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Randomized Cross-Sectional Study to Compare HIV-1 Specific Antibody and Cytokine Concentrations in Female Genital Secretions Obtained by Menstrual Cup and Cervicovaginal Lavage.

Archary D, Liebenberg LJ, Werner L, Tulsi S, Majola N, Naicker N, Dlamini S, Hope TJ, Samsunder N, Abdool Karim SS, Morris L, Passmore JA, Garrett NJ - PLoS ONE (2015)

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.

ABSTRACT

Introduction: 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.

No MeSH data available.


Related in: MedlinePlus

Schema of study design.
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pone.0131906.g001: Schema of study design.

Mentions: Twenty women were randomized to the MC (SoftCup, EuroFemPro, Netherlands, or the SoftCup, Instead Inc., San Diego, CA) arm (Fig 1). This involved the vaginal insertion of a MC by either a study clinician or nurse for a period of two hours. During this two hour period with the inserted MC, participants proceeded with the routine study specific procedures including for e.g. blood draws and clinical examination. Immediately after assisted removal of the MC by the health professional, routine collection of CVL was performed. Participants carried on with their routine study visit during this time. In the MC arm, one participant was excluded from further evaluation due to menstrual blood contamination, and another participant did not provide a CVL specimen. Therefore, there were a total of 19 MC arm samples and 18 with matching post-MC CVLs. A further 20 women were randomized to the CVL only arm of the study, the current standard of sample collection in the CAPRISA 002 study. Questionnaires with 5-point Likert scales describing levels of comfort and acceptability were distributed to all women from the MC arm after the procedure, and were collected after completion by the participants.


Randomized Cross-Sectional Study to Compare HIV-1 Specific Antibody and Cytokine Concentrations in Female Genital Secretions Obtained by Menstrual Cup and Cervicovaginal Lavage.

Archary D, Liebenberg LJ, Werner L, Tulsi S, Majola N, Naicker N, Dlamini S, Hope TJ, Samsunder N, Abdool Karim SS, Morris L, Passmore JA, Garrett NJ - PLoS ONE (2015)

Schema of study design.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4492781&req=5

pone.0131906.g001: Schema of study design.
Mentions: Twenty women were randomized to the MC (SoftCup, EuroFemPro, Netherlands, or the SoftCup, Instead Inc., San Diego, CA) arm (Fig 1). This involved the vaginal insertion of a MC by either a study clinician or nurse for a period of two hours. During this two hour period with the inserted MC, participants proceeded with the routine study specific procedures including for e.g. blood draws and clinical examination. Immediately after assisted removal of the MC by the health professional, routine collection of CVL was performed. Participants carried on with their routine study visit during this time. In the MC arm, one participant was excluded from further evaluation due to menstrual blood contamination, and another participant did not provide a CVL specimen. Therefore, there were a total of 19 MC arm samples and 18 with matching post-MC CVLs. A further 20 women were randomized to the CVL only arm of the study, the current standard of sample collection in the CAPRISA 002 study. Questionnaires with 5-point Likert scales describing levels of comfort and acceptability were distributed to all women from the MC arm after the procedure, and were collected after completion by the participants.

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Centre for the AIDS Programme of Research in South Africa, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.

ABSTRACT

Introduction: 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.

No MeSH data available.


Related in: MedlinePlus