A Pragmatic Trial on Actions For Collaborative Community Engaged Strategies for HPV (ACCESS-HPV)

February 2, 2026 updated by: Washington University School of Medicine
The present study expands on the investigators' earlier pilot study, outlined in ClinicalTrial ID#: NCT06010108. The Actions for Collaborative Community-Engaged Strategies for HPV (ACCESS-HPV), locally referred to as 4 Girls and Women (4GW) in Nigeria, seek to utilize a participatory crowdsourcing approach to enhance HPV prevention efforts among mother-daughter dyads. Specifically, the investigators aim to 1) develop a new combined HPV vaccination and HPV self-collection campaign for mothers/daughters using crowdsourcing open calls and learning community groups, 2) determine whether the co-developed final combined crowdsourced campaign will increase HPV vaccination rates among girls and promote HPV self-collection among mothers, and 3) estimate the impact and cost-effectiveness of the combined crowdsourced campaign in Nigeria.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Following the completion of the open contests, designathons and boot-camp training, seven trained teams (with seven distinct interventions) were selected to undergo a 6-month pilot assessment in the community. Preliminary findings from the feasibility study suggest that crowdsourced interventions have the potential to impact uptake of HPV vaccinations among girls and HPV screening among mothers in Nigeria. As a result, the investigators identified key components from the top 2 interventions to form a single intervention that will be evaluated in the next phase of the research. Thus, the current protocol is focused on evaluating the effectiveness of a combined, crowdsourced intervention on HPV vaccination among girls and HPV screening among mothers in Nigeria.

Using a hybrid effectiveness-implementation type II pragmatic stepped-wedge cluster randomized control trial, this study will test the effectiveness of an implementation strategy bundle; a crowdsourced, tailored, community-engaged, mother-daughter HPV campaign on increasing uptake of HPV vaccination among girls aged 9-14 and HPV screening uptake among women aged 30-65 in Nigeria. The mother-daughter campaign will be tailored to local sites and conducted among 612 mother-daughter dyads (1,224 participants) recruited from 18 LGAs in six geopolitical zones of Nigeria. Upon enrollment, trained community health workers (two per LGA) will collect baseline data, and implement a mother-daughter day campaign that will provide education on cervical cancer control and access to onsite services for HPV vaccination and screening in a private area and engage mothers and daughters simultaneously to increase uptake of the services. A mixed-methods evaluative and iterative assessment will be conducted using Proctor's Implementation Outcomes Framework and the PEN-3 cultural model. The primary outcomes are the uptake of HPV preventive measures -HPV vaccination (one dose) among girls (ascertained by on-site records of vaccine uptake) and HPV self-collection completion among mothers (ascertained by laboratory receipt of self-collected specimens) within 6-months of trial enrollment. Pre-post effectiveness and cost of study components are embedded in the implementation and sustainment phases, with comparison to pre-implementation data assessed for each LGA.

Study Type

Interventional

Enrollment (Actual)

1838

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • Lagos
      • Yaba, Lagos, Nigeria
        • Nigerian Institute of Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female participants
  • Aged between 9 and 14 years old for girls/daughters
  • Aged between 30 and 65 years old for mothers (mothers defined as any female caregiver, including biological and surrogate mothers or close relatives who meet the eligibility criteria)
  • Residing and planning to reside in any of the 18 local government areas for the next 12 months and willing to participate
  • Girls must be unvaccinated for HPV.
  • Mother must have no recent (at least within 5 years cervical cancer screening)
  • Mothers or caregivers must own a mobile phone to follow up with both daughters and mothers.
  • Participants must agree to the informed consent in English before enrolling in the study.

Exclusion Criteria:

  • Inability to comply with the study protocol
  • Recently vaccinated girls for HPV
  • Recently screened mothers for HPV within the last 5 years
  • Illness, cognitive impairment, or threatening behavior with acute risk to self or others
  • No informed consent or cell phone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mother-Daughter Day HPV Campaign
Each of the 18 local government areas begin as part of the control condition and are block-randomized into four waves in the pre-implementation phase, with each wave beginning 2 months after the start of the prior wave and lasting for 6 months. The local government areas will implement the intervention for 6 months, followed by a post implementation phase.
Behavioral: Baseline Assessment For Mother-Daughter Day HPV Campaign

Pre-Implementation:

Identify, screen, and enroll mother-daughter dyads in the study to participate in the upcoming Mother-Daughter Day event on HPV vaccination and screening.

Complete baseline surveys with enrolled participants. Distribute reminder cards and send text messages to mother-daughter dyads who agree to participate in the mother-daughter day campaign.

Other Names:
  • Pre-Implementation Phase
Behavioral: Implement Mother-Daugther Day HPV Campaign

Tailor and adapt to context: Mother-Daughter Day campaigns will be tailored and adapted to the local contexts within the 18 LGA.

Trained community health workers will implement the tailored Mother-Daughter Campaign by providing education on cervical cancer control and educational materials on HPV vaccination and HPV screening.

Engage mothers and daughters with on-site access to services: This includes offer of onsite vaccinations to girls by study nurse as well as offer of onsite self-collection screening kits to mothers and caregivers in a private area, along with instructions on how to use and return the sample.

Distribute gift bags with HPV vaccination cards, follow-up reminders, and linkage cards for participants with positive test results, as community health workers continue to provide onsite support and assistance.

Other Names:
  • Implementation Phase
Behavioral: Post-Implementation Follow-Up

A follow-up invitation will be sent to participate in a consultative phone call with study health workers to review self-collection results.

Participants with positive HPV test results will be linked to follow-up care and treatment.

Other Names:
  • Post-Implementation Phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of HPV Vaccination among girls/daughters
Time Frame: Up to 6 months of enrollment
The proportion of eligible girls who receive at least one dose of HPV vaccine. This will be ascertained by documentation on HPV vaccination cards
Up to 6 months of enrollment
Uptake of HPV Self-collection among mothers/caregivers
Time Frame: Up to 6 months of enrollment
The proportion of eligible women who complete an HPV self-collection. This will be ascertained by laboratory receipt of self-collected specimens.
Up to 6 months of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Acceptability
Time Frame: Measured at baseline, 3 months, and 6 months.
This will be measured using the Acceptability of Intervention Measure (AIM). The subscale is evaluated using a 5-point Likert scale, ranging from 1 to 5, with higher scores reflecting higher levels of acceptability. Cronbach alpha=0.85
Measured at baseline, 3 months, and 6 months.
Intervention Appropriateness
Time Frame: Measured at baseline, 3 months, and 6 months.
This will be assessed using the Intervention Appropriateness Measure (IAM). The subscale is evaluated using a 5-point Likert scale, ranging from 1 to 5, with higher scores indicating higher levels of appropriateness. Cronbach alpha=0.91
Measured at baseline, 3 months, and 6 months.
Intervention Feasibility
Time Frame: Measured at baseline, 3 months, and 6 months.
This will be assessed using the Feasibility of Intervention Measure (FIM). The subscale is rated on a 5-point Likert scale, 1 to 5, with higher scores indicating higher levels of feasibility.
Measured at baseline, 3 months, and 6 months.
Penetration (i.e., population dose)
Time Frame: Measured at baseline, 3 months, and 6 months.
The extent to which components of the mother-daughter HPV campaigns are institutionalized within participating local government area.
Measured at baseline, 3 months, and 6 months.
Implementation Fidelity
Time Frame: Measured at baseline, 3 months, and 6 months.
This will be assessed both quantitatively and qualitatively using the following four dimensions: (1) Frequency: number of intervention-related interactions; (2) Duration: length of each component of the intervention; (3) Content: the knowledge or behavioural change the combined intervention seeks to deliver to the mother/daughter dyads; and (4) Coverage: the number of mother/daughter dyads who receive the intervention as intended over the number of participants who are enrolled.
Measured at baseline, 3 months, and 6 months.
Sustainment
Time Frame: Measured at baseline, 3 months, 6 months, and 12 months
Measured using the Sustainment Measurement System Scale. Items will be rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (all the time), with lower scores indicating lower levels of agreement while higher scores indicating higher levels of agreement.
Measured at baseline, 3 months, 6 months, and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Key Implementation Factors
Time Frame: Up to 12 months of follow-up
Guided by the RE-AIM framework for implementation science, semi-structured, in-depth interviews will be conducted at the individual and setting levels to explore the factors associated with the implementation of the intervention (e.g., reach, adoption, implementation, and maintenance).
Up to 12 months of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Cancer Institute (NCI)
University of North Carolina, Chapel Hill
Nigerian Institute of Medical Research

Investigators

  • Principal Investigator: Juliet Iwelunmor, PhD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

November 22, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Actual)

December 11, 2024

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20240291
  • R01CA271033 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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