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.: PACTR202001741975182 Date of Approval: 14/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness in the Use of MHealth in Improving Screening Rate in the City of Bamenda and Banso in the North West Region of Cameroon
Official scientific title Effectiveness in the Use of MHealth in Improving Screening Rate in the City of Bamenda and Banso in the North West Region of Cameroon
Brief summary describing the background and objectives of the trial Hospitals will be randomly selected in Bamenda (Experimental group) and Banso (control group) that carry out cervical cancer screening. Contacts of women who meet the inclusion criteria in the cities of Bamenda and Banso will be gotten from them during consultation. A baseline measurement will be gotten from those in Banso and Bamenda through a questionnaire on knowledge of cervical cancer and uptake in cervical cancer screening. Messages containing location, time, information on cervical cancer (content) and approximate duration to spend per session will be forwarded every morning (6 a.m.) and evening (6 p.m.) per day on Fridays and Sundays for a period of six months will be sent to those in Bamenda while in Banso (control) no messages will be sent to those recruited. Hence, the hospitals in Banso will be expected to use their routine method of Public and church announcements. At the end of the six months period, an end line measurement (information) will be analyzed through the administration of the same questionnaires used at the baseline and review of registers in three phases based on following objectives: Phase 1: To determine the effects of mhealth (SMS) on behavior change with respect to screening (Uptake). Phase 2: To determine the knowledge level of participants towards cervical cancer and cervical cancer screening. Phase 3: To determine the level of satisfaction of participants on the use of mheath in the screening for cervical cancer in Bamenda and Banso in the North West Region of Cameroon.
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 01/01/2020
Actual trial start date
Anticipated date of last follow up 01/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MHEALTH Messages containing location, time, information on cervical cancer (content) and approximate duration to spend per session will be forwarded every morning (6 a.m.) and evening (6 p.m.) per day on Fridays and Sundays for a period of six months will be sent to those in Bamenda 6 months Interventional study A quasi-experimental study design will be used. This is an empirical intervention study that is used to estimate the causal impact of an intervention on target population but lacks random assignment and at times there is no manipulation or comparison. This type of experimental study is effective because it uses baseline and end line measurement. The women in both the experimental group (Bamenda) and the control group (Banso) are not assigned randomly but already exist in these settings thereby rendering this method very suitable. The quasi-experiment will be done in the follow ways: Phase 1 (pre intervention): Chart review Chart review will be done on the hospital registers of Hospitals in the city of Bamenda (experimental group) and Hospitals in City of Banso (control group). A structured form will be used to determine the average sensitized and the average number screened (uptake) within the past 10 years. Meanwhile, clients who will be coming for regular screening will undergo knowledge assessment on basic aspects about cervical cancer such as: severity of cervical cancer, susceptibility of cervical cancer, effectiveness of treatment of cervical cancer. Phase2: Mhealth (Intervention) Contacts of members of communities in the city of Bamenda will be gotten from the registers of Community Health Personnel and messages containing location, time, information on cervical cancer (content) and approximate duration to spend per session will be forwarded every morning (6 a.m.) and evening (6 p.m.) per day on Fridays and Sundays for 6 months. Specifically, Hospitals that carry out cervical cancer screening (Experimental group) in Bamenda and City of Banso (control group) will be selected through simple random sampling technique. Phase 3: Chart review (post intervention) After six months of screening, auditing will be done on the hospital registers of Hospitals in Bamenda (experimental group) and Hospitals in City of Banso (control group). A structured form will be used to determine the average sensitized and the average number screened (uptake) within these period of 6 months as well as the knowledge level acquired and satisfaction with the use of text messages will also be assessed. 100
Control Group mhealth none 6 months Interventional study A quasi-experimental study design will be used. This type of experimental study is effective because it uses baseline and end line measurement. The women in both the experimental group (Bamenda) and the control group (Banso) are not assigned randomly but already exist in these settings thereby rendering this method very suitable. The quasi-experiment will be done in the follow ways: Phase 1 (pre intervention): Chart review Chart review will be done on the hospital registers of Hospitals in the city of Bamenda (experimental group) and Hospitals in City of Banso (control group). A structured form will be used to determine the average sensitized and the average number screened (uptake) within the past 10 years. Meanwhile, clients who will be coming for regular screening will undergo knowledge assessment on basic aspects about cervical cancer such as: severity of cervical cancer, susceptibility of cervical cancer, effectiveness of treatment of cervical cancer. Phase2: Mhealth (Intervention) Contacts of members of communities in the city of Bamenda will be gotten from the registers of Community Health Personnel and messages containing location, time, information on cervical cancer (content) and approximate duration to spend per session will be forwarded every morning (6 a.m.) and evening (6 p.m.) per day on Fridays and Sundays for 6 months. Specifically, Hospitals that carry out cervical cancer screening (Experimental group) in Bamenda and City of Banso (control group) will be selected through simple random sampling technique. Phase 3: Chart review (post intervention) After six months of screening, auditing will be done on the hospital registers of Hospitals in Bamenda (experimental group) and Hospitals in City of Banso (control group). A structured form will be used to determine the average sensitized and the average number screened (uptake) within these period of 6 months as well as the knowledge level acquired will also be assessed. 100 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Women who are 21 years and above who have never been screened for cervical cancer or who have not been screened for more than three years after the last screening. - Women who are selected but do not have cell phones will be provided with one. -Hospitals that offer screening services for cervical cancer -Non-consenting women -Women who have been screened before Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 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 17/09/2019 FACULTY OF HEALTH SCIENCES INSTITUTIONAL REVIEW BOARD
Ethics Committee Address
Street address City Postal code Country
BUEA Buea 00237 Cameroon
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Knowledge, Satisfaction Monthly
Secondary Outcome Rate of participation Monthly
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Acha Annex Bamenda Small Mankon Bamenda Cameroon
Mbingo Annex Nkwen Bamenda Cameroon
Providence polyclinic Foncha street Bamenda Cameroon
Mezam polyclinic Azire Bamenda Cameroon
Azire Integrated Health Centre Azire Bamenda Cameroon
CMA Nkwen Nkwen Bamenda Cameroon
St Mary Soledad Hospital Nchoubou Bamenda Cameroon
FUNDING SOURCES
Name of source Street address City Postal code Country
Fongang Che Landis Bepanda Douala 00237 Cameroon
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fongang Che Landis Bepanda Douala Cameroon Individual
COLLABORATORS
Name Street address City Postal code Country
Njajou Omer Olembe Yaounde 00237 Cameroon
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fongang Che Landis landische@gmail.com +237677432147 Bepanda
City Postal code Country Position/Affiliation
Douala Cameroon principal investigator
Role Name Email Phone Street address
Public Enquiries Babila Standly lebabs12@gmail.com +237681399501 mboppi
City Postal code Country Position/Affiliation
Douala Cameroon Public enquiries
Role Name Email Phone Street address
Public Enquiries Kamando Eric kamerido@yahoo.com +237677578192 obobobo
City Postal code Country Position/Affiliation
Yaounde Cameroon public enquiries
Role Name Email Phone Street address
Scientific Enquiries Njajou Omer njajou@gmail.com +237695988978 Olembe
City Postal code Country Position/Affiliation
Yaounde Cameroon scientific enquiries
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we intend using tools to collect the IPD during the project.The tools that will be used will be made available. Emphasis will be laid on those tools that will be used in obtaining information that will be presented in the result section in articles. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The IPD will be shared latest six months after the publication of the article and will be available for two years The Editor in chief and the Statistician can access and review the raw data if they think there is violation of ethical issues. Also, if they have evidence that the data has not been rightly represented or analysed.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
None 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