Cancer
Conditions
Interventions
Individual Recruitment
Group Recruitment
Sponsors
Queens University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Tanzania
Contacts
Public ContactKaren ;Gaudensia Yeates;Olomi
Professor and Clinician Scientist at Queens University;Regional Nursing Officer and Local Study Manager
Outcome results
None listed