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.: PACTR202305875223565 Date of Approval: 10/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Determining the most effective recruitment strategy to increase the uptake of visual inspection with/through acetic acid among HPV women in rural Tanzania
Official scientific title Evaluating individual and group recruitment strategies to determine which strategy will increase HPV self-collection uptake among women in the Kilimanjaro region in 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: Compare individual and group recruitment strategies regarding visual inspection with/through acetic acid (VIA) uptake. The primary outcome is the number of HPV-positive participants returning for follow-up (attendance to VIA triage) within 6 weeks of being contacted that their result has been processed. In the spirit of intent-to-treat (ITT), the primary analysis includes all randomized wards and all participants within each ward regardless of whether the participant received an HPV-positive test. Secondary analysis will be completed to 1) generate data at the community- and participant level to determine predictors that may act as moderators of participation in HPV DNA self-collection and cervical cancer screening, 2) understand how recruitment strategies influence preferences for cervical cancer screening uptake, and 3) determine the feasibility, impact, and acceptability of different recruitment strategies and HPV self-sampling. Focus group discussions will be conducted with 1) women who consent to undergo HPV self-sampling and 2) CHWs who completed recruitment to understand the acceptability and feasibility of HPV self-sampling and the recruitment strategies.
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 22/04/2024
Anticipated date of last follow up 01/09/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 1500
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
Parallel: different groups receive different interventions at same time during study 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 Individual Recruitment 3 months Female CHWs, either existing or newly recruited, will be trained to recruit women using the two strategies. Women from both arms will be provided with an informational session about cervical cancer screening and the importance. The session will also discuss HPV and its relationship to cervical cancer. All study participants will be shown ‘Dada’ (‘sister’ in Kiswahili) educational video at the time of recruitment via tablet or mobile phone. The ‘Dada’ educational video consists of a series of testimonies and experiences from Tanzanian women regarding cervical cancer screening, and its importance for prevention of cervical cancer. ‘Dada’ was developed during the initial SEVIA scale-up project with expert and community-based input. Individuals recruited from communities randomized to Arm A will be enrolled using individual recruitment strategies and will be administered with ‘Dada’ to encourage HPV self-collection (and required follow-up). These women will be recruited in one-to-one settings (e.g., markets, saloons, clinic visits). 750 Historical
Experimental Group Group Recruitment 3 months Female CHWs, either existing or newly recruited, will be trained to recruit women using the two strategies. Women from both arms will be provided with an informational session about cervical cancer screening and the importance. The session will also discuss HPV and its relationship to cervical cancer. All study participants will be shown ‘Dada’ (‘sister’ in Kiswahili) educational video at the time of recruitment via tablet or mobile phone. The ‘Dada’ educational video consists of a series of testimonies and experiences from Tanzanian women regarding cervical cancer screening, and its importance for prevention of cervical cancer. ‘Dada’ was developed during the initial SEVIA scale-up project with expert and community-based input. Individuals recruited from communities randomized to Arm B will be administered with ‘Dada’ and enrolled using structured community group-based outreach (we anticipate these will be through faith-based approaches (churches) and women’s financial cooperative groups (VICOBAS)) to encourage HPV self-collection uptake. 750
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) 45 CHWs (at least one CHW per ward for a total of 30 wards) will be selected. The inclusion criteria for 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 54 CECAP providers will be recruited. The inclusion criteria for CECAP 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 27/02/2023 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 27/02/2023 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
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 27/02/2023 Kilimanjaro Christian Medical Centre
Ethics Committee Address
Street address City Postal code Country
PO Box 3010 Moshi 11101 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is the number of HPV positive participants returning for follow-up (attendance to VIA triage) within 6 weeks after being contacted that their result has been processed. In the spirit of intent-to-treat (ITT), the primary analysis includes all randomized wards and all participants within each ward regardless of whether the participant received an HPV positive test. Thus, participants who did not receive a positive HPV test were considered to not meet the primary outcome event, while participants who did test positive for HPV and returned for VIA triage within 6 weeks were considered positive for the primary outcome. This ITT analysis assumes there are no systematic differences in HPV rates between the two treatment groups after controlling for the covariates in the model (described below). However, two sensitivity analyses to confirm the primary results will be performed. First, observed site level HPV positivity rates will be controlled, and second, the analysis among the subgroup of participants who test HPV positive will be performed. The inferential analysis will be performed at the participant level using methods that account for potential heterogeneity between wards (clusters). Due to the relatively small number of wards ruling out robust error approaches (such as generalized estimating equations) combined with the desire to control for both cluster level and participant level variables, a multi-level (i.e. mixed effects) model will be employed, by treating ward as a random effect (i.e. random intercepts model). A generalized mixed log-binomial model will be used to estimate adjusted relative risks and a generalized mixed linear-binomial model to estimate adjusted absolute risk differences. All effect estimates will be provided with 95% confidence intervals. 6 weeks
Secondary Outcome The secondary outcome is to identify demographic factors and geographical location factors associated with HPV screening uptake. Secondary analysis will be completed to 1) generate data at the community- and participant-level to determine predictors that may act as moderators of participation in HPV DNA self-collection and cervical cancer screening, 2) understand how recruitment strategies influence preferences for cervical cancer screening uptake, and 3) determine the feasibility, impact, and acceptability of different recruitment strategies and HPV self-sampling. Focus group discussions will be conducted with 1) women who consent to undergo HPV self-sampling and 2) CHWs who completed recruitment, to understand the acceptability and feasibility of HPV self-sampling and the recruitment strategies. 6 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Pamoja Tunaweza Womens Centre P.O. Box 8434 Moshi 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 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 6135403735 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 Karen Yeates yeatesk@queensu.ca 6135403735 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
Scientific Enquiries Karen Yeates yeatesk@queensu.ca 6135403735 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 Tanzania Regional Nursing Officer and Local Study Manager
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 July 2024. 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