Real-World User Experiences with a Digital Pill System to Measure PrEP Adherence: Perspectives from MSM with Substance Use.
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SUBMITTER: Chai PR
PROVIDER: S-EPMC8795732 | biostudies-literature | 2022 Jul
REPOSITORIES: biostudies-literature
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Real-World User Experiences with a Digital Pill System to Measure PrEP Adherence: Perspectives from MSM with Substance Use.
Chai Peter R PR Goodman Georgia R GR Bronzi Olivia O Gonzales Gerard G Baez Alejandro A Bustamante Maria J MJ Najarro Jesse J Mohamed Yassir Y Sullivan Matthew C MC Mayer Kenneth H KH Boyer Edward W EW O'Cleirigh Conall C Rosen Rochelle K RK
AIDS and behavior 20220128 7
Once-daily oral pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV transmission, but adherence can be challenging for men who have sex with men (MSM) who use substances. A novel method for directly measuring ingestion events is a digital pill system (DPS), which comprises an ingestible radiofrequency emitter that signals a wearable Reader device upon PrEP ingestion, relaying ingestion data to a wearable Reader device and then to a smartphone application. Qualitative interview ...[more]
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Project description:Once-daily oral HIV pre-exposure prophylaxis (PrEP) is an effective strategy to prevent HIV, but is highly dependent on adherence. Men who have sex with men (MSM) who use substances face unique challenges maintaining PrEP adherence. Digital pill systems (DPS) allow for real-time adherence measurement through ingestible sensors. Integration of DPS technology with other digital health tools, such as digital phenotyping, may improve understanding of nonadherence triggers and development of personalized adherence interventions based on ingestion behavior. This study explored the willingness of MSM with substance use to share digital phenotypic data and interact with ancillary systems in the context of DPS-measured PrEP adherence. Adult MSM on PrEP with substance use were recruited through a social networking app. Participants were introduced to DPS technology and completed an assessment to measure willingness to participate in DPS-based PrEP adherence research, contribute digital phenotyping data, and interact with ancillary systems in the context of DPS-based research. Medical mistrust, daily worry about PrEP adherence, and substance use were also assessed. Participants who identified as cisgender male and were willing to participate in DPS-based research (N = 131) were included in this subsample analysis. Most were White (76.3%) and non-Hispanic (77.9%). Participants who reported daily PrEP adherence worry had 3.7 times greater odds (95% CI: 1.03, 13.4) of willingness to share biometric data via a wearable device paired to the DPS. Participants with daily PrEP adherence worry were more likely to be willing to share smartphone data (p = 0.006) and receive text messages surrounding their daily activities (p = 0.003), compared to those with less worry. MSM with substance use disorder, who worried about PrEP adherence, were willing to use DPS technology and share data required for digital phenotyping in the context of PrEP adherence measurement. Efforts to address medical mistrust can increase advantages of this technology for HIV prevention.
| S-EPMC10883553 | biostudies-literature
Project description:Electronic monitoring devices (EMDs) have been trialled in interventions to improve inhaled corticosteroid adherence and clinical outcomes. This study sought to understand the perceptions and experiences of EMD end-users. Participants recruited into a six-month EMD study were invited to a semi-structured interview. Interviews were audio-recorded, transcribed verbatim and analysed using the framework approach. Twenty-eight participants (68% female, median age 47) were interviewed. Individuals described feeling responsible for their asthma control. Recent attacks motivated a desire to maintain control. Study participation led to increased awareness of asthma status and medication use. Several individuals were open to integrating digital monitoring data with other mHealth inputs, perceiving the potential to enhance communication with clinicians and empower self-management. Openness to data sharing was tied to expectations of transparent data use. Data supported integrating beliefs and habit formation to achieve behaviour change. There was a willingness for an integrated, platform-based approach to digital self-management.
| S-EPMC9780314 | biostudies-literature
Project description:BackgroundHeart failure (HF) affects 6.2 million Americans and is a leading cause of hospitalization. The mainstay of the management of HF is adherence to pharmacotherapy. Despite the effectiveness of HF pharmacotherapy, effectiveness is closely linked to adherence. Measuring adherence to HF pharmacotherapy is difficult; most clinical measures use indirect strategies such as calculating pharmacy refill data or using self-report. While helpful in guiding treatment adjustments, indirect measures of adherence may miss the detection of suboptimal adherence and co-occurring structural barriers associated with nonadherence. Digital pill systems (DPSs), which use an ingestible radiofrequency emitter to directly measure medication ingestions in real-time, represent a strategy for measuring and responding to nonadherence in the context of HF pharmacotherapy. Previous work has demonstrated the feasibility of using DPSs to measure adherence in other chronic diseases, but this strategy has yet to be leveraged for individuals with HF.ObjectiveWe aim to explore through qualitative interviews the facilitators and barriers to using DPS technology to monitor pharmacotherapy adherence among patients with HF.MethodsWe conducted individual, semistructured qualitative interviews and quantitative assessments between April and August 2022. A total of 20 patients with HF who were admitted to the general medical or cardiology service at an urban quaternary care hospital participated in this study. Participants completed a qualitative interview exploring the overall acceptability of and willingness to use DPS technology for adherence monitoring and perceived barriers to DPS use. Quantitative assessments evaluated HF history, existing medication adherence strategies, and attitudes toward technology. We analyzed qualitative data using applied thematic analysis and NVivo software (QSR International).ResultsMost participants (12/20, 60%) in qualitative interviews reported a willingness to use the DPS to measure HF medication adherence. Overall, the DPS was viewed as useful for increasing accountability and reinforcing adherence behaviors. Perceived barriers included technological issues, a lack of need, additional costs, and privacy concerns. Most were open to sharing adherence data with providers to bolster clinical care and decision-making. Reminder messages following detected nonadherence were perceived as a key feature, and customization was desired. Suggested improvements are primarily related to the design and usability of the Reader (a wearable device).ConclusionsOverall, individuals with HF perceived the DPS to be an acceptable and useful tool for measuring medication adherence. Accurate, real-time ingestion data can guide adherence counseling to optimize adherence management and inform tailored behavioral interventions to support adherence among patients with HF.
| S-EPMC10905352 | biostudies-literature
Project description:BackgroundAdherence to once daily oral preexposure prophylaxis (PrEP) for HIV prevention can be challenging for men who have sex with men (MSM) with substance use. Digital pill systems (DPS) comprise a radiofrequency emitter integrated into a gelatin capsule containing PrEP, which transmits data to a wearable Reader following ingestion, thereby enabling direct, real-time adherence measurement. This study evaluated the feasibility, acceptability, and accuracy of a DPS to measure PrEP adherence.MethodsA 90-day, single-arm, open-label, pilot demonstration trial was conducted with adult, cisgender, HIV-negative MSM on PrEP with nonalcohol substance use. Feasibility was measured via DPS engagement and timeline followback. Acceptability was assessed via qualitative user experience interviews. Accuracy was evaluated via DPS performance metrics, pill counts, and DBS to quantify tenofovir diphosphate.ResultsSixteen MSM enrolled (median age, 32 years), and 15 completed the study. Engagement remained stable over time. Emergent nonadherence patterns included intercurrent substance use. The DPS was largely acceptable based on interviews; the predominant barrier to use was the Reader. DPS-recorded ingestions totaled 1099, including 83.9% were detected by Reader and 16.1% were reported manually. The DPS recorded 92.2% of 1192 total expected ingestions per pill counts. Point-biserial correlation (R = 0.58; 95% CI: 0.21 to 0.80; P = 0.047) and Pearson correlation (month 1: R = 0.85; 95% CI: 0.57 to 0.95; P = 0.0002; month 3: R = 0.75; 95% CI: 0.17 to 0.94; P = 0.0197) showed strong correlations between DPS-recorded adherence and tenofovir diphosphate in dried blood spots.ConclusionDPS are a feasible, acceptable, and accurate method of measuring PrEP adherence in MSM with substance use. Future investigations should incorporate DPS into behavioral interventions targeting nonadherence.
| S-EPMC8740604 | biostudies-literature
Project description:BackgroundPre-exposure prophylaxis (PrEP) is efficacious for HIV prevention. Black men who have sex with men (MSM) accounted for the largest proportion of new HIV diagnoses in the United States relative to other racial/ethnic groups. Black MSM who use substances are at an increased risk for HIV infection and are ideal candidates for PrEP, but barriers to maintaining PrEP adherence remain a concern. We assessed whether substance use behaviors are associated with initiation and adherence to PrEP among a sample of black MSM in the United States.MethodsData for this analysis come from the HIV Prevention Trails Network Study 073 (HPTN 073). Substance use behaviors-including alcohol, marijuana, poppers (ie, alkyl nitrites), and stimulants (ie, methamphetamine/cocaine use) including use of these substances before/during condomless anal intercourse (CAI)-were assessed longitudinally through self-report. PrEP adherence was assessed by pharmacological testing in blood. Generalized estimating equations were used to evaluate association between substance use behaviors and PrEP initiation and adherence.ResultsAmong 226 HIV-negative black MSM, the majority (60%) were 25+ years of age. Most of the substance use behaviors were not significantly associated with PrEP initiation or adherence. However, stimulant use before/during CAI was significantly associated with lower odds of PrEP adherence (adjusted odds ratio = 0.21, 95% confidence interval = 0.07 to 0.61; P = <0.01).ConclusionsThese findings suggest that PrEP adherence is feasible among black MSM who use substances. However, black MSM who engage in stimulant use before/during CAI may present a unique group for additional study and support with enhanced behavioral health and support services.
| S-EPMC7429251 | biostudies-literature
Project description:Objective. To determine if adherence as measured by pill count would show a significant association with serum-based measures of adherence. Methods. Data were obtained from a prenatal vitamin D supplementation trial where subjects were stratified by race and randomized into three dosing groups: 400 (control), 2000, or 4000 IU vitamin D(3)/day. One measurement of adherence was obtained via pill counts remaining compared to a novel definition for adherence using serum 25-hydroxy-vitamin D (25-OH-D) levels (absolute change in 25(OH)D over the study period and the subject's steady-state variation in their 25(OH)D levels). A multivariate logistic regression model examined whether mean percent adherence by pill count was significantly associated with the adherence measure by serum metabolite levels. Results. Subjects' mean percentage of adherence by pill count was not a significant predictor of adherence by serum metabolite levels. This finding was robust across a series of sensitivity analyses. Conclusions. Based on our novel definition of adherence, pill count was not a reliable predictor of adherence to protocol, and calls into question how adherence is measured in clinical research. Our findings have implications regarding the determination of efficacy of medications under study and offer an alternative approach to measuring adherence of long half-life supplements/medications.
| S-EPMC2821652 | biostudies-literature
Project description:IntroductionFEM-PrEP did not demonstrate a reduction in HIV acquisition because of low study pill adherence. Yet, plasma and intracellular drug concentrations indicated that some participants had evidence of recent pill use. We conducted a follow-up study to identify, among other topics, participants' reasons for taking the study pill.MethodsQualitative, semi-structured interviews (SSIs) were conducted with 88 FEM-PrEP participants. Participants were purposefully selected based on their adherence drug concentrations collected during FEM-PrEP and placed into three adherence interview groups: "high," "moderate," and "none/scarce." Participants in the high and moderate groups described reasons why they adhered most or some of the time, including factors that facilitated their adherence. Participants in all groups described what they believed made it possible for other FEM-PrEP participants to adhere. In addition, 224 FEM-PrEP participants reported on their reasons for taking the study pills through a quantitative, audio computer-assisted self-interview (ACASI). Thematic analysis and descriptive statistics were used to analyze the qualitative and quantitative data, respectively.ResultsFive themes were identified from the SSIs as facilitating factors of adherence: 1) participants' support for the research, 2) HIV risk reduction, 3) routine formation and use of tools, 4) adherence counseling, and 5) partner awareness and support. Participants described similar facilitators when they spoke about other participants' adherence. Among the 172 participants who reported in ACASI that they had taken a study pill, wanting to help answer the research question was the most frequently stated reason for taking the pills (94%, n = 161). We also found evidence of preventive misconception.ConclusionsAdherence was facilitated by personal motivations, such as risk reduction and interest in the research outcome, and by adherence strategies consisting of external cues, reminders, and support. These findings can inform future HIV prevention clinical trials and the rollout of effective antiretroviral-based HIV prevention technologies for women.
| S-EPMC4395082 | biostudies-literature
Project description:Oral pre-exposure prophylaxis (PrEP) is an effective HIV prevention strategy with high efficacy. An increased willingness to use PrEP among at-risk Indian men who have sex with men (MSM) population has been reported; however, little is known about their real experiences that guide their key motivators, facilitators, and barriers with using oral and Long-Acting (LA) Injectable PrEP. We recruited participants (n = 18) through active MSM social media networks. The interviews were conducted using teleconferencing software. Interview topics included participants' sources of knowledge, experiences accessing daily PrEP, safe-sex behaviors while on PrEP, barriers and facilitators around PrEP, long-term goals with PrEP, perceptions around LA PrEP, and discussion around decision-making to switch from oral PrEP to LA PrEP. Transcripts were coded according to interview topics, and key themes were analyzed using a topical data analysis approach. Participants (median age 28 years, ranging from 18 to 40) reported a high perceived risk of HIV. This increased perceived risk was a key motivator for oral PrEP uptake. Most participants shared that they accessed PrEP through non-profit organizations serving the MSM community, where doctor consultations and medication were either free or subsidized. Even when participants reported high adherence to oral PrEP, they expressed discontent with the requirement to take it daily. High condom usage was reported concomitantly with PrEP use among most participants, except for a few who preferred bareback sex. Participants shared that they would prefer to continue PrEP until they are in a monogamous, exclusive relationship. The cost and affordability remained recurring themes, and while participants could afford oral PrEP, they wished it was cheaper, making it more accessible to the community at large. Most participants did not have prior knowledge of LA injectable PrEP but welcomed the intervention, alluding to cost and availability as the key decision-making factors affecting switching. MSM from India we interviewed adopted oral PrEP as an additional HIV prevention strategy to condoms through non-profit and private channels. Cost and broader access remains a concern among the MSM community. More acceptability research about long-acting PrEP is needed among MSM in the Indian context, and it is recommended for government interventions to include oral PrEP groups at higher risk of HIV acquisition.
| S-EPMC10793913 | biostudies-literature
Project description:BackgroundTeletherapy apps have emerged as a promising alternative to traditional in-person therapy, especially after the COVID-19 pandemic, as they help overcome a range of geographical and emotional barriers to accessing care. However, the rapid proliferation of teletherapy apps has occurred in an environment in which development has outpaced the various regulatory and ethical considerations of this space. Thus, researchers have raised concerns about the ethical implications and potential risks of teletherapy apps given the lack of regulation and oversight. Teletherapy apps have distinct aims to more directly replicate practices of traditional care, as opposed to mental health apps, which primarily provide supplemental support, suggesting a need to examine the ethical considerations of teletherapy apps from the lens of existing ethical guidelines for providing therapy.ObjectiveIn this study, we examined user reviews of commercial teletherapy apps to understand user perceptions of whether and how ethical principles are followed and incorporated.MethodsWe identified 8 mobile apps that (1) provided teletherapy on 2 dominant mobile app stores (Google Play and Apple App Store) and (2) had received >5000 app reviews on both app stores. We wrote Python scripts (Python Software Foundation) to scrape user reviews from the 8 apps, collecting 3268 user reviews combined across 2 app stores. We used thematic analysis to qualitatively analyze user reviews, developing a codebook drawing from the ethical codes of conduct for psychologists, psychiatrists, and social workers.ResultsThe qualitative analysis of user reviews revealed the ethical concerns and opportunities of teletherapy app users. Users frequently perceived unprofessionalism in their teletherapists, mentioning that their therapists did not listen to them, were distracted during therapy sessions, and did not keep their appointments. Users also noted technical glitches and therapist unavailability on teletherapy apps that might affect their ability to provide continuity of care. Users held varied opinions on the affordability of those apps, with some perceiving them as affordable and others not. Users further brought up that the subscription model resulted in unfair pricing and expressed concerns about the lack of cost transparency. Users perceived that these apps could help promote access to care by overcoming geographical and social constraints.ConclusionsOur study suggests that users perceive commercial teletherapy apps as adhering to many ethical principles pertaining to therapy but falling short in key areas regarding professionalism, continuity of care, cost fairness, and cost transparency. Our findings suggest that, to provide high-quality care, teletherapy apps should prioritize fair compensation for therapists, develop more flexible and transparent payment models, and invest in measures to ensure app stability and therapist availability. Future work is needed to develop standards for teletherapy and improve the quality and accessibility of those services.
| S-EPMC10559192 | biostudies-literature
Project description:Oral HIV pre-exposure prophylaxis (PrEP) is effective at preventing HIV. However, low adherence is common and undermines these protective effects. This is particularly relevant for groups with disproportionately higher rates of HIV, including Black men who have sex with men (MSM). The current study tested the feasibility, acceptability, and preliminary efficacy of a gamified mobile health contingency management intervention for PrEP adherence-called mSMART (Mobile App-Based Personalized Solutions for Medication Adherence of Rx Pill Tool). Fifteen Black MSM already prescribed PrEP in the community completed baseline and follow-up assessments separated by 8 weeks of using mSMART. Regarding feasibility, there was no study attrition, no mSMART functional difficulties that significantly interfered with use, and a mean rate of 82% daily mSMART use. Acceptability ratings were in the moderately to extremely satisfied range for factors such as willingness to recommend mSMART to others and user-friendliness, and in the low range for ratings on difficulty learning how to use mSMART. Scores on a system usability measure were in the acceptable range for 73% of the sample. Qualitative analysis of follow-up interviews identified individual components of mSMART that could be modified in future iterations to make it more engaging. PrEP composite adherence scores from biomarkers indicated an improvement from baseline to follow-up with a medium effect size, as well as a decrease in the number of perceived barriers to medication adherence. Findings indicate a future efficacy trial is needed to examine the effects of this gamified mobile health contingency management intervention on PrEP adherence.
| S-EPMC9474612 | biostudies-literature