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 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202309878831811 Date of Approval: 21/09/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Human Papilloma Virus Screening for Cervical Cancer in Kiambu County, Kenya
Official scientific title A Multi-modal Intervention to Accelerate Utilization of Human Papilloma Virus Screening for Cervical Cancer in Kiambu County, Kenya
Brief summary describing the background and objectives of the trial Cervical cancer or cancer of the cervix uteri is ranked as the third most common cancer among women globally. Cervical cancer is ranked as the second leading type of female cancer in Kenya and the most common type in women aged 15-44 years. A total of 5,250 new cervical cancer cases were diagnosed in the country in 2018. A hospital-based study in Kiambu County found 5.7% and 4.9% of the women had cervical cell abnormalities and cervical precancerous changes, respectively. The aim is to assess the effect of multimodal interventions on the uptake of human papilloma virus among women in Kiambu County. A quasi experimental study will used with pre and post data collection with a sample of 850 respondents. Baseline data collection will be followed by execution of intervention. The intervention will be technology support using text message support to the women for screening, community interactive education and constructive male involvement. The intervention will be done for 6 months after which exit interview will be done after a period of 6 months after completion of intervention. Descriptive data analysis will be done followed by chi square, fishers exact, difference in difference and multiple logistic regression.
Type of trial RCT
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 Early detection /Screening
Anticipated trial start date 01/05/2021
Actual trial start date 01/11/2021
Anticipated date of last follow up 31/07/2023
Actual Last follow-up date 30/11/2023
Anticipated target sample size (number of participants) 450
Actual target sample size (number of participants) 400
Recruitment status Closed to recruitment,follow-up continuing
Publication URL https://www.tandfonline.com/doi/full/10.1080/21642850.2022.2136184
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Multimodal intervention to accelerate the screen for Human Papilloma Virus 1. Four mobile phone based short messages containing education on Human papilloma virus testing and where to test. 2. Face to face education on testing for Human Papilloma Virus focusing on Self Sample Collection 3 Months The messages contained the description of HPV, need for testing, side effects and places and time of testing 200
Control Group Standard care of clinician based sample collection for HPV testing No dose set 3 Months The regular care is what was offered for the control group 200 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The study will include consenting women Women Aged aged 30-65 years Women who never screened for HPV previously, Women with a willing partner Women able able to read text messages. Critically unwell women will be excluded. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 65 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 07/10/2021 KENYATTA UNIVERSITY CENTER FOR ETHICS AND SAFETY
Ethics Committee Address
Street address City Postal code Country
THIKA ROAD Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Testing for HPV through self sample collection Baseline and Exit
Secondary Outcome Testing for HPV through clinician sample collection Baseline and Exit
Secondary Outcome Knowledge and attitude towards HPV testing Baseline and Exit
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kiambu County Kiambu Town Nairobi Metropolitan 00900 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Kenyatta University Thika Road Nairobi 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kenyatta University Thika Road Nairobi 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Kiambu Level Five Hospital Kiambu Town Nairobi metropolitan 00900 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eliphas Gitonga gitonga.eliphas@ku.ac.ke +254721406609 Thika Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Lecturer Kenyatta University
Role Name Email Phone Street address
Public Enquiries Redempta Mutisya Gitonga mutisya.redempta@ku.ac.ke +254724563316 Thika Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Lecturer Kenyatta University
Role Name Email Phone Street address
Scientific Enquiries Rosebella Iseme rosebella.ondiek@aku.edu +254745259682 Limuru Road
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Professor Agha Khan University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The de-identified data of the study both at baseline and exit will be shared on a platform recognized by WHO for reference and open science requirements. Informed Consent Form,Study Protocol September 2023 to September 2024 Open access to all
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://www.ku.ac.ke/riosite/en/117-grants/245-grants-awarded 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