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

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.

Conditions

• HPV

Interventions

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.

Sponsors & Collaborators

• Nigerian Institute of Medical Research

  collaborator OTHER_GOV

• University of North Carolina, Chapel Hill

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Juliet Iwelunmor, PhD · Washington University School of Medicine

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

9 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-02-15

Primary Completion

2026-12-31

Completion

2027-06-30

Countries

• Nigeria

Study Locations