Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609683563072 Date of Registration: 07/09/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Improving HPV Vaccine Uptake Among Girls Aged 9–14 Years in Akwa Ibom State, Nigeria: A Community-Participatory Pre/Post-Intervention Study
Official scientific title Improving HPV Vaccine Uptake Among Girls Aged 9–14 Years in Akwa Ibom State, Nigeria: A Community-Participatory Pre/Post-Intervention Study
Brief summary describing the background and objectives of the trial Cervical cancer remains a major public health concern in Nigeria, and persistent infection with human papillomavirus (HPV) is its primary cause. Although the HPV vaccine has been introduced into Nigeria’s national immunization programme for girls aged 9–14 years, uptake may be limited by low awareness, misinformation, concerns about vaccine safety, and other contextual factors influencing caregivers’ vaccination decisions. Community-participatory approaches may help address these barriers by ensuring that awareness strategies are responsive to local needs and perspectives. This study evaluated a community-participatory awareness programme designed to improve HPV vaccine uptake among girls aged 9–14 years in selected communities in Akwa Ibom State, Nigeria. The study assessed HPV vaccine uptake and factors influencing vaccination, co-designed culturally appropriate awareness messages with community stakeholders, implemented a targeted community awareness programme, and evaluated changes in knowledge, perceptions, and HPV vaccine uptake following the intervention.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Human papillomavirus (HPV) infection and cervical cancer prevention
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 06/01/2025
Actual trial start date 06/01/2025
Anticipated date of last follow up 20/06/2025
Actual Last follow-up date 20/06/2025
Anticipated target sample size (number of participants) 418
Actual target sample size (number of participants) 686
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Single Group Non-randomised Allocation Sequence/Code was not concealed Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Community participatory HPV vaccination awareness programme Not applicable – community-based awareness intervention delivered through multiple engagement activities between February and May 2025. 14 weeks The intervention was a 14-week community-based HPV vaccination sensitisation programme implemented simultaneously across six communities. It used five complementary channels: (1) sensitisation through religious organisations, including weekly dissemination of messages during church services and in-person sessions at major churches; (2) weekday school outreaches targeting teachers and senior secondary school students; (3) twice-weekly HPV vaccination messages delivered by community announcers (“town criers”); (4) structured one-on-one sessions with healthcare workers at community primary health centres; and (5) sustained use of banners and distribution of printed sensitisation materials. Direct community engagement was delivered by trained medical doctors using messages and materials co-designed with community stakeholders during 12 participatory workshops. 686
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Were a parent or caregiver of at least one female child aged 9–14 years at the time of the study. Resided in one of the six selected study communities in Akwa Ibom State. Were available and willing to participate in the survey. Provided informed consent to participate. Were not a parent or caregiver of a female child aged 9–14 years. Did not reside in one of the selected study communities. Were unable or unwilling to provide informed consent. Were unable to complete the study questionnaire. 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/05/2025 Health Research Ethics Committee University of Uyo Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
Abak Road, Uyo Akwa Ibom 520001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HPV vaccine uptake Baseline and post-intervention assessment following completion of the 14 week sensitisation intervention
Secondary Outcome Awareness of HPV vaccine Baseline and post-intervention assessment following completion of the 14 week sensitisation intervention
Secondary Outcome HPV and HPV Vaccine Knowledge Baseline and post-intervention assessment following completion of the 14 week sensitisation intervention
Secondary Outcome Vaccine attitudes and perception Baseline and post-intervention assessment following completion of the 14 week sensitisation intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Institute of Health Research and Development University of Uyo Teaching Hospital Abak road Uyo Akwa Ibom Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Royal Society of Tropical Medicine and Hygiene Ground Floor, Office Suite 1, 21 John Street London WC1N 2BF United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Institute of Health Research and Development University of Uyo Teaching Hospital Abak road, Uyo Akwa Ibom Nigeria Research Institution
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Victory Ekpin victoryekpin98@gmail.com +2347080117632 6 regent park road, Minfa 1 garden estate
City Postal code Country Position/Affiliation
Abuja Nigeria Research Fellow Institute of Health Research and Development
Role Name Email Phone Street address
Public Enquiries Christie Akwaowo christieakwaowo@uniuyo.edu.ng +2348121007387 Abak road, Uyo
City Postal code Country Position/Affiliation
Akwa Ibom Nigeria Director Institute of Health Research and Development
Role Name Email Phone Street address
Scientific Enquiries Victory Ekpin victoryekpin98@gmail.com +2347080117632 6 regent park road, minfa 1 garden estate
City Postal code Country Position/Affiliation
Abuja Nigeria Research Fellow Institute of Health Research and Development
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data will be made publicly available through Zenodo following publication of the study results. The dataset will be shared without directly identifying information and in accordance with applicable ethical and data protection requirements. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months after publication of the study results Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://doi.org/10.5281/zenodo.21830368 Yes 31/08/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 31/08/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 31/08/2026 Revised the study summary to include brief background information and the rationale for the study, as requested by the reviewer. This study evaluated a community-participatory awareness programme designed to improve human papillomavirus (HPV) vaccine uptake among girls aged 9–14 years in selected communities in Akwa Ibom State, Nigeria. The study aimed to assess HPV vaccine uptake, identify factors influencing vaccination, co-design culturally appropriate awareness messages with community stakeholders, implement the awareness programme, and evaluate changes in knowledge, perceptions, and vaccine uptake following the intervention. Cervical cancer remains a major public health concern in Nigeria, and persistent infection with human papillomavirus (HPV) is its primary cause. Although the HPV vaccine has been introduced into Nigeria’s national immunization programme for girls aged 9–14 years, uptake may be limited by low awareness, misinformation, concerns about vaccine safety, and other contextual factors influencing caregivers’ vaccination decisions. Community-participatory approaches may help address these barriers by ensuring that awareness strategies are responsive to local needs and perspectives. This study evaluated a community-participatory awareness programme designed to improve HPV vaccine uptake among girls aged 9–14 years in selected communities in Akwa Ibom State, Nigeria. The study assessed HPV vaccine uptake and factors influencing vaccination, co-designed culturally appropriate awareness messages with community stakeholders, implemented a targeted community awareness programme, and evaluated changes in knowledge, perceptions, and HPV vaccine uptake following the intervention.
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 31/08/2026 Uploaded the ethical approval letter as requested. TRUE, Health Research Ethics Committee University of Uyo Teaching Hospital , Abak Road, Uyo, Akwa Ibom, 520001, Nigeria, , 28 Feb 2025, +2348089943514, researchinstitute@uuthuyo.net, TRUE, Health Research Ethics Committee University of Uyo Teaching Hospital , Abak Road, Uyo, Akwa Ibom, 520001, Nigeria, , 28 May 2025, +2348089943514, researchinstitute@uuthuyo.net, 44925_40251_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 31/08/2026 Updated summary result as requested Study Protocol, Statistical Analysis Plan, Informed Consent Form Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 31/08/2026 Updated summary result as requested No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 31/08/2026 Uploaded summary result as requested 44925_31016_1045.pdf