title: Randomized Cross-Sectional Study to Compare HIV-1 Specific Antibody and Cytokine Concentrations in Female Genital Secretions Obtained by Menstrual Cup and Cervicovaginal Lavage.
abstract: BACKGROUND
  Optimizing methods for genital specimen collection to accurately characterize mucosal immune responses is a priority for the HIV prevention field. The menstrual cup (MC) has been proposed as an alternative to other methods including cervicovaginal lavage (CVL), but no study has yet formally compared these two methods.
  
  
  METHODS
  Forty HIV-infected, antiretroviral therapy-naïve women from the CAPRISA 002 acute HIV infection cohort study were randomized to have genital fluid collected using the MC with subsequent CVL, or by CVL alone. Qualitative data, which assessed levels of comfort and acceptability of MC using a 5-point Likert scale, was collected. Luminex multiplex assays were used to measure HIV-specific IgG against multiple gene products and 48 cytokines.
  
  
  RESULTS
  The majority (94%) of participants indicated that insertion, wearing and removal of the MC was comfortable. Nineteen MCs with 18 matching, subsequent CVLs and 20 randomized CVLs were available for analysis. Mucosal IgG responses against four HIV-antigens were detected in 99% of MCs compared to only 80% of randomized CVLs (p = 0.029). Higher specific antibody activity and total antibodies were observed in MCs compared to CVL (all p<0.001). In MCs, 42/48 (88%) cytokines were in the detectable range in all participants compared to 27/48 (54%) in CVL (p<0.001). Concentrations of 22/41 cytokines (53.7%) were significantly higher in fluid collected by MC. Both total IgG (r = 0.63; p = 0.005) and cytokine concentrations (r = 0.90; p<0.001) correlated strongly between MC and corresponding post-MC CVL.
  
  
  CONCLUSIONS
  MC sampling improves the detection of mucosal cytokines and antibodies, particularly those present at low concentrations. MC may therefore represent an ideal tool to assess immunological parameters in genital secretions, without interfering with concurrent collection of conventional CVL samples.
authors.affiliation: Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: Derseree
authors.initials: D
authors.lastname: Archary
authors.affiliation: Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: Lenine J
authors.initials: LJ
authors.lastname: Liebenberg
authors.affiliation: Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: Lise
authors.initials: L
authors.lastname: Werner
authors.affiliation: Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: Sahil
authors.initials: S
authors.lastname: Tulsi
authors.affiliation: Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: Nelisile
authors.initials: N
authors.lastname: Majola
authors.affiliation: Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: Nivashnee
authors.initials: N
authors.lastname: Naicker
authors.affiliation: Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: Sarah
authors.initials: S
authors.lastname: Dlamini
authors.affiliation: Department of Cell & Molecular Biology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States of America.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Hope
authors.affiliation: Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: Natasha
authors.initials: N
authors.lastname: Samsunder
authors.affiliation: Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, United States of America.
authors.forename: Salim S
authors.initials: SS
authors.lastname: Abdool Karim
authors.affiliation: Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa; National Institute for Communicable Diseases, Johannesburg, South Africa.
authors.forename: Lynn
authors.initials: L
authors.lastname: Morris
authors.affiliation: Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa; Infectious Disease and Molecular Medicine, University of Cape Town, Observatory, Cape Town, South Africa; National Health Laboratory Services, Cape Town, South Africa.
authors.forename: Jo-Ann S
authors.initials: JA
authors.lastname: Passmore
authors.affiliation: Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
authors.forename: Nigel J
authors.initials: NJ
authors.lastname: Garrett
mesh_terms: D000328:Adult; D001826:Body Fluids / Q000276:immunology*; D002584:Cervix Uteri / Q000276:immunology*; D015331:Cohort Studies; D003430:Cross-Sectional Studies; D016207:Cytokines / Q000276:immunology*; D005260:Female; D015483:HIV Antibodies / Q000276:immunology*; D015488:HIV Antigens / Q000276:immunology; D015658:HIV Infections / Q000276:immunology*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D018928:Immunity, Mucosal / Q000276:immunology; D007074:Immunoglobulin G / Q000276:immunology; D009092:Mucous Membrane / Q000276:immunology; D013048:Specimen Handling / Q000379:methods; D014621:Vagina / Q000276:immunology*
chemical_list: D016207:Cytokines; D015483:HIV Antibodies; D015488:HIV Antigens; D007074:Immunoglobulin G