A Clinical Study of a Temperature Logging Vaginal Ring
Research type
Research Study
Full title
A clinical study to evaluate the use of an investigational medical device, a temperature logging vaginal ring, over 56 days of use
IRAS ID
226609
Contact name
Charles Lacey
Contact email
Sponsor organisation
University of York
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Despite recent advances effective control of the HIV-1 pandemic remains elusive. The overwhelming majority of adult infections worldwide occur in heterosexuals, and globally, 51% of all people living with HIV-1 are female. In sub-Saharan Africa, women account for 56% of new adult HIV-1 infections. There is an urgent need for female-controlled HIV prevention methods, as these are often outside of the control of many women in resource-poor settings, who lack power and influence over their partners’ behaviour. One method is the use of a vaginal ring that contains anti-HIV medication (microbicides), which would be slowly released over a long period of time from the ring. However, it is uncertain how well these will be tolerated by women. We wish to investigate whether the recording of vaginal temperature can monitor adherence to the use of microbicide-releasing vaginal rings. We would compare temperature data from a data logger inserted in the ring to data from a study-specific smartphone app, with which the women could record ring insertion and removal. Studies exist which indicate that vaginal temperature changes during sexual activity and arousal. Therefore, in addition to monitoring adherence, a temperature-recording vaginal ring can also potentially be used to monitor the frequency and duration of sexual intercourse during those times when the ring remains in place, which would provide data on the use of the ring device during sex. Given that a microbicide-releasing vaginal ring is intended to prevent/reduce sexual transmission of HIV, a vaginal ring device offering extended delivery of one or more anti-HIV microbicides while simultaneously gathering temperature data useful for monitoring both adherence and frequency of sexual activity would offer a very significant insight into sexual behaviour as it relates to HIV transmission.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0280
Date of REC Opinion
7 Dec 2017
REC opinion
Further Information Favourable Opinion