A Pragmatic Trial on Actions For Collaborative Community Engaged Strategies for HPV (ACCESS-HPV)

The Washington University

Status: Active, not recruiting

Conditions: HPV

Treatments: Behavioral: Implement Mother-Daugther Day HPV Campaign; Behavioral: Baseline Assessment For Mother-Daughter Day HPV Campaign; Behavioral: Post-Implementation Follow-Up

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06728085

R01CA271033 (U.S. NIH Grant/Contract)

20240291

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,838 patients

Sex: Female

Ages: 9 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,838 participants in 1 patient group

Mother-Daughter Day HPV Campaign

Experimental group

Description:

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.

Treatment:

Behavioral: Post-Implementation Follow-Up

Behavioral: Baseline Assessment For Mother-Daughter Day HPV Campaign

Behavioral: Implement Mother-Daugther Day HPV Campaign