Papillomavirus InfectionsNCT07807202
Improving HPV Vaccination Coverage Among Adolescent Girls in Mali and Côte d'Ivoire Through Community Health Worker Follow-up
A study testing HPV vaccination pro-active community-based follow-up model and Standard community mobilization in people with Papillomavirus Infections and Uterine Cervical Neoplasms, run by Arsène Brunelle Sandie at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 14 years, women only
- Conditions the study is for
- Papillomavirus Infections, Uterine Cervical Neoplasms
- What is being tested?
- HPV vaccination pro-active community-based follow-up model and Standard community mobilization
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17,188 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Apr 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Residence outside the defined study catchment areas
- Not identifiable or registered in the Community Health Toolkit (CHT) programmatic data system
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Côte d’Ivoire1 site
Madinani health district and Diape catchment area
Abidjan
About this study
Official title: 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?
Read more
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.
Read the 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.
- Being tested
- HPV vaccination pro-active community-based follow-up model, Standard community mobilization
- 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
- Medical subject headings
- Papillomavirus Infections, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV vaccination pro-active community-based follow-up modelBehavioural
CHW proactive follow-up with digital decision support
Standard community mobilizationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: HPV vaccination pro-active community-based follow-up model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start8 Apr 2026
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Papillomavirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 17,188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arsène Brunelle Sandie
- Sponsor type
- University, hospital or other
- Collaborators
- Programme Élargi de Vaccination (Côte d'Ivoire), Centre National d'Immunisation (Mali)
- Responsible party
- Sponsor-investigator, Arsène Brunelle Sandie, Muso Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807202
- Sponsor's protocol ID
- 00091
- Status last verified
- Oct 2026
- First submitted
- 30 Aug 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
Gavi the Vaccine Alliance. Mali: HPV vaccination takes root one year after its introduction. 2025.
Gavi the Vaccine Alliance. Mali rolls out cancer-blocking jab 2024
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
Gavi the Vaccine Alliance. Gavi supports Côte d'Ivoire's largest HPV vaccination campaign targeting over 3 million girls.
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.
World Health Organization Regional Office for Africa. HPV Vaccination: Paving the Path toward Cervical Cancer Elimination in Africa. WHO AFRO; 2024.
World Health Organization Regional Office for Africa. Advancing the cervical cancer elimination agenda in the African region. WHO AFRO; 2023.
World Health Organization. Global strategy to accelerate the elimination of cervical cancer as a public health problem. 2020.
World Health Organization. Cervical cancer. WHO Fact Sheet. 2024
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.
PubMed 41044858Mengistie 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.
PubMed 40538696Habila 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.
PubMed 34816234Poole 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.
PubMed 23431375Asempah 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.
PubMed 39294815
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07807202
- Acronym / sponsor ID
- 00091
- Keywords
- Human papillomavirus (HPV), Professional Proactive Community Health Workers, Randomized Controlled Trial, waitlist design, digital health, Mali, Côte d'Ivoire, Adolescent health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17,188 participants (actual)
- Lead sponsor
- Arsène Brunelle SandieUniversity, hospital or other
- Collaborators
- Programme Élargi de Vaccination (Côte d'Ivoire), Centre National d'Immunisation (Mali)
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard community mobilization with routine HPV vaccination follow-up | Active comparator | Behavioral: Standard community mobilizationControl arm: standard community mobilization with routine HPV vaccination follow-up (CHW identification and vaccination-status verification only). |
| CHW home visits with proactive invitation of unvaccinated girls and automated digital follow-up | Experimental | Behavioral: HPV vaccination pro-active community-based follow-up modelCHW home visits with proactive invitation of unvaccinated girls and automated digital follow-up reminders, supported by a real-time supervisor dashboard. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Residence outside the defined study catchment areas
- Not identifiable or registered in the Community Health Toolkit (CHT) programmatic data system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV vaccination pro-active community-based follow-up modelCHW proactive follow-up with digital decision support | Behavioural | CHW home visits with proactive invitation of unvaccinated girls and automated digital follow-up |
| Standard community mobilizationCHWs 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. | Behavioural | Standard community mobilization with routine HPV vaccination follow-up |
Primary outcome
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.
1 secondary outcome
Time to HPV vaccination (days)
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- BackgroundSandie 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.
- BackgroundGavi the Vaccine Alliance. Mali: HPV vaccination takes root one year after its introduction. 2025.
- BackgroundGavi the Vaccine Alliance. Mali rolls out cancer-blocking jab 2024
- BackgroundMinistere 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
- BackgroundGavi the Vaccine Alliance. Gavi supports Côte d'Ivoire's largest HPV vaccination campaign targeting over 3 million girls.
- BackgroundDainguy M, Kouadio E, Kouakou K, Doubané S. Determinants of Human Papilloma Virus Vaccination Status among Adolescent Schoolgirls in Abidjan. HEALTH SCIENCES AND DISEASE. 2024.
- BackgroundWorld Health Organization Regional Office for Africa. HPV Vaccination: Paving the Path toward Cervical Cancer Elimination in Africa. WHO AFRO; 2024.
- BackgroundWorld Health Organization Regional Office for Africa. Advancing the cervical cancer elimination agenda in the African region. WHO AFRO; 2023.
- BackgroundWorld Health Organization. Global strategy to accelerate the elimination of cervical cancer as a public health problem. 2020.
- BackgroundWorld Health Organization. Cervical cancer. WHO Fact Sheet. 2024
- Background: PubMed 41044858Rivero-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.
- Background: PubMed 40538696Mengistie 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV vaccination pro-active community-based follow-up model and Standard community mobilization in people with Papillomavirus Infections and Uterine Cervical Neoplasms, run by Arsène Brunelle Sandie at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Côte d’Ivoire, Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV vaccination coverage (%) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07807202, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.