HPVNCT06010108
Actions For Collaborative Community Engaged Strategies for HPV
A study testing Heroes for Her, The Reach Initiative and W.H.I.T.E project in people with HPV and Stigma, run by Washington University School of Medicine at 1 site in Nigeria.
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. Read more about this study
- Who is it for?
- Ages 9 to 65 years, women onlyHealthy volunteers can take part
- What is being tested?
- Heroes for Her, The Reach Initiative and W.H.I.T.E project
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteNigeria
- Study dates
- 15 Jan 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Actions For Collaborative Community Engaged Strategies for HPV (ACCESS-HPV)
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.
Read the 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.
- Being tested
- Heroes for Her, The Reach Initiative, W.H.I.T.E project, Project Shield, Project SHADE
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heroes for HerBehavioural
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 InitiativeBehavioural
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 projectBehavioural
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 ShieldBehavioural
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 SHADEBehavioural
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) programBehavioural
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 CareBehavioural
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,
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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. Receives: 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 Receives: 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 Receives: 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. Receives: Behavioral: Project Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks following the first encounter
Secondary outcomes (4)
Intersectional Discrimination Index
HPV-and-cervical cancer associated stigma will be assessed using the Intersectional Discrimination Index measure. Higher scores mean greater stigma.
Measured: Measured at baseline and at 8 weeks
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: Measured at baseline and at 8 weeks
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: Measured at baseline and at 8 weeks
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 and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start15 Jan 2024
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- intervention pilot
- Masking
- None (open label)
- Enrolment
- 350 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
- Responsible party
- Principal investigator, Juliet Iwelunmor, PhD, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010108
- Sponsor's protocol ID
- NHREC/01/01/2007
- Status last verified
- Jan 2026
- First submitted
- 7 Aug 2023
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33678235McFarland 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 27434871Lim 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 26853214Devarapalli 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 30829264Amponsah-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 32538437Abuelo 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 24276617Winer 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 26399648Scarinci 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 32354671Lee 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 29579499Cates 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 21804767
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Actions For Collaborative Community Engaged Strategies for HPV (ACCESS-HPV)
- ClinicalTrials.gov ID
- NCT06010108
- Acronym / sponsor ID
- NHREC/01/01/2007
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Nigerian Institute of Medical Research, University of North Carolina, Chapel Hill
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 24 Aug 2023 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- intervention pilot
| Arm | Type | Receives |
|---|---|---|
| Heroes for Her | Active comparator | Behavioral: Heroes for HerMarket 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 |
| The Reach Initiative | Active comparator | Behavioral: The Reach InitiativeSchool 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. |
| W.H.I.T.E Project | Active comparator | Behavioral: W.H.I.T.E projectCommunity 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. |
| Project Shield | Active comparator | Behavioral: Project ShieldDistribution 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. |
| Project SHADE | Active comparator | Behavioral: Project SHADECommunity 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 |
| Operation Reach Her (ORH) | Active comparator | Behavioral: Operation Reach Her (ORH) programFaith-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 |
| Project Care | Active comparator | Behavioral: Project CareUse 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. |
Who may qualify
- Ages
- 9 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Heroes for HerMarket 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 | Behavioural | Heroes for Her |
| The Reach InitiativeSchool 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 | Behavioural | The Reach Initiative |
| W.H.I.T.E projectCommunity 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 | Behavioural | W.H.I.T.E Project |
| Project ShieldUtilization 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 | Behavioural | Project Shield |
| Project SHADECommunity-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 | Behavioural | Project SHADE |
| Operation Reach Her (ORH) programFaith 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 | Behavioural | Operation Reach Her (ORH) |
| Project CareCommunity 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, | Behavioural | Project Care |
Primary outcome
Uptake of HPV Vaccination Over the 8 weeks follow-up
Time frame: 8 weeks following the first encounter
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.
Uptake of HPV Self-collection Over the 8 weeks Follow-up
Time frame: 8 weeks following the first encounter
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.
4 secondary outcomes
Intersectional Discrimination Index
Time frame: Measured at baseline and at 8 weeks
Intervention Acceptability
Time frame: Measured at baseline and at 8 weeks
Intervention Appropriateness
Time frame: Measured at baseline and at 8 weeks
Intervention Feasibility
Time frame: Measured at baseline and at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 33678235Campos 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.
- 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.
- 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 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 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 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 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 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 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 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.
- 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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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heroes for Her, The Reach Initiative and W.H.I.T.E project in people with HPV and Stigma, 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 28 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Over the 8 weeks follow-up (time frame: 8 weeks following the first encounter). 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 NCT06010108, which also lists 10 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 28 Jan 2026.