HPVACCESS-HPVNCT06728085
A Pragmatic Trial on Actions For Collaborative Community Engaged Strategies for HPV
A study testing Baseline Assessment For Mother-Daughter Day HPV Campaign, Implement Mother-Daugther Day HPV Campaign and Post-Implementation Follow-Up in people with HPV, run by Washington University School of Medicine at 1 site in Nigeria.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV
- What is being tested?
- Baseline Assessment For Mother-Daughter Day HPV Campaign, Implement Mother-Daugther Day HPV Campaign and Post-Implementation Follow-Up
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,838 participants
- Where
- 1 siteNigeria
- Study dates
- 15 Feb 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Following the completion of the open contests, designathons and boot-camp training, seven trained teams (with seven distinct interventions) were selected to undergo a 6-month pilot assessment in the community. Preliminary findings from the feasibility study suggest that crowdsourced interventions have the potential to impact uptake of HPV vaccinations among girls and HPV screening among mothers in Nigeria. As a result, the investigators identified key components from the top 2 interventions to form a single intervention that will be evaluated in the next phase of the research. Thus, the current protocol is focused on evaluating the effectiveness of a combined, crowdsourced intervention on HPV vaccination among girls and HPV screening among mothers in Nigeria.
Using a hybrid effectiveness-implementation type II pragmatic stepped-wedge cluster randomized control trial, this study will test the effectiveness of an implementation strategy bundle; a crowdsourced, tailored, community-engaged, mother-daughter HPV campaign on increasing uptake of HPV vaccination among girls aged 9-14 and HPV screening uptake among women aged 30-65 in Nigeria. The mother-daughter campaign will be tailored to local sites and conducted among 612 mother-daughter dyads (1,224 participants) recruited from 18 LGAs in six geopolitical zones of Nigeria. Upon enrollment, trained community health workers (two per LGA) will collect baseline data, and implement a mother-daughter day campaign that will provide education on cervical cancer control and access to onsite services for HPV vaccination and screening in a private area and engage mothers and daughters simultaneously to increase uptake of the services. A mixed-methods evaluative and iterative assessment will be conducted using Proctor's Implementation Outcomes Framework and the PEN-3 cultural model. The primary outcomes are the uptake of HPV preventive measures -HPV vaccination (one dose) among girls (ascertained by on-site records of vaccine uptake) and HPV self-collection completion among mothers (ascertained by laboratory receipt of self-collected specimens) within 6-months of trial enrollment. Pre-post effectiveness and cost of study components are embedded in the implementation and sustainment phases, with comparison to pre-implementation data assessed for each LGA.
- Conditions
- HPV
- Being tested
- Baseline Assessment For Mother-Daughter Day HPV Campaign, Implement Mother-Daugther Day HPV Campaign, Post-Implementation Follow-Up
- Keywords
- HPV Vaccination, HPV Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline Assessment For Mother-Daughter Day HPV CampaignBehavioural
Also called Pre-Implementation Phase
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.
Implement Mother-Daugther Day HPV CampaignBehavioural
Also called Implementation Phase
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.
Post-Implementation Follow-UpBehavioural
Also called Post-Implementation Phase
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Baseline Assessment For Mother-Daughter Day HPV Campaign; Behavioral: Implement Mother-Daugther Day HPV Campaign; Behavioral: Post-Implementation Follow-Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Up to 6 months of enrollment
Secondary outcomes (6)
Intervention Acceptability
This will be measured using the Acceptability of Intervention Measure (AIM). The subscale is evaluated using a 5-point Likert scale, ranging from 1 to 5, with higher scores reflecting higher levels of acceptability. Cronbach alpha=0.85
Measured: Measured at baseline, 3 months, and 6 months.
Intervention Appropriateness
This will be assessed using the Intervention Appropriateness Measure (IAM). The subscale is evaluated using a 5-point Likert scale, ranging from 1 to 5, with higher scores indicating higher levels of appropriateness. Cronbach alpha=0.91
Measured: Measured at baseline, 3 months, and 6 months.
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: Measured at baseline, 3 months, and 6 months.
Penetration (i.e., population dose)
The extent to which components of the mother-daughter HPV campaigns are institutionalized within participating local government area.
Measured: Measured at baseline, 3 months, and 6 months.
Implementation Fidelity
This will be assessed both quantitatively and qualitatively using the following four dimensions: (1) Frequency: number of intervention-related interactions; (2) Duration: length of each component of the intervention; (3) Content: the knowledge or behavioural change the combined intervention seeks to deliver to the mother/daughter dyads; and (4) Coverage: the number of mother/daughter dyads who receive the intervention as intended over the number of participants who are enrolled.
Measured: Measured at baseline, 3 months, and 6 months.
Sustainment
Measured using the Sustainment Measurement System Scale. Items will be rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (all the time), with lower scores indicating lower levels of agreement while higher scores indicating higher levels of agreement.
Measured: Measured at baseline, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start15 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for HPVStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Hybrid Type II, stepped-wedge cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 1,838 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Nigerian Institute of Medical Research, University of North Carolina, Chapel Hill, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Juliet Iwelunmor, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728085
- Sponsor's protocol ID
- 20240291
- Other IDs
- R01CA271033
- Acronym
- ACCESS-HPV
- Status last verified
- Feb 2026
- First submitted
- 22 Nov 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38352305Cates 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.
PubMed 21804767Lee 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.
PubMed 29579499Scarinci 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.
PubMed 32354671Winer 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.
PubMed 26399648Abuelo 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.
PubMed 24276617Amponsah-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.
PubMed 32538437Devarapalli 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.
PubMed 30829264Lim 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.
PubMed 26853214McFarland 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.
PubMed 27434871Iwelunmor J, Wapmuk AE, Okeke N, Akinsolu FT, Gbaja-Biamila T, Abodunrin OR, Ojo T, Olusanya O, Musa AZ, Xian H, Kalulu P, Obiorah A, Afadapa M, Obodoechina N, Bradon A, Nwaozuru U, Anikamadu O, Obi-Jeff C, Onwuamah C, Smith J, Azuogu BN, Ajenifuja K, Bamogo A, Okwunze FK, Ong JJ, Zhang L, Airhihenbuwa CO, Tucker JD, Ezechi OC. HPV vaccination uptake among adolescent girls in Nigeria: A multi-state pilot trial using linked mother-daughter data. Contemp Clin Trials. 2026 Nov 4:108527. doi: 10.1016/j.cct.2026.108527. Online ahead of print.
PubMed 42982272Iwelunmor 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.
PubMed 40312377
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Trial on Actions For Collaborative Community Engaged Strategies for HPV
- ClinicalTrials.gov ID
- NCT06728085
- Acronym / sponsor ID
- ACCESS-HPV / 20240291
- Conditions
- HPV
- Keywords
- HPV Vaccination, HPV Screening
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,838 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Nigerian Institute of Medical Research, University of North Carolina, Chapel Hill, National Cancer Institute (NCI)
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Following the completion of the open contests, designathons and boot-camp training, seven trained teams (with seven distinct interventions) were selected to undergo a 6-month pilot assessment in the community. Preliminary findings from the feasibility study suggest that crowdsourced interventions have the potential to impact uptake of HPV vaccinations among girls and HPV screening among mothers in Nigeria. As a result, the investigators identified key components from the top 2 interventions to form a single intervention that will be evaluated in the next phase of the research. Thus, the current protocol is focused on evaluating the effectiveness of a combined, crowdsourced intervention on HPV vaccination among girls and HPV screening among mothers in Nigeria.
Using a hybrid effectiveness-implementation type II pragmatic stepped-wedge cluster randomized control trial, this study will test the effectiveness of an implementation strategy bundle; a crowdsourced, tailored, community-engaged, mother-daughter HPV campaign on increasing uptake of HPV vaccination among girls aged 9-14 and HPV screening uptake among women aged 30-65 in Nigeria. The mother-daughter campaign will be tailored to local sites and conducted among 612 mother-daughter dyads (1,224 participants) recruited from 18 LGAs in six geopolitical zones of Nigeria. Upon enrollment, trained community health workers (two per LGA) will collect baseline data, and implement a mother-daughter day campaign that will provide education on cervical cancer control and access to onsite services for HPV vaccination and screening in a private area and engage mothers and daughters simultaneously to increase uptake of the services. A mixed-methods evaluative and iterative assessment will be conducted using Proctor's Implementation Outcomes Framework and the PEN-3 cultural model. The primary outcomes are the uptake of HPV preventive measures -HPV vaccination (one dose) among girls (ascertained by on-site records of vaccine uptake) and HPV self-collection completion among mothers (ascertained by laboratory receipt of self-collected specimens) within 6-months of trial enrollment. Pre-post effectiveness and cost of study components are embedded in the implementation and sustainment phases, with comparison to pre-implementation data assessed for each LGA.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Hybrid Type II, stepped-wedge cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Mother-Daughter Day HPV Campaign | Experimental | Behavioral: Baseline Assessment For Mother-Daughter Day HPV Campaign, Behavioral: Implement Mother-Daugther Day HPV Campaign, Behavioral: Post-Implementation Follow-UpEach 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. |
Who may qualify
- Ages
- 9 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline Assessment For Mother-Daughter Day HPV CampaignAlso: Pre-Implementation PhasePre-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. | Behavioural | Mother-Daughter Day HPV Campaign |
| Implement Mother-Daugther Day HPV CampaignAlso: Implementation PhaseTailor 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. | Behavioural | Mother-Daughter Day HPV Campaign |
| Post-Implementation Follow-UpAlso: Post-Implementation PhaseA 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. | Behavioural | Mother-Daughter Day HPV Campaign |
Primary outcome
Uptake of HPV Vaccination among girls/daughters
Time frame: Up to 6 months of enrollment
The proportion of eligible girls who receive at least one dose of HPV vaccine. This will be ascertained by documentation on HPV vaccination cards
Uptake of HPV Self-collection among mothers/caregivers
Time frame: Up to 6 months of enrollment
The proportion of eligible women who complete an HPV self-collection. This will be ascertained by laboratory receipt of self-collected specimens.
6 secondary outcomes
Intervention Acceptability
Time frame: Measured at baseline, 3 months, and 6 months.
Intervention Appropriateness
Time frame: Measured at baseline, 3 months, and 6 months.
Intervention Feasibility
Time frame: Measured at baseline, 3 months, and 6 months.
Penetration (i.e., population dose)
Time frame: Measured at baseline, 3 months, and 6 months.
Implementation Fidelity
Time frame: Measured at baseline, 3 months, and 6 months.
Sustainment
Time frame: Measured at baseline, 3 months, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 38352305Kpokiri 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.
- Background: PubMed 21804767Cates 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.
- Background: PubMed 29579499Lee 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.
- Background: PubMed 32354671Scarinci 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.
- Background: PubMed 26399648Winer 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.
- Background: PubMed 24276617Abuelo 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.
- Background: PubMed 32538437Amponsah-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.
- Background: PubMed 30829264Devarapalli 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.
- Background: PubMed 26853214Lim 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.
- Background: PubMed 27434871McFarland 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.
- Derived from this study: PubMed 42982272Iwelunmor J, Wapmuk AE, Okeke N, Akinsolu FT, Gbaja-Biamila T, Abodunrin OR, Ojo T, Olusanya O, Musa AZ, Xian H, Kalulu P, Obiorah A, Afadapa M, Obodoechina N, Bradon A, Nwaozuru U, Anikamadu O, Obi-Jeff C, Onwuamah C, Smith J, Azuogu BN, Ajenifuja K, Bamogo A, Okwunze FK, Ong JJ, Zhang L, Airhihenbuwa CO, Tucker JD, Ezechi OC. HPV vaccination uptake among adolescent girls in Nigeria: A multi-state pilot trial using linked mother-daughter data. Contemp Clin Trials. 2026 Nov 4:108527. doi: 10.1016/j.cct.2026.108527. Online ahead of print.
- Derived from this study: PubMed 40312377Iwelunmor 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.
- Global strategy to accelerate the elimination of cervical cancer as a public health problemLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliet Iwelunmor, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline Assessment For Mother-Daughter Day HPV Campaign, Implement Mother-Daugther Day HPV Campaign and Post-Implementation Follow-Up in people with HPV, run by Washington University School of Medicine at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uptake of HPV Vaccination among girls/daughters (time frame: Up to 6 months of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06728085, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.