Integrated Cervical Cancer Screening in Mayuge District Uganda (ASPIRE Mayuge)
Condition: Human Papillomavirus 16; Human Papillomavirus 18; Papillomavirus Infections; Cervical Cancer; Pre-Cancerous Dysplasia
MeSH terms: Papillomavirus Infections; Uterine Cervical Neoplasms
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Self-collected HPV testing for cervical cancer screening
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pragmatic cluster randomized control trial
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Human Papillomavirus DNA Tests; Visual inspection with acetic acid; Global Health; Developing Countries; Self-collection; Cervical Cancer Screening