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.: PACTR202307605212308 Date of Approval: 31/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Determining the most effective combination of patient navigation strategies to reduce loss-to-follow-up in the cervical cancer screening pathway in Tanzania
Official scientific title Evaluating the most effective ‘package’ of mHealth supported patient navigation strategies to encourage cervical cancer screening among HPV+ women and reduce the number of women lost-to-follow-up in Kilimanjaro, Tanzania
Brief summary describing the background and objectives of the trial Background: The burden of cervical cancer in Tanzania ranks one of the highest in the world, with 9,772 new cases and 6,695 deaths reported each year. The national Cervical Cancer Prevention (CECAP) program is currently based on visual assessment with acetic acid (VIA) with coverage well below 20%. There is little evidence to inform recruitment strategies that might improve attendance rates. In addition, as per recommendations by the WHO and the MoH, primary HPV DNA testing should be incorporated within the CECAP program and the coverage target is set at 60% by 2024. Aims/Objectives: 1) To determine if the WEMA App can improve patient navigation services, we will evaluate each woman’s access to required follow-up screening and treatment services (called navigation checkpoints) defined as completion of the entire required (guideline-based) screening and treatment care pathway at timed-intervals. Completion of VIA by 6 weeks will be the primary outcome. Examine attendance at a participating CECAP clinic and completion of visual inspection of the cervix for assessment for treatment (if HPV DNA positive for high-risk genotypes). The intent is for the HPV positive women to come into VIA within 4 weeks of receiving their positive result (women will officially be lost to follow-up at 6 weeks). 2) Completion of the navigation passport at 6 months will be the secondary outcome. We will be evaluating the post-intervention in each group through surveys.
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 01/09/2023
Actual trial start date 05/02/2024
Anticipated date of last follow up 05/02/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 2000
Actual target sample size (number of participants)
Recruitment status 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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Enhanced usual care 12 months In the control, each woman will receive standardized nurse-delivered counseling (a standardized script will be prepared). This will be delivered at the time the nurse receives the woman’s HPV+ result. In community recruitment, community health workers will be delivering enhanced-usual care. 500 Historical
Experimental Group Nurse navigation plus enhanced usual care 12 months HPV+ women will receive phone calls from nurses to remind/encourage them to attend visual inspection with/through acetic acid (VIA). Upon attending VIA, women will continue to be reminded and encouraged to attend additional appointments/navigation checkpoints (women will be navigated depending on their unique treatment and care pathway). In this experimental condition, women will receive phone calls from nurses to remind them of their upcoming appointments/navigation checkpoints. 500
Experimental Group App navigation plus enhanced usual care 12 months HPV+ women will receive phone calls from nurses to remind/encourage them to attend visual inspection with/through acetic acid (VIA). Upon attending VIA, women will continue to be reminded and encouraged to attend additional appointments/navigation checkpoints (women will be navigated depending on their unique treatment and care pathway). In this experimental condition, women will receive text/SMS messages from the WEMA application to remind them of their upcoming appointments/navigation checkpoints. 500
Experimental Group Nurse navigation plus app navigation plus enhanced usual care 12 months HPV+ women will receive phone calls from nurses to remind/encourage them to attend visual inspection with/through acetic acid (VIA). Upon attending VIA, women will continue to be reminded and encouraged to attend additional appointments/navigation checkpoints (women will be navigated depending on their unique treatment and care pathway). In this experimental condition, women will receive phone calls from the nurses AND text/SMS messages from the WEMA application to remind them of their upcoming appointments/navigation checkpoints. 500
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criteria for participants is the following: - Gender: person with an intact cervix - Age: 25 (if HIV positive) and/or age 30 to 49 years old at the time of enrollment as reported verbally - Residence in the study-defined catchment area - Language: able to speak/understand English (preferred) or Kiswahili (if the participant cannot read the consent will be read to her and a thumbprint will suffice for consent) The inclusion criteria for the CHWs is the following: - Women - Physically fit/ambulatory - Secondary school completion (preferred) - Can read and write in Kiswahili and ‘basic’ English - Experience using Android smartphone/tablets (preferred) - Can be trained to perform informed consent process The inclusion criteria for the providers is the following: - CECAP provider of a CECAP site in the Kilimanjaro region - Participated in previous SEVIA training (familiar with cervical images and review process) - Can read and write in Kiswahili and English - Experience using technology/tablets (preferred) The exclusion criteria for the women is the following: - Current pregnancy (if verbally reported as currently pregnant or possibly pregnant) - History of cervical cancer - History of hysterectomy - Unwilling to collect vaginal specimen for any reason (note that menstrual bleeding is not a contraindication if women are willing to collect the specimen while bleeding) - Apparent inability to give informed consent - Unwillingness to participate Adult: 19 Year-44 Year 25 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
No 13/03/2023 National Institute of Medical Research
Ethics Committee Address
Street address City Postal code Country
3 Barack Obama Drive Dar es Salaam 11101 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 13/03/2023 Kilimanjaro Christian Medical Centre
Ethics Committee Address
Street address City Postal code Country
PO Box 3010 Moshi 11101 Tanzania
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 13/03/2023 Queens University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board
Ethics Committee Address
Street address City Postal code Country
74 University Avenue Kingston K7L 3N6 Canada
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is women attending VIA within 6 weeks of receiving a positive HPV result. Women will be randomized at the time they receive a phone call to tell them that their result has been processed. 6 weeks
Secondary Outcome The proportion of navigation checkpoints that each woman completes in their unique care/treatment pathway (e.g., completion of thermal ablation), 6 months after attending VIA. 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kilimanjaro Christian Medical Centre PO Box 3010 Moshi Tanzania
Mawenzi Regional Referral Hospital Kilima Street Moshi Tanzania
TPC Hospital N/A Pasua Tanzania
Kibosho Hospital N/A Kibosho Magharibi Tanzania
Hai District Hospital N/A Bomangombe Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Grand Challenges Africa 8 Miotoni Lane Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Queens University 94 Stuart Street Kingston K7L 3N6 Canada University
COLLABORATORS
Name Street address City Postal code Country
Mark Schiffman 9609 Medical Center Drive Rockville 20850 United States of America
Silvia de Sanjose 9609 Medical Center Drive Rockville 20850 United States of America
Karen Yeates 94 Stuart Street Kingston K7L 3N6 Canada
Safina Yuma Wizara Ya Afya Dodoma Tanzania
Bariki Mchome PO Box 3010 Moshi Tanzania
Alex Mremi PO Box 3010 Moshi Tanzania
Federica Inturrisi 9609 Medical Center Drive Rockville United States of America
Melinda Chelva 94 Stuart Street Kingston K7L 3N6 Canada
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Karen Yeates yeatesk@queensu.ca +16135403735 94 Stuart Street
City Postal code Country Position/Affiliation
Kingston K7L 3N6 Canada Professor and Clinician Scientist at Queens University
Role Name Email Phone Street address
Public Enquiries Gaudensia Olomi g.olomi@kcri.ac.tz +255756831210 P.O. Box 8434
City Postal code Country Position/Affiliation
Moshi United Republic of Tanzania Regional Nursing Officer and Local Program Manager
Role Name Email Phone Street address
Scientific Enquiries Karen Yeates yeatesk@queensu.ca +16135403735 94 Stuart Street
City Postal code Country Position/Affiliation
Kingston K7L 3N6 Canada Professor and Clinician Scientist at Queens University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available (including data dictionaries). Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. Study protocol will be available. The data will be available beginning 9 months and ending 36 months following article publication, with investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose. The data will be used for individual participant meta-analysis. Proposal may be submitted up to 36 months following article publication. After 36 months the data will be available in our University’s data warehouse but without investigator support other than deposited metadata. Study Protocol IPD will be available to share once recruitment begins. Study protocol is currently available and will be accessible until March 2023. Only research team members, collaborators, and government stakeholders will be able to access the data (access will be controlled). Data will be used for individual participant meta-analysis. Requests for data should be sent to the listed PI through email; PI will handle all requests. Criteria for reviewing requests will include the quality of the request and the intended purpose.
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