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

Human papillomavirus (HPV) vaccination is one of the most effective strategies forpreventing cervical cancer, yet coverage among adolescent girls in West Africa, includingMali and Côte d'Ivoire, remains far below the World Health Organization (WHO) target of90% coverage by age 15. Barriers include limited community awareness, weak follow‐upsystems, and sociocultural constraints that contribute to missed vaccinationopportunities. Muso Health has previously demonstrated the potential effectiveness of aninnovative community health worker (CHW)‐led, digitally supported follow‐up model forimproving childhood immunization coverage; this model has now been adapted to address HPVvaccination among adolescent girls in the same communities.To evaluate the effectiveness of a community‐based CHW follow‐up intervention, supportedby a digital tool, in increasing HPV vaccination coverage and reducingtime‐to‐vaccination among adolescent girls in Mali and Côte d'Ivoire, using a randomizedcontrolled 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 andCôte 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 yearsin Côte d'Ivoire). Eligible girls are randomized 1:1, stratified by country, site, andCHW 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 toolwith real‐time data visualization and automated task reminders. After the phase 1assessment (3 months post‐launch), the control arm crosses over to receive theintervention (waitlist activation), followed by a phase 2 assessment at 6 months. Theprimary 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 adolescentgirls (9,550 intervention; 7,638 control), providing 80% power at α = 0.05 to detect aminimum absolute difference of 0.94 percentage points (19% relative increase) over anestimated baseline coverage of 4.95%. Primary analyses will use mixed‐effects logisticregression (coverage) and Cox proportional hazards (time‐to‐vaccination), both clusteredat the CHW supervision zone level, as detailed in the study's pre‐registered StatisticalAnalysis Plan.Verbal informed consent was obtained from participants (or their parents/guardians, givenparticipants' minor status) prior to vaccination status assessment, in view of lowliteracy rates in the study population. The protocol has been submitted to the relevantnational and institutional ethical review boards in Mali and Côte d'Ivoire for approvalor exemption. Findings will be disseminated through peer‐reviewed publication,stakeholder workshops, and policy briefs to inform HPV immunization strategies incomparable low‐resource settings.