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A Randomized Crossover Study Evaluating the Use and Acceptability of the SILCS Diaphragm Compared to Vaginal Applicators for Vaginal Gel Delivery

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Abstract

Introduction

This study aimed to assess acceptability and preferences for the SILCS diaphragm for vaginal gel delivery compared to a prefilled applicator.

Methods

A randomized crossover study among 115 women in South Africa, using both methods during five sex acts.

Results

We found no significant differences in acceptability between the two products. Experience of gel leakage after sex was greater when inserted via applicator. More women were interested in SILCS/gel for multipurpose protection (68%) than in either SILCS alone (17%) or microbicide gel alone (14%).

Conclusions

A SILCS gel delivery system for multipurpose prevention seems feasible and acceptable.

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Acknowledgements

We would like to thank the women and men from Commercial City Clinic who generously shared their time and views to make this research possible, and Commercial City Clinic staff for providing support for the research activities. The authors would like to thank Jennifer Foster, Clinical Coordinator at PATH, for assistance in developing and coordinating this study. This project was made possible by the generous support of the American people through the United States Agency for International Development (USAID) under the terms of HealthTech Cooperative Agreement #AID-OAA-A-11-00051. The contents are the responsibility of PATH and the MatCH Research Unit and do not necessarily reflect the views of USAID or the US government.

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Authors and Affiliations

  1. MatCH Research Unit [Maternal, Adolescent and Child Health Research Unit], Department of Obstetrics and Gynaecology, Faculty of Health Sciences, University of the Witwatersrand, Durban, 3629, South Africa

    Mags Beksinska, Ross Greener, Jenni Smit, Busi Maphumulo & Nonhlanhla Mphili

  2. PATH, PO Box 900922, Seattle, WA, 98119, USA

    Maggie Kilbourne-Brook & Patricia S. Coffey

Authors
  1. Mags Beksinska
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  2. Ross Greener
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  3. Jenni Smit
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  4. Busi Maphumulo
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  5. Nonhlanhla Mphili
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  6. Maggie Kilbourne-Brook
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  7. Patricia S. Coffey
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Corresponding author

Correspondence to Mags Beksinska.

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Conflict of interest

The authors declare they have no conflict of interest.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Beksinska, M., Greener, R., Smit, J. et al. A Randomized Crossover Study Evaluating the Use and Acceptability of the SILCS Diaphragm Compared to Vaginal Applicators for Vaginal Gel Delivery. AIDS Behav 22, 127–132 (2018). https://doi.org/10.1007/s10461-017-1913-4

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  • DOI: https://doi.org/10.1007/s10461-017-1913-4

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