An interventional study of Self-collected HPV testing for cervical cancer screening in Human Papillomavirus 16, Human Papillomavirus 18 and Papillomavirus Infections, sponsored by University of British Columbia. Completed at 1 site in Uganda. Open to female participants aged 25 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by University of British Columbia · Not applicable, Interventional, and Screening
The purpose of this pragmatic cluster randomized control trial is to test the effectiveness of cervical cancer screening follow-up completion using two implementation approaches for self-collected HPV testing in a rural, low-resource setting: 1) community health workers recruiting women door-to-door and 2) community health workers recruiting women at community health meetings.
This study will also help to further understand how current patient referral systems are working between health facilities, patient and provider preferences for integrated care and health system related barriers to integrated cervical cancer screening.
Hypothesis: More women will receive screening via the community health meeting but the engagement to care (i.e., visual inspection with acetic acid-our main outcome) will be greater in the door-to-door arm.
A cluster randomized control trial will be conducted with the objective of understanding differences in the effectiveness of cervical cancer screening models using self-collected HPV testing on engagement in care. In 31 villages, women will be recruited for self-collected cervical cancer and sexually transmitted infection (STI) screening by: 1) Community health worker recruitment for self-collection (door-to-door), 2) community health meetings. Visual inspection with acetic acid (VIA), cryotherapy and thermocoagulation will be offered in local health facilities for all women who test positive for high-risk (HR)-HPV types. Women needing advanced cancer care will be referred to the Uganda Cancer Institute in Kampala.
The unit of randomization (2 arms) will be villages and the analysis will also account for clustering within this unit or randomization. All participants will receive an integrated package of cervical cancer screening and education and will participate in a survey at baseline. Samples will be tested using GeneXpert (XpertHPV) point of care testing at the Kigandalo health facility for HPV and high risk HPV (HR-HPV). Intervention arms will be implemented in phases by year to avoid temporal contamination.
505 studies on the registry are indexed under Papillomavirus Infections; 128 are open to participants now.
This study's enrollment of 2,019 is above the median of 202 across 338 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →University of British Columbia is the lead sponsor of 1,335 studies on the registry; 256 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Door-to-door recruitment of women for self-collected HPV testing
Behavioral: Self-collected HPV testing for cervical cancer screening
Community health meeting recruitment of women for self-collected HPV testing
Behavioral: Self-collected HPV testing for cervical cancer screening
Self-collection cervical cancer screening, STI screening, and education on HIV by a community health worker. Women who test positive for high-risk HPV types will be referred to a designated health centre for VIA follow-up and treatment if indicated.
VIA follow-up and treatment when indicated (screen and treat)
Proportion of total screened women who complete VIA follow-up and treatment after testing positive for high-risk HPV type
Time frame: Outcome measured within 6 weeks of self-collection for HPV test
HPV prevalence
Total number of women who test positive for HPV out of the total number of samples obtained
Time frame: Baseline
STI-HPV co-infection rate (Gonorrhea, Syphilis, etc.)
Total number of women who test positive for STIs out of total number of women who test positive for HPV; total number of women who test negative for STIs out of total number of women who test positive for HPV; total number of women who test positive for STIs out of total number of women who test negative for HPV; total number of women who test negative for STIs out of total number of women who test negative for HPV
Time frame: Baseline
HPV and co-morbid conditions
Association (adjusted OR) estimated between HPV and HIV; other STIs
Time frame: Baseline
Barriers and facilitators of engagement in care
Semi-structured focus group discussions with women who did and did not attend follow-up screening in each study arm.
Time frame: FGDs within 3 months of recruitment completion
Identify mediators of engagement of care
Mediation analysis using counterfactual approach to assess mediating effect of patient reported experience, knowledge change and co-infection status with other STIs on engagement in care after positive HR-HPV test
Time frame: Outcome measured within 6 weeks of self-collection for HPV test
Cost-effectiveness of each model of community-based cervical cancer screening
Measured using years of lives saved compared between each study arm and the ICER
Time frame: Modeled lifetime estimates after 1 year follow-up
Process evaluation for integrated community-based cervical cancer screening
Evaluating reach, fidelity, barriers and facilitators of implementation in each arm from the community and health system perspective using mixed methods
Time frame: Within 6 months of final recruitment
Male partner knowledge of cervical cancer screening
Assess men's knowledge level of HPV and cervical cancer and determine which factors impact the supportiveness towards a partner seeking screening.
Time frame: Baseline
Plan to share: No — Data will be available on request through study investigators.
Ran from Aug 2019 to primary completion in Jul 2021, 23 months.
Of 99 non-industry interventional studies with no phase under Papillomavirus Infections, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 55. This study's 23 months is below that.
Counting every sponsor, half of 109 studies reached it within 26 months; a quarter within 12 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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