Development of a Temperature-Recording Vaginal Ring for Monitoring User Adherence

Peter Boyd, Delphine Desjardins, Sandeep Kumar, Susan Fetherston, Roger Le Grand, Nathalie Dereuddre-Bosquet, Berglind Helgadottir, Asgeir Bjarnason, Manjula Lusti-Narasimhan , Karl Malcolm

Research output: Contribution to conferencePosterpeer-review

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Abstract

Background: Vaginal ring devices are being actively developed for controlled delivery of HIV microbicides and as multi-purpose prevention technology (MPT) products combining hormonal contraception with prevention of HIV and other sexually transmitted diseases. Presently, there is no reliable method for monitoring user adherence in HIV vaginal ring trials; previous acceptability studies have included some type of participant self-reporting mechanism, which have often been unreliable. More objective, quantitative and accurate methods for assessing adherence are needed.
Methods: A silicone elastomer vaginal ring containing an encapsulated miniature temperature recording device has been developed that can capture and store real-time temperature data during the period of designated use. Devices were tested in both simulated vaginal environments and following vaginal placement in cynomolgus macaques. Various use protocols and data sampling rates were tested to simulate typical patient usage scenarios. Results: The temperature logging devices accurately recorded vaginal temperature in macaques, clearly showing the regular diurnal temperature cycle. When environmental temperature and vaginal temperature was significantly different, the device was able to accurately pinpoint the insertion and removal times. Based on the data collected it was possible to infer removal periods as short as 5 min when the external environmental temperature was 25 °C. Accuracy increased with data sampling rate. Conclusions: This work provides proof-of-concept for monitoring adherence using a vaginal ring device containing an encapsulated temperature logger. The addition of one or more active agents into the ring body is not anticipated to affect the temperature monitoring function. A clinical study to compare self- reported user adherence data with that obtained by the device would be highly informative.
Original languageEnglish
Publication statusPublished - 29 Oct 2014
EventHIV R4P - HIV Research for Prevention - Cape Town, South Africa
Duration: 28 Oct 201431 Oct 2014
http://hivr4p.org/

Conference

ConferenceHIV R4P - HIV Research for Prevention
CountrySouth Africa
CityCape Town
Period28/10/201431/10/2014
Internet address

Keywords

  • vaginal ring
  • microbicide
  • temperature logger
  • adherence

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