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