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

NCT07807202 | Active Not Recruiting

• 1 other identifier: 00091
• Study Type: interventional
• Target: 17,188
• Locations: 2 countries
• Sites: 2

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.

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Time to HPV vaccination (days)

  12 Weeks

Study Arms (2)

Standard community mobilization with routine HPV vaccination follow-up

ACTIVE COMPARATOR

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

EXPERIMENTAL

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

Interventions

HPV vaccination pro-active community-based follow-up model BEHAVIORAL

CHW proactive follow-up with digital decision support

CHW home visits with proactive invitation of unvaccinated girls and automated digital follow-up

Standard community mobilization BEHAVIORAL

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.

Standard community mobilization with routine HPV vaccination follow-up

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Programme Élargi de Vaccination (Côte d'Ivoire): collaborator
• Centre National d'Immunisation (Mali): collaborator
• Arsène Brunelle Sandie: lead

Study Sites (2)

Madinani health district and Diape catchment area

Abidjan, Côte d’Ivoire

Location

Bankas, Yirimadio, and Bakorobabougou health areas

Bamako, Mali

Location

Related Publications (17)

• Sandie AB, Keita Y, Coulibaly R, Coulibaly Y, Diall I, Koffi JAK, et al. Amélioration des couvertures vaccinales des enfants de 0 à 23 mois par une intervention innovante de suivi communautaire en Côte d'Ivoire et au Mali Protocole de recherche pour une étude de séries chronologiques interrompues contrôlées utilisant les données de routine. Muso Health; 2025.

  BACKGROUND

• Gavi the Vaccine Alliance. Mali: HPV vaccination takes root one year after its introduction. 2025.

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• Gavi the Vaccine Alliance. Mali rolls out cancer-blocking jab 2024

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• Ministere de la Sante dlHPedlCMU. Rapport technique de la campagne nationale de vaccination de la cohorte multi-ages contre le HPV en Côte d'Ivoire : du 07 au 13 avril 2025

  BACKGROUND

• Gavi the Vaccine Alliance. Gavi supports Côte d'Ivoire's largest HPV vaccination campaign targeting over 3 million girls.

  BACKGROUND

• Dainguy M, Kouadio E, Kouakou K, Doubané S. Determinants of Human Papilloma Virus Vaccination Status among Adolescent Schoolgirls in Abidjan. HEALTH SCIENCES AND DISEASE. 2024.

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• World Health Organization Regional Office for Africa. HPV Vaccination: Paving the Path toward Cervical Cancer Elimination in Africa. WHO AFRO; 2024.

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• World Health Organization Regional Office for Africa. Advancing the cervical cancer elimination agenda in the African region. WHO AFRO; 2023.

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• World Health Organization. Global strategy to accelerate the elimination of cervical cancer as a public health problem. 2020.

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• World Health Organization. Cervical cancer. WHO Fact Sheet. 2024

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• Rivero-Mendoza D, Gjoka K, Singh L, Adkins L, Bylund CL, Staras SAS, Salloum RG, Shenkman E, Egbounye NC, Mkuu RS. Health System Strategies to Improve the Uptake of Cervical Cancer Screening in Sub-Saharan Africa: A Scoping Systematic Review. Health Promot Pract. 2026 May;27(3):576-599. doi: 10.1177/15248399251370668. Epub 2025 Oct 3.

  PMID: 41044858 BACKGROUND

• Mengistie BA, Yirsaw AN, Lakew G, Mekonnen GB, Shibabaw AA, Chereka AA, Kitil GW, Wondie WT, Abuhay AE, Getachew E. Human papillomavirus vaccine uptake and its determinants among women in Africa: an umbrella review. Front Public Health. 2025 Jun 5;13:1537250. doi: 10.3389/fpubh.2025.1537250. eCollection 2025.

  PMID: 40538696 BACKGROUND

• Habila MA, Kimaru LJ, Mantina N, Valencia DY, McClelland DJ, Musa J, Madhivanan P, Sagay A, Jacobs ET. Community-Engaged Approaches to Cervical Cancer Prevention and Control in Sub-Saharan Africa: A Scoping Review. Front Glob Womens Health. 2021 Jul 19;2:697607. doi: 10.3389/fgwh.2021.697607. eCollection 2021.

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• Poole DN, Tracy JK, Levitz L, Rochas M, Sangare K, Yekta S, Tounkara K, Aboubacar B, Koita O, Lurie M, De Groot AS. A cross-sectional study to assess HPV knowledge and HPV vaccine acceptability in Mali. PLoS One. 2013;8(2):e56402. doi: 10.1371/journal.pone.0056402. Epub 2013 Feb 19.

  PMID: 23431375 BACKGROUND

• Asempah E, Ikpebe E. Accelerating HPV vaccination in Africa for health equity. Glob Health Res Policy. 2024 Sep 19;9(1):37. doi: 10.1186/s41256-024-00380-z.

  PMID: 39294815 BACKGROUND

• Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.

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• Wei F, Georges D, Man I, Baussano I, Clifford GM. Causal attribution of human papillomavirus genotypes to invasive cervical cancer worldwide: a systematic analysis of the global literature. Lancet. 2024 Aug 3;404(10451):435-444. doi: 10.1016/S0140-6736(24)01097-3.

  PMID: 39097395 BACKGROUND

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research

Model Details: 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.

Study Record Dates

• First Submitted: August 30, 2026
• First Posted: September 8, 2026
• Study Start: April 8, 2026
• Primary Completion: October 1, 2026
• Study Completion: October 1, 2026
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

CÔ (1); MA (1)