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BACKGROUND: Evidence-based practices for reducing opioid-related overdose deaths include overdose education and naloxone distribution, the use of medications for the treatment of opioid use disorder, and prescription opioid safety. Data are needed on the effectiveness of a community-engaged intervention to reduce opioid-related overdose deaths through enhanced uptake of these practices. METHODS: In this community-level, cluster-randomized trial, we randomly assigned 67 communities in Kentucky, Massachusetts, New York, and Ohio to receive the intervention (34 communities) or a wait-list control (33 communities), stratified according to state. The trial was conducted within the context of both the coronavirus disease 2019 (Covid-19) pandemic and a national surge in the number of fentanyl-related overdose deaths. The trial groups were balanced within states according to urban or rural classification, previous overdose rate, and community population. The primary outcome was the number of opioid-related overdose deaths among community adults. RESULTS: During the comparison period from July 2021 through June 2022, the population-averaged rates of opioid-related overdose deaths were similar in the intervention group and the control group (47.2 deaths per 100,000 population vs. 51.7 per 100,000 population), for an adjusted rate ratio of 0.91 (95% confidence interval, 0.76 to 1.09; P = 0.30). The effect of the intervention on the rate of opioid-related overdose deaths did not differ appreciably according to state, urban or rural category, age, sex, or race or ethnic group. Intervention communities implemented 615 evidence-based practice strategies from the 806 strategies selected by communities (254 involving overdose education and naloxone distribution, 256 involving the use of medications for opioid use disorder, and 105 involving prescription opioid safety). Of these evidence-based practice strategies, only 235 (38%) had been initiated by the start of the comparison year. CONCLUSIONS: In this 12-month multimodal intervention trial involving community coalitions in the deployment of evidence-based practices to reduce opioid overdose deaths, death rates were similar in the intervention group and the control group in the context of the Covid-19 pandemic and the fentanyl-related overdose epidemic. (Funded by the National Institutes of Health; HCS ClinicalTrials.gov number, NCT04111939.).
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BACKGROUND: The United States is in the midst of an opioid overdose epidemic; 28.3 per 100,000 people died of opioid overdose in 2020. Simulation models can help understand and address this complex, dynamic, and nonlinear social phenomenon. Using the HEALing Communities Study, aimed at reducing opioid overdoses, and an agent-based model, Simulation of Community-Level Overdose Prevention Strategy, we simulated increases in buprenorphine initiation and retention and naloxone distribution aimed at reducing overdose deaths by 40% in New York Counties. METHODS: Our simulations covered 2020-2022. The eight counties contrasted urban or rural and high and low baseline rates of opioid use disorder treatment. The model calibrated agent characteristics for opioid use and use disorder, treatments and treatment access, and fatal and nonfatal overdose. Modeled interventions included increased buprenorphine initiation and retention, and naloxone distribution. We predicted a decrease in the rate of fatal opioid overdose 1 year after intervention, given various modeled intervention scenarios. RESULTS: Counties required unique combinations of modeled interventions to achieve a 40% reduction in overdose deaths. Assuming a 200% increase in naloxone from current levels, high baseline treatment counties achieved a 40% reduction in overdose deaths with a simultaneous 150% increase in buprenorphine initiation. In comparison, low baseline treatment counties required 250-300% increases in buprenorphine initiation coupled with 200-1000% increases in naloxone, depending on the county. CONCLUSIONS: Results demonstrate the need for tailored county-level interventions to increase service utilization and reduce overdose deaths, as the modeled impact of interventions depended on the county's experience with past and current interventions.
Subject(s)
Buprenorphine , Drug Overdose , Opiate Overdose , Opioid-Related Disorders , Humans , United States , Naloxone/therapeutic use , Opiate Overdose/drug therapy , Opiate Overdose/epidemiology , New York/epidemiology , Opioid-Related Disorders/drug therapy , Buprenorphine/therapeutic use , Drug Overdose/drug therapy , Drug Overdose/epidemiology , Analgesics, Opioid/therapeutic useABSTRACT
Black women in community supervision programs (CSPs) are disproportionately affected by HIV and other sexually transmitted infections (STIs). A randomized controlled trial of a group intervention titled Empowering African-American Women on the Road to Health (E-WORTH) demonstrated effectiveness in reducing sexual risk behaviors and STI incidence among Black women in CSPs. This secondary analysis aimed to assess the moderating effects of housing status and food security on E-WORTH effectiveness in reducing sexual risk behaviors and cumulative incidence of STIs over a 12-month period which were found significant in the original trial among a sample of 351 Black women in CSPs in New York City who use drugs and/or engage in binge drinking who reported engaging in HIV risk behaviors or testing positive for HIV. We examined the moderating effects of housing stability, housing independence, and food insecurity on reducing cumulative STI incidence and number of unprotected sex acts using mixed-effects negative binomial regression and logistic regression models that controlled for age, high school education, employment status, and marital status. Findings indicate that the intervention effect was moderated by housing stability, but not housing independence or food security. Compared to the control group, E-WORTH participants who were housing insecure had 63% fewer acts of condomless sex. Our findings highlight the importance of interventions designed for women in CSPs that account for upstream determinants of health and include service linkages to basic needs provisions. Further research is needed to unpack the cumulative impacts of multiple experiences of poverty faced by this population.
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Women engaged in sex work (WESW) who use drugs are a key population in Kazakhstan's HIV epidemic. Global research suggests susceptibility to HIV varies by sex work environment. This study aims to identify evidence-based typologies of WESW and examine their associations with HIV risk. We surveyed 400 WESW who use drugs in two Kazakhstani cities, including questions on sociodemographic characteristics, social, physical, and economic risk environments, and sexual risk behaviors. Latent class analysis identified four distinct typologies of sex work practice: occasional sex work (n = 61, 15%), professional sex work for money (n = 187, 47%), sex work in exchange for drugs, goods, or other services (n = 117, 29%), and managed sex work under a boss/pimp/madam (n = 35, 9%). We then used logistic regression to examine associations between typologies and risk behaviors. Compared to professional sex work, occasional sex work was associated with lower odds of multiple sexual partners (aOR:0.46[95%CI:0.24,0.90]), of multiple paid clients (aOR:0.25[0.13,0.49]), and of > 1 instance of unprotected sex with a paying partner (aOR:0.33[0.17,0.63]). Compared to professional sex work, sex work for nonmonetary items was associated with higher odds of multiple sexual partners (aOR:1.85[0.96,3.67]) and of > 1 instance of unprotected sex with a paying partner (aOR:1.71[1.01,2.93]). Results suggest heterogeneity among WESW who use drugs in Kazakhstan, and that typologies of sex work are associated with varying HIV risk environment factors and risk behaviors. Effective HIV prevention efforts must be tailored to address these varying risk environments and the resulting variety of needs.
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BACKGROUND: The accessibility of pharmacies has been associated with overall health and wellbeing. Past studies have suggested that low income and racial minority communities are underserved by pharmacies. However, the literature is inconsistent in finding links between area-level income or racial and ethnic composition and access to pharmacies. Here we aim to assess area-level spatial access to pharmacies across New York State (NYS), hypothesizing that Census Tracts with higher poverty rates and higher percentages of Black and Hispanic residents would have lower spatial access. METHODS: The population weighted mean shortest road network distance (PWMSD) to a pharmacy in 2018 was calculated for each Census Tract in NYS. This statistic was calculated from the shortest road network distance to a pharmacy from the centroid of each Census block within a tract, with the mean across census blocks weighted by the population of the census block. Cross-sectional analyses were conducted to assess links between Tract-level socio demographic characteristics and Tract-level PWMSD to a pharmacy. RESULTS: Overall the mean PWMSD to a pharmacy across Census tracts in NYS was 2.07 Km (SD = 3.35, median 0.85 Km). Shorter PWMSD to a pharmacy were associated with higher Tract-level % poverty, % Black/African American (AA) residents, and % Hispanic/Latino residents and with lower Tract-level % of residents with a college degree. Compared to tracts in the lowest quartile of % Black/AA residents, tracts in the highest quartile had a 70.7% (95% CI 68.3-72.9%) shorter PWMSD to a pharmacy. Similarly, tracts in the highest quartile of % poverty had a 61.3% (95% CI 58.0-64.4%) shorter PWMSD to a pharmacy than tracts in the lowest quartile. CONCLUSION: The analyses show that tracts in NYS with higher racial and ethnic minority populations and higher poverty rates have higher spatial access to pharmacies.
Subject(s)
Ethnicity , Pharmacies , Humans , New York , Cross-Sectional Studies , Health Services Accessibility , Minority GroupsABSTRACT
This study examined retention and its relationship to mental health, substance use, and social determinants of health in a randomized clinical trial of a behavioral HIV/sexually transmitted infection prevention intervention with drug-involved Black women (N = 348) under community supervision programs in New York City. Using secondary analysis, we used logistic models to test the association between factors related to mental health, substance use, and social determinants of health and follow-up assessment completion (three, six, and 12 months). Participants who were diagnosed with schizophrenia had lower odds of retention. Participants who misused prescription opiates during their lifetime or food insecure in the past 90 days had higher odds of retention throughout the intervention.
Subject(s)
HIV Infections , Sexually Transmitted Diseases , Substance-Related Disorders , Humans , Female , HIV Infections/diagnosis , Sexually Transmitted Diseases/prevention & control , Substance-Related Disorders/diagnosis , Mental Health , Delivery of Health CareABSTRACT
BACKGROUND: While research has demonstrated associations between experiencing violence from intimate and non-intimate partners and non-fatal drug overdose among women who inject drugs, existing studies focus predominantly on the Global North and are analytically limited. Guided by syndemics theory, this study examined whether different forms of gender-based violence exert independent and interactive effects on non-fatal drug overdose among women who inject drugs in Indonesia. METHODS: We recruited 731 cisgender adult women who injected drugs in the preceding year via respondent-driven sampling. We used multivariate logistic regressions to examine associations between self-reported intimate partner violence (IPV), police sexual violence, and police extortion, and non-fatal drug overdose, with covariance adjustment for factors drawn from the risk environment. We tested for interaction effects among violence measures by calculating metrics for attributable proportion (AP), relative excess risk due to interaction (RERI), and synergy index (S). RESULTS: Experiencing IPV (AOR 2.5; 95 % CI 1.2, 5.1; p = 0.012), police extortion (AOR 2.2; 95 % CI 1.5, 3.2; p ≤ 0.001), and police sexual violence (AOR 3.7; 95 % CI 1.5, 9.4; p = 0.005) each independently predicted non-fatal overdose, after adjusting for potential confounders. A significant positive interaction was detected between IPV and police sexual violence on drug overdose (AP=0.6, p = 0.001; S = 3.8, p = 0.015) such that the joint effect of these two forms of violence was associated with a nearly fourfold increase in non-fatal overdose risk compared to the main effects of each violence exposure. CONCLUSION: This is the first study to show that concurrent IPV and police sexual violence exert an amplifying effect on non-fatal overdose beyond the additive effects of each exposure. Supporting the value of gender-responsive harm reduction services that integrate violence and overdose responses, results suggest that eliminating one form of violence when multiple forms of GBV are present could magnify the expected reduction in overdose.
Subject(s)
Drug Overdose , Intimate Partner Violence , Police , Substance Abuse, Intravenous , Humans , Female , Indonesia/epidemiology , Adult , Substance Abuse, Intravenous/epidemiology , Drug Overdose/epidemiology , Young Adult , Intimate Partner Violence/statistics & numerical data , Sex Offenses/statistics & numerical data , Adolescent , Risk Factors , Gender-Based Violence/statistics & numerical dataABSTRACT
Introduction: The population of women involved in criminal legal systems (WICL), a majority of whom are reproductive-aged, has risen steadily in the United States. They contend with numerous barriers to sexual and reproductive health services resulting in high rates of unmet need for contraception and unintended pregnancy. Materials and Methods: This study included 132 non-pregnancy seeking reproductive-aged WICL enrolled in the baseline assessment of the HIV prevention intervention, "Women on the Road to Health" (WORTH). A multivariate generalized linear logistic regression model with robust estimation examined effects of past 6-month intimate partner violence (IPV; sexual and physical/injurious), past 3-month substance use (binge drinking, cannabis, other illegal drug use), and lifetime mental health diagnoses (anxiety, depression, bipolar disorder) on women's unmet need for modern contraception, adjusting for significant demographic and socioeconomic factors. Results: Women who were younger in age (odds ratio [OR]: 0.74; 95% confidence interval [CI]: 0.63-0.88) and reporting lifetime diagnoses of anxiety disorders (OR: 13.64; 95% CI: 2.71-68.34) were significantly more likely to meet the criteria for unmet need for modern contraception. Women with a regular gynecologist (OR: 0.11; 95% CI: 0.01-0.86) reporting lifetime diagnoses of bipolar disorder and past 6-month sexual IPV histories (OR: 0.04; 95% CI: 0.002-0.86) were significantly less likely to meet the criteria for unmet need for modern contraception. Conclusions: Distinct mental health diagnoses and experiences of IPV may uniquely impact unmet need for modern contraception among WICL. These findings emphasize the need for a more nuanced comprehension of these relationships to deliver comprehensive and holistic health services that address the intersecting needs of this population.Trial registration: ClinicalTrials.gov NCT01784809. Registered 6 February 2013.
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BACKGROUND: Expanding public naloxone access is a key strategy to reduce opioid overdose fatalities. We describe tailored community-engaged, data-driven approaches to install and maintain naloxone housing units (naloxone boxes) in New York State and estimate the cost of these approaches. METHODS: Guided by the Consolidated Framework for Implementation Research, we collected data from administrative records and key informant interviews that documented the unique processes employed by four counties enrolled in the HEALing Communities Study to install and maintain naloxone housing units. We conducted a prospective micro-costing analysis to estimate the cost of each naloxone housing unit strategy from the community perspective. RESULTS: While all counties used a coalition to guide action planning for naloxone distribution, we identified unique approaches to implementing naloxone housing units: 1) County-led with technology expansion; 2) County-led grassroots; 3) Small-scale rural opioid overdose prevention program (OOPP) contract and 4) Comprehensive OOPP contract including overdose education and naloxone distribution (OEND) to individuals. The first two county-led approaches had lower cost per naloxone dose disbursed ($28-$38) compared to outsourcing to an OOPP ($183-$266); costs depended on services added to installing and maintaining units, such as OEND. Barriers included competing demands on public health resources (i.e., COVID-19) and stigma toward naloxone and opioid use disorder. Geographic access was a barrier in rural areas whereas existing infrastructure was a facilitator in urban counties. The policy landscape in New York State, which provides free naloxone kits and financial support to OOPPs, facilitated implementation in all counties. CONCLUSIONS: If a community has the resources, installing and maintaining naloxone housing units in-house can be less expensive than contracting with an outside partner. However, contracts that include OEND may be more effective at reaching target populations. Financial support from health departments and legislative authorization are important facilitators to making naloxone available in public settings.
Subject(s)
Naloxone , Narcotic Antagonists , Naloxone/administration & dosage , Humans , Narcotic Antagonists/administration & dosage , New York , Opiate Overdose/prevention & control , Opiate Overdose/drug therapy , Opioid-Related Disorders/drug therapy , Health Services Accessibility , Prospective Studies , Drug Overdose/prevention & control , Drug Overdose/drug therapy , Community ParticipationABSTRACT
The HEALing (Helping to End Addiction Long-term) Communities Study (HCS) aims to test the effectiveness of the Communities That HEAL intervention in decreasing opioid overdose deaths in 67 communities across four U.S. states. This intervention enlists a collaborative team of researchers, academic experts, and community coalitions to select and implement interventions from a menu of evidence-based practices, including medications for opioid use disorder (MOUD). The HCS's New York team developed an integrated network systems (INS) approach with a mapping tool to coach coalitions in the selection of strategies to enhance medication treatment. With the INS approach, community coalitions develop a map of service delivery venues in their local county to better engage people with medication treatment wherever this need arises. The map is structured around core services that can provide maintenance MOUD and satellite services, which include all settings where people with opioid use disorder are encountered and can be identified, possibly given medication, and referred to core programs for ongoing MOUD care. This article describes the rationale for the INS mapping tool, with a discussion framed by the consolidated framework for implementation research, and provides a case example of its application.
Subject(s)
Opioid-Related Disorders , Humans , Opioid-Related Disorders/drug therapy , Opiate Substitution Treatment/methods , United States , Opiate Overdose/drug therapy , Analgesics, Opioid/therapeutic useABSTRACT
INTRODUCTION: There is a research gap in how mental health and cognition are associated with antiretroviral treatment (ART) adherence among people living with HIV (PLWH) in Kazakhstan. METHODS: We randomly selected and enrolled 230 PLWH from the Almaty City AIDS Center registry (June-November 2019) into a cross-sectional study. We examined associations between self-reported ART adherence for the last 1 and 2 weeks; the Adherence Self-Efficacy Scale (ASES) and symptoms of depression (Patient Health Questionnaire-9 [PHQ-9]), anxiety (Generalized Anxiety Disorder tool [GAD-7]), post-traumatic stress disorder (PTSD Checklist [PTSD]); cognitive function (PROMIS v2.0 Adult Cognitive Function 8a short form) and forgetfulness (Forgetfulness Assessment Inventory). We used cut points of ≥5 for at least mild and ≥10 for at least moderate symptom severity for PHQ-9 and GAD-7 and of ≥44 for PTSD. Logistic and linear regression analyses were used. RESULTS: Participants' median age was 40.0 (IQR: 34-47) with 40.9% (n = 94) of females in the sample. Those who missed at least one pill for the last 2 weeks had higher odds of reporting at least mild depression (aOR = 3.34, 95% CI: 1.22-9.11, p < 0.05); mild anxiety (aOR = 3.27, 95% CI: 1.20-8.92, p < 0.05); and PTSD (aOR = 4.04, 95% CI: 1.15-14.21, p < 0.05) symptoms. Participants who missed at least one pill for the last week had higher odds of at least mild depression (aOR = 7.74, 95% CI: 1.31-45.7, p < 0.05), moderate anxiety (aOR = 21.33, 95% CI: 3.24-140.33, p < 0.005) and PTSD (aOR = 13.81, 95% CI: 2.36-80.84, p < 0.005) symptoms. Participants with better cognitive function had lower odds of non-adherence over the last week (aOR = 0.88, 95% CI: 0.81-0.96, p < 0.005) and higher ASES scores (ß = 0.26, 95% CI: 0.13-0.40, p < 0.005). Poor memory was associated with higher odds of non-adherence over the last week (aOR = 4.64, 95% CI: 1.76-12.24, p < 0.005) and lower ASES score (ß = -0.31, 95% CI: -0.45 to 0.16, p < 0.005). Those who had at least mild depression (ß = -0.21, 95% CI: -0.35 to -0.07, p < 0.005); moderate anxiety (ß = -0.21, 95% CI: -0.34 to -0.07, p < 0.005) and PTSD (ß = -0.19, 95% CI: -0.33 to -0.05, p < 0.005) symptoms had lower ASES scores. CONCLUSIONS: Depression, anxiety and PTSD symptoms, poorer cognition, and forgetfulness were associated with poorer ART adherence and worse adherence self-efficacy. It is crucial to assess and treat mental illness and provide support for PLWH with worsened cognition to enhance ART adherence.
Subject(s)
Cognition , Depression , HIV Infections , Medication Adherence , Mental Health , Humans , Cross-Sectional Studies , Male , Female , Adult , HIV Infections/drug therapy , HIV Infections/psychology , Middle Aged , Medication Adherence/statistics & numerical data , Medication Adherence/psychology , Kazakhstan/epidemiology , Depression/epidemiology , Depression/psychology , Stress Disorders, Post-Traumatic/epidemiology , Stress Disorders, Post-Traumatic/drug therapy , Stress Disorders, Post-Traumatic/psychology , Anxiety/epidemiology , Anxiety/psychology , Anti-HIV Agents/therapeutic use , Anti-Retroviral Agents/therapeutic use , Self ReportABSTRACT
BACKGROUND: Persons with opioid use disorders who inject drugs (PWID) in the United States (US) face multiple and intertwining health risks. These include interference with consistent access, linkage, and retention to health care including medication for opioid use disorder (MOUD), HIV prevention using pre-exposure prophylaxis (PrEP), and testing and treatment for sexually transmitted infections (STIs). Most services, when available, including those that address substance misuse, HIV prevention, and STIs, are often provided in multiple locations that may be difficult to access, which further challenges sustained health for PWID. HPTN 094 (INTEGRA) is a study designed to test the efficacy of an integrated, "whole-person" strategy that provides integrated HIV prevention including antiretroviral therapy (ART), PrEP, MOUD, and STI testing and treatment from a mobile health delivery unit ("mobile unit") with peer navigation compared to peer navigation alone to access these services at brick and mortar locations. METHODS: HPTN 094 (INTEGRA) is a two-arm, randomized controlled trial in 5 US cities where approximately 400 PWID without HIV are assigned either to an experimental condition that delivers 26 weeks of "one-stop" integrated health services combined with peer navigation and delivered in a mobile unit or to an active control condition using peer navigation only for 26 weeks to the same set of services delivered in community settings. The primary outcomes include being alive and retained in MOUD and PrEP at 26 weeks post-randomization. Secondary outcomes measure the durability of intervention effects at 52 weeks following randomization. DISCUSSION: This trial responds to a need for evidence on using a "whole-person" strategy for delivering integrated HIV prevention and substance use treatment, while testing the use of a mobile unit that meets out-of-treatment PWID wherever they might be and links them to care systems and/or harm reduction services. Findings will be important in guiding policy for engaging PWID in HIV prevention or care, substance use treatment, and STI testing and treatment by addressing the intertwined epidemics of addiction and HIV among those who have many physical and geographic barriers to access care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04804072 . Registered on 18 March 2021.
Subject(s)
Drug Users , HIV Infections , Opioid-Related Disorders , Sexually Transmitted Diseases , Substance Abuse, Intravenous , Humans , Pharmaceutical Preparations , Substance Abuse, Intravenous/epidemiology , Substance Abuse, Intravenous/complications , HIV Infections/diagnosis , HIV Infections/epidemiology , HIV Infections/prevention & control , Sexually Transmitted Diseases/diagnosis , Sexually Transmitted Diseases/epidemiology , Sexually Transmitted Diseases/prevention & control , Opioid-Related Disorders/diagnosis , Opioid-Related Disorders/epidemiology , Opioid-Related Disorders/prevention & control , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND: In the U.S. there are significant racial and gender disparities in the uptake of pre-exposure prophylaxis (PrEP). Black Americans represented 14% of PrEP users in 2022, but accounted for 42% of new HIV diagnoses in 2021 and in the South, Black people represented 48% of new HIV diagnoses in 2021 but only 21% of PrEP users in 2022. Women who use drugs may be even less likely than women who do not use drugs have initiated PrEP. Moreover, women involved in community supervision programs (CSP) are less likely to initiate or use PrEP, More PrEP interventions that focus on Black women with recent history of drug use in CSPs are needed to reduce inequities in PrEP uptake. METHODS: We conducted a secondary analysis from a randomized clinical trial with a sub-sample (n = 336) of the total (N = 352) participants from the parent study (E-WORTH), who tested HIV negative at baseline were considered PrEP-eligible. Black women were recruited from CSPs in New York City (NYC), with recent substance use. Participants were randomized to either E-WORTH (n = 172) an HIV testing plus, receive a 5-session, culturally-tailored, group-based HIV prevention intervention, versus an HIV testing control group (n = 180). The 5 sessions included an introduction to PrEP and access. This paper reports outcomes on improved awareness of PrEP, willingness to use PrEP, and PrEP uptake over the 12-month follow-up period. HIV outcomes are reported in a previous paper. RESULTS: Compared to control participants, participants in this study assigned to E-WORTH had significantly greater odds of being aware of PrEP as a biomedical HIV prevention strategy (OR = 3.25, 95% CI = 1.64-6.46, p = 0.001), and indicated a greater willingness to use PrEP as an HIV prevention method (b = 0.19, 95% CI = 0.06-0.32, p = 0.004) over the entire 12-month follow-up period. CONCLUSIONS: These findings underscore the effectiveness of a culturally-tailored intervention for Black women in CSP settings in increasing awareness, and intention to initiate PrEP. Low uptake of PrEP in both arms highlight the need for providing more robust PrEP-on-demand strategies that are integrated into other services such as substance abuse treatment. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02391233 .
Subject(s)
Black or African American , HIV Infections , Pre-Exposure Prophylaxis , Humans , Female , HIV Infections/prevention & control , HIV Infections/ethnology , Adult , New York City , Middle Aged , Substance-Related Disorders/ethnology , Substance-Related Disorders/prevention & control , Anti-HIV Agents/therapeutic use , Anti-HIV Agents/administration & dosage , Culturally Competent Care , Young Adult , Health Knowledge, Attitudes, PracticeABSTRACT
BACKGROUND: HIV burden in the US among people who inject drugs (PWID) is driven by overlapping syndemic factors such as co-occurring health needs and environmental factors that synergize to produce worse health outcomes among PWID. This includes stigma, poverty, and limited healthcare access (e.g. medication to treat/prevent HIV and for opioid use disorder [MOUD]). Health services to address these complex needs, when they exist, are rarely located in proximity to each other or to the PWID who need them. Given the shifting drug use landscapes and geographic heterogeneity in the US, we evaluate a data-driven approach to guide the delivery of such services to PWID in local communities. METHODS: We used a hybrid, type I, embedded, mixed method, data-driven approach to identify and characterize viable implementation neighborhoods for the HPTN 094 complex intervention, delivering integrated MOUD and HIV treatment/prevention through a mobile unit to PWID across five US cities. Applying the PRISM framework, we triangulated geographic and observational pre-implementation phase data (epidemiological overdose and HIV surveillance data) with two years of implementation phase data (weekly ecological assessments, study protocol meetings) to characterize environmental factors that affected the viability of implementation neighborhoods over time and across diverse settings. RESULTS: Neighborhood-level drug use and geographic diversity alongside shifting socio-political factors (policing, surveillance, gentrification) differentially affected the utility of epidemiological data in identifying viable implementation neighborhoods across sites. In sites where PWID are more geographically dispersed, proximity to structural factors such as public transportation and spaces where PWID reside played a role in determining suitable implementation sites. The utility of leveraging additional data from local overdose and housing response systems to identify viable implementation neighborhoods was mixed. CONCLUSIONS: Our findings suggest that data-driven approaches provide a contextually relevant pragmatic strategy to guide the real-time implementation of integrated care models to better meet the needs of PWID and help inform the scale-up of such complex interventions. This work highlights the utility of implementation science methods that attend to the impact of local community environmental factors on the implementation of complex interventions to PWID across diverse drug use, sociopolitical, and geographic landscapes in the US. TRIAL REGISTRATION: ClincalTrials.gov, Registration Number: NCT04804072 . Registered 18 February 2021.
Subject(s)
HIV Infections , Opioid-Related Disorders , Substance Abuse, Intravenous , Humans , HIV Infections/epidemiology , HIV Infections/prevention & control , Substance Abuse, Intravenous/epidemiology , United States , Opioid-Related Disorders/epidemiology , Implementation Science , Health Services Accessibility/organization & administration , Residence Characteristics , Female , Male , Social Stigma , Delivery of Health Care, Integrated/organization & administrationABSTRACT
Background: Community stigma against people with opioid use disorder (OUD) and intervention stigma (e.g., toward naloxone) exacerbate the opioid overdose crisis. We examined the effects of the Communities that HEAL (CTH) intervention on perceived opioid-related community stigma by stakeholders in the HEALing Communities Study (HCS). Methods: We collected three surveys from community coalition members in 66 communities across four states participating in HCS. Communities were randomized into Intervention (Wave 1) or Wait-list Control (Wave 2) arms. We conducted multilevel linear mixed models to compare changes in primary outcomes of community stigma toward people treated for OUD, naloxone, and medication for opioid use disorder (MOUD) by arm from time 1 (before the start of the intervention) to time 3 (end of the intervention period in the Intervention arm). Findings: Intervention stakeholders reported a larger decrease in perceived community stigma toward people treated for OUD (adjusted mean change (AMC) -3.20 [95% C.I. -4.43, -1.98]) and toward MOUD (AMC -0.33 [95% C.I. -0.56, -0.09]) than stakeholders in Wait-list Control communities (AMC -0.18 [95% C.I. -1.38, 1.02], p = 0.0007 and AMC 0.11 [95% C.I. -0.09, 0.31], p = 0.0066). The relationship between intervention status and change in stigma toward MOUD was moderated by rural-urban status (urban AMC -0.59 [95% CI, -0.87, -0.32], rural AMC not sig.) and state. The difference in stigma toward naloxone between Intervention and Wait-list Control stakeholders was not statistically significant (p = 0.18). Interpretation: The CTH intervention decreased stakeholder perceptions of community stigma toward people treated for OUD and stigma toward MOUD. Implementing the CTH intervention in other communities could decrease OUD stigma across diverse settings nationally. Funding: US National Institute on Drug Abuse.
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BACKGROUND: The U.S. opioid overdose crisis persists. Outpatient behavioral health services (BHS) are essential components of a comprehensive response to opioid use disorder and overdose fatalities. The Helping to End Addiction Long-Term® (HEALing) Communities Study developed the Communities That HEAL (CTH) intervention to reduce opioid overdose deaths in 67 communities in Kentucky, Ohio, New York, and Massachusetts through the implementation of evidence-based practices (EBPs), including BHS. This paper compares the rate of individuals receiving outpatient BHS in Wave 1 intervention communities (n = 34) to waitlisted Wave 2 communities (n = 33). METHODS: Medicaid data included individuals ≥18 years of age receiving any of five BHS categories: intensive outpatient, outpatient, case management, peer support, and case management or peer support. Negative binomial regression models estimated the rate of receiving each BHS for Wave 1 and Wave 2. Effect modification analyses evaluated changes in the effect of the CTH intervention between Wave 1 and Wave 2 by research site, rurality, age, sex, and race/ethnicity. RESULTS: No significant differences were detected between intervention and waitlisted communities in the rate of individuals receiving any of the five BHS categories. None of the interaction effects used to test the effect modification were significant. CONCLUSIONS: Several factors should be considered when interpreting results-no significant intervention effects were observed through Medicaid claims data, the best available data source but limited in terms of capturing individuals reached by the intervention. Also, the 12-month evaluation window may have been too brief to see improved outcomes considering the time required to stand-up BHS. TRIAL REGISTRATION: Clinical Trials.gov http://www. CLINICALTRIALS: gov: Identifier: NCT04111939.
Subject(s)
Behavior Therapy , Opioid-Related Disorders , Humans , Female , Male , Adult , Opioid-Related Disorders/therapy , Middle Aged , Behavior Therapy/methods , Waiting Lists , United States/epidemiology , Medicaid , Young AdultABSTRACT
Importance: Buprenorphine significantly reduces opioid-related overdose mortality. From 2002 to 2022, the Drug Addiction Treatment Act of 2000 (DATA 2000) required qualified practitioners to receive a waiver from the Drug Enforcement Agency to prescribe buprenorphine for treatment of opioid use disorder. During this period, waiver uptake among practitioners was modest; subsequent changes need to be examined. Objective: To determine whether the Communities That HEAL (CTH) intervention increased the rate of practitioners with DATA 2000 waivers and buprenorphine prescribing. Design, Setting, and Participants: This prespecified secondary analysis of the HEALing Communities Study, a multisite, 2-arm, parallel, community-level, cluster randomized, open, wait-list-controlled comparison clinical trial was designed to assess the effectiveness of the CTH intervention and was conducted between January 1, 2020, to December 31, 2023, in 67 communities in Kentucky, Massachusetts, New York, and Ohio, accounting for approximately 8.2 million adults. The participants in this trial were communities consisting of counties (n = 48) and municipalities (n = 19). Trial arm randomization was conducted using a covariate constrained randomization procedure stratified by state. Each state was balanced by community characteristics including urban/rural classification, fatal opioid overdose rate, and community population. Thirty-four communities were randomized to the intervention and 33 to wait-list control arms. Data analysis was conducted between March 20 and September 29, 2023, with a focus on the comparison period from July 1, 2021, to June 30, 2022. Intervention: Waiver trainings and other educational trainings were offered or supported by the HEALing Communities Study research sites in each state to help build practitioner capacity. Main Outcomes and Measures: The rate of practitioners with a DATA 2000 waiver (overall, and stratified by 30-, 100-, and 275-patient limits) per 100â¯000 adult residents aged 18 years or older during July 1, 2021, to June 30, 2022, were compared between the intervention and wait-list control communities. The rate of buprenorphine prescribing among those waivered practitioners was also compared between the intervention and wait-list control communities. Intention-to-treat and per-protocol analyses were performed. Results: A total of 8â¯166â¯963 individuals aged 18 years or older were residents of the 67 communities studied. There was no evidence of an effect of the CTH intervention on the adjusted rate of practitioners with a DATA 2000 waiver (adjusted relative rate [ARR], 1.04; 95% CI, 0.94-1.14) or the adjusted rate of practitioners with a DATA 2000 waiver who actively prescribed buprenorphine (ARR, 0.97; 95% CI, 0.86-1.10). Conclusions and Relevance: In this randomized clinical trial, the CTH intervention was not associated with increases in the rate of practitioners with a DATA 2000 waiver or buprenorphine prescribing among those waivered practitioners. Supporting practitioners to prescribe buprenorphine remains a critical yet challenging step in the continuum of care to treat opioid use disorder. Trial Registration: ClinicalTrials.gov Identifier: NCT04111939.