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 Influence of Housing Status and Food Insecurity on a Behavioral HIV/STI Prevention Intervention for Black Women under Community Supervision in New York City: A Moderation Analysis.

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.

'Yeah, they suck. It's like they don't care about our health.' Medical mistrust among Black women under community supervision in New York city.

Black women in the USA experience some of the poorest health outcomes and this is especially true for those involved in the carceral system who are at elevated risks for HIV/STIs, reproductive health, and chronic diseases. This study aimed to investigate Black women's experience accessing healthcare services. We conducted semi-structured interviews with 43 women from Project EWORTH under community supervision in New York City. We analysed responses focusing on barriers to healthcare engagement. All interviews were recorded, and data analysis was conducted using NVivo. Themes influencing Black women's ability to engage with healthcare providers and systems included: 1) disclosed provider mistrust/judgement; 2) feeling disrespected by providers and the medical system; 3) mistrust of medical providers/system/hospital/government; 4) lack of health communication; 5) low health literacy; 6) provider gender preference. Findings highlight the need to improve trust and collaboration between healthcare providers and Black women. This study addresses the critical gap in understanding perceptions of discrimination, stigma, and barriers to attaining health care. Funders and accreditation agencies must hold providers and organisations accountable for acquiring and making available diversity, equity and inclusion training for providers, demonstrating increasingly equitable medical relationships through responsiveness to patient feedback, and increasing the number of Black providers.

Characteristics of drug-involved black women under community supervision; implications for retention in HIV clinical trials and healthcare.

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.

Moderation Analysis of a couple-based HIV/STI Intervention Among Heterosexual Couples in the Criminal Legal System Experiencing Intimate Partner Violence: Results from a Randomized Controlled Trial.

Since the COVID-19 pandemic, intimate partner violence (IPV) rates have increased in the United States. Although accumulating research has documented the effectiveness of couple-based interventions in reducing HIV/STIs, it remains unclear whether they are effective and safe for couples experiencing IPV. We used moderation analysis from a randomized clinical trial to evaluate whether a couples-based HIV/STI intervention may have differential effectiveness in reducing HIV/STI risks among couples where one or both partners reported experiencing IPV compared to couples without such IPV among a sample of 230 men at risk for HIV/STIs who reported using drugs and were mandated to community supervision settings in New York City and their main female sexual partners. The findings of this study suggest that the effectiveness of this evidence-based couple HIV intervention in reducing condomless sex and other HIV/STI risks did not differ between couples with IPV compared to couples without IPV. Intimate partners who use drugs and are involved in the criminal legal system are disproportionately impacted by both HIV/STIs and IPV, underscoring the importance of couple-level interventions that may be scaled up to address the dyadic HIV risks and IPV together in community supervision settings.

Intervening on the Intersecting Issues of Intimate Partner Violence, Substance Use, and HIV: A Review of Social Intervention Group's (SIG) Syndemic-Focused Interventions for Women.

Intimate partner violence (IPV), HIV, and substance use are serious intersecting public health issues. This paper aims to describe the Social Intervention Group (SIG)'s syndemic-focused interventions for women that address the co-occurrence of IPV, HIV, and substance use, referred to as the SAVA syndemic. We reviewed SIG intervention studies from 2000 to 2020 that evaluated the effectiveness of syndemic-focused interventions which addressed two or more outcomes related to reducing IPV, HIV, and substance use among different populations of women who use drugs. This review identified five interventions that co-targeted SAVA outcomes. Of the five interventions, four showed a significant reduction in risks for two or more outcomes related to IPV, substance use, and HIV. The significant effects of SIG's interventions on IPV, substance use, and HIV outcomes among different populations of women demonstrate the potential of using syndemic theory and methods in guiding effective SAVA-focused interventions.

Intervention Adaptation and Implementation Method for Real-World Constraints and Using New Technologies.

Purpose: Rigorous adaptation methods are needed to revise existing evidence-based behavioral interventions for implementation for new target populations, revised/updated outcomes, new delivery modalities, recent advances, and new technologies. We describe an adaptation method designed to overcome the real-world challenges of having very limited existing expertise, resources, and time. Method: This adaptation method and accompanying visualization tool ("Deconstruction/Reconstruction Matrix") preserves theoretical mechanisms of behavior change, accounts for challenges in utilizing new technologies, and strengthens clinical processes, with an emphasis on safety. Results: The adaptation of an in-person HIV behavioral intervention for sexual and gender diverse men in Kazakhstan to one delivered remotely via telecommunication and social media technologies exemplifies the process and strengths of the method, concomitantly resulting in recommendations for adaptation and implementation of mobile health (mHealth) and digital health interventions. Discussion: This method allows researchers and clinicians to adapt interventions rapidly and rigorously and to benefit from new technologies.

A Dyadic Analysis of Criminal Justice Involvement and Sexual HIV Risk Behaviors Among Drug-Involved Men in Community Corrections and Their Intimate Partners in New York City: Implications for Prevention, Treatment and Policies.

People in community corrections have rates of HIV and sexual risk behaviors that are much higher than the general population. Prior literature suggests that criminal justice involvement is associated with increased sexual risk behaviors, yet these studies focus on incarceration and use one-sided study designs that only collect data from one partner. To address gaps in the literature, this study used the Actor Partner-Interdependence Model with Structural Equation Modeling (SEM), to perform a dyadic analysis estimating individual (actor-only) partner-only, and dyadic patterns (actor-partner) of criminal justice involvement and greater sexual risks in a sample of 227 men on probation and their intimate partners in New York City, United States. Standard errors were bootstrapped with 10,000 replications to reduce bias in the significance tests. Goodness of fit indices suggested adequate or better model fit for all the models. Significant actor-only relationships included associations between exposures to arrest, misdemeanor convictions, time spent in jail or prison, felony convictions, lifetime number of incarceration events, prior conviction for disorderly conduct and increased sexual risk behaviors. Partner only effects included significant associations between male partners conviction for a violent crime and their female partners' sexual risk behaviors. Men's encounters with police and number of prior misdemeanors were associated with their own and intimate partners' sexual risk behaviors. Women's prior arrest was associated with their own and intimate partners' sexual risk behaviors. The results from the present study suggest that men on probation and their intimate partners' criminal justice involvement are associated with increased engagement in sexual risk behaviors. It is necessary to conduct greater research into developing dyadic sexual risk reduction and HIV/STI prevention interventions for people who are involved in the criminal justice system.

Assessing the relationship between syringe exchange, pharmacy, and street sources of accessing syringes and injection drug use behavior in a pooled nationally representative sample of people who inject drugs in the United States from 2002 to 2019.

Provision of sterile syringes is an evidence-based strategy of reducing syringe sharing and reusing and yet, access to sterile syringes through pharmacies and syringe exchange programs (SEPs) in the United States remains inadequate. This nationally representative study examined associations between obtaining syringes from pharmacies, SEPs, and sterilizing syringes with bleach and risk of syringe borrowing, lending and reusing syringes in a pooled cross-sectional dataset of 1737 PWID from the 2002-2019 National Survey on Drug Use and Health. Logistic regression was used to produce odds ratios (OR) of the odds of injection drug behaviors after adjusting for obtaining syringes from SEPs, pharmacies, the street, and other sources and potential confounders of race, ethnicity, sex, education, and insurance coverage. Obtaining syringes through SEPs was associated with lower odds of borrowing (OR = .4, CI95% = .2, .9, p = .022) and reusing syringes (OR = .3, CI95% = .2, .6, < .001) compared to obtaining syringes on the street. Obtaining syringes from pharmacies was associated with lower odds of borrowing (OR = .5, CI95% = .3, .9, p = .037) and lending (OR = .5 CI95% = .3, .9, p = .020) syringes. Using bleach to clean syringes was associated with increased odds of borrowing (OR = 2.0, CI95% = 1.3, 3.0, p = .002), lending (OR = 2.0, CI95% = 1.3, 3.0, p = .002) and reusing syringes (OR = 2.4, CI95% = 1.6, 3.6, p < .001). Our findings support provision of syringes through pharmacies and SEPs as a gold-standard strategy of reducing sharing and reuse of syringes in the US.

Mental Health Consequences of Sexual Misconduct by Law Enforcement and Criminal Justice Personnel among Black Drug-Involved Women in Community Corrections.

This study examines the prevalence, correlates, and mental health consequences of sexual misconduct by law enforcement and criminal justice (LECJ) personnel. Baseline data for Project E-WORTH (Empowering African-American Women on the Road to Health) were collected between November 2015 and May 2018 from 351 drug-involved Black women from community corrections in New York City. LECJ sexual misconduct was self-reported and we measured mental health outcomes with the CESD-4 and the PTSD Checklist. Univariate and multivariable logistic regression analyses were performed. Approximately 14% of our sample had experienced LECJ sexual misconduct. Participants who reported multiple arrests, recent drug use, and having experienced childhood sexual victimization were more likely to have experienced LECJ sexual misconduct. Further, LECJ sexual misconduct was positively associated with depression and PTSD. These findings suggest that LECJ sexual misconduct is a previously unreported risk factor for adverse mental health outcomes among criminal-legal system-involved women. There is a need for recognition of LECJ sexual victimization among criminal-legal system-involved women. As such, prevention, treatment, and community corrections service delivery for this population should be trauma informed.

Men in Community Correction Programs and Their Female Primary Sex Partners: Latent Class Analysis to Identify the Relationship of Clusters of Drug Use and Sexual Behaviors and HIV Risks.

Existing research indicates that justice-involved individuals use a variety of different drugs and polysubstance use is common. Research shows that different typologies of drug users, such as polydrug users versus users of a single drug, have differing types of individual-, structural-, and neighborhood-level risk characteristics. However, little research has been conducted on how different typologies of drug use are associated with HIV risks among individuals in community corrections and their intimate sex partners. This paper examines the different types of drug use typologies among men in community correction programs and their female primary sex partners. We used latent class analysis to identify typologies of drug use among men in community correction programs in New York City and among their female primary sex partners. We also examined the associations between drug use typologies with sexual and drug use behaviors that increase the risk of HIV acquisition. The final analysis included a total of 1167 participants (822 male participants and 345 of their female primary sex partners). Latent class analyses identified three identical typologies of drug use for both men and their female primary sex partners: (1) polydrug use, (2) mild polydrug users with severe alcohol and marijuana use, and (3) alcohol and marijuana users. Men and women who were classified as polydrug users and mild polydrug users, compared to those who were classified as alcohol and marijuana users, tended to be older and non-Hispanic Caucasians. Polydrug users and mild polydrug users were also more likely to have risky sex partners and higher rates of criminal justice involvement. There is a need to provide HIV and drug use treatment and linkage to service and care for men in community correction programs, especially polydrug users. Community correction programs could be the venue to provide better access by reaching out to this high HIV risk key population with increased rates of drug use and multiple sex partners.

Reproductive Health Concerns among Substance-Using Women in Community Corrections in New York City: Understanding the Role of Environmental Influences.

Women living in urban settings who are engaged in the criminal justice system are disproportionately affected by HIV and also contend with poor sexual and reproductive health (SRH). While studies have examined environmental influences of HIV, few have examined how these influences relate to poor SRH among this population. We used baseline data from an HIV-risk reduction study among substance-using women with a pregnancy history in community corrections in New York City (N = 299). We examined risk environment factors typically associated with HIV, and SRH outcomes of abortion, and miscarriage. We used logistic regression models to examine associations between risk environment factors with SRH outcomes. Most women identified as black and ranged in age from 18 to 62. Approximately half had miscarriages and/or abortions in their lifetime. Few women used birth control despite not wanting children in the future. While most women faced high rates of environmental influences of HIV risk, only intimate partner violence (IPV) was associated with SRH outcomes. Women experiencing IPV were significantly more likely to report both miscarriage and abortion. Community corrections present a unique opportunity for intervention around HIV risk reduction and SRH outcomes, given that effective programming for each often requires multiple and formal contacts with health providers.

Trichomonas vaginalis and Human Immunodeficiency Virus Coinfection Among Women Under Community Supervision: A Call for Expanded T. vaginalis Screening.

BACKGROUND: The United States has a large community supervision population, a growing number of whom are women. Trichomonas vaginalis infection is strongly associated with an increased risk of human immunodeficiency virus (HIV) acquisition and transmission, particularly among women, but there is a paucity of research on HIV and T. vaginalis co-infection among women under community supervision. METHODS: This article examines the prevalence of T. vaginalis infection and T. vaginalis and HIV coinfection at baseline among women under community supervision in New York City. It also examines the 12-month outcomes of women treated for T. vaginalis. Women received biological tests for HIV and T. vaginalis at baseline and 12 months follow-up. RESULTS: Of the 333 women tested for sexually transmitted infections, 77 women (23.1%) tested positive for T. vaginalis at baseline and 44 (13.3%) were HIV positive. Human immunodeficiency virus-positive women had significantly higher rates of T. vaginalis infection than HIV-negative women (36.4% vs 21.3%, P ≤ 0.05). Sixteen women (4.8%) were coinfected with T. vaginalis and HIV. Of the 77 women who were positive for T. vaginalis infection at baseline, 58 (75.3%) received treatment by a health care provider. Of those who received treatment, 17 (29.3%) tested positive for T. vaginalis at the 12-month follow-up. CONCLUSIONS: Given the high prevalence of T. vaginalis among this sample of women, particularly among HIV-positive women, and high levels of reinfection or persistent infection, screening for T. vaginalis among women under community supervision may have a substantial impact on reducing HIV acquisition and transmission among this high-risk population.

Efficacy of a Computerized Intervention on HIV and Intimate Partner Violence Among Substance-Using Women in Community Corrections: A Randomized Controlled Trial.

OBJECTIVES: To test the efficacy of a computerized, group-based HIV and intimate partner violence (IPV) intervention on reducing IPV victimization among substance-using women mandated to community corrections. METHODS: Between November 2009 and January 2012, we randomly allocated 306 women from community corrections in New York City to 3 study arms of a computerized HIV and IPV prevention trial: (1) 4 group sessions intervention with computerized self-paced IPV prevention modules (Computerized Women on the Road to Health [WORTH]), (2) traditional HIV and IPV prevention intervention group covering the same HIV and IPV content as Computerized WORTH without computers (Traditional WORTH), and (3) a Wellness Promotion control group. Primary outcomes were physical, injurious, and sexual IPV victimization in the previous 6 months at 12-month follow-up. RESULTS: Computerized WORTH participants reported significantly lower risk of physical IPV victimization, severe injurious IPV victimization, and severe sexual IPV victimization at 12-month follow-up when compared with control participants. No significant differences were seen between Traditional WORTH and control participants for any IPV outcomes. CONCLUSIONS: The efficacy of Computerized WORTH across multiple IPV outcomes highlights the promise of integrating computerized, self-paced IPV prevention modules in HIV prevention groups.

Project WINGS (Women Initiating New Goals of Safety): A randomised controlled trial of a screening, brief intervention and referral to treatment (SBIRT) service to identify and address intimate partner violence victimisation among substance-using women receiving community supervision.

BACKGROUND: The high rate of intimate partner violence (IPV) victimisation found among substance-using women receiving community supervision underscores the need for effective IPV victimisation screening, brief intervention and referral to treatment services (SBIRT) for this population. AIMS: This randomised controlled trial (RCT) aims to assess the feasibility, safety and efficacy of a single-session computerised self-paced IPV SBIRT (Computerised WINGS) in identifying IPV victimisation among women under community supervision and increasing access to IPV services, compared to the same IPV SBIRT service delivered by a case manager (Case Manager WINGS). METHODS: This RCT was conducted with 191 substance-using women in probation and community court sites in New York City. RESULTS: No significant differences were found between Computerised and Case Manager WINGS arms on any outcomes. Both arms reported identical high rates of any physical, sexual or psychological IPV victimisation in the past year (77% for both arms) during the intervention. Both arms experienced significant increases from baseline to the 3-month follow-up in receipt of IPV services, social support, IPV self-efficacy and abstinence from drug use. CONCLUSIONS: Findings suggest that both modalities of WINGS show promise in identifying and addressing IPV victimisation among substance-using women receiving community supervision.

Opioid use, prescribing and fatal overdose patterns among racial/ethnic minorities in the United States: A scoping review and conceptual risk environment model.

ISSUES: To date, there has been no synthesis of research addressing the scale and nuances of the opioid epidemic in racial/ethnic minority populations in the United States that considers the independent and joint impacts of dynamics such as structural disadvantage, provider bias, health literacy, cultural norms and various other risk factors. APPROACH: Using the "risk environment" framework, we conducted a scoping review on PubMed, Embase and Google Scholar of peer-reviewed literature and governmental reports published between January 2000 and February 2024 on the nature and scale of opioid use, opioid prescribing patterns, and fatal overdoses among racial/ethnic minorities in the United States, while also examining macro, meso and individual-level risk factors. KEY FINDINGS: Results from this review illuminate a growing, but fragmented, literature lacking standardisation in racial/ethnic classification and case reporting, specifically in regards to Indigenous and Asian subpopulations. This literature broadly illustrates racial/ethnic minorities' increasing nonmedical use of opioids, heightened burdens of fatal overdoses, specifically in relation to polydrug use and synthetic opioids, with notable elevations among Black/Latino subgroups, in addition uneven opioid prescribing patterns. Moreover, the literature implicates a variety of unique risk environments corresponding to dynamics such as residential segregation, provider bias, overpolicing, acculturative stress, patient distrust, and limited access to mental health care services and drug treatment resources, including medications for opioid use disorder. IMPLICATIONS: There has been a lack of rigorous, targeted study on racial/ethnic minorities who use opioids, but evidence highlights burgeoning increases in usage, especially polydrug/synthetic opioid use, and disparities in prescriptions and fatal overdose risk-phenomena tied to multi-level forms of entrenched disenfranchisement. CONCLUSION: There is a need for further research on the complex, overlapping risk environments of racial/ethnic minorities who use opioids, including deeper inclusion of Indigenous and Asian individuals, and efforts to generate greater methodological synergies in population classification and reporting guidelines.

Development and validation of a community-level social determinants of health index for drug overdose deaths in the HEALing Communities Study.

INTRODUCTION: Social determinants of health (SDoH), such as socioeconomic status, education level, and food insecurity, are believed to influence the opioid crisis. While global SDoH indices such as the CDC's Social Vulnerability Index (SVI) and Area Deprivation Index (ADI) combine the explanatory power of multiple social factors for understanding health outcomes, they may be less applicable to the specific challenges of opioid misuse and associated outcomes. This study develops a novel index tailored to opioid misuse outcomes, tests the efficacy of this index in predicting drug overdose deaths across contexts, and compares the explanatory power of this index to other SDoH indices. METHODS: Focusing on four HEALing Communities Study (HCS) states (Kentucky, Massachusetts, New York and Ohio; encompassing 4269 ZIP codes), we identified multilevel SDoH potentially associated with opioid misuse and aggregated publicly available data for each measure. We then leveraged a random forest model to develop a composite measure that predicts age-adjusted drug overdose mortality rates based on SDoH. We used this composite measure to understand HCS and non-HCS communities in terms of overdose risk across areas of varying racial composition. Finally, we compared variance in drug overdose deaths explained by this index to variance explained by the SVI and ADI. RESULTS: Our composite measure included 28 SDoH measures and explained approximately 89 % percent of variance in age-adjusted drug overdose mortality across HCS states. Health care measures, including emergency department visits and primary care provider availability, were top predictors within the index. Index accuracy was robust within and outside of HCS communities and states. This measure identified high levels of overdose mortality risk in segregated communities. CONCLUSIONS: Existing SDoH indices fail to explain much variation in area-level overdose mortality rates. Having tailored composite indices can help us to identify places in which residents are at highest risk based on their composite contexts. A comprehensive index can also help to develop effective community interventions for programs such as HCS by considering the context in which people live.

Effectiveness of a culturally tailored HIV intervention in promoting PrEP among black women who use drugs in community supervision programs in New York City: a randomized clinical trial.

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 .

Impact of the Communities That HEAL Intervention on Buprenorphine-Waivered Practitioners and Buprenorphine Prescribing: A Prespecified Secondary Analysis of the HCS Randomized Clinical Trial.

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 100 000 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 8 166 963 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.