Developing and Assessing the Feasibility of a Home-based Preexposure Prophylaxis Monitoring and Support Program.
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ABSTRACT:
SUBMITTER: Siegler AJ
PROVIDER: S-EPMC6336909 | biostudies-other | 2019 Jan
REPOSITORIES: biostudies-other
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Developing and Assessing the Feasibility of a Home-based Preexposure Prophylaxis Monitoring and Support Program.
Siegler Aaron J AJ Mayer Kenneth H KH Liu Albert Y AY Patel Rupa R RR Ahlschlager Lauren M LM Kraft Colleen S CS Fish Rossi R Wiatrek Sarah E SE Sullivan Patrick S PS
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 20190101 3
We piloted PrEP@Home, a preexposure prophylaxis system of remote laboratory and behavioral monitoring designed to replace routine quarterly follow-up visits with home care to reduce the patient and provider burden. The system was highly acceptable and in-demand for future use, and more than one-third of participants reported greater likelihood of persisting in care if available. ...[more]
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Project description:Preexposure prophylaxis is a highly protective HIV prevention strategy, yet nonadherence can significantly reduce its effectiveness. We conducted a mixed methods evaluation of a mobile health intervention (iText) that utilized weekly bidirectional text or e-mail support messages to encourage preexposure prophylaxis (PrEP) adherence among participants in the multi-site iPrEx open-label extension study. A convenience sample of PrEP users from the San Francisco and Chicago sites participated in a 12-week pilot study. Fifty-six men who have sex with men were enrolled; a quarter of them were less than 30 years of age, 13% were black/African American, 11% were Latino, and most (88%) completed some college. Two-thirds opted for text message delivery. Of the 667 messages sent, only 1 individual requested support; initial nonresponse was observed in 22% and was higher among e-mail compared to text message recipients. Poststudy, a majority of participants would recommend the intervention to others, especially during PrEP initiation. Moreover, younger participants and men of color were more likely to report that they would use the iText strategy if it were available to them. Several participants commented that while they were aware that the messages were automated, they felt supported and encouraged that "someone was always there." Study staff reported that the intervention is feasible to administer and can be incorporated readily into clinic flow. A pre-post intervention regression discontinuity analysis using clinic-based pill counts showed a 50% reduction in missed doses [95% confidence interval (CI) 16-71; p?=?0.008] and 77% (95% CI 33-92; p?=?0.007) when comparing pill counts at quarterly visits just before and after iText enrollment. A mobile health intervention using weekly bidirectional messaging was highly acceptable and demonstrated promising effects on PrEP adherence warranting further evaluation for efficacy in a randomized controlled trial.
| S-EPMC5865612 | biostudies-literature
Project description:There are few psychosocial support programs specifically designed to meet the unique developmental and health needs of LGBTQ youth. Even when available, many youth face significant barriers to accessing LGBTQ-specific services for fear of being "outed" to parents, peers, and community members. The current study assessed the utility, feasibility, and acceptability of a synchronous, adult-facilitated, chat-based Internet community support program for LGBTQ youth aged 13-19. Chat transcripts were analyzed to examine how LGBTQ youth used the chat-based platform to connect with peers and trusted adults. A separate user satisfaction survey was collected to assess the personal (e.g., sexual orientation, gender identity, age) and contextual (e.g., geography, family environment) characteristics of youth engaging in the platform, their preferred topics of discussion, and their satisfaction with the program focus and facilitators. Qualitative data analysis demonstrated the degree to which LGBTQ youth were comfortable disclosing difficult and challenging situations with family, friends, and in their community and in seeking support from peers and facilitators online. Youth also used the platform to explore facets of sexual and gender identity/expression and self-acceptance. Overall, users were very satisfied with the platform, and participants accurately reflect the program's desired populations for engagement (e.g., LGBTQ youth of color, LGBTQ youth in the South). Together, findings support the feasibility and acceptability of synchronous, adult-facilitated, chat-based Internet programs to connect and support LGBTQ youth, which encourage future research and innovation in service delivery.
| S-EPMC8420963 | biostudies-literature
Project description:OBJECTIVES:To review the main factors influencing the costs of nondaily oral preexposure prophylaxis (PrEP) with tenofovir (±emtricitabine). To estimate the cost reductions possible with nondaily PrEP compared with daily PrEP for different populations (MSM and heterosexual populations). DESIGN:Systematic review and data triangulation. METHODS:We estimated the required number of tablets/person/week for dosing regimens used in the HPTN 067/ADAPT (daily/time-driven/event-driven) and IPERGAY (on-demand) trials for different patterns of sexual intercourse. Using trial data, and behavioural and cost data obtained through systematic literature reviews, we estimated cost savings resulting from tablet reductions for nondaily versus daily oral PrEP, assuming 100% adherence. RESULTS:Among different populations being prioritized for PrEP, the median reported number of days of sexual activity varied between 0 and 2 days/week (0-1.5 days/week for MSM, 1-2 days/week for heterosexual populations). With 100% adherence and two or fewer sex-days/week, HPTN 067/ADAPT nondaily regimens reduced the number of tablets/week by more than 40% compared with daily PrEP. PrEP program costs were reduced the most in settings with high drug costs, for example, by 66-69% with event-driven PrEP for French/US populations reporting on average one sex-day/week. CONCLUSION:Nondaily oral PrEP could lower costs substantially (>50%) compared with daily PrEP, particularly in high-income countries. Adherence and efficacy data are needed to determine cost-effectiveness.
| S-EPMC5854532 | biostudies-literature
Project description:Despite tremendous promise as a female-controlled HIV prevention strategy, implementation of preexposure prophylaxis (PrEP) among women has been limited, in part because of disparate efficacy results from randomized trials in this population. This review synthesizes existing evidence regarding PrEP efficacy for preventing HIV infection in women and considerations for delivering PrEP to women.In three efficacy trials, conducted among men and women, tenofovir-based oral PrEP reduced HIV acquisition in subgroups of women by 49-79% in intent-to-treat analyses, and by >85% when accounting for PrEP adherence. Two trials did not demonstrate an HIV prevention benefit from PrEP in women, but substantial evidence indicates those results were compromised by very low adherence to the study medication. Qualitative research has identified risk perception, stigma, and aspects of clinical trial participation as influencing adherence to study medication. Pharmacokinetic studies provide supporting evidence that PrEP offers HIV protection in women who are adherent to the medication.Tenofovir-based daily oral PrEP prevents HIV acquisition in women. Offering PrEP as an HIV prevention option for women at high risk of HIV acquisition is a public health imperative and opportunities to evaluate implementation strategies for PrEP for women are needed.
| S-EPMC4705855 | biostudies-other
Project description:Reproductive-age women need effective interventions to prevent the acquisition of human immunodeficiency virus type 1 (HIV-1) infection.We conducted a randomized, placebo-controlled trial to assess daily treatment with oral tenofovir disoproxil fumarate (TDF), oral tenofovir-emtricitabine (TDF-FTC), or 1% tenofovir (TFV) vaginal gel as preexposure prophylaxis against HIV-1 infection in women in South Africa, Uganda, and Zimbabwe. HIV-1 testing was performed monthly, and plasma TFV levels were assessed quarterly.Of 12,320 women who were screened, 5029 were enrolled in the study. The rate of retention in the study was 91% during 5509 person-years of follow-up. A total of 312 HIV-1 infections occurred; the incidence of HIV-1 infection was 5.7 per 100 person-years. In the modified intention-to-treat analysis, the effectiveness was -49.0% with TDF (hazard ratio for infection, 1.49; 95% confidence interval [CI], 0.97 to 2.29), -4.4% with TDF-FTC (hazard ratio, 1.04; 95% CI, 0.73 to 1.49), and 14.5% with TFV gel (hazard ratio, 0.85; 95% CI, 0.61 to 1.21). In a random sample, TFV was detected in 30%, 29%, and 25% of available plasma samples from participants randomly assigned to receive TDF, TDF-FTC, and TFV gel, respectively. Independent predictors of TFV detection included being married, being older than 25 years of age, and being multiparous. Detection of TFV in plasma was negatively associated with characteristics predictive of HIV-1 acquisition. Elevations of serum creatinine levels were seen more frequently among participants randomly assigned to receive oral TDF-FTC than among those assigned to receive oral placebo (1.3% vs. 0.2%, P=0.004). We observed no significant differences in the frequencies of other adverse events.None of the drug regimens we evaluated reduced the rates of HIV-1 acquisition in an intention-to-treat analysis. Adherence to study drugs was low. (Funded by the National Institutes of Health; VOICE ClinicalTrials.gov number, NCT00705679.).
| S-EPMC4341965 | biostudies-literature
Project description:BACKGROUND:Daily preexposure prophylaxis (PrEP) is an effective HIV prevention strategy, but adherence is required for maximum benefit. To date, there are no empirically supported PrEP adherence interventions. This article describes the process of developing a PrEP adherence intervention and presents results on its impact on adherence. METHODS:The Partners PrEP Study was a placebo-controlled efficacy trial of daily oral tenofovir and emtricitabine/tenofovir PrEP among uninfected members of HIV-serodiscordant couples. An ancillary adherence study was conducted at 3 study sites in Uganda. Participants with <80% adherence as measured by unannounced pill count received an additional adherence counseling intervention based on Lifesteps, an evidence-based HIV treatment adherence intervention, based on principles of cognitive-behavioral theory. FINDINGS:Of the 1147 HIV-seronegative participants enrolled in the ancillary adherence study, 168 (14.6%) triggered the adherence intervention. Of participants triggering the intervention, 62% were men; median age was 32.5 years. The median number of adherence counseling sessions was 10. Mean adherence during the month before the intervention was 75.7% and increased significantly to 84.1% in the month after the first intervention session (P < 0.001). The most frequently endorsed adherence barriers at session 1 were travel and forgetting. INTERPRETATION:A PrEP adherence intervention was feasible in a clinical trial of PrEP in Uganda and PrEP adherence increased after the intervention. Future research should identify PrEP users with low adherence for enhanced adherence counseling and determine optimal implementation strategies for interventions to maximize PrEP effectiveness.
| S-EPMC4191829 | biostudies-literature
Project description:BackgroundPatients with heart failure (HF) can be affected by disabling symptoms and low quality of life. Furthermore, they may frequently need to visit the emergency department or be hospitalized due to their condition deteriorating. Home telemonitoring can play a role in tracking symptoms, reducing hospital visits, and improving quality of life.ObjectiveOur objective was to conduct a feasibility study of a home health monitoring (HHM) solution for patients with HF in British Columbia, Canada, to prepare for conducting a randomized controlled trial.MethodsPatients with HF were recruited from 3 urban hospitals and provided with HHM technology for 60 days of monitoring postdischarge. Participants were asked to monitor their weight, blood pressure, and heart rate and to answer symptomology questions via Bluetooth sensors and a tablet computer each day. A monitoring nurse received this data and monitored the patient's condition. In our evaluation, the primary outcome was the combination of unscheduled emergency department revisits of discharged participants or death within 90 days. Secondary outcomes included 90-day hospital readmissions, patient quality of life (as measured by Veterans Rand 12-Item Health Survey and Kansas City Cardiomyopathy Scale), self-efficacy (as measured by European Heart Failure Self-Care Behaviour Scale 9), end-user experience, and health system cost-effectiveness including cost reduction and hospital bed capacity. In this feasibility study, we also tested the recruitment strategy, clinical protocols, evaluation framework, and data collection methods.ResultsSeventy participants were enrolled into this trial. Participant engagement to monitoring was measured at 94% (N=70; ie, data submitted 56/60 days on average). Our evaluation framework allowed us to collect sound data, which also showed encouraging trends: a 79% reduction of emergency department revisits post monitoring, an 87% reduction in hospital readmissions, and a 60% reduction in the median hospital length of stay (n=36). Cost of hospitalization for participants decreased by 71%, and emergency department visit costs decreased by 58% (n=30). Overall health system costs for our participants showed a 56% reduction post monitoring (n=30). HF-specific quality of life (Kansas City Cardiomyopathy Scale) scores showed a significant increase of 101% (n=35) post monitoring (P<.001). General quality of life (Veterans Rand 12-Item Health Survey) improved by 19% (n=35) on the mental component score (P<.001) and 19% (n=35) on the physical component score (P=.02). Self-efficacy improved by 6% (n=35). Interviews with participants revealed that they were satisfied overall with the monitoring program and its usability, and participants reported being more engaged, educated, and involved in their self-management.ConclusionsResults from this small-sample feasibility study suggested that our HHM intervention can be beneficial in supporting patients post discharge. Additionally, key insights from the trial allowed us to refine our methods and procedures, such as shifting our recruitment methods to in-patient wards and increasing our scope of data collection. Although these findings are promising, a more rigorous trial design is required to test the true efficacy of the intervention. The results from this feasibility trial will inform our next step as we proceed with a randomized controlled trial across British Columbia.Trial registrationClinicalTrials.gov NCT03439384; https://clinicaltrials.gov/ct2/show/NCT03439384.
| S-EPMC8212633 | biostudies-literature
Project description:Introduction:Increased physical exercise is linked to enhanced brain health and reduced dementia risk. Exercise intervention studies usually are conducted at facilities in groups under trainer supervision. To improve scalability, accessibility, and engagement, programs may need to be structured such that individuals can execute and adjust routines in their own homes. Methods:One hundred eighty-three healthy older adults from two sites (the United States and Sweden) were screened. One hundred fifty-six subjects (mean age 73.2), randomly assigned to one of four interventions (PACE-Yourself physical exercise program, mindfulness meditation, or Cogmed® adaptive or nonadaptive computerized working memory training) began the study. All interventions were structurally similar: occurring in subjects' homes using interactive, web-based software, over five weeks, ?175 minutes/week. In the PACE-Yourself program, video segments presented aerobic exercises at different pace and intensity (P&I). The program paused frequently, allowing subjects to indicate whether P&I was "too easy," "too hard," or "somewhat hard." P&I of the subsequent exercise set was adjusted, allowing subjects to exercise at a perceived exertion level of "somewhat hard." Program completion was defined as finishing ?60% of sessions. Results:A high percentage of participants in all groups completed the program, although the number (86%) was slightly lower in the PACE-Yourself group than the other three. Excluding dropouts, the PACE-Yourself group had a lower adherence rate of 93%, compared with the other three (?98%). Over the five weeks, PACE-Yourself participants increased exercising at the highest intensity level, consistent with augmented aerobic activity over time. The number of exercise sessions completed predicted the postintervention versus preintervention increase in self-reported level of physical activity. Discussion:This study supports the feasibility of a home-based, subject-controlled, exercise program in which P&I is regulated via real-time participant feedback, which may promote self-efficacy. Further study is needed to determine if similar results are found over longer periods and in more diverse populations.
| S-EPMC6883315 | biostudies-literature
Project description:BACKGROUND:Many state and local health departments now promote and support the use of HIV preexposure prophylaxis (PrEP), yet monitoring use of the intervention at the population level remains challenging. METHODS:We report the results of an online survey designed to measure PrEP use among men who have sex with men (MSM) in Washington State. Data on the proportion of men with indications for PrEP based on state guidelines and levels of awareness, interest, and use of PrEP are presented for 1080 cisgender male respondents who completed the survey between January 1 and February 28, 2017. We conducted bivariate and multivariable logistic regression to identify factors associated with current PrEP use. To examine patterns of discontinuation, we conducted Cox proportional hazards regression and fit a Kaplan-Meier curve to reported data on time on PrEP. RESULTS:Eighty percent of respondents had heard of PrEP, 19% reported current use, and 36% of men who had never used PrEP wanted to start taking it. Among MSM for whom state guidelines recommend PrEP, 31% were taking it. In multivariable analysis, current PrEP use was associated with older age, higher education, and meeting indications for PrEP use. Our data suggest that 20% of PrEP users discontinue within 12 months, and men with lower educational attainment were more likely to discontinue. CONCLUSIONS:Despite high levels of use, there is significant unmet need for PrEP in Washington. Our experience indicates that Internet surveys are feasible and informative for monitoring PrEP use in MSM.
| S-EPMC7687921 | biostudies-literature
Project description:Purpose: Increasing attention is being paid to the role of the intelligent self-management of hypertension under the context of increasing prevalence but limited medical resources. However, heterogeneity in interventions and outcome measures has hindered the interpretation of research evaluating mobile health technologies for hypertension control, and little study of such technology has been performed in China. Objective: This was a feasibility study aimed to understand patient and medical practitioners' acceptance and experience of a mobile-phone based platform for the management of hypertensive patients. Methods: The model used behavioral incentives for daily blood pressure measurement and physician-facing prioritization of patients based on level of blood-pressure control. Patients were enrolled by purposive sampling. The platform was used for two-week blood pressure monitoring through WeChat, which simulated our future app. Qualitative interviews with patients and providers were conducted in time. Results: Twenty hypertensive patients and two providers were enrolled and used the platform throughout the two weeks. Patients reported daily home blood pressure monitoring to be simple, feasible and increased their health awareness. Specifically, patients self-reported that reminders, the daily frequency and time of monitoring, and positive reinforcement were important for maintaining adherence. Providers reported that they could manage patients more quickly and accurately, but reasonable feedback information was needed to avoid excessive increases in workload. Conclusion: The adoption of mobile-based technology to monitor patient's blood pressure may provide a practical solution for managing patients in Chongqing, China. Patient health education and enhanced app functionality could improve patient compliance and satisfaction while reducing provider workload.
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