Obstetrician and Gynecologist Malawi Inaugural Cancer Symposium 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 Key Outcomes Statistical analysis Ethical considerations Future directions

Introduction

Introduction

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 ICC:

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 Known barriers consist of long distances as well as a failure to integrate cancer screening services into HIV and reproductive health services

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

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

Schema

Overview of the study

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

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.

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 If we find that multiple variables are associated with an abnormal VIA result, multivariate analyses will be performed to assess for factors associated with histologically-proven high-grade dysplasia from cervical biopsy specimen

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

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.