Prevention of Cervical Cancer Through an HPV-based Screen-and-treat Strategy in Malawi
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The purpose of the study is to determine the acceptability, appropriateness, and feasibility
      of implementing new strategies to screen and treat eligible women for cervical cancer through
      a cluster randomized trial of two different models. Both models offer the same screening and
      treatment algorithm, but one will be based in Voluntary Family Planning (VFP) or other
      clinics and the second will be based in the community. Participants will be recruited from
      two districts in Malawi with the highest HIV prevalence in the country: Lilongwe in the
      Central Region and Zomba in the Southern Region.
    

Detailed description: 
      Cervical cancer is largely preventable through screening and preventive therapy. This is a
      cluster randomized trial that will integrate a novel cervical cancer screen-and-treat
      algorithm into voluntary family planning (VFP) services via two different models aimed at
      reducing barriers to screening and treatment in resource limited settings. Model 1 involves:
      1) cervico-vaginal self-sampling for high-risk HPV (hr-HPV) while waiting for appointments at
      the VFP clinic or other clinics, 2) same-day visual inspection with acetic acid (VIA) for
      those women found to be hr-HPV-positive by rapid GeneXpert HPV testing, and 3) same-day
      thermocoagulation treatment for HPV-positive women who are eligible for ablative therapy by
      VIA. Model 2 will offer women the same services as in Model 1, but they will also be given
      the option to perform cervico-vaginal self-sampling in the community via Heath Surveillance
      Assistants (HSAs) who will bring their HPV sample to the clinic and notify them to return to
      the clinic for VIA and possible same-day thermocoagulation if their hr-HPV test is positive.
      Participants will be recruited from 16 high HIV-prevalence clinics in either Lilongwe in the
      Central Region or Zomba in the Southern Region. The broad objective of the project is to
      compare the effectiveness and budget impact of these two models for averting potential
      cervical cancer cases and to evaluate the implementation and acceptability of the models in
      multiple different health care facility settings.

      A systematic Implementation Evaluation will be conducted throughout implementation of the
      assigned models at the study health facilities to determine the success/failure in the
      delivery of intervention packages. The study team will employ the following mixed method data
      collection assessments:

        -  In-Depth Interviews with purposively selected healthcare facility staff and clients in
           the sampled facilities (N = approximately 60).

        -  Focus group discussions (FGDs) with purposively selected in-clinic services providers
           and HSAs (N = approximately 160).

        -  Structured weekly observations of service delivery by clinical mentors using an
           observation checklist, to observe providers and laboratorians adherence to standards,
           guidelines and intervention protocols.

        -  Aggregate collection of routine quantitative service utilization data from adapted
           family planning and cervical cancer screening registers.

        -  Implementation of assessment tools to assess changes in service providers' workload.

        -  Client Exit Surveys with women in the catchment areas of the targeted facilities who
           received or declined family planning and/or cervical cancer screening services at the
           facility or in the community (N= approximately 1,000).

        -  Time and motion studies to observe visits and staff time spent on counseling, screening
           and treatment procedures, and managing and testing specimens.

      Finally, an Endline Household Survey will be completed among a random sample of women
      selected from all of the facilities' catchment areas (N= approximately 8,000). This survey
      will ask questions about basic demographic information, reproductive health information, HIV
      status, distance to the nearest health facility, prior VFP use, VFP use during project
      implementation, prior cervical cancer screening and preventive therapy (CCSPT) services
      received, and any CCSPT services received during project implementation.
    

Intervention name(s): Community-based HPV screening strategy; Clinic-based HPV screening strategy
Intervention type(s): Other; Other
Intervention description(s): Offering HPV self-collection for cervical cancer screening in the community; Offering HPV self-collection for cervical cancer screening in the clinic
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Model 1 involves: 1) cervico-vaginal self-sampling for high-risk HPV (hr-HPV) while waiting for appointments at the VFP clinic or other clinics, 2) same-day VIA for those women found to be hr-HPV-positive by rapid GeneXpert HPV testing, and 3) same-day thermocoagulation treatment for HPV-positive women who are eligible for ablative therapy by VIA.
Model 2 will offer women the same services as in Model 1, but they will also be given the option to perform cervico-vaginal self-sampling in the community, via Heath Surveillance Assistants (HSAs) who will bring their HPV sample to the clinic and notify them to return to the clinic for VIA and possible same-day thermocoagulation if their hr-HPV test is positive.
Masking: None (Open Label)
Primary purpose: Health Services Research