Background: The incidence and mortality rates of cervical cancer in Haiti are among the highest in the world, yet the screening coverage rate is among the lowest. Efforts to ameliorate this problem using cytology-based programs have fallen short due to geographic, socioeconomic, cultural, and infrastructural barriers to access. A prevention strategy based on vaginal, self-screening for high-risk (HR) HPV in communities may increase coverage by avoiding or diminishing these impediments. This study examined the diagnostic performance of self-screening when compared to clinician screening in two clinics in Port-au-Prince.

Methods: 1836 women participated in a cross-sectional study in which each underwent vaginal and cervical screening for HR HPV, and HIV rapid testing. HR HPV positive women returned for follow-up testing with colposcopy and biopsy. Data analysis explored the concomitant tests' comparative performance using percent agreements with Kappa statistics, test positivity, and the ability to detect various levels of biopsy-confirmed cervical intraepithelial neoplasia. Age related prevalence rates were also determined. Statistical associations were measured using Chi-Square, Fisher’s Exact, and McNemar’s Tests.

Results: Overall concomitant test agreement was strong (91.39%, K=0.73), but varied with statistical significance by age in the youngest and oldest quartiles. Women between 42 and 48 years old demonstrated the highest concordance (93.45%, K=0.70). Vaginal test positivity was uniformly higher than cervical test positivity among participants of all ages. Vaginal samples identified 84.46% of HR HPV cases that cervical samples identified, and more than 90% of all high grade disease. However, clinician screening accurately detected several more clinically relevant cases of disease (= CIN I) (56) than self-screening (53).

Conclusion: Strong test agreement indicated that vaginal screening produced comparable results to clinician screening, and age-related statistics may be able to inform test algorithms in the future. With plans to establish pathology labs in Leogane and Port-au-Prince that employ local talent and utilize the relatively affordable CareHPV Assay (QIAGEN), self-screening may be a diagnostically sound and financially feasible cervical cancer prevention strategy in Haiti.