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Outline

Safety and acceptability of a community-based screen-and-treat strategy of cervical cancer prevention in rural Lilongwe, Malawi Lameck Chinula MD Obstetrician and Gynecologist Malawi Inaugural Cancer Symposium. Outline. Introduction Rationale Aim Schema Overview of the Study

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Outline

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  1. Safety and acceptability of a community-based screen-and-treat strategy of cervical cancer prevention in rural Lilongwe, Malawi LameckChinula MD Obstetrician and Gynecologist Malawi Inaugural Cancer Symposium

  2. Outline • Introduction • Rationale • Aim • Schema • Overview of the Study • Key Outcomes • Statistical analysis • Ethical considerations • Future directions

  3. Introduction

  4. Introduction

  5. Rationale • HIV and HPV have synergistic relationship • Between 2007 and 2010, cervical cancer represented 25.4% of AIDS Defining Cancers • Malawi has HIV prevalence of 13% among 15-49yrs old women with highest prevalence (24%) among women aged 35-39 years

  6. Rationale • Cervical cancer is preventable with screening and treatment of precancerous lesions (+HPV vaccine) • However, VIA uptake has been poor, particularly in rural areas, because of limited access to health services Challenges with supplies and consumables: cryogas • Promising data demonstrating the effectiveness of thermo-coagulation

  7. Rationale • Offering cervical cancer screening and HIV testing together, in a community-based campaign, represents a potential solution to the problem of poor access

  8. Aim To assess the safety and acceptability of a community-based cervical cancer screening and treatment program with Visual Inspection with Acetic acid (VIA) and thermo-coagulation, delivered through a campaign in rural Lilongwe, Malawi

  9. Schema

  10. Overview of the study

  11. Key Outcomes Acceptability outcomes: • The proportion of eligible women approached for screening who undergo VIA during the campaign • The proportion of eligible women for thermo-coagulation who undergo thermo-coagulation during the campaign Safety outcome: • The proportion of women attending a health facility for a VIA or thermo-coagulation - related complication

  12. Key Outcomes Effectiveness outcome: • The proportion of women who had CIN II/III at pre-treatment cervical biopsy and regression of CIN II/III or normal histologic result at the 12 week post-treatment cervical biopsy Other outcomes: • The prevalence of abnormal VIA result (either VIA positive or cancer suspect) among women screened. • The prevalence of abnormal VIA result among HIV-infected and HIV-uninfected women screened. • The proportion of women with abnormal VIA result who adhere to referral recommendation within 12 weeks of screening without being traced. • Determinants (enablers and barriers) of adherence or lack thereof to referral recommendation among women with abnormal VIA result.

  13. Statistical Analysis • Continuous variables will be summarized using mean with standard deviation or median and Interquartile Range (IQR) and compared between women with normal and abnormal VIA results using either the Student’s t-test or Kruskal-Wallis test • Categorical variables will be summarized using proportions and compared using Chi-squared test or Fisher’s exact test. • Multivariate analyses will be performed, as needed, to assess for factors associated with histologically-proven high-grade dysplasia from cervical biopsy specimen • For qualitative analysis, we will develop and refine codes, extract subthemes and central ideas, and then identify and explain the data’s core meanings

  14. Ethical Considerations • The protocol, the informed consent form, and study-related documents as required, will be reviewed by Malawi NHSRC and UNC IRB • Participants will be required to give a written informed consent • Approval will also be sought from local authorities, Lilongwe District Health Office and KCH • All unanticipated problems involving risks to human subjects

  15. Future directions • Provide preliminary data on the acceptability, safety, and effectiveness of a community-based screen-and-treat strategy with VIA and thermo-coagulation for cervical cancer prevention in Malawi • May strengthen considerations for larger community-based interventional programmes/studies of cervical cancer screening particularly in underserved population • May necessitate evaluation of the cost-effectiveness of community-based cervical cancer screening programs.

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