow-up visits if not yet vaccinated (intervention group only, until crossover) Have their vaccination status recorded through routine community health records, with no additional tests, surveys, or clinic visits required

After an initial assessment period, girls in the standard-outreach group will also begin receiving the CHW follow-up program.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Human papillomavirus (HPV) vaccination is one of the most effective strategies for preventing cervical cancer, yet coverage among adolescent girls in West Africa, including Mali and Côte d'Ivoire, remains far below the World Health Organization (WHO) target of 90% coverage by age 15. Barriers include limited community awareness, weak follow-up systems, and sociocultural constraints that contribute to missed vaccination opportunities. Muso Health has previously demonstrated the potential effectiveness of an innovative community health worker (CHW)-led, digitally supported follow-up model for improving childhood immunization coverage; this model has now been adapted to address HPV vaccination among adolescent girls in the same communities.

To evaluate the effectiveness of a community-based CHW follow-up intervention, supported by a digital tool, in increasing HPV vaccination coverage and reducing time-to-vaccination among adolescent girls in Mali and Côte d'Ivoire, using a randomized controlled trial (RCT) design with a waitlist.

This is a multi-site, pragmatic, parallel-group RCT with a waitlist (delayed-intervention) design, implemented across Muso Health catchment areas in Mali and Côte d'Ivoire. Eligible participants are adolescent girls who are, or will become, eligible for HPV vaccination during the study period (aged 10 years in Mali; 9-14 years in Côte d'Ivoire). Eligible girls are randomized 1:1, stratified by country, site, and CHW supervision zone, to: (i) a control arm receiving standard community mobilization; or (ii) an intervention arm receiving proactive CHW home visits guided by a digital tool with real-time data visualization and automated task reminders. After the phase 1 assessment (3 months post-launch), the control arm crosses over to receive the intervention (waitlist activation), followed by a phase 2 assessment at 6 months. The primary outcome is HPV vaccination coverage (proportion vaccinated among eligible girls) compared between arms at the phase 1 endline. The secondary outcome is the time (in days) from study initiation to vaccination. The planned total sample size is 17,188 adolescent girls (9,550 intervention; 7,638 control), providing 80% power at α = 0.05 to detect a minimum absolute difference of 0.94 percentage points (19% relative increase) over an estimated baseline coverage of 4.95%. Primary analyses will use mixed-effects logistic regression (coverage) and Cox proportional hazards (time-to-vaccination), both clustered at the CHW supervision zone level, as detailed in the study's pre-registered Statistical Analysis Plan.

Verbal informed consent was obtained from participants (or their parents/guardians, given participants' minor status) prior to vaccination status assessment, in view of low literacy rates in the study population. The protocol has been submitted to the relevant national and institutional ethical review boards in Mali and Côte d'Ivoire for approval or exemption. Findings will be disseminated through peer-reviewed publication, stakeholder workshops, and policy briefs to inform HPV immunization strategies in comparable low-resource settings.

Study Type

Interventional

Enrollment (Actual)

17188

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Côte d’Ivoire
      • Abidjan, Côte d’Ivoire
        • Madinani health district and Diape catchment area
  • Mali
      • Bamako, Mali
        • Bankas, Yirimadio, and Bakorobabougou health areas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female adolescent residing within a participating Muso Health catchment area in Mali or Côte d'Ivoire
  • Age-eligible for HPV vaccination under national immunization guidelines during the study period: 10 years of age in Mali; 9 to 14 years of age in Côte d'Ivoire
  • Not yet age-eligible at study launch but expected to reach the nationally recommended vaccination age during the study period

Exclusion Criteria:

  • Residence outside the defined study catchment areas
  • Not identifiable or registered in the Community Health Toolkit (CHT) programmatic data system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard community mobilization with routine HPV vaccination follow-up
Control arm: standard community mobilization with routine HPV vaccination follow-up (CHW identification and vaccination-status verification only).
Behavioral: Standard community mobilization
CHWs in the control arm conduct home visits using a digital form that identifies eligible girls and documents their current HPV vaccination status. This baseline identification and status-verification workflow reflects standard practice but does not include proactive invitation or follow-up prompts for unvaccinated girls.
Experimental: CHW home visits with proactive invitation of unvaccinated girls and automated digital follow-up
CHW home visits with proactive invitation of unvaccinated girls and automated digital follow-up reminders, supported by a real-time supervisor dashboard.
Behavioral: HPV vaccination pro-active community-based follow-up model
CHW proactive follow-up with digital decision support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HPV vaccination coverage (%)
Time Frame: 12 weeks
HPV vaccination coverage, defined as the number of adolescent girls with a documented completed HPV vaccination per 100 eligible adolescent girls (aged 10 years in Mali; 9-14 years in Côte d'Ivoire) with known vaccination status. The primary endpoint is the between-arm difference in HPV vaccination coverage (intervention versus control) at the phase 1 endline.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to HPV vaccination (days)
Time Frame: 12 Weeks
Time to HPV vaccination, defined as the number of days elapsed between study initiation and receipt of the HPV vaccine. The secondary endpoint is the between-arm difference (intervention versus control) in mean time to vaccination.
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arsène Brunelle Sandie

Collaborators

Programme Élargi de Vaccination (Côte d'Ivoire)
Centre National d'Immunisation (Mali)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

August 30, 2026

First Submitted That Met QC Criteria

September 1, 2026

First Posted (Actual)

September 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified individual participant data (IPD) that will be shared consist of the analytic dataset underlying the primary and secondary outcome analyses, limited to: arm assignment (control/intervention), country, site and CHW supervision zone, age at randomization, age-eligibility category, HPV vaccination status at the phase 1 and phase 2 assessment points, individual assessment dates and derived follow-up time (days_observed_phase1), and time to vaccination (days from launch to vaccination date, where applicable). No direct identifiers (names, contact information, exact addresses, or CHT platform record IDs) will be included. A de-identified data dictionary and the full statistical analysis code (R scripts implementing the pre-specified SAP) will be shared alongside the dataset to support reproduction of the reported analyses.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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