A Temperature-Monitoring Vaginal Ring for Measuring Adherence

Boyd, Peter; Desjardins, Delphine; Kumar, Sandeep; Fetherston, Susan; Legrand, R.; Dereuddre‐Bosquet, Nathalie; Helgadottir, Berglind; Bjarnason, Ásgeir; Narasimhan, Manjulaa; Malcolm, R. Karl

doi:10.1371/journal.pone.0125682

Cited by 19 publications

(16 citation statements)

References 35 publications

(37 reference statements)

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“…Boyd et al [68] describes the development of a technology to address the pivotal issue of inaccurate self-reporting of patient adherence during clinical trials. They report a temperature-monitoring microbicide-releasing vaginal ring that uses DST nano-T temperature loggers to monitor user adherence.…”

Section: Introductionmentioning

confidence: 99%

Drug delivery strategies and systems for HIV/AIDS pre-exposure prophylaxis and treatment

Nelson

Zhang

Ganapathi

et al. 2015

Journal of Controlled Release

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The year 2016 will mark an important milestone - the 35th anniversary of the first reported cases of HIV/AIDS. Antiretroviral Therapy (ART) including Highly Active Antiretroviral Therapy (HAART) drug regimens is widely considered to be one of the greatest achievements in therapeutic drug research having transformed HIV infection into a chronically managed disease. Unfortunately, the lack of widespread preventive measures and the inability to eradicate HIV from infected cells highlight the significant challenges remaining today. Moving forward there are at least three high priority goals for anti-HIV drug delivery (DD) research: (1) to prevent new HIV infections from occurring, (2) to facilitate a functional cure, i.e., when HIV is present but the body controls it without drugs and (3) to eradicate established infection. Pre-exposure Prophylaxis (PrEP) represents a significant step forward in preventing the establishment of chronic HIV infection. However, the ultimate success of PrEP will depend on achieving sustained antiretroviral (ARV) tissue concentrations and will require strict patient adherence to the regimen. While first generation long acting/extended release (LA/ER) DDS currently in development show considerable promise, significant DD treatment and prevention challenges persist. First, there is a critical need to improve cell specificity through targeting in order to selectively achieve efficacious drug concentrations in HIV reservoir sites to control/eradicate HIV as well as mitigate systemic side effects. In addition, approaches for reducing cellular efflux and metabolism of ARV drugs to prolong effective concentrations in target cells need to be developed. Finally, given the current understanding of HIV pathogenesis, next generation anti-HIV DDS need to address selective DD to the gut mucosa and lymph nodes. The current review focuses on the DDS technologies, critical challenges, opportunities, strategies, and approaches by which novel delivery systems will help iterate towards prevention, functional cure and eventually the eradication of HIV infection.

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Section: Introductionmentioning

confidence: 99%

Drug delivery strategies and systems for HIV/AIDS pre-exposure prophylaxis and treatment

Nelson

Zhang

Ganapathi

et al. 2015

Journal of Controlled Release

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“…This temperature was selected based on the temporal variation in macaque vaginal temperature described by Boyd et al . [17] and the normal sheep body temperature measured in this study and by others,[22] with a margin for error to prevent false readings of IVR removal. The reference temperature will need to be optimized in clinical trial to accommodate differences between human and sheep basal temperatures.…”

Section: Discussionmentioning

confidence: 83%

“…Until recently, no methods for real-time monitoring of IVR adherence had been reported. Boyd, et al demonstrated proof-of-principle for using IVR temperature as a surrogate measure of adherence [17]. They employed a commercially available temperature logging device inserted in the vaginal cavity to continuously monitor device temperature, and compared it to intravaginal (body) temperature to determine periods of device insertion and removal.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, Malcolm, et al . reported a method for measuring adherence to intravaginal implant use by monitoring vaginal temperature using a commercially available DST nano-T implantable temperature logger (Star-Oddi, Gardabaer, Iceland) embedded in the device [17]. The DST-nano-T devices encapsulated in silicone tubing of varying wall thickness to approximate an IVR accurately measured environmental temperature changes during 7 days of continuous monitoring in vitro .…”

Section: Introductionmentioning

confidence: 99%

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An intravaginal ring for real-time evaluation of adherence to therapy

et al. 2017

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Two recent Phase III clinical trials to investigate an intravaginal ring for preventing HIV infection demonstrated that adherence to prescribed device use was a primary driver of efficacy. Surrogate methods for determining adherence in the studies were limited in their inability to monitor temporal patterns of use and allow deconvolution of the effects of adherence and device efficacy on HIV infection rates. To address this issue, we have developed functionality in an intravaginal ring to continuously monitor when the device is being used and maintain a log of adherence that can be accessed by clinicians after it is removed. An electronic module fabricated with common, inexpensive electronic components was encapsulated in a silicone intravaginal ring. The device uses temperature as a surrogate measure of periods of device insertion and removal, and stores a record of the data for subsequent retrieval. The adherence-monitoring intravaginal ring accurately recorded the device status over 33 simulated IN-OUT cycles and more than 1000 measurement cycles in vitro. Following initial in vitro testing in a temperature-controlled chamber, the device was evaluated in vivo in sheep using a predetermined insertion/removal pattern to simulate intravaginal ring use. After insertion into the vaginal cavity of a sheep, the logged data correctly indicated the device status over 29 hours of continuous measurement including three cycles of insertion and removal. The device described here is a promising, low-cost method for real-time adherence assessment in clinical trials involving medicated intravaginal rings or other intravaginal devices.

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“…One device, Exhale, measures the metabolite via a breathalyzer. Additionally, biometric monitors (e.g., vaginal rings) are also being explored, but thus far only in animal models [61]. No publications of these measures have involved RLS to date.…”

Section: Future Eamsmentioning

confidence: 99%

Cell Phone-Based and Adherence Device Technologies for HIV Care and Treatment in Resource-Limited Settings: Recent Advances

Campbell

Haberer

2015

Curr HIV/AIDS Rep

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Numerous cell phone-based and adherence monitoring technologies have been developed to address barriers to effective HIV prevention, testing, and treatment. Because most people living with HIV and AIDS reside in resource-limited settings (RLS), it is important to understand the development and use of these technologies in RLS. Recent research on cell phone-based technologies has focused on HIV education, linkage to and retention in care, disease tracking, and antiretroviral therapy adherence reminders. Advances in adherence devices have focused on real-time adherence monitors, which have been used for both antiretroviral therapy and pre-exposure prophylaxis. Real-time monitoring has recently been combined with cell phone-based technologies to create real-time adherence interventions using short message service (SMS). New developments in adherence technologies are exploring ingestion monitoring and metabolite detection to confirm adherence. This article provides an overview of recent advances in these two families of technologies and includes research on their acceptability and cost-effectiveness when available. It additionally outlines key challenges and needed research as use of these technologies continues to expand and evolve.

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A Temperature-Monitoring Vaginal Ring for Measuring Adherence

Cited by 19 publications

References 35 publications

Drug delivery strategies and systems for HIV/AIDS pre-exposure prophylaxis and treatment

Drug delivery strategies and systems for HIV/AIDS pre-exposure prophylaxis and treatment

An intravaginal ring for real-time evaluation of adherence to therapy

Cell Phone-Based and Adherence Device Technologies for HIV Care and Treatment in Resource-Limited Settings: Recent Advances

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