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.: PACTR201911712227881 Date of Approval: 14/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role of Health Education on Cervical Cancer Screening Uptake at Health Centers of Addis Ababa
Official scientific title Role of Health Education on Cervical Cancer Screening Uptake at Health Centers of Addis Ababa
Brief summary describing the background and objectives of the trial Background: Cervical cancer is one of the most common causes of death among women in developing countries including Ethiopia. Despite its grave outcome, it can also be prevented if detected early. However, awareness about the illness in general and about its way of prevention and the availability of screening and treatment of the illness in specific is limited. Hence, this study aims to determine the role of health education on cervical cancer screening uptake at the health centers of Addis Ababa. Methods: Two arm clustered randomized control trial was conducted at eight primary health centers that provide cervical cancer screening services using visual inspection with acetic acid (VIA) screening method in Addis Ababa, Ethiopia. The eight selected health centers were stratified into two groups as intervention and non-intervention (four intervention and four control groups). Women aged 30-49 years who sought care from these government health centers at family planning, immunization services and children’s clinics (who are underage of five years) and who never screened for cervical cancer participated in the study. In the intervention health centers, all eligible women received a one-to-one brief health education and a brochure concerning cervical cancer in general and the benefits of cervical cancer screening. After two months of time, following the initial data collection, follow-up data were collected to check whether they were screened for cervical cancer
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 31/07/2017
Actual trial start date 02/08/2017
Anticipated date of last follow up 29/12/2017
Actual Last follow-up date 26/01/2018
Anticipated target sample size (number of participants) 2300
Actual target sample size (number of participants) 2139
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health education by the health care provider plus educational brochure The intervention was done once when the study participants visit the health facility After the intervention group got health education; we have waited for two months to check whether they have screened for cervical cancer or not The intervention: Health education based on the health belief model addressed by one-to-one brief health education and educational brochure. Intervention group: In the intervention primary health centers, eligible women were recruited from the selected three units (family planning, immunization service or under five sick child clinics). After mothers were recruited into the study, background information was collected by a structured questionnaire and one-to-one brief health talk which took 5-10 minutes was provided by the health care provider concerning about cervical cancer, risk factors, susceptibility, mode of transmission, treatment and about cervical cancer screening. Additionally, a brochure was given for a mother to read it at her home. If the study participant, could not read and write, information was given for her so that someone from her neighborhood or family member could read the brochure for her. Each woman who participated in the intervention group was communicated by phone after two months from the first day of contact and asked if she has screened for cervical cancer or not. If a woman reported that she was not screened, the reasons for not screening were asked. 2139
Control Group Routine health care service At least once Two months In the control group: Women in the control group were interviewed using the same standard questionnaire. They did not receive both the one-to-one brief health talk and educational brochure except the regular health education provided at health centers. In the package of health education, education about CC is given at least twice a week. Similarly, each woman was asked whether she had screened for cervical cancer through telephone and reasons were asked for those who did not screen two months after the first contact. 1077 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Who had no history of cervical cancer screening Never diagnosed with cervical cancer. Women who gave birth in the past 45 days Pregnant during the study period were excluded from the study. 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 25/01/2017 Addis Ababa University College of Health Sciences Institutional review Board
Ethics Committee Address
Street address City Postal code Country
Zambia Addis Ababa 9086 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Being screened for cervical cancer using VIA or not After two months of time from receiving the intervention
Secondary Outcome Risk factors for not being screened Two months of time
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kolfe Health center Fit. Habte Gyorgis street Addis Ababa Ethiopia
Lideta Health center South Africa street Addis Ababa Ethiopia
Bole Health Center Bole subcity Addis Ababa Ethiopia
Kolfe Wordea 09 health center Kolfe sub city Addis Ababa Ethiopia
Addis Ketema Health center John Melly street Addis Ababa Ethiopia
Nifas Silk Lafto Wordea 09 Health center Nifas silk Lafto sub city Addis Ababa Ethiopia
Arada Health Center Arada sub city Addis Ababa Ethiopia
Felege Selam Health Center Lideta sub city Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Research project Zambia street Addis Ababa 9086 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Research project at AAU Zambia street Addis Ababa 9086 Ethiopia Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Dr. Mitke Molla Zambia Addis Ababa 9008 Ethiopia
Dr. Mahlet Zambia street Addis Ababa Ethiopia
Ms. Abigiya Wondemagenhu Zambia Addis Ababa Ethiopia
Mrs. Esehiwot Tilahun Zambia Addis Ababa Ethiopia
Berhan Tassew Zambia Addis Ababa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Selamawit Abu selamawit.hirpa@gmail.com +251911416192 Bole
City Postal code Country Position/Affiliation
Addis Ababa 1106 Ethiopia Research Fellow Addis Ababa University School of Public Helth
Role Name Email Phone Street address
Scientific Enquiries Mitike Sisay mitikemolla@gmail.com +251911131805 Zambia
City Postal code Country Position/Affiliation
Addis Ababa 9008 Ethiopia Associate professor Addis Ababa University
Role Name Email Phone Street address
Public Enquiries Abigiya Tilahun abitowon@gmail.com +251911567345 Zambia
City Postal code Country Position/Affiliation
Addis Ababa 9008 Ethiopia Lecturer Addis Ababa University School of public Health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data entered with EPidata sofware Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol We have already the data Based on the request to the study team
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not applicable Yes Abstract Background: Cervical cancer is one of the most common causes of death among women in developing countries including Ethiopia. Despite its grave outcome, it can also be prevented if detected early. However, awareness about the illness in general and about its way of prevention and the availability of screening and treatment of the illness in specific is limited. Hence, this study aims to determine the role of health education on cervical cancer screening uptake at the health centers of Addis Ababa. Methods: Two arm clustered randomized control trial was conducted at eight primary health centres that provide cervical cancer screening services using visual inspection with acetic acid (VIA) screening method in Addis Ababa, Ethiopia. The eight selected health centers were stratified into two groups as intervention and non-intervention (four intervention and four control groups). Women aged 30-49 years who sought care from these government health centers at family planning, immunization services and children’s clinics (who are underage of five years) and who never screened for cervical cancer participated in the study. In the intervention health centers, all eligible women received a one-to-one brief health education and a brochure concerning cervical cancer in general and the benefits of cervical cancer screening. After two months of time, following the initial data collection, follow-up data were collected to check whether they were screened for cervical cancer by a phone call. Result: A total of 2,139 women participated in the study, 215 (10%) were screened for cervical cancer, where 151(70%) were from the intervention health centers. Seventy-four percent (74%) of screened women in the intervention health facilities reported that their awareness about the benefits of screening came from either the one to one health education or the print media. Women from the intervention health centers had higher odds of screening (AOR= 2.43,95%CI;1.58-2.90) than those from the control facilities. Women with a first degree or above were two times more likely to screen (AOR=2.03,95%CI;(1.15-2.58) than those who had no formal education. History of STI increased the odds of screening (AOR=1.55,95%CI;1.01-2.40). Conclusion and Recommendation-Providing health education supported by printed educational materials in our case brochure increase the uptake of cervical cancer screening. We recommend integrating one-to-one health education and administering educational brochure about cervical cancer screening with the existing maternal health programs. 12/11/2019 12/11/2019
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks Not applicable
Changes to trial information