A Temperature-Monitoring Vaginal Ring for Measuring Adherence
| Autor: | Delphine Desjardins, R. Karl Malcolm, Sandeep Kumar, Berglind Helgadóttir, Nathalie Dereuddre-Bosquet, Susan M. Fetherston, Roger LeGrand, Peter Boyd, Ásgeir Bjarnason, Manjulaa Narasimhan |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
Temperature monitoring
medicine.medical_specialty Sexual transmission Thermometers Human immunodeficiency virus (HIV) lcsh:Medicine medicine.disease_cause Body Temperature Medical grade silicone chemistry.chemical_compound Silicone SDG 3 - Good Health and Well-being medicine Animals lcsh:Science Clinical Trials as Topic Multidisciplinary Vaginal microbicide business.industry lcsh:R Contraceptive Devices Female Vaginal ring Surgery Microbicides for sexually transmitted diseases Macaca fascicularis chemistry Silicone Elastomers Female lcsh:Q business Research Article Biomedical engineering |
| Zdroj: | Boyd, P, Desjardins, D, Kumar, S, Fetherston, S M, Le-Grand, R, Dereuddre-Bosquet, N, Helgadottir, B, Bjarnason, A, Narasimhan, M & Malcolm, R K 2015, ' A Temperature-Monitoring Vaginal Ring for Measuring Adherence ', PLoS ONE, vol. 10, no. 5, e0125682 . https://doi.org/10.1371/journal.pone.0125682 PLoS ONE, Vol 10, Iss 5, p e0125682 (2015) PLoS ONE |
| ISSN: | 1932-6203 |
| DOI: | 10.1371/journal.pone.0125682 |
| Popis: | BackgroundProduct adherence is a pivotal issue in the development of effective vaginal microbicides to reduce sexual transmission of HIV. To date, the six Phase III studies of vaginal gel products have relied primarily on self-reporting of adherence. Accurate and reliable methods for monitoring user adherence to microbicide-releasing vaginal rings have yet to be established.MethodsA silicone elastomer vaginal ring prototype containing an embedded, miniature temperature logger has been developed and tested in vitro and in cynomolgus macaques for its potential to continuously monitor environmental temperature and accurately determine episodes of ring insertion and removal.ResultsIn vitro studies demonstrated that DST nano-T temperature loggers encapsulated in medical grade silicone elastomer were able to accurately and continuously measure environmental temperature. The devices responded quickly to temperature changes despite being embedded in different thickness of silicone elastomer. Prototype vaginal rings measured higher temperatures compared with a subcutaneously implanted device, showed high sensitivity to diurnal fluctuations in vaginal temperature, and accurately detected periods of ring removal when tested in macaques.ConclusionsVaginal rings containing embedded temperature loggers may be useful in the assessment of product adherence in late-stage clinical trials. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|