Cervical cancer and cervical pre-cancer Cancer
Conditions
Interventions
The purpose of this randomized control trial is to test the effectiveness of cervical cancer screening follow-up completion using two implementation approaches for self-collected HPV (human papilloma
Sponsors
University of British Columbia
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women with no previous history of hysterectomy or invasive cervical cancer 2. Aged 25-49 years old 3. Not previously been screened and treated for cervical cancer 4. Provided written informed consent
Exclusion criteria
Exclusion criteria: Do not fulfil inclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the rate of follow-up care for women who test positive for HR-HPV types out of all women screened in each trial arm. This will include the total number of women who completed self-collection cervical cancer screening at baseline and the proportion of women who complete VIA follow-up and treatment after testing positive for high-risk HPV type at endline (two weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. HPV prevalence at baseline: Total number of women who test positive for HPV out of the total number of samples obtained. 2. STI-HPV co-infection rate (Gonorrhea, Syphilis, etc.) at baseline: 2.1 Total number of women who test positive for STIs out of total number of women who test positive for HPV 2.2 Total number of women who test negative for STIs out of total number of women who test positive for HPV 2.3 Total number of women who test positive for STIs out of total number of women who test negative for HPV 2.4 Total number of women who test negative for STIs out of total number of women who test negative for HPV. 3. HPV and co-morbid conditions at baseline: Association (adjusted OR) estimated between HPV and HIV; other STIs. 4. Health system related challenges to women accessing integrated care in communities and facilities: 4.1 The number of HPV+ women who received VIA/treatment at endline out of the number of women referred for VIA/Treatment at baseline 4.2 The number of HPV+ women who did not receive VIA/treatment at endline out of the number of women referred for VIA/Treatment at baseline. Reasons for attending or not attending follow-up will be identified through surveys at endline. 5. Identify differences and challenges in treatment outcomes for WLWHA: risk difference in treatment follow-up attendance between WLWHA vs. non-HIV participants at endline. Other outcomes: 6. Cost and feasibility collected through surveys at the local health centre and by review of the national stores pricing for all consumables required for the screening and follow-up program. Program costs will be collected through review of the study related budget and receipts and time to task variables collected through clinical observation and study process documentation. 7. Determinants of successful training and capacity building of the health workforce, and 8. Government engagement and evidence uptake successes and challenges collected through ongoing documentation of study proces | — |
Countries
Canada, Uganda
Contacts
Public ContactBeth Payne
Outcome results
None listed