Clinical trial NCT06728085: A Pragmatic Trial on Actions For Collaborative Community Engaged Strategies for HPV
Official title: A Pragmatic Trial on Actions For Collaborative Community Engaged Strategies for HPV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HPV
Keywords: HPV Vaccination
HPV Screening
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Nigerian Institute of Medical Research
name: University of North Carolina, Chapel Hill
name: National Cancer Institute (NCI)
First posted: 2024-12-11
Enrollment: 1224
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Hybrid Type II, stepped-wedge cluster randomized trial
Primary purpose: PREVENTION

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 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Uptake of HPV Vaccination among girls/daughters
timeFrame: Up to 6 months of enrollment
measure: Uptake of HPV Self-collection among mothers/caregivers
timeFrame: Up to 6 months of enrollment
Secondary outcomes:
measure: Intervention Acceptability
timeFrame: Measured at baseline, 3 months, and 6 months.
measure: Intervention Appropriateness
timeFrame: Measured at baseline, 3 months, and 6 months.
measure: Intervention Feasibility
timeFrame: Measured at baseline, 3 months, and 6 months.
measure: Penetration (i.e., population dose)
timeFrame: Measured at baseline, 3 months, and 6 months.
measure: Implementation Fidelity
timeFrame: Measured at baseline, 3 months, and 6 months.
measure: Sustainment
timeFrame: Measured at baseline, 3 months, 6 months, and 12 months
Other outcomes:
measure: Key Implementation Factors
timeFrame: Up to 12 months of follow-up
Locations:
city: Yaba
country: Nigeria
facility: Nigerian Institute of Medical Research
state: Lagos
Study officials:
affiliation: Washington University School of Medicine
name: Juliet Iwelunmor, PhD
role: PRINCIPAL_INVESTIGATOR
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