Incident hyperglycaemia among older adults with or at-risk for HIV infection

HIV infection has been associated with development of prediabetes and diabetes. Optimum screening practices for these disorders in HIV-infected populations remain unclear

Preliminary Evidence of the Association between Time on Buprenorphine and Cognitive Performance among Individuals with Opioid Use Disorder Maintained on Buprenorphine: A Pilot Study

People on buprenorphine maintenance treatment (BMT) commonly present cognitive deficits that have been associated with illicit drug use and dropout from buprenorphine treatment. This study has compared cognitive responses to the Stroop Task and the Continuous Performance Task (CPT) among individuals on BMT, with recent drug use, and healthy controls and explored the associations between cognitive responses and drug use, craving, and buprenorphine use among participants on BMT. The participants were 16 individuals on BMT and 23 healthy controls. All participants completed a 60 min laboratory session in which they completed the Stroop Task and the CPT, a saliva drug test, a brief clinical history that collected substance-use- and treatment-related information, and the Opioid Craving Scale. The results showed that the BMT participants presented more commission errors (MBMT participants = 2.49; Mhealthy controls = 1.38; p = 0.048) and longer reaction times (MBMT participants = 798.09; Mhealthy controls = 699.09; p = 0.047) in the Stroop Task than did the healthy controls. More days on buprenorphine were negatively associated with reaction time in the CPT (−0.52) and the number of commission errors (−0.53), simple reaction time (−0.54), and reaction time correct (−0.57) in the Stroop Task. Neither drug use nor craving was significantly associated with the results for the cognitive tasks. Relative to the control participants, the BMT individuals performed worse in terms of longer reaction times and more commission errors in the Stroop Task. Within the BMT participants, longer times on buprenorphine were associated with better cognitive results in terms of faster reaction times for both tasks and lower commission errors for the Stroop Task

Empowering With PrEP (E-PrEP), a Peer-Led Social Media–Based Intervention to Facilitate HIV Preexposure Prophylaxis Adoption Among Young Black and Latinx Gay and Bisexual Men: Protocol for a Cluster Randomized Controlled Trial

Background: Young black and Latinx, gay, bisexual, and other men who have sex with men (YBLGBM, aged 18-29 years) have among the highest rates of new HIV infections in the United States and are not consistently reached by existing prevention interventions. Preexposure prophylaxis (PrEP), an oral antiretroviral regimen taken daily by HIV-uninfected individuals to prevent HIV acquisition, is highly efficacious in reducing HIV acquisition and could help stop the HIV epidemic in YBLGBM. Use of social media (eg, Facebook, Twitter, online dating sites) is ubiquitous among young people, providing an efficient avenue to engage YBLGBM to facilitate PrEP adoption. Objective: Our overall goal was to develop and pilot test a theoretically grounded, social media–based, peer-led intervention to increase PrEP uptake in YBLGBM. We used diffusion of innovation and information-motivation-behavioral skills frameworks to (1) identify potential factors associated with interest in and adoption of PrEP among YBLGBM; (2) develop Empowering with PrEP (E-PrEP), a social media–based, peer-led intervention to increase PrEP uptake in YBLGBM; and (3) pilot test the feasibility and acceptability of E-PrEP, and determine its preliminary efficacy for increasing adoption of PrEP by YBLGBM. We describe the development and protocol for E-PrEP. Methods: Using a participatory research approach, we partnered with YBLGBM intervention development partners to develop a social media–based behavioral intervention to facilitate PrEP uptake, which involved an online messaging campaign disseminated by YBLGBM peer leaders to their existing online networks. We designed the 6-week campaign to provide education about PrEP, increase motivation to use PrEP, and facilitate access to PrEP. We then conducted a cluster-randomized trial of E-PrEP compared with an attention-matched general health control condition (E-Health) among YBLGBM aged 18 to 29 years to assess E-PrEP’s feasibility, acceptability, preliminary efficacy for increasing self-reported intention to use PrEP, PrEP uptake, and impact on knowledge and attitudes about PrEP at 12-week follow-up (6 weeks after the end of the online campaign). Results: From October 2016 to March 2017, we developed, pretested, and refined E-PrEP with 6 YBLGBM intervention development partners. From May to June 2017, we recruited, enrolled, and randomly assigned 10 peer leaders (n=5 for each condition). The 10 peer leaders then recruited and enrolled 152 participants from their existing online networks (range 3-33 per peer leader), during June and July 2017. Intervention follow-up was completed after 12 weeks, in November 2017, with analyses underway. Conclusions: We hypothesize that, compared with E-Health, participants randomly assigned to E-PrEP will be more likely to express intention to use PrEP and greater PrEP uptake, and will also show changes in potential mediators of PrEP uptake (knowledge, attitudes, stigma, and access). A Web-based biobehavioral intervention model such as E-PrEP could be rapidly scaled even with limited resources and have significant population-level impact

MACH14: A Multi-Site Collaboration on ART Adherence Among 14 Institutions

The integration of original data from multiple antiretroviral (ARV) adherence studies offers a promising, but little used method to generate evidence to advance the field. This paper provides an overview of the design and implementation of MACH14, a collaborative, multi-site study in which a large data system has been created for integrated analyses by pooling original data from 16 longitudinal ARV adherence studies. Studies selected met specific criteria including similar research design and data domains such as adherence measured with medication event monitoring system, psychosocial factors related to adherence behavior, and virologic and clinical outcomes. The data system created contains individual data (collected between 1997 and 2009) from 2,860 HIV patients. Collaboration helped resolve the challenges inherent in pooling data across multiple studies, yet produced a data system with strong statistical power and potentially greater capacity to address key scientific questions than possible with single-sample studies or even meta-analytic designs

The Validity of Self-Reported Medication Adherence as an Outcome in Clinical Trials of Adherence-Promotion Interventions: Findings from the MACH14 Study

In medication adherence-promotion trials, participants in the intervention arm are often cognizant of the researcher’s aim to improve adherence; this may lead to their inflating reports of their own adherence compared to control arm participants. Using data from 1,247 HIV-positive participants across eight U.S. Studies in the Multisite Adherence Collaboration on HIV (MACH14) collaboration, we evaluated the validity of self-reported adherence by examining whether its association with two more objective outcomes [1], electronically monitored adherence and [2] viral load, varied by study arm. After adjusting for potential confounders, there was no evidence of greater overestimation of self-reported adherence among intervention arm participants, supporting its potential as a trial outcome indicator

PRimary Care Opioid Use Disorders treatment (PROUD) trial protocol: a pragmatic, cluster-randomized implementation trial in primary care for opioid use disorder treatment

BACKGROUND: Most people with opioid use disorder (OUD) never receive treatment. Medication treatment of OUD in primary care is recommended as an approach to increase access to care. The PRimary Care Opioid Use Disorders treatment (PROUD) trial tests whether implementation of a collaborative care model (Massachusetts Model) using a nurse care manager (NCM) to support medication treatment of OUD in primary care increases OUD treatment and improves outcomes. Specifically, it tests whether implementation of collaborative care, compared to usual primary care, increases the number of days of medication for OUD (implementation objective) and reduces acute health care utilization (effectiveness objective). The protocol for the PROUD trial is presented here. METHODS: PROUD is a hybrid type III cluster-randomized implementation trial in six health care systems. The intervention consists of three implementation strategies: salary for a full-time NCM, training and technical assistance for the NCM, and requiring that three primary care providers have DEA waivers to prescribe buprenorphine. Within each health system, two primary care clinics are randomized: one to the intervention and one to Usual Primary Care. The sample includes all patients age 16-90 who visited the randomized primary care clinics from 3 years before to 2 years after randomization (anticipated to be \u3e 170,000). Quantitative data are derived from existing health system administrative data, electronic medical records, and/or health insurance claims ( electronic health records, [EHRs]). Anonymous staff surveys, stakeholder debriefs, and observations from site visits, trainings and technical assistance provide qualitative data to assess barriers and facilitators to implementation. The outcome for the implementation objective (primary outcome) is a clinic-level measure of the number of patient days of medication treatment of OUD over the 2 years post-randomization. The patient-level outcome for the effectiveness objective (secondary outcome) is days of acute care utilization [e.g. urgent care, emergency department (ED) and/or hospitalizations] over 2 years post-randomization among patients with documented OUD prior to randomization. DISCUSSION: The PROUD trial provides information for clinical leaders and policy makers regarding potential benefits for patients and health systems of a collaborative care model for management of OUD in primary care, tested in real-world diverse primary care settings

Rationale and design of a randomized controlled trial of directly observed hepatitis C treatment delivered in methadone clinics

<p>Abstract</p> <p>Background</p> <p>Most methadone-maintained injection drug users (IDUs) have been infected with hepatitis C virus (HCV), but few initiate HCV treatment. Physicians may be reluctant to treat HCV in IDUs because of concerns about treatment adherence, psychiatric comorbidity, or ongoing drug use. Optimal HCV management approaches for IDUs remain unknown. We are conducting a randomized controlled trial in a network of nine methadone clinics with onsite HCV care to determine whether modified directly observed therapy (mDOT), compared to treatment as usual (TAU), improves adherence and virologic outcomes among opioid users.</p> <p>Methods/Design</p> <p>We plan to enroll 80 HCV-infected adults initiating care with pegylated interferon alfa-2a (IFN) plus ribavirin, and randomize them to mDOT (directly observed daily ribavirin plus provider-administered weekly IFN) or TAU (self-administered ribavirin plus provider-administered weekly IFN). Our outcome measures are: 1) self-reported and pill count adherence, and 2) end of treatment response (ETR) or sustained viral response (SVR). We will use mixed effects linear models to assess differences in pill count adherence between treatment arms (mDOT v. TAU), and we will assess differences between treatment arms in the proportion of subjects with ETR or SVR with chi square tests. Of the first 40 subjects enrolled: 21 have been randomized to mDOT and 19 to TAU. To date, the sample is 77% Latino, 60% HCV genotype-1, 38% active drug users, and 27% HIV-infected. Our overall retention rate at 24 weeks is 92%, 93% in the mDOT arm and 92% in the TAU arm.</p> <p>Discussion</p> <p>This paper describes the design and rationale of a randomized clinical trial comparing modified directly observed HCV therapy delivered in a methadone program to on-site treatment as usual. Our trial will allow rigorous evaluation of the efficacy of directly observed HCV therapy (both pegylated interferon and ribavirin) for improving adherence and clinical outcomes. This detailed description of trial methodology can serve as a template for the development of future DOT programs, and can also guide protocols for studies among HCV-infected drug users receiving methadone for opiate dependence.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01442311">NCT01442311</a></p

Association Between Alcohol Consumption and Both Osteoporotic Fracture and Bone Density

OBJECTIVE: Alcoholism is a risk factor for osteoporotic fractures and low bone density, but the effects of moderate alcohol consumption on bone are unknown. We performed a systematic review and metaanalysis to assess the associations between alcohol consumption and osteoporotic fractures, bone density and bone density loss over time, bone response to estrogen replacement, and bone remodeling. METHODS: MEDLINE, Current Contents, PsychINFO, and Cochrane Libraries were searched for studies published before May 14, 2007. We assessed quality using the internal validity criteria of the US Preventive Services Task Force. RESULTS: We pooled effect sizes for 2 specific outcomes (hip fracture and bone density) and synthesized data qualitatively for 4 outcomes (non-hip fracture, bone density loss over time, bone response to estrogen replacement, and bone remodeling). Compared with abstainers, persons consuming from more than 0.5 to 1.0 drinks per day had lower hip fracture risk (relative risk = 0.80 [95% confidence interval, 0.71-0.91]), and persons consuming more than 2 drinks per day had higher risk (relative risk = 1.39 [95% confidence interval, 1.08-1.79]). A linear relationship existed between femoral neck bone density and alcohol consumption. Because studies often combined moderate and heavier drinkers in a single category, we could not assess relative associations between alcohol consumption and bone density in moderate compared with heavy drinkers. CONCLUSION: Compared with abstainers and heavier drinkers, persons who consume 0.5 to 1.0 drink per day have a lower risk of hip fracture. Although available evidence suggests a favorable effect of alcohol consumption on bone density, a precise range of beneficial alcohol consumption cannot be determined