Cassim, Nazira, Khatija Ahmed, Gita Ramjee, Thesla Palanee, Tselane Thebe, Lydia Altini, Smruti Patel, Pekka Lähteenmäki, Stephanie Skoler, and Frank J. Kizis. "The prevalence of abnormal Pap smear lesions in HIV-positive and -negative women screened for the Phase 3 trial of Carraguard."

Abstract

BACKGROUND: According to statistics in South Africa, cervical cancer remains the most common malignancy. Premalignant lesions can be detected by Pap smear screening, and early treatment can prevent progression to invasive carcinoma. Therefore our objective is to determine the prevalence of abnormal Pap smear lesions in HIV-positive and -negative women screened for the Phase 3 trial of Carraguard™

METHODS: At screening, women undergo HIV counseling and testing. Their HIV status is confirmed using two rapid tests, Determine™ and Oraquick^®. A Pap smear is performed and microscopic examination is graded according to the Bethesda Classification to exclude cervical carcinoma. Women who are HIV-positive or who have cervical carcinoma are excluded from the trial.

RESULTS: A total of 6,965 women were screened across the three sites, 27% (1,868) were HIV-positive and 73% (5,097) were HIV-negative of whom 9.45% (n=658) had abnormal Pap smear lesions and 21.6% (n=403/1,868) of these abnormal Pap smear lesions detected were found in HIV-positive women as opposed to 5% (n=255/5,097) in HIV-negative women, indicating a significant association between the detection of an abnormal Pap smear lesion and being HIV-positive (p value of < 0.0001). The following abnormal Pap smear findings are indicated according to their HIV-positive and HIV-negative status respectively: High Intraepithelial Lesion (HSIL) 4.2% (n=79/1,868) and 1.3% (n=69/5,097), Low Grade Intraepithelial Lesion (LSIL) 1.1% (n=20/1,868) and 2% (n=92/5,097), Atypical Cells of Undetermined Significance (ASCUS) 4.7% (n=87/1,868) and 1.2% (n=63/5,097), Atypical Cells of Undetermined Significance-cannot exclude High Grade Intraepithelial Lesion (ASCUS-HSIL) 1.40% (n=28/1,868) and 0.50% (n=28/5,097), Atypical Glandular Cells of Undetermined Significance (AGUS) 0.05% (n=1/1,868) and 0% (n=0) and Squamous Carcinoma (CA) 0.01% (n=2/1,868) and 0.05% (n=3/5,097).

CONCLUSION: Women who are HIV-positive have a higher prevalence of abnormal Pap smear lesions than those who are HIV-negative. Due to their immunosuppression, HIV-positive women should be encouraged to have regular Pap smears to detect premalignant lesions, which can be treated early, avoiding rapid progression to carcinoma.

Poster Session
Monday, 24 April 2006, 12:30–1:30 pm
Tuesday, 25 April 2006, 12:30–1:30 pm

Microbicides 2006

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This page updated 3 April 2006

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