Provider Adherence to Pre-exposure Prophylaxis Monitoring Guidelines in a Large Primary Care Network.
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ABSTRACT:
SUBMITTER: Spinelli MA
PROVIDER: S-EPMC6016415 | biostudies-literature | 2018 Jun
REPOSITORIES: biostudies-literature
Publications
Provider Adherence to Pre-exposure Prophylaxis Monitoring Guidelines in a Large Primary Care Network.
Spinelli Matthew A MA Scott Hyman M HM Vittinghoff Eric E Liu Albert Y AY Morehead-Gee Alicia A Gonzalez Rafael R Buchbinder Susan P SP
Open forum infectious diseases 20180504 6
Insufficient pre-exposure prophylaxis (PrEP) laboratory monitoring could increase HIV resistance and sexually transmitted infections. We examined test-ordering in a primary care network. Providers did not order HIV testing before almost one-quarter of PrEP initiations; panel management was associated with higher testing. Effective monitoring is needed to maximize PrEP's preventive impact. ...[more]
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Project description:Tenofovir diphosphate (TFV-DP) concentrations measured with dried blood spots (DBS) can be used to classify adherence to emtricitabine/tenofovir disoproxil fumarate (F/TDF) for HIV pre-exposure prophylaxis (PrEP). A TFV-DP of 700 fmol/punch was previously associated with high PrEP efficacy, and was estimated to represent ≥4 doses/week on average. However, interindividual variability in TFV-DP concentrations may lead to adherence misclassification and decrease the precision of adherence-efficacy relationships. The purpose of this analysis was to evaluate sources of TFV-DP variability to improve the precision of TFV-DP for adherence assessments by incorporating individual characteristics. Data and samples from a 36-week study of TFV-DP in DBS, collected biweekly, among 48 HIV-negative volunteers (25 Females/26 Caucasian/10 African American/14 Hispanic) receiving F/TDF at 33%, 67%, and 100% of daily dosing under directly observed therapy were used for analysis. The simplest pharmacokinetic model to describe TFV-DP accumulation with acceptable performance was a one-compartment constant input model. Covariates, including laboratory values and demographics were ranked in importance of their association with post hoc pharmacokinetic (PK) parameters using random forest analyses. Weight and platelet count were included in the final model and simulations were conducted to generate benchmarks for <2, 2-3, 4-5, and 6-7 doses/week. Based on these simulations, the previously established protective TFV-DP concentration of ≥700 fmol/punch was observed in those taking 2-3 (in individuals ≤110 kg) and ≥4 (in individuals >110 kg) doses/week, amounting to a much lower rate of misspecification (17% vs. 30%) with this individualized model versus previous interpretations. Incorporating body weight and platelet count improved the precision of TFV-DP concentrations for adherence assessments. Previous benchmarks were conservative, indicating that the pharmacological forgiveness of F/TDF may be higher than currently recognized and supports continued investigation of intermittent PrEP dosing regimens. Clinical Trial Registration number, NCT02022657.
| S-EPMC8213008 | biostudies-literature
Project description:As pre-exposure prophylaxis (PrEP) effectiveness is strongly linked to adherence, we sought to determine if certain self-report measures could be used to inform objective PrEP adherence. We studied participants from the TAPIR study (a multicenter randomized study of daily text messages to support adherence to PrEP In At-Risk), a 48-week randomized controlled trial of HIV-uninfected men who have sex with men (MSM) randomized to receive text message to support adherence versus standard of care. Self-reported medication adherence was assessed using several validated measures modified for PrEP. Objective PrEP adherence was determined through dried blood spot (DBS) measurement of intracellular tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP). A summary of adherence was estimated using responses to the seven adherence items at weeks 12 and 48 using confirmatory factor analysis. Correlations between self-report questions and drug concentrations were estimated with Pearson's correlations for continuous outcomes and point-biserial correlations for dichotomous outcomes. Receiver operating characteristic (ROC) analyses were conducted to assess the performance of self-report measures in predicting protective or perfect TFV-DP concentrations. Of the 369 participants who completed week 12 or 48 visits, the mean age was 35 (standard deviation 9 years), with 79% White, 12% Black, and 29% Hispanic. Correlations between self-report measures of adherence (both individual items and the adherence factor) and quantifiable FTC-TP and continuous TFV-DP concentrations showed that all self-report measures were significantly associated with these objective measures. Compared to a summary measure of self-reported adherence, the 4-week percent taken question medication recall was the only self-report item similarly or more strongly associated with recent adherence and long-term protective and perfect adherence at weeks 12 and 48. ROC analysis also showed that 4-week percent taken question had a reasonable AUC (0.798 at week 12 and 0.758 at week 48) in predicting protective TFV-DP concentrations. All single-item self-report questions assessing PrEP adherence were significantly associated with biomarker quantification, with the 4-week percent taken question performing best. Therefore, in the absence of drug concentration measurements, a 4-week self-report percent taken question may be a good single-item measure of PrEP adherence.
| S-EPMC6624646 | biostudies-literature
Project description:Purpose of reviewThis review summarizes the recent advancements and future directions of digital pill systems (DPS) - which utilize ingestible sensors to directly measure medication ingestion events in real-time - in the context of HIV prevention and treatment.Recent findingsTwo DPS are cleared by the US Food and Drug Administration. The bioequivalence and stability of digitized pre-exposure prophylaxis (PrEP) and antiretroviral therapy (ART) have been established, and pilot studies have demonstrated the feasibility and acceptability of using DPS for PrEP and ART adherence measurement. Important bioethical and implementation considerations have been identified for future clinical trials. Continued technological advancement may reduce barriers to use, and integration of DPS into behavioral interventions may facilitate adherence improvement efforts. DPS represent an innovative tool for PrEP and ART adherence measurement. Future work will optimize the technology to reduce operational barriers. DPS have significant potential for expansion across a diverse array of diseases, though key bioethical considerations must be examined prior to large-scale implementation.
| S-EPMC9509467 | biostudies-literature
Project description:ObjectiveTo present detailed analyses of long-term pre-exposure prophylaxis (PrEP) use and associated behaviors and perceptions among young Kenyan women.DesignProspective, observational cohort.MethodsThe Monitoring PrEP among Young Adult women Study involved 18 to 24-year-old women at high HIV risk initiating PrEP in Kisumu and Thika, Kenya. Visits for PrEP counseling and dispensing, HIV testing, and socio-behavioral data collection occurred at Month 1 and quarterly for 2 years. PrEP adherence was measured with pharmacy refill and real-time electronic monitoring, plus tenofovir diphosphate levels in 15% of participants. HIV risk behavior and perception were assessed by self-report in weekly short message service surveys from Months 6-24. Predictors of adherence were assessed with multivariable logistic regression analysis.ResultsThree hundred forty-eight women (median age 21, VOICE risk score 7) were followed for 617 person-years. Pharmacy refills steadily declined from 100% (Month 0-1) to 54% (Months 22-24). Average electronically monitored adherence similarly declined from 65% (Month 0-1) to 15% (Months 22-24). Electronically monitored adherence had moderately high concordance with tenofovir diphosphate levels (67%). High average adherence (5+ doses/week) was seen at 385/1898 (20%) participant-visits and associated with low baseline VOICE risk score, >1 current sexual partner, ≤1-hour travel time to clinic, and the Kisumu site. short message service-reported behavior and risk perception were not associated with adherence. Four women acquired HIV (incidence 0.7/100 person-years).ConclusionsPrEP adherence was modest and declined over time. HIV risk was inconsistently associated with adherence; clinic access and site-level factors were also relevant. Relatively low HIV incidence suggests participants may have achieved protection through multiple strategies.
| S-EPMC8826617 | biostudies-literature
Project description:Introduction/objectivesPre-exposure prophylaxis (PrEP) use in the southern United States is low despite its effectiveness in preventing HIV acquisition and high regional HIV prevalence. Our objectives were to assess PrEP knowledge, attitudes, and prescribing practices among Tennessee primary care providers.MethodsWe developed an anonymous cross-sectional electronic survey from March to November 2019. Survey development was guided by the Capability, Opportunity, Motivation, and Behavior framework and refined through piloting and interviews. Participants included members of professional society and health center listservs licensed to practice in Tennessee. Respondents were excluded if they did not complete the question regarding PrEP prescription in the previous year or were not in a position to prescribe PrEP (e.g., hospital medicine). Metrics included PrEP prescription in the preceding year, PrEP knowledge scores (range 0-8), provider attitudes about PrEP, and provider and practice characteristics. Knowledge scores and categorical variables were compared across PrEP prescriber status with Wilcoxon rank-sum and Fisher's exact tests, respectively.ResultsOf 147 survey responses, 99 were included and 43 (43%) reported PrEP prescription in the preceding year. Compared with non-prescribers: prescribers had higher median PrEP knowledge scores (7.3 vs 5.6, P < .01), a higher proportion had self-reported patient PrEP inquiries (95% vs 21%, P < .01), and a higher proportion had self-reported good or excellent ability to take a sexual history (83% vs 58%, P = .01) and comfort taking a sexual history (92% vs 63%, P < .01) from men who have sex with men, a subgroup with high HIV risk. Most respondents felt obligated to provide PrEP (65%), and felt all primary care providers should provide PrEP (63%).ConclusionPrEP provision is significantly associated with PrEP knowledge, patient PrEP inquiries, and provider sexual history taking ability and comfort. Future research should evaluate temporal relationships between these associations and PrEP prescription as potential routes to increase PrEP provision.
| S-EPMC7768326 | biostudies-literature
Project description:There are 34 million people living with human immunodeficiency virus (HIV) worldwide and each year this number increases. Until a vaccine is discovered, the prevention of new HIV infections remains an urgent priority. Several trials studying the use of oral and topical agents for the prevention of HIV infection have already been completed. Adherence has proved to be a major challenge in achieving product efficacy.To provide the clinical pharmacist with an understanding of the oral pre-exposure prophylaxis (PrEP) and topical microbicide product pipeline whilst emphasizing the critical importance of adherence to these drugs to avert HIV infection.PubMed/Medline and the web-based clinical trials registry (ClinTrials.gov) were searched using appropriate key words. For the time period 1992-2013--all phase II and phase III safety and effectiveness studies--testing agents for prevention of HIV infection were included in the review. Efficacy estimates, adherence estimates and reported challenges with adherence were extracted.Twenty-four phase II and III clinical trials were found during review. Of these, 20 trials have been completed, and six trials show effectiveness in preventing HIV infection. The majority of the successful trials were to oral PrEP and to date only one microbicide trial of a vaginal antiretroviral microbicide gel has showed effectiveness. Adherence to study product played a major role in trial outcomes and there are several reasons for non-adherence. These include high on-trial pregnancy rates, low trial retention rates, low participant perception of risk, participant characteristics such as age <25 years, single status, migratory partners and trial fatigue. Study product characteristics such as dosage form, dosing interval, as well as associated adverse events may also influence adherence.Moderate to high adherence is critical to demonstrate efficacy of drugs for HIV prevention. For topical agents, intermittent use associated with coitus is more effective than daily use, particularly if sex is infrequent or partners migrant. For oral agents, daily use is effective but the motivation to use the drug and high risk perception is important. In serodiscordant couples, early initiation of highly active antiretroviral therapy in the infected partner affords almost complete protection to the negative partner. Drugs need to be tailored to the population at risk and availability of multiple drug options are important.
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Project description:BackgroundPre-exposure prophylaxis (PrEP) provides a strong preventative benefit to individuals at risk for HIV. While PrEP adherence is highly correlated with its efficacy, adherence rates are variable both across and within persons.ObjectiveThe objective of this study was to develop and pilot-test a smartphone-based intervention, known as mSMART, that targets PrEP adherence. mSMART provides contingency management in the form of monetary incentives for daily PrEP adherence based on a real-time adherence assessment using a camera-based medication event-monitoring tool as well as medication reminders, PrEP education, individualized behavioral strategies to address PrEP adherence barriers, and medication adherence feedback.MethodsThis was a 4-week open-label, phase I trial in a community sample of young men who have sex with men already on PrEP (N=10).ResultsAlthough adherence composite scores corresponding to PrEP biomarkers indicated that 90% (9/10) of the sample already had an acceptable baseline adherence in the protective range, by the end of the 4-week period, the scores improved for 30% (3/10) of the sample-adherence did not worsen for any participants. Participants reported mean PrEP adherence rates of 91% via daily entries in mSMART. At the end of the 4-week period, participants indicated acceptable ratings of satisfaction, usability, and willingness to recommend mSMART to others. There were no technical difficulties associated with smartphone compatibility, user misunderstandings about mSMART features that interfered with daily use, or study attrition.ConclusionsThis study is the first to apply contingency management to PrEP adherence. Findings indicated that mSMART is feasible and acceptable. Such an adherence intervention administered via a user-friendly smartphone app can allow for widespread dissemination. Future efficacy trials are needed.Trial registrationClinicalTrials.gov NCT02895893; https://clinicaltrials.gov/ct2/show/NCT02895893 (Accessed by Webcite at http://www.webcitation.org/72JskjDJq).
| S-EPMC6231728 | biostudies-literature
Project description:There are several guidelines for the use of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) which are used in other countries. However, the implementation of such guidelines in each country should be modified according to the country's clinical and epidemiological situation. Therefore, The Korean Society for AIDS founded a committee in 2016 to develop guidelines for the use of PrEP for HIV that are optimal for Korea's clinical and epidemiological situation. These guidelines aim to provide comprehensive information for PrEP implementation in Korea. The recommendations contain important information for physicians working to prevent HIV infection in actual clinical fields. The committee will regularly review and revise the guidelines based on changes in PrEP administration and HIV prevention practices.
| S-EPMC5620396 | biostudies-literature
Project description:ObjectiveWe evaluated pre-exposure prophylaxis (PrEP) initiation, persistence, and adherence measured via tenofovir-diphosphate (TFV-DP) concentrations in dried blood spots (DBS) among women offered PrEP during pregnancy.MethodsWe prospectively analyzed data from participants in the PrIMA Study (NCT03070600) who were offered PrEP during the second trimester and followed through 9 months postpartum. At follow-up visits (monthly in pregnancy; 6 weeks, 6 months, 9 months postpartum), self-reported PrEP use was assessed, and DBS were collected for quantifying TFV-DP concentrations.ResultsIn total, 2949 participants were included in the analysis. At enrollment, median age was 24 years [interquartile range IQR) 21-29], gestational age 24 weeks (IQR 20-28), and 4% had a known partner living with HIV. Overall, 405 (14%) participants initiated PrEP in pregnancy with higher frequency among those with risk factors for HIV acquisition, including >2 lifetime sexual partners, syphilis during pregnancy, forced sex, and intimate partner violence ( P < 0.05). At 9 months postpartum, 58% of PrEP initiators persisted with PrEP use, of which 54% self-reported not missing any PrEP pills in the last 30 days. Among DBS randomly selected from visits where participants persisted with PrEP ( n = 427), 50% had quantifiable TFV-DP. Quantifiable TFV-DP was twice as likely in pregnancy than postpartum [adjusted risk ratio (aRR) = 1.90, 95% confidence interval (CI) 1.40-2.57, P < 0.001]. Having a partner known to be living with HIV was the strongest predictor of PrEP initiation, persistence, and quantifiable TFV-DP ( P < 0.001).ConclusionsPrEP persistence and adherence waned postpartum, though over half of PrEP initiators persisted through 9-months postpartum. Interventions should prioritize increasing knowledge of partner HIV status and sustaining adherence in the postpartum period.
| S-EPMC10527305 | biostudies-literature
Project description:Pre-exposure prophylaxis (PrEP) with antiretroviral drugs is a novel biomedical intervention that can prevent HIV transmission among high-risk populations. As findings from multiple PrEP studies have suggested that adherence is vital to achieve the full prevention benefits of PrEP, it is important to understand the clinical pharmacology and pharmacokinetic (PK) properties of PrEP antiretrovirals, the association of PK and PrEP efficacy, and the potential for drug concentration measurement to be used as a tool to monitor PrEP adherence.This review examines studies related to PrEP adherence with attention to the clinical pharmacology and PK of current and novel PrEP agents. Studies of animal models, PK, and clinical trials related to PrEP and adherence were reviewed.In summary, when combined as part of a comprehensive prevention strategy that includes use of condoms and risk-reduction counseling, PrEP has tremendous promise as an adjunctive biomedical HIV prevention intervention, providing that adherence is maintained.
| S-EPMC3954121 | biostudies-other