For girls and women (4GW) HPV RCT protocol: a crowdsourced, pragmatic stepped-wedge cluster randomized trial to improve uptake of HPV vaccination and screening among mother-daughter dyads in Nigeria.
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BACKGROUND: Expanding human papillomavirus (HPV) vaccination for girls and HPV self-collection for women can reduce the global burden of cervical cancer. However, HPV vaccination and self-collection services are rarely implemented simultaneously in mother-daughter dyads, leaving a critical gap in cervical cancer prevention. From 2023 to 2024, a community-engaged model for combined HPV vaccination and screening was co-designed using crowdsourcing open calls and designathons with mother-daughter teams and pilot-tested by trained research facilitators. This study explores the impact of this crowdsourced, community-engaged mother-daughter campaign and implementation strategy bundle on HPV vaccination among girls and HPV screening among their mothers in Nigeria over 6 months in 18 Nigerian local government areas (LGAs). METHODS: A hybrid effectiveness-implementation type II pragmatic stepped-wedge cluster randomized control trial has been employed to 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 30-49 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. Trained community health workers will collect baseline data and implement a mother-daughter campaign that will provide education on cervical cancer control and access to onsite services for HPV vaccination and screening in a private area while engaging 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 onsite clinical records of vaccine uptake) and HPV self-collection completion among mothers (ascertained by laboratory receipt of self-collected specimens) within six months of trial enrollment. Pre-post effectiveness and cost of study components are embedded in the implementation and sustainment phases, compared to pre-implementation data assessed for each LGA. DISCUSSION: This study is a unique dyadic intervention focused on both girls and their mothers or female caregivers to drive cervical cancer control in Africa. Findings have the potential to inform local and global policies aimed at reducing the cervical cancer burden in African countries like Nigeria, eliminating missed opportunities by closing the research-to-translation gap. The protocol was registered with clinicaltrials.gov under registration NCT06728085.