Actions For Collaborative Community Engaged Strategies for HPV

HPV Clinical Trial

Official title:

Actions For Collaborative Community Engaged Strategies for HPV (ACCESS-HPV)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06010108
• Other study ID #: NHREC/01/01/2007
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Washington University School of Medicine
• Contact: Juliet Iwelunmor, PhD
• Phone: 2405280123
• Email: ijuliet[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Step 1: Health facilities training. For the purposes of this research study, the Nigerian Institute of Medical Research team would provide training to health centers currently working with the Nigerian Institute of Medical Research .The training would be to ensure that these health facilities are trained to provide follow up services to participants who be referred. Following the training, the NIMR research team would in charge of collecting data to record participants HPV self-collection uptake and HPV vaccination uptake.

Step 2: Participant enrollment. This will involve recruiting women and girls to participate in the pilot study. Participant recruitment strategies will include: social media, online, event- and venue based, participant referral, and walk-ins at study clinics. Participant enrollment will be completed by study team.

Step 3: Baseline data collection. After enrollment, study team will collect baseline data on HPV self-collection and cervical cancer screening history, knowledge of cervical cancer, HPV screening, determine the role of intersectional stigma on barriers and facilitators of HPV-related service delivery (HPV vaccination/HPV self-collection) among Nigerian girls and women, assess the feasibility, acceptability, and preliminary impact of three asset-based mother-daughter interventions that address intersectional stigma and HPV service uptake among Nigerian girls and women and other related outcomes will be collected from recruited participants. Participants mobile phone numbers will also be collected as tracking information for follow-up and retention in a coupon format. The mobile phone numbers would be used to contact study participants through text messages and phone calls. These contacts would serve as reminders for participants to participate in follow-up data collection. The mobile phone service charge would be covered by the research. No other personal identifiers will be collected and no biological specimens will be collected at baseline. The investigators will obtain informed consent before proceeding with any data collection.

Step 4: Intervention implementation. Following participant recruitment and enrollment in the study as well as completion of baseline study, participants will be assigned to one of the seven mother-daughter interventions focused on expanding the uptake of HPV self-sampling, HPV vaccination and addressing stigma associated with HPV prevention services uptake among Nigerian women and girls.The pilot intervention implementation would occur for 30 days. Nigerian Institute of Medical Research (NMIR) will provide local training on HPV prevention to the seven participatory interventions following their existing guidelines. The participatory interventions will be conducted in the locations of the seven teams who emerged as winners from the innovation boot-camp. These participatory interventions will only provide HPV self-sampling and vaccination and instructions of how to perform the test to participants. They will also provide referral coupons to women who test positive or participants who have any adverse effects. The referral coupons are intended to provide study participants information on health facilities and specialists that are involved with the research. The intervention only provide participants with the HPV self-collection and vaccination kits and does not involve monitoring HPV self-collection procedure, the investigators will only be asking for self-reported HPV self-collection and vaccination uptake

Step 5: Follow up surveys at 8 weeks. At 8 weeks post intervention implementation, study team will collect similar baseline data from study participants. The follow-up survey will assess HPV self-testing, HPV vaccination assess the feasibility, acceptability, and preliminary impact of 7 mother-daughter interventions focused on expanding the uptake of HPV self-sampling, HPV vaccination and addressing stigma associated with HPV prevention services uptake among Nigerian women and girls.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• HPV
• Stigma

Intervention

Behavioral:
• Heroes for Her
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
• The Reach Initiative
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
• W.H.I.T.E project
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
• Project Shield
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 SHADE
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
• Operation Reach Her (ORH) program
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
• Project Care
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,

Locations

Country	Name	City	State
Nigeria	Nigerian Institute of Medical Research	Yaba	Lagos

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Nigerian Institute of Medical Research, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

Nigeria, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Key Implementation Factors	Guided by the RE-AIM framework for implementation science, semi-structured, in-depth interviews will be conducted at the individual and setting levels to explore the factors associated with the implementation of the intervention (e.g., reach, adoption, implementation, and maintenance).	Up to 8 weeks
Primary	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
Primary	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	Intersectional Discrimination Index	HPV-and-cervical cancer associated stigma will be assessed using the Intersectional Discrimination Index measure. Higher scores mean greater stigma.	Measured at baseline and at 8 weeks
Secondary	Intervention Acceptability	This will be assessed using the Acceptability of Intervention Measure (AIM). The subscale is rated on a 5-point Likert scale, 1 to 5 with higher scores indicating higher levels of acceptability.	Measured at baseline and at 8 weeks
Secondary	Intervention Appropriateness	This will be assessed using the Intervention Appropriateness Measure (IAM). The subscale is rated on a 5-point Likert scale, 1 to 5 with higher scores indicating higher levels of Appropriateness.	Measured at baseline and at 8 weeks
Secondary	Intervention Feasibility	This will be assessed using the Feasibility of Intervention Measure (FIM). The subscale is rated on a 5-point Likert scale, 1 to 5 with higher scores indicating higher levels of feasibility.	Measured at baseline and at 8 weeks

External Links

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