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.: PACTR202204872514841 Date of Approval: 22/04/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effectiveness of a letter and brochure to a male partner on Improving Women’s Uptake Of Cervical Cancer Screening in Bahi districts, Dodoma Tanzania: A Cluster Randomized Control Trial
Official scientific title Effectiveness of a letter and brochure to a male partner on Improving Women’s Uptake Of Cervical Cancer Screening in Bahi districts, Dodoma Tanzania: A Cluster Randomized Control Trial
Brief summary describing the background and objectives of the trial Male involvement has been associated with positive reproductive and maternal health outcomes especially in maternal health care utilization, contraceptive use and HIV transmission prevention. As in other reproductive health issues, male involvement may have significant influence on uptake of cervical cancer screening among women, but lack of innovative methods on how to involve male partners in cervical cancer screening services may be the reason for low uptake.
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 01/01/2021
Actual trial start date 01/01/2021
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date 31/03/2021
Anticipated target sample size (number of participants) 315
Actual target sample size (number of participants) 275
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Letter and brochure to male partner None Three months The study is a three-armed cluster randomized control trial that will involve 315 women aged 30 to 50 in Bahi council. One group of women will receive no treatment, Another group will be given health education about cervical cancer and invited to attend screening and the Third group in addition to health education and invitation, will be given a brochure and a letter addressed to their male partner asking them to support their women to undergo screening. Educational materials will be obtained from the Ministry of Health. 91
Control Group Control group Three months Preparation phase • Health education materials: The content and direction for health education about cervical cancer will be obtained from the Ministry of Health (MoH), Section of Reproductive and Child Health (RCHS), Unit of Reproductive Cancers (Rca). • Lesson plan: will be prepared. • Brochures and letters: brochures will be obtained from the MoH. A letter will be prepared by the researcher, edited and stamped by the Department of Public Health of the University of Dodoma and also approved and stamped by the related ministry or government authority. Pre-intervention phase • Training research assistants: cervical cancer screening staff in the health facilities and Community Health Workers from the given study villages will be trained on the research process. • Sampling: After passing through all the required protocols of authority, the researcher will obtain the sampling frame from the three village executive officers and chairmen which is the census of all the eligible women in the given villages and systematically draw the sample population from it. • Recruitment: each individual in the sample list will be contacted by face to face by the research assistants (Community Health Workers) and invited to attend a “women health seminar” for the control group, the participants who will consent, will be required to answer a questionnaire and will be given an identity number and their addresses recorded for follow up. Intervention: The participants will be divided into two classes upon invitation, a morning class and an evening class. The researcher will explain about the research to the possible participants. The researcher will clarify that one can participate in the health education session but not necessarily answer the questionnaire if they did not like to. After filling out the baseline data, a participative health education session will proceed. Those who will consent to answering the questionnaire will be termed as the participants. For t 91 Dose Comparison
Experimental Group Education only Once one week Participants were educated on cervical cancer and cervical cancer screening 93
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Aged 30 to 50 • Have male partner (by marriage, cohabitation or engagement) • Able to speak, read, and understand the Swahili language; and provide informed consent. • Pregnant or in the 3-month postpartum period. According to Tanzanian guidelines, this group of women are not recommended for cervical screening 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 30/12/2020 University of Dodoma ethical Review Board
Ethics Committee Address
Street address City Postal code Country
Iyumbu Dodoma 41xxx United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cervical cancer screening uptake Three weeks
Secondary Outcome Knowledge Immediately
Secondary Outcome Attitude Immediately
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kigwe health centre Kigwe Dodoma 41xxx United Republic of Tanzania
Bahi Health centre Bahi Dodoma 41xxx United Republic of Tanzania
Mundemu health centre Mundemu Dodoma 41xxx United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Atugonza Laurent Iyumbu Dodoma 41xxx United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Atugonza Laurent Iyumbu Dodoma 41xxx United Republic of Tanzania Individual
COLLABORATORS
Name Street address City Postal code Country
Leonard Katalambula Mwangaza Dodoma 41xxx United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Atugonza Laurent laurentatugonza@gmail.com +255768550445 Iyumbu
City Postal code Country Position/Affiliation
Dodoma 41xxx United Republic of Tanzania Student
Role Name Email Phone Street address
Scientific Enquiries Leonard Katalamnula katalambulal@gmail.com +255758921000 Kisasa
City Postal code Country Position/Affiliation
Dodoma 41xxx United Republic of Tanzania Lecturer
Role Name Email Phone Street address
Public Enquiries Enock Mwakalila emwakalila2@gmail.com +255719048451 Iyumbu
City Postal code Country Position/Affiliation
Dodoma 41xxx United Republic of Tanzania Ethical review board member
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data that will be collected will be available after deiddentification Clinical Study Report,Study Protocol Immediately following publication Researchers who provide methodologically sound proosal
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