DigiPrEP: A Pilot Trial to Evaluate the Feasibility, Acceptability, and Accuracy of a Digital Pill System to Measure PrEP Adherence in Men Who Have Sex With Men Who Use Substances

Chai, Peter R.; Mohamed, Yassir A.; Bustamante, María José; Goodman, Georgia R; Najarro, Jesse; Castillo‐Mancilla, José; Baez, Alejandro; Bronzi, Olivia; Sullivan, Matthew C.; Pereira, Luis M.; Baumgartner, Susan L; Carnes, Tony C; Mayer, Kenneth H.; Rosen, Rochelle K.; Boyer, Edward W.; O’Cleirigh, Conall

doi:10.1097/qai.0000000000002854

Cited by 19 publications

(12 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Including biomarkers of PrEP and substance use would enhance the scientific rigor of future studies by mitigating misclassification based on self-report. Furthermore, although tenofovir-diphosphate is a validated biomarker of daily oral PrEP adherence, novel approaches (e.g., digital pills) could assist in objectively measuring event-based PrEP adherence [ 95 ]. There were also relatively few studies that employed event-level measurements of substance use, PrEP adherence, and CAS [ 96 , 97 ].…”

Section: Discussionmentioning

confidence: 99%

Running with Scissors: a Systematic Review of Substance Use and the Pre-exposure Prophylaxis Care Continuum Among Sexual Minority Men

et al. 2022

View full text Add to dashboard Cite

Purpose of Review Patterns of sexualized drug use, including stimulants (e.g., methamphetamine) and chemsex drugs, are key drivers of HIV incidence among sexual minority men (SMM). Although pre-exposure prophylaxis (PrEP) mitigates HIV risk, there is no consensus regarding the associations of substance use with the PrEP care continuum. Recent Findings SMM who use substances are as likely or more likely to use PrEP. Although SMM who use stimulants experience greater difficulties with daily oral PrEP adherence, some evidence shows that SMM who use stimulants or chemsex drugs may achieve better adherence in the context of recent condomless anal sex. Finally, SMM who use substances may experience greater difficulties with PrEP persistence (including retention in PrEP care). Summary SMM who use stimulants and other substances would benefit from more comprehensive efforts to support PrEP re-uptake, adherence, and persistence, including delivering behavioral interventions, considering event-based dosing, and providing injectable PrEP.

show abstract

Section: Discussionmentioning

confidence: 99%

Running with Scissors: a Systematic Review of Substance Use and the Pre-exposure Prophylaxis Care Continuum Among Sexual Minority Men

et al. 2022

View full text Add to dashboard Cite

show abstract

“… 33 In one prior DPS-based study in this population, we informed participants during consent that feedback would be provided if non-adherence patterns suggested waning HIV protection. 20 In a separate study, we informed participants during consent, and throughout the study, that, if randomised to the control arm (involving DPS use alone with no intervention), feedback would not be provided. 34 Data from this study reaffirm this approach—that is, providing participants with clear information on enrolment surrounding the frequency of DPS data query, as well as the algorithmic actions that occur if non-adherence is detected, in order to reduce potential misconceptions around expected feedback.…”

Section: Discussionmentioning

confidence: 99%

Attitudes towards participating in research involving digital pill systems to measure oral HIV pre-exposure chemoprophylaxis: a cross-sectional study among men who have sex with men with substance use in the USA

Chai

Albrechta

et al. 2023

BMJ Open

View full text Add to dashboard Cite

ObjectivesThis quantitative survey sought to understand, among men who have sex with men (MSM) with potentially problematic substance use, the attitudes towards participation in research involving digital pill systems (DPS) for HIV pre-exposure prophylaxis (PrEP) adherence measurement, and the barriers and facilitators to research participation.DesignOne-time, cross-sectional, online sampling-based survey.SettingUS social networking app predominantly focused on MSM.ParticipantsMSM without HIV who reported current use of oral PrEP, potentially problematic substance use and sexual activity in the past 3 months. A total of 157 participants were eligible, passed validity checks and enrolled.Outcome measuresPerceptions of DPS usefulness, accuracy and usability (System Usability Scale (SUS)); willingness and motivations to participate in DPS research; preferences for access to and feedback on DPS adherence data; data sharing considerations; and medical mistrust (Group-Based Medical Mistrust Scale (GBMMS)).ResultsMost of the sample (N=157) was white (n=119, 75.8%), gay (n=124, 79.0%) and cisgender (n=150, 95.5%). The median age was 33 years (IQR: 14). The mean GBMMS score was 13.5 (SD=5.2), and the median SUS score was 70 (IQR: 27.5). In the past 3 months, 36.3% (n=57) reported frequent use of substances before or during sex, and 62.4% (n=98) engaged in condomless sex. While most were adherent to PrEP, approximately 34.4% (n=54) expressed significant worry about daily adherence. Participants wished to monitor their PrEP adherence daily (n=66, 42.0%) and 52% (n=82) were very willing to participate in DPS-based research. The majority were minimally concerned about sharing DPS-detected adherence data with research teams (n=126, 80.3%), and were extremely willing to share these data with healthcare providers (n=109, 69.4%).ConclusionsIn this sample, MSM without HIV who use substances reported willingness to use DPS to measure PrEP adherence in a research context, and identified benefits to accessing real-time, DPS-detected adherence data.

show abstract

“…Prior to our study, the unique Proteus Discover System had been used exclusively for chronic diseases and has not been adapted for antiretroviral treatment or PrEP in the HIV field. Although the company has since filed for bankruptcy, use of this microsensor system has recently been replicated elsewhere 34 . More research is warranted to explore how best to optimize PrEP adherence through real‐time monitoring and support platforms, particularly in promoting high user persistence beyond the first few weeks of utilization.…”

Section: Discussionmentioning

confidence: 99%

“…Although the company has since filed for bankruptcy, use of this microsensor system has recently been replicated elsewhere. 34 More research is warranted to explore how best to optimize PrEP adherence through real‐time monitoring and support platforms, particularly in promoting high user persistence beyond the first few weeks of utilization.…”

Section: Discussionmentioning

confidence: 99%

The ATEAM study: Advances in technology to enhance PrEP adherence monitoring (ATEAM) among young men who have sex with men

Brothers

Hosek

Keckler

et al. 2022

Clinical Translational Sci

View full text Add to dashboard Cite

Young age has consistently correlated with lower adherence to pre-exposure prophylaxis (PrEP) in young men who have sex with men (YMSM). Digital medicine, a dynamic healthcare platform of wearable physiological sensors and mobile communication technology that can respond to medication nonadherence rapidly, has the potential in promoting PrEP adherence. We evaluated the feasibility and acceptability of Proteus Discover, a digital monitoring adherence system, to measure PrEP adherence and provide real-time feedback among cisgender YMSM and transgender women. One hundred HIV-negative young men and transgender women ages 16-24 years were enrolled in a 24-week randomized controlled crossover study to tenofovir disoproxil fumarate with emtricitabine (TDF/FTC) coencapsulated with Proteus Discover versus TDF/FTC standard-ofcare. Participants in the 12-week Proteus Discover arm received weekly SMS text messages to promote pill taking based on Proteus Discover adherence data. Dried blood spots (DBS) were collected at 4-week intervals for tenofovir diphosphate (TFV-DP) in red blood cells as the referent and questionnaires were completed to assess acceptability, usability, and patterns of use. Linear mixed models analyzed the relationship between 30-day adherence measured by DBS and Proteus Discover. PrEP adherence was high overall. Adherence, as measured by DBS, was correlated with adherence as measured by Proteus Discover (p value = 0.03).Most participants reported that Proteus Discover helped them take their PrEP daily and that the system was easy to use. However, a majority (53.5%-60.5%) disagreed with the statement that wearing the patch was not an issue. There was an incremental increase in TFV-DP in DBS with adherence by Proteus Discover. More research is warranted to explore optimizing PrEP adherence for youth through real-time monitoring. Study Highlights WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC? Lack of efficacy to pre-exposure prophylaxis (PrEP) is due almost exclusively to low drug adherence and the failure of traditional adherence metrics to precisely document drug adherence, identify patterns of adherence behaviors, and facilitate timely intervention when lapses in adherence occurred. WHAT QUESTION DID THIS STUDY ADDRESS? What is the feasibility and acceptability of Proteus Discover, a digital monitoring adherence system, to measure PrEP adherence and provide real-time feedback among cisgender young men who have sex with men (YMSM) and transgender women? WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE? This study successfully developed an integrated system that confirms ingestion of oral PrEP, monitors adherence both in real-time and longitudinally, and provides feedback mechanisms to promote enhanced adherence behaviors for YMSM. HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE? This study warrants further exploration in the use of digital medicine and realtime monitoring to optimize PrEP adherence for youth. How to cite this article: Brothers J, Hosek S, Keckler K, et al. The ATEAM study: Adva...

show abstract

DigiPrEP: A Pilot Trial to Evaluate the Feasibility, Acceptability, and Accuracy of a Digital Pill System to Measure PrEP Adherence in Men Who Have Sex With Men Who Use Substances

Abstract: Supplemental Digital Content is Available in the Text.

Cited by 19 publications

References 27 publications

Running with Scissors: a Systematic Review of Substance Use and the Pre-exposure Prophylaxis Care Continuum Among Sexual Minority Men

Running with Scissors: a Systematic Review of Substance Use and the Pre-exposure Prophylaxis Care Continuum Among Sexual Minority Men

Attitudes towards participating in research involving digital pill systems to measure oral HIV pre-exposure chemoprophylaxis: a cross-sectional study among men who have sex with men with substance use in the USA

The ATEAM study: Advances in technology to enhance PrEP adherence monitoring (ATEAM) among young men who have sex with men

Contact Info

Product

Resources

About