An interventional study of HPV vaccination pro-active community-based follow-up model and Standard community mobilization in Papillomavirus Infections and Uterine Cervical Neoplasms, sponsored by Arsène Brunelle Sandie. Completed at 2 sites in 2 countries. Open to female participants aged 9 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Arsène Brunelle Sandie · Not applicable, Interventional, and Health services research
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.
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.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
This study's enrollment of 17,188 is above the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →This is the only study on the registry with Arsène Brunelle Sandie as lead sponsor.
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Exclusion Criteria:
Control arm: standard community mobilization with routine HPV vaccination follow-up (CHW identification and vaccination-status verification only).
Behavioral: Standard community mobilization
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
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.
HPV vaccination coverage (%)
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.
Time frame: 12 weeks
Time to HPV vaccination (days)
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.
Time frame: 12 Weeks
HPV vaccination coverage at 25 weeks (early versus delayed start of the intervention)
Number of adolescent girls with a documented completed HPV vaccination per 100 eligible girls with known vaccination status, assessed 25 weeks after enrollment. Girls are analyzed in their originally allocated arm. Because the control arm begins receiving the intervention at week 12 (waitlist crossover), the between-arm difference at 25 weeks compares an early start (from enrollment) with a delayed start (from week 12) of the community health worker follow-up intervention.
Time frame: 25 weeks
Change in HPV vaccination coverage between 12 and 25 weeks
Change in the percentage of eligible girls with a documented completed HPV vaccination between week 12 and week 25 after enrollment, within each arm. The between-arm comparison of this change assesses whether the coverage gap between arms narrows after the control arm crosses over to the intervention at week 12.
Time frame: 12 weeks and 25 weeks
Time to HPV vaccination over 25 weeks
Number of days from enrollment to receipt of the HPV vaccine, summarized as the restricted mean time to vaccination over 25 weeks in each arm. Hazard ratios comparing arms are estimated separately before and after the week-12 crossover, to distinguish the period when only the intervention arm received the intervention from the period when both arms did.
Time frame: 25 weeks
HPV vaccination uptake at 12 weeks among girls unvaccinated at enrollment
Percentage of eligible girls with no documented HPV vaccination before enrollment who receive a documented HPV vaccination within 12 weeks after enrollment, compared between the intervention and control arms overall and separately for Mali and Côte d'Ivoire. Because most girls in Côte d'Ivoire were already vaccinated during a national campaign before enrollment, this measure assesses the effect of the intervention among the girls who could still be vaccinated. Analyzed in all allocated girls and in randomized girls only.
Time frame: 12 weeks
HPV vaccination uptake at 25 weeks among girls unvaccinated at enrollment
Percentage of eligible girls with no documented HPV vaccination before enrollment who receive a documented HPV vaccination within 25 weeks after enrollment, compared between the originally allocated arms overall and separately for Mali and Côte d'Ivoire. Because the control arm begins receiving the intervention at week 12, this compares an early start (from enrollment) with a delayed start (from week 12) of the community health worker follow-up intervention. Analyzed in all allocated girls and in randomized girls only.
Time frame: 25 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Ran from Apr 2026 to primary completion in Oct 2026, 5 months.
Of 106 non-industry interventional studies with no phase under Papillomavirus Infections, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 5 months is below that.
Counting every sponsor, half of 115 studies reached it within 26 months; a quarter within 12 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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