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Clinical Trial NCT06728085 (ACCESS-HPV) for HPV is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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A Pragmatic Trial on Actions For Collaborative Community Engaged Strategies for HPV (ACCESS-HPV) 1,838 Prevention

Active, not recruiting
Clinical Trial NCT06728085 (ACCESS-HPV) is an interventional study for HPV that is active, not recruiting. It started on 15 February 2025 with plans to enroll 1,838 participants. Led by Washington University School of Medicine, it is expected to complete by 30 June 2027. The latest data from ClinicalTrials.gov was last updated on 4 February 2026.
Brief Summary
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...Show More
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 resul...Show More
Official Title

A Pragmatic Trial on Actions For Collaborative Community Engaged Strategies for HPV

Conditions
HPV
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
NCT ID Number
NCT06728085
Start Date (Actual)
2025-02-15
Last Update Posted
2026-02-04
Completion Date (Estimated)
2027-06-30
Enrollment (Estimated)
1,838
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
HPV Vaccination
HPV Screening
Primary Purpose
Prevention
Design Allocation
N/A
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalMother-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.
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.
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 onsi...Show More
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Uptake of HPV Vaccination among girls/daughters
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
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 MeasureMeasure DescriptionTime Frame
Intervention Acceptability
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
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
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)
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
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
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Child, Adult, Older Adult
Minimum Age
9 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
  • 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.

  • 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
Washington University School of Medicine logoWashington University School of Medicine462 active studies to explore
No contact data.
1 Study Locations in 1 Countries

Lagos

Nigerian Institute of Medical Research, Yaba, Lagos, Nigeria