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

NCT06728085 | Active Not Recruiting DMC

• 2 other identifiers: 20240291R01CA271033
• Study Type: interventional
• Target: 1,838
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV

Keywords

HPV Vaccination; HPV Screening

Outcome Measures

Primary Outcomes (2)

• Uptake of HPV Vaccination among girls/daughters

  The proportion of eligible girls who receive at least one dose of HPV vaccine. This will be ascertained by documentation on HPV vaccination cards

  Up to 6 months of enrollment

• Uptake of HPV Self-collection among mothers/caregivers

  The proportion of eligible women who complete an HPV self-collection. This will be ascertained by laboratory receipt of self-collected specimens.

  Up to 6 months of enrollment

Secondary Outcomes (6)

• Intervention Acceptability

  Measured at baseline, 3 months, and 6 months.

• Intervention Appropriateness

  Measured at baseline, 3 months, and 6 months.

• Intervention Feasibility

  Measured at baseline, 3 months, and 6 months.

• Penetration (i.e., population dose)

  Measured at baseline, 3 months, and 6 months.

• Implementation Fidelity

  Measured at baseline, 3 months, and 6 months.

Other Outcomes (1)

• Key Implementation Factors

  Up to 12 months of follow-up

Study Arms (1)

Mother-Daughter Day HPV Campaign

EXPERIMENTAL

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.

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

Interventions

Implement Mother-Daugther Day HPV Campaign BEHAVIORAL

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.

Also known as: Implementation Phase

Mother-Daughter Day HPV Campaign

Post-Implementation Follow-Up BEHAVIORAL

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.

Also known as: Post-Implementation Phase

Mother-Daughter Day HPV Campaign

Baseline Assessment For Mother-Daughter Day HPV Campaign BEHAVIORAL

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.

Also known as: Pre-Implementation Phase

Mother-Daughter Day HPV Campaign

Eligibility Criteria

• Age: 9 Years - 65 Years
• Gender Eligibility Details: Female participants
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Nigerian Institute of Medical Research: collaborator
• University of North Carolina, Chapel Hill: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Nigerian Institute of Medical Research

Yaba, Lagos, Nigeria

Location

Related Publications (11)

• Kpokiri EE, Wapmuk A, Obiezu-Umeh C, Nwaozuru U, Gbaja-Biamila T, Obionu I, Kokelu E, Smith J, Benedict AN, Ajenifuja K, Babatunde AO, Ezechi O, Tucker JD, Iwelunmor J. A designathon to co-create HPV screening and vaccination approaches for mothers and daughters in Nigeria: findings from a community-led participatory event. Res Sq [Preprint]. 2024 Jan 29:rs.3.rs-3829727. doi: 10.21203/rs.3.rs-3829727/v1.

  PMID: 38352305 BACKGROUND

• Cates JR, Shafer A, Diehl SJ, Deal AM. Evaluating a County-Sponsored Social Marketing Campaign to Increase Mothers' Initiation of HPV Vaccine for their Pre-teen Daughters in a Primarily Rural Area. Soc Mar Q. 2011 Spring;17(1):4-26. doi: 10.1080/15245004.2010.546943.

  PMID: 21804767 BACKGROUND

• Lee H, Kim M, Cooley ME, Kiang PN, Kim D, Tang S, Shi L, Thiem L, Kan P, Peou S, Touch C, Chea P, Allison J. Using narrative intervention for HPV vaccine behavior change among Khmer mothers and daughters: A pilot RCT to examine feasibility, acceptability, and preliminary effectiveness. Appl Nurs Res. 2018 Apr;40:51-60. doi: 10.1016/j.apnr.2017.12.008. Epub 2017 Dec 18.

  PMID: 29579499 BACKGROUND

• Scarinci IC, Hansen B, Kim YI. HPV vaccine uptake among daughters of Latinx immigrant mothers: Findings from a cluster randomized controlled trial of a community-based, culturally relevant intervention. Vaccine. 2020 May 22;38(25):4125-4134. doi: 10.1016/j.vaccine.2020.03.052. Epub 2020 Apr 27.

  PMID: 32354671 BACKGROUND

• Winer RL, Gonzales AA, Noonan CJ, Buchwald DS. A Cluster-Randomized Trial to Evaluate a Mother-Daughter Dyadic Educational Intervention for Increasing HPV Vaccination Coverage in American Indian Girls. J Community Health. 2016 Apr;41(2):274-81. doi: 10.1007/s10900-015-0093-2.

  PMID: 26399648 BACKGROUND

• Abuelo CE, Levinson KL, Salmeron J, Sologuren CV, Fernandez MJ, Belinson JL. The Peru Cervical Cancer Screening Study (PERCAPS): the design and implementation of a mother/daughter screen, treat, and vaccinate program in the Peruvian jungle. J Community Health. 2014 Jun;39(3):409-15. doi: 10.1007/s10900-013-9786-6.

  PMID: 24276617 BACKGROUND

• Amponsah-Dacosta E, Kagina BM, Olivier J. Health systems constraints and facilitators of human papillomavirus immunization programmes in sub-Saharan Africa: a systematic review. Health Policy Plan. 2020 Jul 1;35(6):701-717. doi: 10.1093/heapol/czaa017.

  PMID: 32538437 BACKGROUND

• Devarapalli P, Labani S, Nagarjuna N, Panchal P, Asthana S. Barriers affecting uptake of cervical cancer screening in low and middle income countries: A systematic review. Indian J Cancer. 2018 Oct-Dec;55(4):318-326. doi: 10.4103/ijc.IJC_253_18.

  PMID: 30829264 BACKGROUND

• Lim JN, Ojo AA. Barriers to utilisation of cervical cancer screening in Sub Sahara Africa: a systematic review. Eur J Cancer Care (Engl). 2017 Jan;26(1). doi: 10.1111/ecc.12444. Epub 2016 Feb 7.

  PMID: 26853214 BACKGROUND

• McFarland DM, Gueldner SM, Mogobe KD. Integrated Review of Barriers to Cervical Cancer Screening in Sub-Saharan Africa. J Nurs Scholarsh. 2016 Sep;48(5):490-8. doi: 10.1111/jnu.12232. Epub 2016 Jul 19.

  PMID: 27434871 BACKGROUND

• Iwelunmor J, Wapmuk AE, Kokelu E, Ojo T, Olusanya O, Gbaja-Biamila T, Akinsolu FT, Musa AZ, Xian H, Abodunrin OR, Kalulu P, Obiorah A, Afadapa M, Obodoechina N, Nwaozuru U, Anikamadu O, Smith J, Azuogu BN, Ajenifuja K, Jia M, Bamogo A, Babatunde A, Ong JJ, Zhang L, Zou Z, Airhihenbuwa CO, Tucker JD, Ezechi OC. 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. Implement Sci. 2025 May 1;20(1):18. doi: 10.1186/s13012-025-01428-5.

  PMID: 40312377 DERIVED

Related Links

• Global strategy to accelerate the elimination of cervical cancer as a public health problem

Study Officials

• Juliet Iwelunmor, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hybrid Type II, stepped-wedge cluster randomized trial

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 11, 2024
• Study Start: February 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)