Reducing perceived barriers to scaling up overdose education and naloxone distribution and medications for opioid use disorder in the United States in the HEALing (helping end addiction long-term®) communities study.

BACKGROUND: Scaling up overdose education and naloxone distribution (OEND) and medications for opioid use disorder (MOUD) is needed to reduce opioid overdose deaths, but barriers are pervasive. This study examines whether the Communities That HEAL (CTH) intervention reduced perceived barriers to expanding OEND and MOUD in healthcare/behavioral health, criminal-legal, and other/non-traditional venues. METHODS: The HEALing (Helping End Addiction Long-Term®) Communities Study is a parallel, wait-list, cluster randomized trial testing the CTH intervention in 67 communities in the United States. Surveys administered to coalition members and key stakeholders measured the magnitude of perceived barriers to scaling up OEND and MOUD in November 2019-January 2020, May-June 2021, and May-June 2022. Multilevel linear mixed models compared Wave 1 (intervention) and Wave 2 (wait-list control) respondents. Interactions by rural/urban status and research site were tested. RESULTS: Wave 1 respondents reported significantly greater reductions in mean scores for three outcomes: perceived barriers to scaling up OEND in Healthcare/Behavioral Health Venues (-0.26, 95% confidence interval, CI: -0.48, -0.05, p = 0.015), OEND in Other/Non-traditional Venues (-0.53, 95% CI: - 0.84, -0.22, p = 0.001) and MOUD in Other/Non-traditional Venues (-0.34, 95% CI: -0.62, -0.05, p = 0.020). There were significant interactions by research site for perceived barriers to scaling up OEND and MOUD in Criminal-Legal Venues. There were no significant interactions by rural/urban status. DISCUSSION: The CTH Intervention reduced perceived barriers to scaling up OEND and MOUD in certain venues, with no difference in effectiveness between rural and urban communities. More research is needed to understand facilitators and barriers in different venues.

The policy landscape for naloxone distribution in four states highly impacted by fatal opioid overdoses.

Background: Expanding access to naloxone is one of the most impactful interventions in decreasing opioid-related mortality. However, state distribution rates of naloxone are insufficient to meet community need. The current study sought to better understand this gap by focusing on state policies that may facilitate or impede naloxone distribution in four states highly impacted by fatal opioid overdoses - Kentucky, Massachusetts, New York, and Ohio. Methods: We provide a descriptive analysis of the policy landscape impacting naloxone distribution through pharmacy and community channels in the four states participating in the HEALing Communities Study (HCS). Publicly available data and the expertise of the research team were used to describe each state's naloxone access laws (NALs), Medicaid coverage of naloxone, and community overdose education and naloxone distribution infrastructure. Data presented in this study represent the most current policy landscape through September 2022. Results: Variation exists between specific components of the NALs of each state, the structure of Medicaid coverage of naloxone, and the community distribution infrastructure networks. Massachusetts and New York have a statewide standing order, but other states use different strategies short of a statewide standing order to expand access to naloxone. Quantity limits specific to naloxone may limit access to Medicaid beneficiaries in some states. Conclusion: States participating in the HCS have developed innovative but different mechanisms to ensure naloxone access. Policies were dynamic and moved towards greater access. Research should consider the policy landscape in the implementation and sustainability of interventions as well as the analysis of outcomes.

Problems with evidence assessment in COVID-19 health policy impact evaluation: a systematic review of study design and evidence strength.

INTRODUCTION: Assessing the impact of COVID-19 policy is critical for informing future policies. However, there are concerns about the overall strength of COVID-19 impact evaluation studies given the circumstances for evaluation and concerns about the publication environment. METHODS: We included studies that were primarily designed to estimate the quantitative impact of one or more implemented COVID-19 policies on direct SARS-CoV-2 and COVID-19 outcomes. After searching PubMed for peer-reviewed articles published on 26 November 2020 or earlier and screening, all studies were reviewed by three reviewers first independently and then to consensus. The review tool was based on previously developed and released review guidance for COVID-19 policy impact evaluation. RESULTS: After 102 articles were identified as potentially meeting inclusion criteria, we identified 36 published articles that evaluated the quantitative impact of COVID-19 policies on direct COVID-19 outcomes. Nine studies were set aside because the study design was considered inappropriate for COVID-19 policy impact evaluation (n=8 pre/post; n=1 cross-sectional), and 27 articles were given a full consensus assessment. 20/27 met criteria for graphical display of data, 5/27 for functional form, 19/27 for timing between policy implementation and impact, and only 3/27 for concurrent changes to the outcomes. Only 4/27 were rated as overall appropriate. Including the 9 studies set aside, reviewers found that only four of the 36 identified published and peer-reviewed health policy impact evaluation studies passed a set of key design checks for identifying the causal impact of policies on COVID-19 outcomes. DISCUSSION: The reviewed literature directly evaluating the impact of COVID-19 policies largely failed to meet key design criteria for inference of sufficient rigour to be actionable by policy-makers. More reliable evidence review is needed to both identify and produce policy-actionable evidence, alongside the recognition that actionable evidence is often unlikely to be feasible.

Problems with Evidence Assessment in COVID-19 Health Policy Impact Evaluation: A systematic review of study design and evidence strength.

INTRODUCTION: Assessing the impact of COVID-19 policy is critical for informing future policies. However, there are concerns about the overall strength of COVID-19 impact evaluation studies given the circumstances for evaluation and concerns about the publication environment. This study systematically reviewed the strength of evidence in the published COVID-19 policy impact evaluation literature. METHODS: We included studies that were primarily designed to estimate the quantitative impact of one or more implemented COVID-19 policies on direct SARS-CoV-2 and COVID-19 outcomes. After searching PubMed for peer-reviewed articles published on November 26, 2020 or earlier and screening, all studies were reviewed by three reviewers first independently and then to consensus. The review tool was based on previously developed and released review guidance for COVID-19 policy impact evaluation, assessing what impact evaluation method was used, graphical display of outcomes data, functional form for the outcomes, timing between policy and impact, concurrent changes to the outcomes, and an overall rating. RESULTS: After 102 articles were identified as potentially meeting inclusion criteria, we identified 36 published articles that evaluated the quantitative impact of COVID-19 policies on direct COVID-19 outcomes. The majority (n=23/36) of studies in our sample examined the impact of stay-at-home requirements. Nine studies were set aside because the study design was considered inappropriate for COVID-19 policy impact evaluation (n=8 pre/post; n=1 cross-section), and 27 articles were given a full consensus assessment. 20/27 met criteria for graphical display of data, 5/27 for functional form, 19/27 for timing between policy implementation and impact, and only 3/27 for concurrent changes to the outcomes. Only 1/27 studies passed all of the above checks, and 4/27 were rated as overall appropriate. Including the 9 studies set aside, reviewers found that only four of the 36 identified published and peer-reviewed health policy impact evaluation studies passed a set of key design checks for identifying the causal impact of policies on COVID-19 outcomes. DISCUSSION: The reviewed literature directly evaluating the impact of COVID-19 policies largely failed to meet key design criteria for inference of sufficient rigor to be actionable by policymakers. This was largely driven by the circumstances under which policies were passed making it difficult to attribute changes in COVID-19 outcomes to particular policies. More reliable evidence review is needed to both identify and produce policy-actionable evidence, alongside the recognition that actionable evidence is often unlikely to be feasible.

Ecological Momentary Assessment of Illicit Drug Use Compared to Biological and Self-Reported Methods.

BACKGROUND: The use of mHealth methods for capturing illicit drug use and associated behaviors have become more widely used in research settings, yet there is little research as to how valid these methods are compared to known measures of capturing and quantifying drug use. OBJECTIVE: We examined the concordance of ecological momentary assessment (EMA) of drug use to previously validated biological and audio-computer assisted self-interview (ACASI) methods. METHODS: The Exposure Assessment in Current Time (EXACT) study utilized EMA methods to assess drug use in real-time in participants' natural environments. Utilizing mobile devices, participants self-reported each time they used heroin or cocaine over a 4-week period. Each week, PharmChek sweat patch samples were collected for measurement of heroin and cocaine and participants answered an ACASI-based questionnaire to report behaviors and drug using events during the prior week. Reports of cocaine and heroin use captured through EMA were compared to weekly biological or self-report measures through percent agreement and concordance correlation coefficients to account for repeated measures. Correlates of discordance were obtained from logistic regression models. RESULTS: A total of 109 participants were a median of 48.5 years old, 90% African American, and 52% male. During 436 person-weeks of observation, we recorded 212 (49%) cocaine and 103 (24%) heroin sweat patches, 192 (44%) cocaine and 161 (37%) heroin ACASI surveys, and 163 (37%) cocaine and 145 (33%) heroin EMA reports. The percent agreement between EMA and sweat patch methods was 70% for cocaine use and 72% for heroin use, while the percent agreement between EMA and ACASI methods was 77% for cocaine use and 79% for heroin use. Misreporting of drug use by EMA compared to sweat patch and ACASI methods were different by illicit drug type. CONCLUSIONS: Our work demonstrates moderate to good agreement of EMA to biological and standard self-report methods in capturing illicit drug use. Limitations occur with each method and accuracy may differ by type of illicit drugs used.

Uptake and Acceptability of Information and Communication Technology in a Community-Based Cohort of People Who Inject Drugs: Implications for Mobile Health Interventions.

BACKGROUND: Mobile phone and Internet-based technologies are increasingly used to disseminate health information and facilitate delivery of medical care. While these strategies hold promise for reducing barriers to care for medically-underserved populations, their acceptability among marginalized populations such as people who inject drugs is not well-understood. OBJECTIVE: To understand patterns of mobile phone ownership, Internet use and willingness to receive health information via mobile devices among people who inject drugs. METHODS: We surveyed current and former drug injectors participating in a longitudinal cohort study in Baltimore, Maryland, USA. Respondents completed a 12-item, interviewer-administered questionnaire during a regular semi-annual study visit that assessed their use of mobile technology and preferred modalities of receiving health information. Using data from the parent study, we used logistic regression to evaluate associations among participants' demographic and clinical characteristics and their mobile phone and Internet use. RESULTS: The survey was completed by 845 individuals, who had a median age of 51 years. The sample was 89% African-American, 65% male, and 33% HIV-positive. Participants were generally of low education and income levels. Fewer than half of respondents (40%) indicated they had ever used the Internet. Mobile phones were used by 86% of respondents. Among mobile phone owners, 46% had used their phone for text messaging and 25% had accessed the Internet on their phone. A minority of respondents (42%) indicated they would be interested in receiving health information via phone or Internet. Of those receptive to receiving health information, a mobile phone call was the most favored modality (66%) followed by text messaging (58%) and Internet (51%). CONCLUSIONS: Utilization of information and communication technology among this cohort of people who inject drugs was reported at a lower level than what has been estimated for the general U.S. POPULATION: Our findings identify a potential barrier to successful implementation of mobile health and Internet-based interventions for people who inject drugs, particularly those who are older and have lower levels of income and educational attainment. As mobile communication technology continues to expand, future studies should re-examine whether mHealth applications become more accessible and accepted by socioeconomically disadvantaged groups.

Utilizing mHealth methods to identify patterns of high risk illicit drug use.

INTRODUCTION: We assessed patterns of illicit drug use using mobile health (mHealth) methods and subsequent health care indicators among drug users in Baltimore, MD. METHODS: Participants of the EXposure Assessment in Current Time (EXACT) study were provided a mobile device for assessment of their daily drug use (heroin, cocaine or both), mood and social context for 30 days from November 2008 through May 2013. Real-time, self-reported drug use events were summed for individuals by day. Drug use risk was assessed through growth mixture modeling. Latent class regression examined the association of mHealth-defined risk groups with indicators of healthcare access and utilization. RESULTS: 109 participants were a median of 48.5 years old, 90% African American, 52% male and 59% HIV-infected. Growth mixture modeling identified three distinct classes: low intensity drug use (25%), moderate intensity drug use (65%) and high intensity drug use (10%). Compared to low intensity drug users, high intensity users were younger, injected greater than once per day, and shared needles. At the subsequent study visit, high intensity drug users were nine times less likely to be medically insured (adjusted OR: 0.10, 95%CI: 0.01-0.88) and at greater risk for failing to attend any outpatient appointments (aOR: 0.13, 95%CI: 0.02-0.85) relative to low intensity drug users. CONCLUSIONS: Real-time assessment of drug use and novel methods of describing sub-classes of drug users uncovered individuals with higher-risk behavior who were poorly utilizing healthcare services. mHealth holds promise for identifying individuals engaging in high-risk behaviors and delivering real-time interventions to improve care outcomes.

Capturing illicit drug use where and when it happens: an ecological momentary assessment of the social, physical and activity environment of using versus craving illicit drugs.

AIMS: To understand the environmental and contextual influences of illicit cocaine and heroin use and craving using mobile health (mHealth) methods. DESIGN: Interactive mHealth methods of ecological momentary assessment (EMA) were utilized in the Exposure Assessment in Current Time (EXACT) study to assess drug use and craving among urban drug users in real time. Participants were provided with mobile devices and asked to self-report every time they either craved (without using) or used heroin or cocaine for 30 days from November 2008 through May 2013. SETTING: Baltimore, MD, USA. PARTICIPANTS: A total of 109 participants from the AIDS Linked to the IntraVenous Experience (ALIVE) study. MEASUREMENTS: For each drug use or craving event, participants answered questions concerning their drug use, current mood and their social, physical and activity environments. Odds ratios (OR) of drug use versus craving were obtained from logistic regression models with generalized estimating equations of all reported events. FINDINGS: Participants were a median of 48.5 years old, 90% African American, 52% male and 59% HIV-infected. Participants were significantly more likely to report use rather than craving drugs if they were with someone who was using drugs [adjusted odds ratio (aOR) = 1.45, 95% confidence interval (CI) = 1.13, 1.86), in an abandoned space (aOR = 6.65, 95% CI = 1.78, 24.84) or walking/wandering (aOR = 1.68, 95% CI = 1.11, 2.54). Craving drugs was associated with being with a child (aOR = 0.26, 95% CI = 0.12, 0.59), eating (aOR = 0.54, 95% CI = 0.34, 0.85) or being at the doctor's office (aOR = 0.31, 95% CI = 0.12, 0.80). CONCLUSIONS: There are distinct drug using and craving environments among urban drug users, which may provide a framework for developing real-time context-sensitive interventions.

The exposure assessment in current time study: implementation, feasibility, and acceptability of real-time data collection in a community cohort of illicit drug users.

Objective. We describe the study design and evaluate the implementation, feasibility, and acceptability of an ecological momentary assessment (EMA) study of illicit drug users. Design. Four sequential field trials targeting observation of 30 individuals followed for a four week period. Participants. Participants were recruited from an ongoing community-cohort of current or former injection drug users. Of 113 individuals enrolled, 109 completed study procedures during four trials conducted from November 2008 to May 2013. Methods. Hand-held electronic diaries used in the initial trials were transitioned to a smartphone platform for the final trial with identical data collection. Random-prompts delivered five times daily assessed participant location, activity, mood, and social context. Event-contingent data collection involved participant self-reports of illicit drug use and craving. Main Outcome Measures. Feasibility measures included participant retention, days of followup, random-prompt response rates, and device loss rate. Acceptability was evaluated from an end-of-trial questionnaire. Sociodemographic, behavioral, clinical, and trial characteristics were evaluated as correlates of weekly random-prompt response rates ≥80% using logistic regression with generalized estimating equations. Results. Study participants were a median of 48.5 years old, 90% African American, 52% male, and 59% HIV-infected with limited income and educational attainment. During a median followup of 28 days, 78% of 11,181 random-prompts delivered were answered (mean of 2.8 responses daily), while 2,798 participant-initiated events were reported (30% drug use events; 70% craving events). Self-reported acceptability to study procedures was uniformly favorable. Device loss was rare (only 1 lost device every 190 person-days of observation). Higher educational attainment was consistently associated with a higher response rate to random-prompts, while an association of HIV infection with lower response rates was not observed after accounting for differences in trial recruitment procedures. Conclusion. Near real-time EMA data collection in the field is feasible and acceptable among community-dwelling illicit drug users. These data provide the basis for future studies of EMA-informed interventions to prevent drug relapse and improve HIV treatment outcomes in this population.

Sources of personal income and HIV risk among sexually active women.

We examined the relationship between sources of income and sex behaviors among a sample of low-income, sexually active women in Baltimore, MD (n = 517). Data were collected through interviews administered by a trained interviewer and audio computer-assisted self-interviewing (ACASI). The study assessed four categories of income: government payments, money from other people, selling items, and irregular jobs (i.e., odds jobs). Having multiple sex partners was associated with receiving income from other people [AOR: 2.60, 95% CI: 1.66-4.09], selling items [AOR: 2.67, 95% CI: 1.64-4.36], and irregular jobs [AOR: 1.57, 95% CI: 1.08, 2.29]. Women who exchanged sex were more likely to acquire income through these sources but less likely to receive government assistance [AOR: 0.62, 95% CI: 0.39-0.97]. Sexual behaviors are associated with multiple sources of personal income. HIV prevention interventions should address the role that economic factors play in risk behaviors.

Relative time to pregnancy among HIV-infected and uninfected women in the Women's Interagency HIV Study, 2002-2009.

OBJECTIVES: To determine the incidence rate of, and the relative time to pregnancy by HIV status in US women between 2002 and 2009. DESIGN: The Women's Interagency HIV Study (WIHS) is an ongoing, multicenter prospective cohort study of the natural and treated history of HIV infection and related outcomes among women with and without HIV. METHODS: Eligible participants were 45 years of age or less; sexually active with male partner(s) or reported a pregnancy outcome within the past year; and never reported hysterectomy, tubal ligation, or oopherectomy. Poisson regression was conducted to compare pregnancy incidence rates over time by HIV status. Relative time to pregnancy was ascertained via Kaplan-Meier plots and generalized gamma survival analysis. RESULTS: Adjusting for age, number of male sex partners, contraception, parity, exchanging sex, and alcohol use, HIV infection was associated with a 40% reduction in the incidence rate of pregnancy [incidence rate ratio = 0.60, 95% confidence interval (CI) 0.46-0.78]. The time for HIV-infected women to become pregnant was 73% longer relative to HIV-uninfected women (relative time = 1.73, 95% CI 1.35-2.36). In addition to HIV infection, decreased parity and older age were independent predictors of lower pregnancy incidence. CONCLUSIONS: Despite the beneficial effects of modern antiretroviral therapy on survival and prevention of maternal-to-child transmission, our findings suggest that pregnancy incidence remains lower among HIV-infected women. Whether this lower incidence is due to behavioral differences or reduced biologic fertility remains an area worthy of further study.