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.: PACTR202002753354517 Date of Registration: 20/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of mobile technologies on cervical cancer screening practices in Lagos, Nigeria: A randomised controlled trial "mHealth-Cervix"
Official scientific title Impact of mobile technologies on cervical cancer screening practices in Lagos, Nigeria: A randomised controlled trial "mHealth-Cervix"
Brief summary describing the background and objectives of the trial Cervical cancer is a major public health problem and is the fourth most common cancer in women worldwide accounting for an estimated 570,000 new cases annually.[1] More than 80% of the global burden of cervical cancer occurs in the less developed regions, where it accounts for almost 12% of all female malignancies.[2,3] In 2018, an estimated 311,000 deaths were attributed to cervical cancer, which accounts for 7.5% of all female cancer deaths with 70% of these occurring in developing countries.[1] Early detection of precursor lesions of cervical cancer through the use of screening tests has drastically reduced the incidence of the disease especially in the Western countries where Pap smear (cytology) screening has been introduced and now covers almost all eligible women.[4] However, in the resource-constraint countries of the world such as Nigeria, cervical cancer incidence and mortality have remained high due to many obstacles facing the implementation of organized screening programs.[5] Use of mobile technologies has increased exponentially in the last few years.[7] We reported in a study conducted in 2018 that mobile telephones could be found in 95% of households in Lagos and were widely distributed across all socioeconomic classes.[8] Because of this technological explosion, mobile health (mHealth), or “medical and public health practice supported by mobile devices”,[9] has great potential in many health areas such as promotion and prevention.[10] There is limited evidence supporting mHealth technologies in cancer prevention and there is currently no reported randomized controlled trial in Sub-Saharan Africa (SSA) that examines the use of mobile health technologies in cancer prevention. This study will, therefore, aim to ascertain the efficacy of an intervention using mobile technologies on Pap smear screening adherence compared to a control condition and also determine the factors affecting the uptake of Pap smear screening services among women in Lagos.
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 03/02/2020
Actual trial start date 31/07/2020
Anticipated date of last follow up 29/01/2021
Actual Last follow-up date 29/01/2021
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group mHealth messages Twice monthly 6 months Intervention (mHealth) arm – We chose Nexmo® as the platform to deliver the mHealth messages given its reliability and low cost. Participants will be sent messages containing information and encouragement to undergo cervical cancer screening. Information will also be provided about the Cytology clinic hours, contact information and locations in the two participating hospitals. Information and motivational text messages will be delivered twice monthly for the next 6-months after enrollment. 100
Control Group Usual care None 6 months Usual care (control) arm – Participants randomized to the control arm will not receive additional educational or motivational messages from study staff other than the usual care received at enrollment. Usual care consists of any information on Pap tests and cervical cancer risk reduction typically provided by midwives to all women at the clinics as will be done at enrollment. These women can then schedule an appointment for their Pap smear testing in person at the GOP or Cytology clinics at any time during the 6-month follow-up period. 100 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
NHIS enrollees Aged between 25 and 65 years No prior history of cervical cancer or cervical dysplasia Those not adherent with current recommendations for Pap smear screening (have not had a Pap smear within the last three years) Those owning and using a personal cellphone Those free from any mental or physical disabilities that inhibit them from understanding the implications of the study Those not considering relocating from their current residence within the next year. Women younger than 25 and older than 65 years old, Those with history of cervical dysplasia and cancer Those who had a Pap test within the last three years Those with an ongoing pregnancy Those who refuse or withdraw consent during the course of the study. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 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 02/02/2020 College of Medicine University of Lagos Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
College of Medicine, University of Lagos Research Management Office Lagos 2345 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome This is the completion of a Pap smear within 6 months of enrollment in the study. Participants will be tracked via medical record review as well as through phone call at 6-month after their enrolment. At 6 month of enrolment
Secondary Outcome This is an assessment of the various factors affecting Pap smear uptake or adherence within 6-month of enrollment among the participating women. At 6 month of enrolment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital PMB 12003 Surulere Lagos 2345 Nigeria
Lagos State University Teaching Hospital Ikeja GRA Ikeja 10027 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Conquer Cancer Foundation 2318 Mill road, Suite 800 Alexandria 22314 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor College of Medicine University of Lagos PMB 12003 Surulere Lagos 2345 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Omolola Salako Department of Radiation Oncology College of Medicine University of Lagos Lagos 2345 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kehinde Okunade kehindeokunade@gmail.com +2348034728139 Department of Obstetrics and Gynaecology College of Medicine University of Lagos
City Postal code Country Position/Affiliation
Lagos 2345 Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Kehinde Okunade kehindeokunade@gmail.com +2348034728139 Department of Obstetrics and Gynaecology College of Medicine University of Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Kehinde Okunade kehindeokunade@gmail.com +2348034728139 Department of Obstetrics and Gynaecology College of Medicine University of Lagos
City Postal code Country Position/Affiliation
Lagos Nigeria Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The investigators will share the IPD as per WHO requirement within 12 months of the study completion date. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Within 12 months of study completion date. Open Access
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