Shameem Z Jaumdally1, Heidi E Jones2, Donald R Hoover3, Hoyam Gamieldien1, Jean-Mari Kriek1, Nontokozo Langwenya4, Landon Myer4, Jo-Ann S Passmore1,5, Catherine S Todd6. 1. Division of Medical Virology, Institute of Infectious Disease and Molecular Medicine (IDM), University of Cape Town, Cape Town, South Africa. 2. Department of Epidemiology and Biostatistics, City University of New York Graduate School of Public Health & Health Policy, New York, NY, USA. 3. Department of Statistics & Biostatistics, Rutgers The State University, Piscataway, NJ, USA. 4. Division of Epidemiology & Biostatistics and Centre for Infectious Diseases Epidemiology & Research School of Public Health & Family Medicine, University of Cape Town, Cape Town, South Africa. 5. National Health Laboratory Services, Cape Town, South Africa. 6. FHI 360, Durham, NC, USA.
Abstract
PROBLEM: How does menstrual cup (MC) compare to other genital sampling methods for HIV RNA recovery? METHOD OF STUDY: We compared HIV RNA levels between MC, endocervical swab (ECS), and ECS-enriched cervicovaginal lavage (eCVL) specimens in 51 HIV-positive, antiretroviral therapy-naive women at enrollment, 3 and 6 months, with order rotated by visit. Paired comparisons were analyzed with McNemar's exact tests, signed-rank tests, and an extension of Somer's D for pooled analyses across visits. RESULTS: MC specimens had the highest proportion of quantifiable HIV VL at enrollment and month 3, but more MC specimens (n=12.8%) were insufficient for testing, compared with ECS (2%, P=0.006) and eCVL (0%, P<0.001). Among sufficient specimens, median VL was significantly higher for MC (2.62 log10 copies/mL) compared to ECS (1.30 log10 copies/mL, P<0.001) and eCVL (1.60 log10 copies/mL, P<0.001) across visits. CONCLUSION: MC may be more sensitive than eCVL and CVS, provided insufficient specimens are reduced.
RCT Entities:
PROBLEM: How does menstrual cup (MC) compare to other genital sampling methods for HIV RNA recovery? METHOD OF STUDY: We compared HIV RNA levels between MC, endocervical swab (ECS), and ECS-enriched cervicovaginal lavage (eCVL) specimens in 51 HIV-positive, antiretroviral therapy-naive women at enrollment, 3 and 6 months, with order rotated by visit. Paired comparisons were analyzed with McNemar's exact tests, signed-rank tests, and an extension of Somer's D for pooled analyses across visits. RESULTS:MC specimens had the highest proportion of quantifiable HIV VL at enrollment and month 3, but more MC specimens (n=12.8%) were insufficient for testing, compared with ECS (2%, P=0.006) and eCVL (0%, P<0.001). Among sufficient specimens, median VL was significantly higher for MC (2.62 log10 copies/mL) compared to ECS (1.30 log10 copies/mL, P<0.001) and eCVL (1.60 log10 copies/mL, P<0.001) across visits. CONCLUSION:MC may be more sensitive than eCVL and CVS, provided insufficient specimens are reduced.
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