Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge) (ASPIRE)

  • STATUS
    Recruiting
  • days left to enroll
    16
  • participants needed
    1655
  • sponsor
    University of British Columbia
Updated on 5 March 2022
cancer
hysterectomy
cancer screening
cervical cancer screening
human papilloma virus vaccine
Accepts healthy volunteers

Summary

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.

Description

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.

Details
Condition Human Papillomavirus 16, Human Papillomavirus 18, Papillomavirus Infections, Cervical Cancer, Pre-Cancerous Dysplasia
Treatment Self-collected HPV testing for cervical cancer screening
Clinical Study IdentifierNCT04000503
SponsorUniversity of British Columbia
Last Modified on5 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Women with no previous history of hysterectomy
aged 25-49 years old
no previous history of treatment for cervical cancer
provided written informed consent

Exclusion Criteria

Women who are under 25 or over 49 years of age
who have previously had a hysterectomy or been treated for cervical cancer
unable to provided informed consent
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