Clinical trial NCT06010108: Actions for Collaborative Community Engaged Strategies for HPV
Official title: Actions for Collaborative Community Engaged Strategies for HPV (ACCESS-HPV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HPV
Stigma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Nigerian Institute of Medical Research
name: University of North Carolina, Chapel Hill
First posted: 2023-08-24
Enrollment: 350
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention pilot
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Uptake of HPV Vaccination Over the 8 weeks follow-up
timeFrame: 8 weeks following the first encounter
measure: Uptake of HPV Self-collection Over the 8 weeks Follow-up
timeFrame: 8 weeks following the first encounter
Secondary outcomes:
measure: Intersectional Discrimination Index
timeFrame: Measured at baseline and at 8 weeks
measure: Intervention Acceptability
timeFrame: Measured at baseline and at 8 weeks
measure: Intervention Appropriateness
timeFrame: Measured at baseline and at 8 weeks
measure: Intervention Feasibility
timeFrame: Measured at baseline and at 8 weeks
Other outcomes:
measure: Key Implementation Factors
timeFrame: Up to 8 weeks
Locations:
city: Yaba
country: Nigeria
facility: Nigerian Institute of Medical Research
state: Lagos
Study officials:
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