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

Not Applicable

Not yet recruiting

• Conditions: HPV

• Registration Number: NCT06728085
• Lead Sponsor: Washington University School of Medicine

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-daugh...

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 ...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-11-22
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-11
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-18
• Study Start: 2025-01-13
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1224

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Uptake of HPV Vaccination among girls/daughters	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
Uptake of HPV Self-collection among mothers/caregivers	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.

Secondary Outcome Measures

Name	Time	Method
Intervention Acceptability	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
Intervention Appropriateness	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
Intervention Feasibility	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.
Penetration (i.e., population dose)	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.
Implementation Fidelity	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...
Sustainment	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.

Trial Locations

Locations (1)

Nigerian Institute of Medical Research; 🇳🇬 Yaba, Lagos, Nigeria