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.: PACTR202108529472385 Date of Approval: 05/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Usefulness of Husband-wife pair Education and Counseling on Knowledge, Attitude and Utilization of Cervical Cancer Checkup Services among Child Giving Women in Southern Ethiopia
Official scientific title Effectiveness of Couple Education and Counseling on Knowledge, Attitude and Uptake of Cervical Cancer Screening Service among Women of Child Bearing Age in Southern Ethiopia
Brief summary describing the background and objectives of the trial Cervical cancer occurred nearly in 570 000 women and 311 000 women died from the disease worldwide in 2018. Of the new cases diagnosed globally in 2012, approximately 85% of the share took place in low- and middle-income countries. Human Papiloma virus is the necessary cause for cervical cancer and the majority of these infections resolve naturally but progress to precancerous lesions whenever there is persistence. When treatment is delayed, the precancerous lesions progress to the advanced cancerous stage. Majority of the cervical cancer cases over 80% in sub-Saharan Africa including Ethiopia have been detected at a late stage mainly due to lack of information & effective preventive measures. Implementation of effective interventions could increase early detection and treatment of precancerous changes and significantly reduce the morbidity & mortality associated with advanced disease. Our study, therefore, aims to test the effectiveness of couple education and counseling on knowledge, attitude and uptake of cervical cancer screening.
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 08/10/2021
Actual trial start date 22/10/2021
Anticipated date of last follow up 07/04/2022
Actual Last follow-up date 21/04/2022
Anticipated target sample size (number of participants) 288
Actual target sample size (number of participants) 288
Recruitment status Not yet recruiting
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Usual standard of care Routinely provided services Six months the control group receives the usual standard of care routinely provided by the health care facilities 144 Uncontrolled
Experimental Group Brochure assisted couple education and counseling followed by formal invitation Monthly for three months Six months The intervention group receives brochure assisted couple based education and counseling followed by formal invitation. The couple education and counseling session will be conducted at the participants' residential homes once every month for the first three months. The second three months are passively left for the participants to give them the opportunity to translate the information to behavioral change. 144
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 30-49 years, Legal residency within their respective living quarters for at least six months, Non-pregnant women, Postpartum women beyond three months Women had received the screening services within the last 5 years, Women had hysterectomy, Women diagnosed for any gynecological cancer Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 49 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 16/07/2021 Jimma University Institute of Health Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Kochi Jimma 1000 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cervical cancer screening uptake At baseline and in six months
Secondary Outcome Participants knowledge and attitude At baseline and in six months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kembata Tembaro Zone Health Department Durame Durame 1000 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Jimma University Research Budget Kochi Jimma 1000 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Jimma University Kochi Jimma 1000 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Hosanna College of Health Sciences Hosanna Hosanna 1000 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samuel Yohannes Ayanto contactsamijohn@gmail.com +251912009158 Kochi
City Postal code Country Position/Affiliation
Jimma 1000 Ethiopia PhD fellow
Role Name Email Phone Street address
Public Enquiries Muluemebet Abera Wordofa mulu_abera.ts2009@yahoo.com +251985171738 Kochi
City Postal code Country Position/Affiliation
Jimma 1000 Ethiopia Dean of Public Health Faculty in Jimma University
Role Name Email Phone Street address
Scientific Enquiries Samuel Yohannes Ayanto contactsamijohn@gmail.com +251912009158 Kochi
City Postal code Country Position/Affiliation
Jimma 1000 Ethiopia PhD fellow
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD will be generated after the completion of the data collection Informed Consent Form,Statistical Analysis Plan After the completion of the data collection Official requests
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