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.: PACTR201808126223676 Date of Approval: 21/08/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title THE DEMAND OF CERVICAL CANCER SCREENING AMONG ADULT WOMEN IN TIGRAY REGION, ETHIOPIA
Official scientific title Impact of health education intervention on demand of adult women toward cervical cancer screening
Brief summary describing the background and objectives of the trial Cervical cancer is an entirely preventable and the second largest killer disease among women in developing countries. Based on reports from WHO 2013, an estimated 275,000 women died, and 500,000 new cervical cancer cases reported every year. In Sub-Saharan Africa, an estimated 57,000 cases of cervical cancer occurred in the year 2000. A report from Pathfinder Ethiopia 2010 showed that cervical cancer is the leading cause of cancer mortality among Ethiopian women; 7,600 were diagnosed with the disease and roughly 6,000 women die each year. Few studies were done in Ethiopia related to cervical cancer. As a primary prevention, there is an experience with Health education intervention in the world (in Jamaica, Nigeria); which provides a great improvement in responses to questions about cervical cancer and its management. The screening rate in Ethiopia is low (0.8%); and still, the dominating barriers are community awareness, knowledge, and fear of the procedure. Though those barriers to cervical cancer screening, there is no community-based health education interventions. Objectives: The objective of the study is to assess community demand, the impact of health education intervention on demand of adult women towards cervical cancer screening, barriers and the challenges of cervical cancer service delivery among adult women in Tigray, Northern Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Cluster Randomized Controled Trial
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 26/04/2018
Actual trial start date 30/04/2018
Anticipated date of last follow up 26/10/2018
Actual Last follow-up date 30/12/2018
Anticipated target sample size (number of participants) 700
Actual target sample size (number of participants) 674
Recruitment status Completed
Publication URL Manuscript is ready for submission
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 Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Central randomisation by phone/fax Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health education intervention Measured by session duration and follow up Three days education session followed by a week consultancy time by Health Extension Workers Women in the intervention group will arrange in groups as per the Women Developmental Army (assigned under one health extension worker each) and will receive the educational intervention with culturally-tailored and local language based power point presentation for about two day; as well as they will attend another one day presentation followed group discussion and peer communication with a total 433 Active-Treatment of Control Group
Control Group Treatment as usual Measured by the time of the intervention group 6 months Treatment As Usual (TAU) comparison condition will be used to complement the potential impact of health education for the demands of study subjects on cervical cancer screening. The control group will be used the treatment as usual untill the 6 months post follow up datacollection is completed. 433 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult women aged between 21 to 50 years, who live in the study area for six months or more, have sexual experience, and are voluntary to participate will be included. Adult women or professionals who are not able to communicate will be excluded. We will not enroll women if they exhibited distress that would impede our ability to obtain written consent or response. A woman who is known cervical cancer and stayed under medical care and those who get the cervical cancer training will be excluded from the study. Adult: 19 Year-44 Year 21 Year(s) 50 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 07/12/2017 Research and community service for vise president office
Ethics Committee Address
Street address City Postal code Country
University of Gondar, Gondar, Ethiopia Gondar 1871 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome demand of woment towards cervical cancer screenig at baseline data collection 2018/04/26 and 6 months after intervention 2018/10/26
Secondary Outcome Knowledge and perception on cervical cancer screening at baseline data collection 2018/04/26 and 6 months after intervention 2018/10/26
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
All towns in Tigray, Ethiopia Tigray, Ethiopia Tigray, Ethiopia 1871 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Mekelle University Mekelle, Tigray, Ethiopia Mekelle 1871 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mekelle University Mekelle, Tigray, Ethiopia Mekelle 1871 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
University of Gondar University of Gondar, Gondar, Ethiopia Gondar 196 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gerezgiher Buruh Abera gbamsc2002@gmail.com :+251910903186 Mekelle, Tigray, Ethiopia
City Postal code Country Position/Affiliation
Mekelle 1871 Ethiopia Mekelle University, College of Health Sciences
Role Name Email Phone Street address
Public Enquiries Solomon Mekonen Abebe solomekonnen@yahoo.com + 251 914 735748 Gondar, Amhara, Ethiopia
City Postal code Country Position/Affiliation
Gondar 196 Ethiopia University of Gondar, College of Medicine and Health Sciences, institute of public health
Role Name Email Phone Street address
Scientific Enquiries Abebaw Gebeyehu Tadese abebawgebeyehu@yahoo.com +251920314519 Gondar, Amhara, Ethiopia
City Postal code Country Position/Affiliation
Gondar 1871 Ethiopia Director University of Gondar College of medicine and health sciences Gondar Ethiopia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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