NCT06728085

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,838 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 9 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• HPV

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2025-02-15
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2024-12-11
• Last updated: 2026-02-04

Locations

1 site across 1 country: Nigeria