Clinical evaluation of a temperature logging vaginal ring for measuring user adherence

  • Malcolm, Karl (Principal investigator)
  • Martin, Fabiola (Co-investigator)
  • Lacey, Charles N J (Co-investigator)
  • Desai, Monica (Co-investigator)

Project: Research project (funded)Research

Project Details


Here, we propose to assess for the first time a temperaturelogging
vaginal ring (TVLR) in women. The proposed study has been designed to answer the following
specific questions:
1. Can the TLVR be used to accurately detect ring insertion and removal events?
2. How does self-reported adherence information, captured using a smartphone app, compare with
adherence inferred from analysis of vaginal temperature data as recorded by the TLVR?
3. Can the TLVR detect sexual intercourse events via changes in vaginal temperature?
4. Can the TLVR detect the diurnal temperature cycle in women?
5. Can the TLVR detect the menstrual cycle via vaginal temperature variations?
6. Is a custom-designed smartphone app useful in capturing self-reported adherence and other
relevant clinical data?
World Health Organisation (WHO) $462.871.

Layman's description

Vaginal administration of antiretroviral drugs is one of the major strategies currently being tested to reduce sexual transmission of human immunodeficiency virus (HIV) in women. Data from previous clinical studies with vaginal microbicide gels have clearly revealed that many women do not use the products as intended. This lack of adherence is probably the most important factor contributing to lack of clinical efficacy. Moreover, accurate monitoring of user adherence during clinical studies is notoriously difficult. In self-reported questionnaires, women do not always truthfully report their use of a product, while measurement of antiretroviral levels in the blood requires women to return regularly to the clinic for testing.
Given the lack of clinical efficacy observed with vaginal microbicide gels, there is considerable interest in the use of long-acting vaginal devices that have the potential to continuously administer antiretrovirals over long time periods. A first-generation vaginal ring device offering controlled release of the antiretroviral drug dapivirine over 30 days is presently being tested in two major clinical trials. Designed as a ‘fit once and forget’ product, antiretroviral-releasing vaginal rings offer the possibility of increased user adherence compared with vaginal gels.
Following preliminary proof-of-concept studies in macaques, we are now proposing to test for the first time in humans a novel vaginal ring device fitted with a miniature temperature recorder. Unlike other methods for measuring user adherence, this temperature-recording vaginal ring device is able to continuously and quantitatively capture environmental temperature data, such that ring removal and insertion events are readily determined. The new approach to measuring user adherence will likely provide important insights into the patterns of ring use, particularly when implemented as part of Phase III clinical studies. In this study, an internationally-acclaimed project team with extensive expertise in vaginal ring product development and clinical testing of HIV microbicides will develop, manufacture and test a human-sized vaginal ring for its potential to accurately monitor vaginal and environmental temperature and to reliably detect ring removal and insertion events.

Effective start/end date25/11/15 → …