Reducing cardiovascular risk among people living with HIV: Rationale and design of the INcreasing Statin Prescribing in HIV Behavioral Economics REsearch (INSPIRE) randomized controlled trial.
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ABSTRACT:
SUBMITTER: Takada S
PROVIDER: S-EPMC8670826 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:The heightened risk of persons with serious mental illness (SMI) to contract and transmit human immunodeficiency virus (HIV) is a public health problem. Our objective was test the effectiveness of a community-based advanced practice nurse intervention to promote adherence to HIV and psychiatric treatment regimens call Preventing AIDS Through Health for Positives (PATH+). We enrolled 238 HIV-positive subjects with SMI who were in treatment at community HIV provider agencies from 2004 to 2009. Participants in the intervention group were assigned an advanced practice nurse who provided community-based care management at a minimum of one visit/week and coordinated their medical and mental healthcare for 12 months. A parallel process latent growth curve model using three data points for biomarkers (baseline, 12 and 24 months) and five data points for health related quality of life (baseline, 3, 6, 12, and 24 months) showed moderate to excellent fit for modeling changes in CD4, viral load, and mental and physical SF-12 subscales. Results suggest that positive effects for PATH+ persisted at 24 months; 12 months after the intervention ended. This project demonstrates the effectiveness of a nurse-led, community-based, individually tailored adherence intervention. We demonstrated improved outcomes in individuals with HIV/SMI and regarding health-related quality of life and reductions in disease burden.
| S-EPMC3940688 | biostudies-literature
Project description:BACKGROUND:In observational studies, patients with HIV have higher levels of soluble ST2 (sST2), galectin-3, and growth differentiation factor-15 (GDF-15) than non-HIV controls. As statins exert pleiotropic immunomodulatory effects that may affect markers of myocardial fibrosis, the objective of the current study is to determine whether biomarkers of myocardial fibrosis reflecting subclinical pathology may be modified by statin therapy in patients with HIV. SETTING AND METHODS:Forty HIV+ men and women participated in a single center 12-month randomized, double-blind placebo-controlled trial of atorvastatin 40 mg every day vs. placebo. At baseline and 12-months, sST2, GDF-15, galectin-3 were measured. RESULTS:The changes in sST2 were -0.310 (-4.195, 2.075) vs. 1.163 (0.624, 4.715) ng/mL, median (interquartile range) atorvastatin vs. placebo (P = 0.04). The change in sST2 was significantly related to changes in monocyte activation marker sCD14 (r = 0.63, P < 0.0001) and MCP (r = 0.52, P = 0.0009), markers of generalized inflammation hs-IL-6 (r = 0.58, P = 0.0002), oxLDL (r = 0.49, P = 0.002), and GDF-15 (r = 0.54, P = 0.0008). CONCLUSIONS:sST2, a member of the IL-1 receptor family and a marker of fibrosis and inflammation increases over time among patients with HIV and this increase is attenuated by statin therapy in HIV. This effect may relate to immunomodulatory mechanisms of statins.
| S-EPMC5889348 | biostudies-literature
Project description:BackgroundMany HIV-positive patients do not appropriately adhere to their antiretroviral medication (ART). This leads to higher viral loads and greater probability of HIV transmission. Present bias-a tendency to give in to short-term temptations at the expense of long-term outcomes-is a potential driver of low adherence. In this study we test a novel intervention rooted in behavioral economics that is designed to overcome present bias and increase ART adherence.Methods/designWe will enroll 330 HIV-positive patients at Mildmay Hospital in Kampala, Uganda, into a 2-year randomized controlled trial. Participants will be randomized to one of three groups. The first intervention group (T1, n = 110) will be eligible for small lottery prizes based on timely clinic visits and demonstration of viral suppression. Group 2 (T2, n = 110) will be eligible for the same lottery prizes conditional on high adherence measured by a medication event management system (MEMS) cap. The control group (n = 110) will receive the usual standard of care. Adherence will be measured continuously throughout the intervention period and for 12 months post-intervention to evaluate effect persistence. Surveys will be conducted at baseline and then every 6 months. Viral loads will be measured annually. Primary outcomes are whether the viral load is detectable and MEMS-measured adherence. Secondary outcomes are the log-transformed viral load as a continuous measure and a binary measure for whether the person took at least 90% of their ART pills.DiscussionOur study is one of the first to investigate the effectiveness of lottery incentives for improving ART adherence, and in addition, it compares the relative efficacy of using electronically measured adherence versus viral load to determine lottery eligibility. MEMS caps are relatively costly, whereas viral load testing is now part of routine clinical care in Uganda. BEST will test whether directly incentivizing viral suppression (which can be implemented using readily available clinic data) is as effective as incentivizing electronically measured adherence. Cost-effectiveness analyses of the two implementation modes will also be performed.Trial registrationClinicalTrials.gov, NCT03494777. Registered on 11 April 2018.
| S-EPMC6942278 | biostudies-literature
Project description:Alcohol and drug use peaks during young adulthood and can interfere with critical developmental tasks and set the stage for chronic substance misuse and associated social, educational, and health-related outcomes. There is a need for novel, theory-based approaches to guide substance abuse prevention efforts during this critical developmental period. This paper discusses the particular relevance of behavioral economic theory to young adult alcohol and drug misuse, and reviews of available literature on prevention and intervention strategies that are consistent with behavioral economic theory. Behavioral economic theory predicts that decisions to use drugs and alcohol are related to the relative availability and price of both alcohol and substance-free alternative activities, and the extent to which reinforcement from delayed substance-free outcomes is devalued relative to the immediate reinforcement associated with drugs. Behavioral economic measures of motivation for substance use are based on relative levels of behavioral and economic resource allocation towards drug versus alternatives, and have been shown to predict change in substance use over time. Policy and individual level prevention approaches that are consistent with behavioral economic theory are discussed, including brief interventions that increase future orientation and engagement in rewarding alternatives to substance use. Prevention approaches that increase engagement in constructive future-oriented activities among young adults (e.g., educational/vocational success) have the potential to reduce future health disparities associated with both substance abuse and poor educational/vocational outcomes.
| S-EPMC5085883 | biostudies-literature
Project description:Background:Nonadherence to study protocols reduces the generalizability, validity, and statistical power of longitudinal studies. Purpose:To determine whether an automated electronically-delivered regret lottery would improve adherence to an intensive mHealth self-monitoring protocol as part of a longitudinal observational study. Methods:We enrolled 77 adults into a 52-week study requiring five daily ecologic momentary assessments (EMA) of stress and daily accelerometer use. We performed a pre/post single-arm study to evaluate the efficacy of a lottery intervention in improving adherence to this protocol. Midway through the study, participants were invited to enter a weekly regret lottery ($50 prize, expected value <$1) in which prize collection was contingent upon meeting adherence thresholds for the prior week. Study protocol adherence before and after lottery initiation were compared using mixed models repeated measures analysis of variance. Results:62 participants consented to lottery participation. In the 12 weeks prior to lottery initiation, weekly adherence was declining (slope -1.4%/week). The weekly per-participant probability of adherence was higher after lottery initiation when comparing the 4-week (32% pre-lottery vs 50% post-lottery, p < 0.001), 8-week (37% vs 49%, p < 0.001), and 12-week periods (39% vs 45%, p = 0.001) before and after lottery initiation. However, the rate of decline in adherence over time was unchanged. Conclusion:The implementation of an automated, electronically-delivered weekly regret lottery improved adherence with an intensive self-monitoring study protocol. Regret lotteries may represent a cost-effective tool to improve adherence and reduce bias caused by dropout or nonadherence.
| S-EPMC6555893 | biostudies-other
Project description:Delayed reward discounting is a behavioral economic index of impulsivity, referring to how much an individual devalues a reward based on its delay in time. As a behavioral process that varies considerably across individuals, delay discounting has been studied extensively as a model for self-control, both in the general population and in clinical samples. There is growing interest in genetic influences on discounting and, in particular, the prospect of discounting as an endophenotype for addictive disorders (i.e., a heritable mechanism partially responsible for conferring genetic risk). This review assembles and critiques the evidence supporting this hypothesis. Via numerous cross-sectional studies and a small number of longitudinal studies, there is considerable evidence that impulsive discounting is associated with addictive behavior and appears to play an etiological role. Moreover, there is increasing evidence from diverse methodologies that impulsive delay discounting is temporally stable, heritable, and that elevated levels are present in nonaffected family members. These findings suggest that impulsive discounting meets the criteria for being considered an endophenotype. In addition, recent findings suggest that genetic variation related to dopamine neurotransmission is significantly associated with variability in discounting preferences. A significant caveat, however, is that the literature is modest in some domains and, in others, not all the findings have been supportive or consistent. In addition, important methodological considerations are necessary in future studies. Taken together, although not definitive, there is accumulating support for the hypothesis of impulsive discounting as an endophenotype for addictive behavior and a need for further systematic investigation.
| S-EPMC3881595 | biostudies-other
Project description:ImportanceSince 1994, the US Department of Health and Human Services has published treatment guidelines for pregnant women living with HIV. Understanding how well prescribing patterns correspond with treatment guidelines could inform health policy and influence future clinical practice.ObjectivesTo compare antiretroviral prescribing practices over time among pregnant women living with HIV with Department of Health and Human Services treatment guidelines and identify factors associated with receiving recommended regimens.Design, setting, and participantsA prospective cohort study of 1582 pregnant women living with HIV were enrolled in the Pediatric HIV/AIDS Cohort Study Surveillance Monitoring of ART (antiretroviral therapy) Toxicities study between January 1, 2008, and June 30, 2017. The study was conducted at 18 academic research hospitals in the United States.ExposuresAntiretroviral medications (ARVs) prescribed during pregnancy.Main outcomes and measuresProportion of regimens prescribed to pregnant women living with HIV qualifying as preferred or alternative according to Department of Health and Human Services guidelines, stratified by timing of initiation.ResultsOf 1867 pregnancies (among 1582 pregnant women living with HIV with a mean [SD] age of 28.6 [6.1] years at conception), 1264 (67.7%) occurred among women self-identified as black, 480 (25.7%) self-identified as white, and 123 (6.6%) self-identified as other or unreported race/ethnicity. Antiretroviral medications were initiated prior to conception for 790 women (42.3%), resumed during pregnancy for 625 women (33.5%), and initiated during pregnancy for 452 women (24.2%). Only 925 pregnancies (49.5%) were associated with prescribed ARVs designated as preferred or alternative, while 492 (26.4%) involved ARVs with insufficient evidence for use during pregnancy and 136 (7.3%) involved ARVs that were not recommended during pregnancy. A higher proportion of treatment-naive pregnant women initiating ARVs were prescribed preferred or alternative ARVs compared with those resuming ARVs or those treated with ARVs before conception (316 of 452 [69.9%] vs 325 of 625 [52.0%] vs 284 of 790 [35.9%]; P?<?.001). A total of 91 of 452 women (20.1%) initiating ARVs during pregnancy were prescribed ARVs with insufficient evidence for use during pregnancy or not recommended during pregnancy. Among women resuming ARVs, those with a viral load greater than 1000 copies/mL early in pregnancy had higher odds of being prescribed guideline-recommended ARVs (adjusted odds ratio, 2.03 [95% CI, 1.33-3.10]) compared with those with a viral load of 400 copies/mL or less.Conclusions and relevanceThis study suggests that US ARV prescribing practices for pregnant women living with HIV do not align well with national guidelines. This finding is particularly concerning when treatment is initiated during pregnancy. Further research is needed to understand disparities between prescribing practices and evidence-based guideline recommendations.
| S-EPMC6991210 | biostudies-literature
Project description:There is a need for new, targeted smoking cessation interventions for smokers living with HIV. The Information-Motivation-Behavioral Skills (IMB) model has been applied effectively to HIV-related health behaviors and was used in this qualitative study to elicit factors that could lead to the development of innovative and successful cessation interventions for this population. Twenty individuals who smoked from two clinics providing care to people living with HIV participated in open-ended interviews, responding to questions covering the domains of the IMB model, as applied to smokers living with HIV. Participants were enrolled from a larger survey cohort to recruit into groups based on the impact of HIV diagnosis on smoking as well as attempting to enroll a mix of demographics characteristics. Interviews were recorded, transcribed, coded and thematically analyzed using a grounded theory qualitative approach. Interviews continued until thematic saturation was reached. Major themes included: Presence of knowledge deficits regarding HIV-specific health risks of smoking; use of smoking for emotional regulation, where many reported close contacts who smoke and concern with the effect of cessation on their social networks; Use of smoking cessation aids or a telephone-based wellness intervention were acceptable to most. Providing HIV-specific information in cessation advice is of the utmost importance for clinicians caring for smokers living with HIV, as this theme was noted consistently as a potential motivator to quit. Innovative and effective interventions must account for the social aspect of smoking and address other methods of emotional regulation in this population.
| S-EPMC5725260 | biostudies-literature
Project description:There has been a global increase in HIV infection in persons 50 years of age and older. This group is at risk for development of chronic illness that may be exacerbated by socio-behavioral risk factors such as smoking, unhealthy alcohol use, and sedentary lifestyle. However, socio-behavioral risk factors in this older HIV infected population are not well described. The current study aims to describe and document factors related to alcohol use, tobacco smoking, and physical exercise in older adults living with HIV (OALHIV).This cross-sectional quantitative study was conducted between August and September 2015, and enrolled HIV-infected participants aged 50 years and older from 12 community hospitals in Chiang Mai Province, Northern Thailand.Of the 364 participants recruited in the study, 57.1% were female, and 67.3% were between 50-59 years of age. Respectively, 15.1%, 59.1%, and 18.7% were current smokers, currently engaged in physical exercises, and reported ever drank alcohol in the past year. 22.1% of those who drank alcohol reported experience of heavy episodic drinking. Male gender was one of the strongest predictors of ever drank alcohol in the past year (AOR, 4.66; CI, 2.28-9.49; P<0.001) and of being a current smoker (AOR, 13.41; CI, 7.23-24.87; P<0.001). Lower household income was associated with increased odds of ever drank alcohol in the past year (household income (1 USD = 35 THB) of ? 5,000 Baht versus > 20,000 Baht: AOR, 5.34; CI, 1.28-22.25; P = 0.021). Lower educational level was associated with decreased odds of physical exercises (no education versus secondary and higher: AOR, 0.22; CI, 0.08-0.55; P = 0.001).Smoking and alcohol use is common among OALHIV, with a substantial proportion not engaging in physical exercises. Interventions for OALHIV should particularly target males and those of lower socio-economic status to deter smoking and alcohol use and to promote physical exercises.
| S-EPMC5685602 | biostudies-literature
Project description: Not available
| S-EPMC1569957 | biostudies-literature