Actions For Collaborative Community Engaged Strategies for HPV

NCT06010108 | Completed

• 1 other identifier: NHREC/01/01/2007
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

In the current pilot study, Actions for Collaborative Community-Engaged Strategies for HPV (ACCESS-HPV), investigators will use participatory crowdsourcing methods to drive HPV prevention among mother-daughter dyads. Crowdsourcing open calls will allow us to identify locally relevant messages and dissemination techniques to increase uptake of HPV prevention. Then, participatory learning communities will build capacity for community led implementation of selected strategies. Informed by social learning theory and the PEN-3 cultural model, our multi-disciplinary research team proposes the following specific aims: (1) to develop a new combined campaign to increase HPV vaccination for young girls (ages 9-14) and HPV self-collection for mothers (ages 30-65) using crowdsourcing open calls and participatory learning communities; and (2) to determine the preliminary effectiveness of, seven crowdsourced campaign on uptake of HPV vaccination among young girls/women and HPV self-collection among their mothers. Our primary outcome will be HPV vaccine uptake (ascertained by clinic records of vaccine uptake) among young girls and HPV self-collection (ascertained by laboratory receipt of specimens) among their mothers. The strong support of the Nigerian Institute for Medical Research (NIMR) alongside national HPV programs creates a rich research infrastructure and increases the likelihood of successful implementation. Our multi-disciplinary research team has experience organizing implementation research focused on crowdsourcing and community participation in Nigeria. This pilot study will enhance our understanding of HPV prevention in resource-constrained settings.

Conditions

HPV; Stigma

Outcome Measures

Primary Outcomes (2)

• Uptake of HPV Vaccination Over the 8 weeks follow-up

  Proportion of eligible girls who receive at least one dose of HPV vaccine at 8 weeks after baseline. This will be ascertained by clinic records of vaccine uptake.

  8 weeks following the first encounter

• Uptake of HPV Self-collection Over the 8 weeks Follow-up

  Proportion of eligible women who complete an HPV self-test at 8 weeks after baseline. This will be ascertained by laboratory receipt of self-collected specimens.

  8 weeks following the first encounter

Secondary Outcomes (4)

• Intersectional Discrimination Index

  Measured at baseline and at 8 weeks

• Intervention Acceptability

  Measured at baseline and at 8 weeks

• Intervention Appropriateness

  Measured at baseline and at 8 weeks

• Intervention Feasibility

  Measured at baseline and at 8 weeks

Other Outcomes (1)

• Key Implementation Factors

  Up to 8 weeks

Study Arms (7)

Heroes for Her

ACTIVE COMPARATOR

Market outreach intervention- Community entry to engage major stakeholders. Awareness of the project will be made in the community through a public market crier who makes public announcements in the market daily using an audio recording. Lead/Mentor mothers who are mothers from the neighbourhood will be recruited to go door-to-door to reach out to the community. Before the screening and vaccination exercise, the woman will be counselled properly and taught about the HPV self-screening procedure. Mothers are expected to come to the hospital when returning their samples with their daughter so their daughter receive the vaccine

Behavioral: Heroes for Her

The Reach Initiative

ACTIVE COMPARATOR

School based intervention-The Reach Initiative involves the Mother-Daughter Day (MDD) to create awareness and provide screening and vaccination to women and girls. This will adopt the following components. MDD which is a campaign that includes educative activities and participants will be given souvenir packs containing key-cards. On-site vaccination and sample collection kits education to be provided by healthcare providers. To foster community engagement and promote sustainability, mothers and daughters will be encouraged to volunteer to be on the Mother-Daughter Planning Committee and participate in creating awareness.

Behavioral: The Reach Initiative

W.H.I.T.E Project

ACTIVE COMPARATOR

Community based intervention- Community engagement by consulting with stakeholders in the community, and seeking their support for the W.H.I.T.E Project through advocacy visits. Study participants will be recruited through community based outreaches and will be educated on Human Papilloma virus and cervical cancer. This will be carried out through inter-personal communication, and use of Information, Education and Communication (IEC) materials designed for the purpose of this intervention. Vaccination of girls age 9-14years recruited for the study will be through referral to the service point (health facility) and vaccination at outreach site. The W.H.I.T.E self-sample kit, will be distributed to women age 30 to 65 years through referral to the service point and distribution at outreach site.

Behavioral: W.H.I.T.E project

Project Shield

ACTIVE COMPARATOR

Distribution of branded self-sampling kits for HPV screening and vaccination through community based structures- Participants will be recruited through fliers, posters and community volunteers. The branded kit will include the Evalyn brush, sanitary pad/panty liner, a user manual which will be translated in local languages. Mothers who purchase the self-sampling kit will receive a free vaccination voucher for their daughters. The kits will be sold at a discounted rate. The voucher will enable the daughters to receive the HPV vaccine for free. To create awareness about cervical cancer, banners will be displayed at pharmacies and the community health facilities. The Community Development Association (CDA) will participate in awareness campaigns utilizing local languages and culturally appropriate messages. Community hospitals and pharmacies will serve as points of access for the self-sampling kits and vaccines.

Behavioral: Project Shield

Project SHADE

ACTIVE COMPARATOR

Community based intervention using a uniquely designed bag "Eno Iban" to package and distribute the self collection kit and use of a simple app (d-SHADE) to collect participants data- Community outreaches will be carried out in several areas within the community such as markets to create awareness on cervical cancer prevention and to recruit women and girls. Female healthcare providers will be actively involved in these outreaches. Interested participants will be given uniquely branded kits containing a self-sampling brush from the mothers and a vaccination voucher for daughters. Mothers will be required to collect their samples either at the community facility or at home. When returning the Samples to the community facility, mothers will be expected to come with their daughters who then receive the HPV vaccination. All collected samples will be returned to the reference laboratory for analysis

Behavioral: Project SHADE

Operation Reach Her (ORH)

ACTIVE COMPARATOR

Faith-based intervention- Reaching women and girls through places of religious worship and religious leaders. Awareness programs would be conducted in the chosen religious centres to educate women and girls about their health, cervical cancer, its prevention. This would be achieved by organizing a " Health Day " for free health check-ups for all members of the congregation. HPV screening and vaccination would be a part of these check-ups. Announcements would be carried out in worship centres to enrol women and girls. HPV vaccination to girls will be provided by health care providers stationed at the religious centres in the area. The self-sampling kit would be distributed to women in mobile tents stationed in churches and mosques. Girls who have been successfully vaccinated would receive a vaccination card and wristband to show that they have been vaccinated. The self-sampling kits would be collected from the women on the same day and transported to the reference laboratory

Behavioral: Operation Reach Her (ORH) program

Project Care

ACTIVE COMPARATOR

Use of community pharmacies to promote awareness and serve as service points for self-collection and vaccination-Trained pharmacists and healthcare workers, student pharmacists, and students in other fields of study will serve as ambassadors to recruit, provide education and provide guidance on the use of the self- sample kit when needed. Participants will be recruited through community outreach programs, awareness campaigns in hair saloons, workplaces, social media and collaboration with local healthcare facilities. In addition, pharmacies will display promotional materials and provide information to potential participants. Dedicated areas within the local pharmacies will be set up for screening and vaccinations. The mothers and daughters on participation will be given hair accessories as incentives. The screening and HPV vaccination will also be provided at discounted prices.

Behavioral: Project Care

Interventions

Heroes for Her BEHAVIORAL

Market outreach intervention- daily awareness creation through public market announcements, and distribution of educational fliers in local dialects. Community women will also be involved in the spread awareness through door to door approach. Thee will be repeated radio jingles to promote awareness. Interested women and girls will be provided with screening and vaccination services at a designated community health facility. All samples will be returned to the facility by the women and sent to a designated laboratory for testing. Participants contact information will be collected for follow up

Heroes for Her

The Reach Initiative BEHAVIORAL

School based intervention-The Reach Initiative involves the organisation of the Mother-Daughter Day (MDD) by Mother-Daughter Planning Committee (MDPC) who are volunteer young school girls and their mothers and provision of a Key-Card which is a cervical cancer awareness card attached to a key chain for awareness creation. HPV vaccination and HPV -self sampling will be carried out in private rooms within the venue of the intervention and all samples will be sent to designated laboratory for testing. Participants contact information will be collected for follow up and communication of results

The Reach Initiative

W.H.I.T.E project BEHAVIORAL

Community based intervention- This will involve the engagement of women's trade unions and organisations in the community to create awareness and women and girls interested in the uptake of HPV prevention services will be directed to receive these services at a designated community facility accessible to women and girls in the community. Participants contact details will be collected for follow uo and communication of results

W.H.I.T.E Project

Project Shield BEHAVIORAL

Utilization of community based structures (pharmacy and health center)- The intervention will involve the creation of a branded self-sampling kit for HPV screening and a free vaccination voucher to encourage mother-daughter uptake of cervical cancer prevention measures. Awareness will be raised through banners at the points of access of the vaccines and kits, use of jingles, and the involvement of the Community Development Association (CDA) to help mobilize girls, women and the men. Women and girls will be referred to community health centers to receive the HPV vaccination and carry out the screening

Project Shield

Project SHADE BEHAVIORAL

Community-based approach- health education of girls and women. The use of a uniquely designed bag "Eno Iban" to package and distribute the self-collection tool, vaccination of the adolescent girls. Screening and HPV will be provided at designated areas within the community for women and girls. A simple app (d-SHADE) will be used to collect data of the girls and women by the health professionals and volunteers, as well as send the reminders for next screening dates and test results

Project SHADE

Operation Reach Her (ORH) program BEHAVIORAL

Faith based approach- Awareness programs would be conducted in the chosen religious centres to educate women and girls about their health, cervical cancer, its prevention, and the benefits of screening and HPV vaccination. This would be achieved by organizing a " Health Day " for free health check-ups for all members of the congregation. The self-sampling kit would be distributed to women aged 30-65 in mobile tents stationed in churches in Akoka and HPV vaccinations would be administered to girls aged 9-14 in mobile tents stationed at churches and mosques in Akoka, Lagos

Operation Reach Her (ORH)

Project Care BEHAVIORAL

Community pharmacy intervention-Trained community volunteers will be involved in creating awareness of HPV prevention services and cervical cancer. There will be distribution of cervical cancer self-sampling kits to community pharmacies which will serve as service points for screening (self-collection point) and vaccination point for girls in the community,

Project Care

Eligibility Criteria

• Age: 9 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Both the mothers'/caregivers' (between ages 30-65 years) and daughters' (Between 9 to 14 years) willingness to participate in the study
• All participants must agree to an informed consent in English
• Parental guardian's cell phone number for follow-up and/or retention

You may not qualify if:

• Inability to comply with study protocol
• 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

Study Sites (1)

Nigerian Institute of Medical Research

Yaba, Lagos, Nigeria

Location

Related Publications (10)

• Campos NG, Demarco M, Bruni L, Desai KT, Gage JC, Adebamowo SN, de Sanjose S, Kim JJ, Schiffman M. A proposed new generation of evidence-based microsimulation models to inform global control of cervical cancer. Prev Med. 2021 Mar;144:106438. doi: 10.1016/j.ypmed.2021.106438. Epub 2021 Mar 4.

  PMID: 33678235 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Related Links

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

MeSH Terms

Conditions

Social Stigma

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: intervention pilot

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 24, 2023
• Study Start: January 15, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)