Overreporting of adherence to hepatitis C direct-acting antiviral therapy and sustained virologic response among people who inject drugs in the HERO study.

BACKGROUND: Self-reported adherence to direct-acting antivirals (DAAs) to treat hepatitis C virus (HCV) among persons who inject drugs (PWID) is often an overreport of objectively measured adherence. The association of such overreporting with sustained virologic response (SVR) is understudied. This study among PWID aimed to determine a threshold of overreporting adherence that optimally predicts lower SVR rates, and to explore correlates of the optimal overreporting threshold. METHODS: This study analyzed per-protocol data of participants with adherence data (N = 493) from the HERO (Hepatitis C Real Options) study. Self-reported and objective adherence to a 12-week DAA regimen were measured using visual analogue scales and electronic blister packs, respectively. The difference (Δ) between self-reported and objectively measured adherence was calculated. We used the Youden index based on receiver operating characteristic (ROC) curve analysis to identify an optimal threshold of overreporting for predicting lower SVR rates. Factors associated with the optimal threshold of overreporting were identified by comparing baseline characteristics between participants at/above versus those below the threshold. RESULTS: The self-reported, objective, and Δ adherence averages were 95.1% (SD = 8.9), 75.9% (SD = 16.3), and 19.2% (SD = 15.2), respectively. The ≥ 25% overreporting threshold was determined to be optimal. The SVR rate was lower for ≥ 25% vs. < 25% overreporting (86.7% vs. 95.8%, p <.001). The factors associated with ≥ 25% Δ adherence were unemployment; higher number of days and times/day of injecting drugs; higher proportion of positive urine drug screening for amphetamine, methamphetamine, and oxycodone, and negative urine screening for THC (tetrahydrocannabinol)/cannabis. CONCLUSIONS: Self-reported DAA adherence was significantly greater than objectively measured adherence among PWID by 19.2%. Having ≥ 25% overreported adherence was associated with optimal prediction of lower SVR rates. PWID with risk factors for high overreporting may need to be more intensively managed to promote actual adherence.

A randomized control trial to test a peer support group approach for reducing social isolation and depression among female Mexican immigrants.

BACKGROUND: Female Mexican Immigrants (FMIs) experience high rates of depression compared with other populations. For this population, depression is often exacerbated by social isolation associated with the experience of immigration. Aim 1. To measure whether a culturally situated peer group intervention will reduce depression and stress associated with the experience of immigration. Aim 2. To test whether an intervention using a "women's funds of knowledge" approach results in improved resilience, knowledge and empowerment. Aim 3. To investigate whether a culturally situated peer group intervention using a women's funds of knowledge approach can give participants a sense and experience of social and physical connection ("emplacement") that is lost in the process of immigration. METHODS: This mixed-methods study will implement "Tertulias" ("conversational gatherings" in Spanish), a peer support group intervention designed to improve health outcomes for FMI participants in Albuquerque, New Mexico. We will document results of the intervention on our primary hypotheses of a decrease in depression, and increases in resilience and social support, as well as on our secondary hypotheses of decreased stress (including testing of hair cortisol as a biomarker for chronic stress), and an increase in social connectedness and positive assessment of knowledge and empowerment. DISCUSSION: This project will address mental health disparities in an underserved population that experiences high rates of social isolation. Successful completion of this project will demonstrate that health challenges that may appear too complex and too hard to address can be using a multi-level, holistic approach. Our use of hair samples to test for the 3-month average levels of systemic cortisol will contribute to the literature on an emerging biomarker for analyzing chronic stress. TRIAL REGISTRATION: This study was registered with ClinicalTrials.gov on 2/3/20, Identifier # NCT04254198 .

A comparative effectiveness study of two culturally competent models of diabetes self-management programming for Latinos from low-income households.

BACKGROUND: Diabetes risk is extremely high for Latinos from low-income households. Health guidelines recommend that individuals learn strategies to self-manage their diabetes, but getting people to adopt required lifestyle changes is challenging and many people are not able to prevent their pre-diabetes from escalating or effectively control their diabetes. Systematic reviews show that culturally competent self-management programs can significantly improve diabetes outcomes and different models for culturally competent programming have been developed. METHODS: This patient-engaged study will compare the effectiveness of two distinct evidence-based models for culturally competent diabetes health promotion at two sites that serve a large Latino patient population from low-income households: 1) The Diabetes Self-Management Support Empowerment Model, an educational session approach, and 2) The Chronic Care Model, a holistic community-based program. Data collection will involve interviews, focus groups, surveys and assessments of each program; and testing of patient participants for A1c, depression, Body Mass Index (BMI), and chronic stress with hair cortisol levels. We will recruit a total of 240 patient-social support pairs: Patients will be adults (men and women over the age of 18) who: 1.) Enter one of the two diabetes programs during the study; 2.) Self-identify as "Latino;" 3.) Are able to identify a social support person or key member of their social network who also agrees to participate with them; 4.) Are not pregnant (participants who become pregnant during the study will be excluded); and 5.) Have household income 250% of the Federal Poverty Level (FPL) or below. Social supports will be adults who are identified by the patient participants. PRIMARY OUTCOME: Improved capacity for diabetes self-management measured through improvements in diabetes knowledge and diabetes-related patient activation. SECONDARY OUTCOME: Successful diabetes self-management as measured by improvements in A1c, depression scale scores, BMI, and circulating levels of cortisol to determine chronic stress. DISCUSSION: Our hypothesis is that the program model that interfaces most synergistically with patients' culture and everyday life circumstances will have the best diabetes health outcomes. TRIAL REGISTRATION: This study was registered with ClinicalTrials.gov on December 16, 2016 (Registration # NCT03004664 ).

A Prospective Trial of Ayurveda for Coronary Heart Disease: A Pilot Study.

CONTEXT: Coronary heart disease is the leading cause of death worldwide, and its incidence is rapidly accelerating in developing nations. Patients often search for therapies that are alternatives to traditional treatments, such as heart medicines, coronary bypass surgery, or coronary stenting. Ayurveda is an ancient, East Indian, holistic approach to health care, and its use has never been formally evaluated for patients with coronary heart disease. OBJECTIVES: The study intended to examine the feasibility and effectiveness of comprehensive ayurvedic therapy-incorporating diet, meditation, breathing exercises, yoga, and herbs-for patients with established coronary heart disease. DESIGN: The study was a prospective, single-group, pilot study. SETTING: The study took place at the University of New Mexico Cardiology Clinic and at the Ayurvedic Institute in Albuquerque, NM, USA. PARTICIPANTS: The participants were adults with a history of a prior heart attack, coronary bypass surgery, or a coronary intervention (ie, a coronary angioplasty and/or stent). INTERVENTION: All enrolled patients were evaluated by a single ayurvedic physician with >40 y of experience, and each received therapy consisting of a calorically unrestricted ayurvedic diet; instruction in yoga, meditation, and breathing; and use of ayurvedic herbs. OUTCOME MEASURES: The primary endpoint was arterial pulse wave velocity, a marker of arterial function and vascular health. Secondary endpoints included the following measurements: (1) body mass index (BMI); (2) blood pressure (BP) and amount of reduction in BP medications; and (3) levels of total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. All parameters were measured at baseline and after 90 d of therapy. RESULTS: Twenty-two patients were enrolled in the study, and 19 patients completed it. The research team observed significant improvements in arterial pulse wave velocity (P = .015), and favorable reductions in BMI (P < .0001), total cholesterol (P = .028), LDL cholesterol (P = .024), and triglycerides (P = .046). HDL cholesterol did not change significantly (P = .90). A majority of hypertensive patients were able to reduce or eliminate their antihypertensive medications (P = .0058). CONCLUSIONS: The study's results suggest a favorable effect for ayurveda on arterial function and multiple risk factors in patients with established coronary heart disease.

Mindfulness meditation in older adults with postherpetic neuralgia: a randomized controlled pilot study.

This parallel-group, randomized controlled pilot study examined daily meditation in a diverse sample of older adults with postherpetic neuralgia. Block randomization was used to allocate participants to a treatment group (n = 13) or control group (n = 14). In addition to usual care, the treatment group practiced daily meditation for six weeks. All participants completed questionnaires at enrollment in the study, two weeks later, and six weeks after that, at the study's end. Participants recorded daily pain and fatigue levels in a diary, and treatment participants also noted meditation practice. Results at the 0.10 level indicated improvement in neuropathic, affective, and total pain scores for the treatment group, whereas affective pain worsened for the control group. Participants were able to adhere to the daily diary and meditation requirements in this feasibility pilot study.