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.: PACTR202003570419141 Date of Approval: 04/03/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of peer-Led navigation approach as a form of Task Shifting in Promoting Cervical Cancer Screening Knowledge, Intention, and Practices among urban women in Tanzania: A randomized controlled trial
Official scientific title The effect of peer-Led navigation approach as a form of Task Shifting in Promoting Cervical Cancer Screening Knowledge, Intention, and Practices among urban women in Tanzania: A randomized controlled trial
Brief summary describing the background and objectives of the trial Cancer is a global leading non-communicable disease contributing to over 7.9 million deaths annually and the figure is anticipated to escalate to 10 million if effective interventions are not deployed (Ministry of health and social welfare, 2013). The incidence of cervical cancer can be reduced by 80% only under the presence of an effective screening, access to cervical cancer services and improved follow up services (Morrison, 2015). The incidence rate of cervical cancer in Tanzania is 54 per 100,000 population (Kathleen et al, 2016), which is fifth highest in the world (Morrison, 2015). Despite the fact, cervical cancer screening (CCS) services are free of costs (Linde et al., 2019), the participation of women in CCS screened remains unsatisfactory in Tanzania as 6-21% of population (Runge et al., 2019). Knowledge deficit about the disease and screening remains a predominant factor for poor participation in CCS (Powell Pernga et al., 2013). Even though the government conducts public health education to promote awareness of cervical cancer screening aim to overcome the knowledge deficit Medical Women Association of Tanzania, 2018), the screening uptake remain unsatisfactory. This indicates the deficiency of the health education approach (in terms of content), deliverers, and beneficiaries, or it stipulates the presence of multiple screening hindrances that have not been successfully addressed by public health education (Moshi et al., 2018). Therefore, the new intervention approach should be adopted to address multiple screening hindrances. Peer-Led navigation (PLNav) is now widely applied to promote screening behaviour. Even though PLNav is an important approach to increase CCS uptake, there is lack of studies in Tanzania concerning the utilization of this approach. This study aims to assess the effect of peer-led navigation (PLNav) as a form of task shifting in promoting cervical cancer screening knowledge, intention, and practices among urban women in Tanzania.
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 20/03/2020
Actual trial start date 27/03/2020
Anticipated date of last follow up 20/09/2020
Actual Last follow-up date 30/09/2020
Anticipated target sample size (number of participants) 88
Actual target sample size (number of participants) 88
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Usual care Participants in control group will continue to receive usual care Participants in control group will continue to receive usual care for six months Participants randomized to the control group will continue to receive the usual care from the nation awareness rising campaign, information from different Media, friends and relatives. 44 Historical
Experimental Group The Peer Led Navigation PLNav One-time health education session will be delivered by community health workers. Follow-up will conducted at a second week after health education, thereafter monthly. During follow-up, participants received counseling and navigation assistances The health education will be delivered for 2 hours, but the follow-up care will be delivered for six months Participants randomized to the intervention group will receive peer-led navigation (PLNav) from CHWs. Each CHWs will deliver a one-time group education of 11 community women (COMW) (Fang et al., 2017; Han et al., 2017) that last for 2 hours (Fang et al., 2017; Schuster et al., 2015). The health education will be interactive and conducted by a power point, projector, and flip chart to help COMW understand the content clearly (Dunn et al., 2017). During the health education sessions, free drinks will be given to COMW make them feeling comfortable.The education will have 6 sessions and 20 minutes opening session. The details of specific activities and the allocated time is explained here. Introduction session (20 Minutes), learning about the female genital organs (20 Minutes), cervical cancer meaning, causes, risk factors, signs and symptoms (50 Minutes), and prevention of cervical cancer (30 Minutes) (Anne L.R. Schuster et al., 2015). Theory of diffusion of innovation will be utilized to ensure the information from COMW circulate within the community to bring good outcome. The sessions will be conducted with flipcharts to facilitate learning (Dunn et al., 2017; Grace X. Ma et al., 2015). At the end of each session, CHWs will ask questions and facilitate the discussions to promote interactive learning. On the same day, CHWs will schedule appointment dates for women to attend the nearby dispensary to uptake screening (Braun et al., 2015; Thompson, Carosso, Jhingan, Wang, & Holte, 2017). The CHWs will conduct a follow-up by telephone or home visit two weeks after delivered education to find out whether COMW have gone for screening. After that, the follow-ups will be conducted monthly. The purpose of follow-up care will be first to identify COMW’s screening hindrances and provide possible solutions. For instance, counseling will promote positive health beliefs, screening intentions, clear existing misconceptions, and resolve doubts among COMW. 44
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Community women (COMW) should have neither screened for cervical cancer nor received any education related with cancer and aged 30-50 years old. Pregnat women and those with plan to change the residences before six months study period will be excluded from the study Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 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 21/06/2019 Directorate of Research and Publications Consultancy and Insitutional Collaboration of the University of Dodoma
Ethics Committee Address
Street address City Postal code Country
Dodoma Dodoma 41201 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Completion of the uptake of cervical cancer screening and changes in cervical cancer knowledge level 6-months
Secondary Outcome Changes in awareness, intention and health beliefs towards cervical cancer and screening after peer-led navigation PLNav intervention. Other outcomes are social demographic characteristic. 6-months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kawe street Kawe street, Kinondoni manucipal Dar es Salaam United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
The University of Dodoma P.o.box 259, Dodoma Dodoma 41201 United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The University of Dodoma P.o.box 259, Dodoma Dodoma 41201 United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joanes Mboineki 624639045@qq.com +8615639930859 Dodoma, P.o.box 259
City Postal code Country Position/Affiliation
Dodoma 41120 United Republic of Tanzania Assistant Lecturer at the University of Dodoma
Role Name Email Phone Street address
Scientific Enquiries Changying Chen changying.c@yahoo.com +8613523713861 Zhenghou
City Postal code Country Position/Affiliation
Zhengzhou 450000 China Nurse at the first teaching hospital of Zhengzhou University
Role Name Email Phone Street address
Public Enquiries Panpan Wang panpanwang1@outlook.com +8615138927592 Zhenghou University
City Postal code Country Position/Affiliation
Zhengzhou 450000 China Lecturer at Zhenghou University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Four Data collection tools (questionnaires), Interview guide, intervention training model, and health educational guide will be available Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The IPD documents will be available 6 months after the intervention IPD will be open access, and the process of requesting the data or documents will be sent to the correspondent author
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