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.: PACTR201305000526384 Date of Registration: 04/04/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title THE USE OF THE MOBILE PHONE SHORT TEXT MESSAGE SERVICE TO ENHANCE CERVICAL CANCER SCREENING AT THIKA HOSPITAL, KIAMBU COUNTY, KENYA. (SMART SCREENING)
Official scientific title THE USE OF THE MOBILE PHONE SHORT TEXT MESSAGE SERVICE TO ENHANCE CERVICAL CANCER SCREENING AT THIKA HOSPITAL, KIAMBU COUNTY, KENYA
Brief summary describing the background and objectives of the trial Cervical cancer is a major public health problem among adult women in developing countries and despite this there exists no effective way of call recall for scheduled screening adherence. This study will aim to determine the influence of using the mobile medicine through the SMS in enhancing repeat scheduled screening for cervical cancer in Thika Hospital,
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SMART Screening
Disease(s) or condition(s) being studied Cancer,cervical cancer,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 15/04/2013
Actual trial start date 15/04/2013
Anticipated date of last follow up 02/05/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 286
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
p97/26013/11 Kenyatta University
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 where a data base of all participants mobile phone numbers are put into a data base from which a computor generated program randomly allocates this numbers through a 1:1 allocation into intervention or control arm central randomisation will be used where a computor based program has been developed to randomly select and allocate as well as send the SMS from the data base. Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group none NA NA none 143
Experimental Group SMS reminders NA NA reminder SMS sent at 3, 2 and 1 month before next schedulled screening and a week before the schedulled screening 143
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women of 25 years Never had cervical cancer screening Attending the general female outpatient clinic at Thika Level 5 hospital Consents for the study. Own a mobile phone and consent to receive communication through their mobile phones during the study period. Women who are not attending the general outpatient clinic Those that do not give consent Those with overt cancer of cervix or high grade squamus intraepithelial lesion (HSIL) Those below the age of 25 years Women with previous hysterectomies, Those who do not own a mobile phones Those who have been screened for cervical cancer before. Patients who are too sick and need hospital admission and those with vaginal bleeding will also be excluded. 25 Year(s) 69 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 KENYATTA UNIVERSITY ETHICS REVIEW COMMMITTEE
Ethics Committee Address
Street address City Postal code Country
PO BOX 43844 NAIROBI 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome will be defined as study subjects with normal Pap test at beseline who complete a repeat Pap test at 12 months from baseline 12 months after the primary screening
Secondary Outcome 2. Women with low grade lesion who return for re-screening at 6 months 6 months after baseline screening
Secondary Outcome 1. Women who comply with recommendation of repeat Pap test after 12 months 12 months after the primary screening
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
thika level 5 hospital, kiambu county hospital road thika 001000- Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Kenyatta University PO BOX 43844 NAIROBI 00100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kenyatta University PO BOX 43844 NAIROBI 00100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
PROF. EPHANTUS KABIRU SCHOOL OF PUBLIC HEALTH PO BOX 43844 NAIROBI 00100 Kenya
PROF ELIZABETH BUKUSI KEMRI. PO BOX 54840 NAIROBI 00100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ANTHONY WANYORO wanyoroka@yahoo.com +254722747903 PO BOX 1993
City Postal code Country Position/Affiliation
THIKA 001000 Kenya Senior lecturer and Phd student
Role Name Email Phone Street address
Public Enquiries ANTHONY WANYORO wanyoroka@yahoo.com +254722747903 PO BOX 1993
City Postal code Country Position/Affiliation
THIKA 001000 Kenya Senior lecturer and Phd student
Role Name Email Phone Street address
Scientific Enquiries ANTHONY WANYORO wanyoroka@yahoo.com +254722747903 PO BOX 1993
City Postal code Country Position/Affiliation
THIKA 001000 Kenya Senior lecturer and Phd student
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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