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.: PACTR202607679243122 Date of Registration: 10/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of a health education intervention on the knowledge and attitude towards cervical cancer screening among women attending PHC facilities in Kwara State
Official scientific title Effectiveness of a health education intervention on the knowledge and attitude towards cervical cancer screening among women attending PHC facilities in Kwara State
Brief summary describing the background and objectives of the trial Cervical cancer remains a major public health problem in Nigeria, with the country recording among the highest incidence and mortality rates in Africa. Despite being largely preventable through screening, uptake among women attending primary health care (PHC) facilities remains critically low, driven by poor knowledge, negative attitudes, socio-cultural barriers, and low perceived risk. Kwara State, a predominantly Muslim state in North-Central Nigeria, is particularly affected by these challenges. This study assessed the effect of a structured health education intervention on knowledge, attitude, uptake, behavioral intention, and perceived benefit, susceptibility, severity, and barriers to cervical cancer screening among married women of reproductive age attending PHC facilities in Kwara State, Nigeria. A quasi-experimental pre-test post-test design with a control group was employed among 452 participants (226 intervention, 226 control). The health education intervention significantly improved knowledge, attitude, screening uptake, behavioral intention, and all Health Belief Model constructs in the intervention group. The study recommends integration of structured health education into routine PHC services targeting women of reproductive age across Nigeria.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 03/03/2025
Actual trial start date 07/04/2025
Anticipated date of last follow up 03/10/2025
Actual Last follow-up date 19/11/2026
Anticipated target sample size (number of participants) 452
Actual target sample size (number of participants) 452
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
Parallel: different groups receive different interventions at same time during study 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 Health Education Programme on Cervical Cancer Screening Three daily sessions of approximately one hour each, delivered over three consecutive days per group. Each centre had three groups of approximately 20 participants, with each group receiving training in consecutive weeks. The intervention ran for three weeks at each of the four intervention PHC centres, totalling twelve weeks across all sites. Twelve weeks across four intervention PHC centres (three weeks per centre). Post-test data were collected four months after completion of the intervention. The intervention consisted of a structured face-to-face health education programme on cervical cancer delivered to participants in the intervention group at four PHC centres in Kwara State. Participants were divided into groups of approximately 20 and received three consecutive daily sessions of one hour each. Day 1 covered basic facts about cervical cancer, risk factors, and signs and symptoms. Day 2 focused on prevention, screening methods (Papanicolaou smear and visual inspection with acetic acid), and the importance of early detection. Day 3 covered the screening procedure, available screening types, treatment options following a positive test, and benefits of early detection. Information, Education and Communication (IEC) materials in the form of an educational pamphlet developed by the researcher were distributed at each session. The control group received only the pre-intervention questionnaire and were not exposed to the educational sessions, IEC materials, or educational booklet during the study period. Following post-test data collection, the control group received the same health education intervention. 226
Control Group Standard Care No intervention during the study period Four months (duration of the study period). Health education was provided after post-test data collection was completed. Participants in the control group received only the pre-intervention questionnaire during the study period and were not exposed to the face-to-face health education sessions, IEC materials, or educational booklet. Following completion of post-test data collection five months later, the control group received the same structured health education programme on cervical cancer screening as the intervention group. 226 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The following women were eligible to participate in the study: i. Women between the ages of 18 and 60 years who were attending the selected primary healthcare centres at the time of data collection. ii. Women between the ages of 18 and 60 years with no prior diagnosis of cervical cancer and not currently undergoing radiotherapy treatment. iii. Women who consented to participate in the study. The following women were excluded from the study: i. Women aged between 18 and 60 years who had undergone cervical cancer screening within the previous three years. ii. Women aged between 18 and 60 years who had already been diagnosed with cervical cancer. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Female
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 03/04/2025 Ethical Review Committee of the Kwara State Ministry of Health
Ethics Committee Address
Street address City Postal code Country
Fate roundabout, Ilorin Ilorin 1055 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knowledge and attitude towards cervical cancer screening were measured before and after the intervention using a pretested interviewer-administered structured questionnaire. Assessed using paired t-test and McNemar test at p < 0.05. Baseline and four months post-intervention
Secondary Outcome Cervical cancer screening uptake, behavioral intention towards cervical cancer prevention, perceived benefit, perceived susceptibility, perceived severity, and perceived barriers to cervical cancer screening were all measured before and after the intervention using McNemar test and Pearson chi-square at p < 0.05. Baseline and four months post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Primary Health Care Centres EDIDI Edidi town Edidi Nigeria
OJOMU NORTHNORTH Primary health centre Ojomu Offa Nigeria
Primary Health care centre Oke onigbin Oke Onigbin Oke onigbin Nigeria
Primary Health care centre Ote Oja Ote Ote oja Nigeria
Primary Health care centre Kulende Kulende Ilorin Nigeria
Primary Health care centre Essa B Essa B Eessa Nigeria
Primary Health care centre Afon Afon Afon Nigeria
Primary Health care centre Tanke Tanke Ilorin Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded House C48, Ministerial Housing Estate, Along Unilorin Road, Arafat Street, tanke Oke Odo, Ilorin , Kwara State, Nigeria Ilorin 240222 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Selffunded House C48 MINISTERIAL HOUSING ESTATE, ALONG ARAFAT STREET, TANKE, OKE ODO, ILORIN 240211 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Halimah Shittu shittu.hib@unilorin.edu.ng +2347031251654 House C48, Ministerial Housing Estate, Along University of Ilorin, Tanke, Oke odo
City Postal code Country Position/Affiliation
Ilorin 240211 Nigeria Lecturer
Role Name Email Phone Street address
Public Enquiries Halimah Shittu shittu.hib@unilorin.edu.ng +2347031251654 House C48, Ministerial Housing Estate, Along Arafat street, tanke oke odo
City Postal code Country Position/Affiliation
Ilorin 240211 Nigeria Lecturer
Role Name Email Phone Street address
Scientific Enquiries Halimah Shittu shittu.hib@unilorin.edu.ng +2347031251654 House C48, Ministerial Housing Estate, Along Arafat Street, tanke oke odo
City Postal code Country Position/Affiliation
Ilorin 240211 Nigeria Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will not be publicly shared to protect the privacy and confidentiality of participants. Summary results of this trial will be made available through publication in a peer-reviewed journal within 12 months of study completion. Data may be made available to researchers upon reasonable request to the principal investigator, subject to ethical approval and a data sharing agreement. Informed Consent Form Within 12 months of publication of the primary study results in a peer-reviewed journal Data will be made available to researchers upon reasonable written request to the principal investigator. Requestors must provide a research proposal outlining the purpose of the data request. Access will be granted subject to ethical approval from the requestor's institution and execution of a formal data sharing agreement. Data shared will be anonymised to protect participant confidentiality.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information