Papillomavirus Infections, Uterine Cervical Neoplasms
Conditions
Keywords
Human papillomavirus (HPV), Professional Proactive Community Health Workers, Randomized Controlled Trial, waitlist design, digital health, Mali, Côte d'Ivoire, Adolescent health, Cervical cancer prevention, Implementation research
Brief summary
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.
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.
Interventions
BEHAVIORALHPV vaccination pro-active community-based follow-up model
CHW proactive follow-up with digital decision support
BEHAVIORALStandard 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.
Sponsors
Arsène Brunelle Sandie
Programme Élargi de Vaccination (Côte d'Ivoire)
Centre National d'Immunisation (Mali)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Eligible adolescent girls were randomly assigned 1:1 to a control arm or an intervention arm at study launch, stratified by country, site, and community health worker (CHW) supervision zone. Both arms are followed in parallel from launch through the phase 1 assessment (rolling window, 2 July-30 August 2026). At that point, the control arm crosses over to receive the full intervention package (waitlist activation), so that all participants have access to the CHW follow-up program by the end of the study. This is a delayed-intervention (waitlist) design rather than a standard two-arm parallel design without crossover: the phase 1 comparison between arms is the trial's primary analysis, while the phase 2 period (after crossover) provides a within-arm before/after comparison for the former control group but is not used as a between-arm causal comparison, since both arms receive the intervention from that point forward.
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HPV vaccination coverage (%) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to HPV vaccination (days) | 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. |
Countries
Côte d’Ivoire, Mali
Outcome results
None listed