Empirical Development of a Behavioral Intervention for African American/Black and Latino Persons with Unsuppressed HIV Viral Load Levels: An Application of the Multiphase Optimization Strategy (MOST) Using Cost-Effectiveness as an Optimization Objective.

We used results from an optimization randomized controlled trial which tested five behavioral intervention components to support HIV antiretroviral adherence/HIV viral suppression, grounded in the multiphase optimization strategy and using a fractional factorial design to identify intervention components with cost-effectiveness sufficiently favorable for scalability. Results were incorporated into a validated HIV computer simulation to simulate longer-term effects of combinations of components on health and costs. We simulated the 32 corresponding long-term trajectories for viral load suppression, health related quality of life (HRQoL), and costs. The components were designed to be culturally and structurally salient. They were: motivational interviewing counseling sessions (MI), pre-adherence skill building (SB), peer mentorship (PM), focused support groups (SG), and patient navigation (short version [NS], long version [NL]. All participants also received health education on HIV treatment. We examined four scenarios: one-time intervention with and without discounting and continuous interventions with and without discounting. In all four scenarios, interventions that comprise or include SB and NL (and including health education) were cost effective (< $100,000/quality-adjusted life year). Further, with consideration of HRQoL impact, maximal intervention became cost-effective enough to be scalable. Thus, a fractional factorial experiment coupled with cost-effectiveness analysis is a promising approach to optimize multi-component interventions for scalability. The present study can guide service planning efforts for HIV care settings and health departments.

Utility of self-report antiretroviral adherence for predicting HIV viral load among persons who inject drugs in Hai Phong Vietnam: assessing differences by methamphetamine use.

ABSTRACTIn resource-limited settings, alternatives to HIV viral load testing may be necessary to monitor the health of people living with HIV. We assessed the utility of self-report antiretroviral therapy (ART) to screen for HIV viral load among persons who inject drugs in Hai Phong Vietnam, and consider differences by recent methamphetamine use. From 2016 to 2018 we recruited PWID through cross sectional surveys and collected self-report ART adherence and HIV viral load to estimate sensitivity, specificity, positive and negative predictive values (PPV, NPV) and likelihood ratios (LR+, LR-) for self-reported ART adherence as a screening test for HIV viral load. We used three HIV viral load thresholds: < 1000, 500 and 250 copies/mL; laboratory-confirmed HIV viral load was the gold standard. Among 792 PWID recruited, PPV remained above 90% regardless of recent methamphetamine use with slightly higher PPV among those not reporting recent methamphetamine use. The results remained consistent across all three HIV viral load thresholds. Our findings suggest that when HIV viral load testing is not possible, self-reported ART adherence may inform decisions about how to prioritize HIV viral load testing among PWID. The high PPV values suggest self-reported high ART adherence indicates likely HIV viral suppression, irrespective of methamphetamine use.

Posttraumatic Stress Disorder Symptoms and Incarceration: The Impact on Sexual Risk-Taking, Sexually Transmitted Infections, and Depression Among Black Sexual Minority Men in HIV Prevention Trials Network (HPTN) 061.

Black men and people belonging to sexual minority groups are disproportionately impacted by criminal legal involvement and sexually transmitted infections (STIs). Traumatic experiences are often associated with later criminal legal involvement, depression symptoms, sexual risk behavior, and STIs. Research on the joint influence of trauma and incarceration on STI risk among racial and/or sexual minority people is limited. This study tested the association between post-traumatic stress disorder (PTSD) symptoms and incarceration on sexual risk behavior and STI among Black sexual minority men, a population that may be at higher risk for contracting STIs. Using data from the HIV Prevention Trials Network 061 Study, a longitudinal study of adult Black sexual minority men in six U.S. cities (N = 855), we tested associations between past six-month incarceration and subsequent sexual risk behavior, STI, and depression symptoms, for those with and without pre-incarceration PTSD symptoms. PTSD symptoms were elevated among participants who reported Hispanic ethnicity, having sex with both men and women, and previous incarceration. Although there were not significant differences between recent incarceration and sexual risk for those with and without PTSD, incarceration was linked to some sexual risk behaviors regardless of PTSD symptoms. Among people with PTSD symptoms, there was a higher prevalence of sexual risk and depression symptoms, regardless of incarceration. These findings suggest a potentially compounding influence of PTSD symptoms and incarceration on sexual risk and infection among Black sexual minority men.

Feasibility and Acceptability of the Adherence Connection Counseling, Education, and Support (ACCESS) Proof of Concept: A Peer-Led, Mobile Health (mHealth) Cognitive Behavioral Antiretroviral Therapy (ART) Adherence Intervention for HIV-Infected (HIV+) Adolescents and Young Adults (AYA).

Effective antiretroviral therapy (ART) adherence strategies for HIV+ adolescents and young adults (AYA) are needed to prevent HIV-related morbidity, mortality, and onward transmission. In the Adherence Connection for Counseling, Education, and Support (ACCESS) pilot, an exploratory sequential mixed-methods design was used to develop and test a peer-led, mobile health (mHealth) cognitive behavioral ART adherence intervention. HIV+ AYA (ages 16-29 years) with unsuppressed plasma HIV RNA (HIV viral load) were eligible for this five-session intervention directed to improving ART adherence and HIV viral load. A total of 78 peer-led remote videoconferencing sessions (via WebEx) were delivered to 16 participants. High completion rates (97.5%) and client satisfaction scores (mean = 29.13 of 32; SD = 2.45) were observed. Self-reported ART adherence improved (32% increase in doses taken; 95th CI 11.2-53.3) with an annualized average rate of 47.5% (0.28 log10) reduction in HIV viral load. We established proof of concept for the ACCESS peer-led, mHealth cognitive behavioral ART adherence intervention, with promising adherence and virologic outcome data.

RESUMEN: Se necesitan estrategias efectivas de adherencia a la terapia antirretroviral (TAR) para adolescentes y adultos jóvenes (AAJ) VIH+ para prevenir la morbilidad, la mortalidad y las transmisiones futuras relacionadas con el VIH. En el proyecto piloto Adherence Connection for Counseling, Education, and Support (ACCESS), se utilizó un diseño exploratorio secuencial de métodos mixtos para desarrollar y testear una intervención de adherencia cognitiva conductual de salud móvil (mHealth) dirigida por pares a la TAR. AAJ VIH+ (de 16 a 29 años de edad) con ARN del VIH (carga viral del VIH) en plasma no suprimido fueron elegibles para esta intervención de cinco sesiones dirigida a mejorar la adherencia a la TAR y la carga viral del VIH. Se dictaron un total de 78 sesiones de videoconferencias remotas dirigidas por pares (a través de WebEx) a 16 participantes. Fueron observadas tasas altas de finalización (97.5%) y puntuaciones de satisfacción del cliente (media=29.13 de 32; SD=2.45). La adherencia autoinformada a la TAR mejoró (aumento del 32% en las dosis tomadas; IC del 95=11.2 a 53.3) con una tasa promedio anualizada de reducción en la carga viral del VIH del 47.5% (0.28 log 10). Establecimos una prueba de concepto para ACCESS, la intervención de adherencia a la TAR cognitivo conductual mHealth dirigida por pares, con datos prometedores sobre la adherencia y los resultados virológicos.

Mediation of the Effect of Incarceration on Selling Sex Among Black Sexual Minority Men and Black Transgender Women in the HPTN 061 Study.

Incarceration among Black sexual minority men and Black transgender women (BSMM/BTW) is disproportionately high in the United States. Limited research has documented the disruptive effect of incarceration on sexual networks and sexual partnership exchange among BSMM/BTW. We estimate the influence of incarceration on selling sex and mediating pathways among 1169 BSMM/BTW enrolled in the HIV Prevention Trials Network (HPTN) 061 cohort to assess this relationship. Mediators investigated were social support, violence, illicit drug use, and distress due to experienced racism and homophobia. During the 6 months following baseline, 14% of the cohort was incarcerated, including 24% of BTW. After adjustment, recent incarceration was associated with 1.57 (95% CI 1.02, 2.42) times the risk of subsequently selling sex. The hypothesized mediators together explained 25% of the relationship, with an indirect effect risk ratio of 1.09 (95% CI 0.97, 1.24). Our results document an association and call for more research investigating mechanisms.

Effects of Behavioral Intervention Components for African American/Black and Latino Persons Living with HIV with Non-suppressed Viral Load Levels: Results of an Optimization Trial.

There is an urgent need for efficient behavioral interventions to increase rates of HIV viral suppression for populations with serious barriers to engagement along the HIV care continuum. We carried out an optimization trial to test the effects of five behavioral intervention components designed to address barriers to HIV care continuum engagement for African American/Black and Latino persons living with HIV (PLWH) with non-suppressed HIV viral load levels: motivational interviewing sessions (MI), focused support groups (SG), peer mentorship (PM), pre-adherence skill building (SB), and navigation with two levels, short (NS) and long (NL). The primary outcome was HIV viral suppression (VS) and absolute viral load (VL) and health-related quality of life were secondary outcomes. Participants were 512 African American/Black and Latino PLWH poorly engaged in HIV care and with detectable HIV viral load levels in New York City, recruited mainly through peer referral. Overall, VS increased to 37%, or 45% in a sensitivity analysis. MI and SG seemed to have antagonistic effects on VS (z = - 1.90; p = 0.057); the probability of VS was highest when either MI or SG was assigned, but not both. MI (Mean Difference = 0.030; 95% CI 0.007-0.053; t(440) = 2.60; p = 0.010) and SB (Mean Difference = 0.030; 95% CI 0.007-0.053; t(439) = 2.54; p = 0.012) improved health-related quality of life. This is the first optimization trial in the field of HIV treatment. The study yields a number of insights into approaches to improve HIV viral suppression in PLWH with serious barriers to engagement along the HIV care continuum, including chronic poverty, and underscores challenges inherent in doing so.

Understanding why racial/ethnic inequities along the HIV care continuum persist in the United States: a qualitative exploration of systemic barriers from the perspectives of African American/Black and Latino persons living with HIV.

BACKGROUND: Racial/ethnic inequities along the HIV care continuum persist in the United States despite substantial federal investment. Numerous studies highlight individual and social-level impediments in HIV, but fewer foreground systemic barriers. The present qualitative study sought to uncover and describe systemic barriers to the HIV care continuum from the perspectives of African American/Black and Latino persons living with HIV (PLWH) with unsuppressed HIV viral load, including how barriers operated and their effects. METHODS: Participants were African American/Black and Latino PLWH with unsuppressed HIV viral load (N = 41). They were purposively sampled for maximum variability on key indices from a larger study. They engaged in semi-structured in-depth interviews that were audio-recorded and professionally transcribed. Data were analyzed using directed content analysis. RESULTS: Participants were 49 years old, on average (SD = 9), 76% were assigned male sex at birth, 83% were African American/Black and 17% Latino, 34% were sexual minorities (i.e., non-heterosexual), and 22% were transgender/gender-nonbinary. All had indications of chronic poverty. Participants had been diagnosed with HIV 19 years prior to the study, on average (SD = 9). The majority (76%) had taken HIV medication in the six weeks before enrollment, but at levels insufficient to reach HIV viral suppression. Findings underscored a primary theme describing chronic poverty as a fundamental cause of poor engagement. Related subthemes were: negative aspects of congregate versus private housing settings (e.g., triggering substance use and social isolation); generally positive experiences with health care providers, although structural and cultural competency appeared insufficient and managing health care systems was difficult; pharmacies illegally purchased HIV medication from PLWH; and COVID-19 exacerbated barriers. Participants described mitigation strategies and evidenced resilience. CONCLUSIONS: To reduce racial/ethnic inequities and end the HIV epidemic, it is necessary to understand African American/Black and Latino PLWH's perspectives on the systemic impediments they experience throughout the HIV care continuum. This study uncovers and describes a number of salient barriers and how they operate, including unexpected findings regarding drug diversion and negative aspects of congregate housing. There is growing awareness that systemic racism is a core determinant of systemic barriers to HIV care continuum engagement. Findings are interpreted in this context.

Exploring behavioral intervention components for African American/Black and Latino persons living with HIV with non-suppressed HIV viral load in the United States: a qualitative study.

BACKGROUND: The persistence of racial/ethnic inequities in rates of engagement along the HIV care continuum signals the need for novel approaches. We developed six behavioral intervention components for use in an optimization trial, grounded in a model that integrates critical race theory, harm reduction, and self-determination theory, designed to address various barriers that African American/Black and Latino persons living with HIV (PLWH) experience to the HIV care continuum. The components were: health education, motivational interviewing sessions, pre-adherence skill building, peer mentorship, focused support groups, and navigation. The present qualitative exploratory study describes participants' perspectives on the components' acceptability, feasibility, and impact. METHODS: Participants were African American/Black and Latino PLWH poorly engaged in HIV care and with non-suppressed HIV viral load in New York City. From a larger trial, we randomly selected 46 participants for in-depth semi-structured interviews. Interviews were audio-recorded and transcribed verbatim, and data were analyzed using directed content analysis. Quantitative data on sociodemographic and background characteristics and components' acceptability and feasibility were also collected. RESULTS: On average, participants were 49 years old and had lived with HIV for 19 years. Most were cisgender-male and African American/Black. Participants reported a constellation of serious social and structural challenges to HIV management including chronic poverty, unstable housing, and stigma. Across components, a non-judgmental and pressure-free approach and attention to structural and cultural factors were seen as vital to high levels of engagement, but lacking in most medical/social service settings. Prominent aspects of individual components included establishing trust (health education); developing intrinsic motivation, goals, and self-reflection (motivational interviewing sessions); learning/practicing adherence strategies and habits (pre-adherence skill building); reducing social isolation via peer role models (peer mentorship); reflecting on salient goals and common challenges with peers without stigma (focused support groups); and circumventing structural barriers to HIV management with support (navigation). Components were found acceptable and feasible. Findings suggested ways components could be improved. CONCLUSIONS: The present study advances research on interventions for African American/Black and Latino PLWH, who experience complex barriers to engagement along the HIV care continuum. Future study of the components is warranted to address racial/ethnic health inequities in HIV.

Facilitation of team-based care to improve HTN management and outcomes: a protocol for a randomized stepped wedge trial.

BACKGROUND: There are well-established guidelines for treating hypertension (HTN), yet only half of patients with HTN meet the defined target of < 140/90. Team-based care (TBC) is an evidence-based strategy for improving blood pressure (BP) management and control. TBC is defined as the provision of health services by at least two health professionals "who work collaboratively with patients and their caregivers to accomplish shared goals to achieve coordinated, high-quality care". However, primary care practices experience challenges to implementing TBC principles and care processes; these are more pronounced in small independent practice settings (SIPs). Practice facilitation (PF) is an implementation strategy that may overcome barriers to adopting evidence-based TBC to improve HTN management in SIPs. METHODS: Using a stepped wedge randomized controlled trial design, we will test the effect of PF on the adoption of TBC to improve HTN management in small practices (< 5 FTE clinicians) in New York City, and the impact on BP control compared with usual care. We will enroll 90 SIPs and randomize them into one of three 12-month intervention waves. Practice facilitators will support SIPs to adopt TBC principles to improve implementation of five HTN management strategies (i.e., panel management, population health, measuring BP, supporting medication adherence, self-management). The primary outcome is the adoption of TBC for HTN management measured at baseline and 12 months. Secondary outcomes include the rate of BP control and sustainability of TBC and BP outcomes at 18 months. Aggregated data on BP measures are collected every 6 months in all clusters so that each cluster provides data points in both the control and intervention conditions. Using a mixed methods approach, we will also explore factors that influence the effectiveness of PF at the organization and team level. DISCUSSION: This study will provide much-needed guidance on how to optimize adoption and sustainability of TBC in independent primary care settings to reduce the burden of disease related to suboptimal BP control and advance understanding of how facilitation works to improve implementation of evidence-based interventions. TRIAL REGISTRATION: ClinicalTrials.gov; NCT05413252 .

"As safe as possible": a qualitative study of opioid withdrawal and risk behavior among people who use illegal opioids.

BACKGROUND: Opioid withdrawal is a regular occurrence among many people who use illicit opioids (PWUIO) that has also been shown to increase their willingness to engage in risk-involved behavior. The proliferation of fentanyl in the illicit opioid market may have amplified this relationship, potentially putting PWUIO at greater risk of negative health outcomes. Understanding the relationship between withdrawal and risk-involved behavior may also have important implications for the ways that problematic drug use is conceptualized, particularly in disease models of addiction, which position risk behavior as evidence of pathology that helps to justify ontological distinctions between addicts and non-addicts. Examining withdrawal, and its role in PWUIO's willingness to engage in risk, may aid in the development of alternative theories of risk involvement and create discursive spaces for de-medicalizing and de-othering people who use illegal drugs. METHODS: This article is based on 32 semi-structured interviews with PWUIO in the New York City area who also reported recent withdrawal experience. Interviews were conducted remotely between April and August 2022 and recorded for later transcription. Data were then coded and analyzed based on a combination of inductive and deductive coding strategies and informed by the literature. RESULTS: Participants described a strong relationship between withdrawal and their willingness to engage in risk-involved behavior that was exacerbated by the proliferation of fentanyl. Yet, their descriptions did not align with narratives of risk as a product of bad decisions made by individuals. Rather, data demonstrated the substantial role of social and structural context, particularly drug policies like prohibition and criminalization, in the kinds of risks that PWUIO faced and their ability to respond to them. CONCLUSIONS: Withdrawal should be taken more seriously both from an ethical perspective and as an important catalyst of risk behavior. However, theories that position activities taken to avoid withdrawal as irrational and as evidence of pathology are poorly aligned with the complexity of PWUIO's actual lives. We recommend the use of less deterministic and less medicalized theories of risk that better account for differences between how people view the world, and for the role of socio-structural forces in the production of risk.

Incarceration and Sexual Risk Behavior and Incident Sexually Transmitted Infection/HIV in HIV Prevention Trials Network 061: Differences by Study City and Among Black Sexual Minority Men Who Have Sex With Men, Black Sexual Minority Men Who Have Sex With Men and Women, and Black Transgender Women.

BACKGROUND: Black sexual minority men (BSMM) and Black transgender women face a disproportionate risk of incarceration and sexually transmitted infection (STI)/HIV, yet research on the longitudinal association between incarceration and STI/HIV risk in these groups is limited. METHODS: We used data from the HIV Prevention Trials Network (HPTN) 061 study conducted among BSMM and Black transgender women in Atlanta, Boston, Los Angeles, New York City, San Francisco, and Washington, DC, restricting analyses to those who returned for the 6-month follow-up visit when recent incarceration was measured (n = 1169). Using inverse probability of treatment weighting, we measured associations between incarceration and next 6-month multiple partnerships; selling or buying sex; condomless anal intercourse; and incident chlamydia, gonorrhea, syphilis, and HIV. We explored differences by study city, and among BSMM who had sex with men only, BSMM who had sex with men and women, and Black transgender women. RESULTS: Approximately 14% reported past 6-month incarceration. Incarceration was associated with next 6-month selling sex (adjusted risk ratio [ARR], 1.80; 95% confidence interval [CI], 1.12-2.87) in the overall sample and multiple partnerships among BSMM who had sex with men and women (ARR, 1.34; 95% CI, 1.10-1.63) and transgender women (ARR, 1.77; 95% CI, 1.22-2.57). There is evidence suggesting that incarceration may predict gonorrhea (ARR, 2.35; 95% CI, 0.95-5.77), with particularly strong associations observed in Los Angeles (ARR, 6.48; 95% CI, 1.48-28.38). CONCLUSIONS: Incarceration may increase STI/HIV risk among BSMM and Black transgender women. Additional mixed-methods research is needed to validate associations and understand pathways.

Considerations Before Selecting a Stepped-Wedge Cluster Randomized Trial Design for a Practice Improvement Study.

PURPOSE: Despite the growing popularity of stepped-wedge cluster randomized trials (SW-CRTs) for practice-based research, the design's advantages and challenges are not well documented. The objective of this study was to identify the advantages and challenges of the SW-CRT design for large-scale intervention implementations in primary care settings. METHODS: The EvidenceNOW: Advancing Heart Health initiative, funded by the Agency for Healthcare Research and Quality, included a large collection of SW-CRTs. We conducted qualitative interviews with 17 key informants from EvidenceNOW grantees to identify the advantages and challenges of using SW-CRT design. RESULTS: All interviewees reported that SW-CRT can be an effective study design for large-scale intervention implementations. Advantages included (1) incentivized recruitment, (2) staggered resource allocation, and (3) statistical power. Challenges included (1) time-sensitive recruitment, (2) retention, (3) randomization requirements and practice preferences, (4) achieving treatment schedule fidelity, (5) intensive data collection, (6) the Hawthorne effect, and (7) temporal trends. CONCLUSIONS: The challenges experienced by EvidenceNOW grantees suggest that certain favorable real-world conditions constitute a context that increases the odds of a successful SW-CRT. An existing infrastructure can support the recruitment of many practices. Strong retention plans are needed to continue to engage sites waiting to start the intervention. Finally, study outcomes should be ones already captured in routine practice; otherwise, funders and investigators should assess the feasibility and cost of data collection.VISUAL ABSTRACT.

The associations of incarceration and depression with healthcare experiences and utilization among Black men who have sex with men in HPTN 061.

Associations of incarceration with healthcare access and utilization among Black sexual minority men (BSMM) and differences in association among those with and without pre-incarceration symptoms of depression were measured. Secondary analysis using survey data from the longitudinal cohort HIV Prevention Trials Network 061 study was conducted among 1553 BSMM from six major U.S. cities from 2009 to 2011. We used modified log-binomial regression with robust standard errors to estimate associations of incarceration (reported at 6 month follow-up) on next six-month healthcare utilization and access (reported at the 12 month follow-up). We tested the significance of baseline depressive symptoms by incarceration interaction and reported differences in associations when observed. Participants with a history of incarceration were more likely to have depressive symptoms at baseline compared to those without. Recent incarceration was associated with almost twice the risk of mistrust in healthcare providers and emergency room utilization. Among men reporting depressive symptoms, a history of incarceration was associated with almost tripled risk of reporting providers do not communicate understandably. Among those with depression, one in five reported a missed visit regardless of incarceration status.

Advancing behavioral interventions for African American/Black and Latino persons living with HIV using a new conceptual model that integrates critical race theory, harm reduction, and self-determination theory: a qualitative exploratory study.

BACKGROUND: Rates of participation in HIV care, medication uptake, and viral suppression are improving among persons living with HIV (PLWH) in the United States. Yet, disparities among African American/Black and Latino PLWH are persistent, signaling the need for new conceptual approaches. To address gaps in services and research (e.g., insufficient attention to structural/systemic factors, inadequate harm reduction services and autonomy support) and improve behavioral interventions, we integrated critical race theory, harm reduction, and self-determination theory into a new conceptual model, then used the model to develop a set of six intervention components which were tested in a larger study. The present qualitative study explores participants' perspectives on the study's acceptability, feasibility, and impact, and the conceptual model's contribution to these experiences. METHODS: Participants in the larger study were African American/Black and Latino PLWH poorly engaged in HIV care and with non-suppressed HIV viral load in New York City (N = 512). We randomly selected N = 46 for in-depth semi-structured interviews on their experiences with and perspectives on the study. Interviews were audio-recorded and professionally transcribed verbatim, and data were analyzed using directed qualitative content analysis. RESULTS: On average, participants were 49 years old (SD = 9) and had lived with HIV for 19 years (SD = 7). Most were male (78%) and African American/Black (76%). All had taken HIV medication previously. Challenging life contexts were the norm, including poverty, poor quality/unstable housing, trauma histories exacerbated by current trauma, health comorbidities, and substance use. Participants found the study highly acceptable. We organized results into four themes focused on participants' experiences of: 1) being understood as a whole person and in their structural/systemic context; 2) trustworthiness and trust; 3) opportunities for self-reflection; and 4) support of personal autonomy. The salience of nonjudgment was prominent in each theme. Themes reflected grounding in the conceptual model. Participants reported these characteristics were lacking in HIV care settings. CONCLUSIONS: The new conceptual model emphasizes the salience of systemic/structural and social factors that drive health behavior and the resultant interventions foster trust, self-reflection, engagement, and behavior change. The model has potential to enhance intervention acceptability, feasibility, and effectiveness with African American/Black and Latino PLWH.

Effectiveness of a Multicomponent Strategy for Implementing Guidelines for Treating Tobacco Use in Vietnam Commune Health Centers.

INTRODUCTION: Strategies are needed to increase implementation of evidence-based tobacco dependence treatment (TDT) in health care systems in low-and middle-income countries (LMICs). AIMS AND METHODS: We conducted a two-arm cluster randomized controlled trial to compare the effectiveness of two strategies for implementing TDT guidelines in community health centers (n = 26) in Vietnam. Arm 1 included training and a tool kit (eg, reminder system) to promote and support delivery of the 4As (Ask about tobacco use, Advise to quit, Assess readiness, Assist with brief counseling) (Arm 1). Arm 2 included Arm 1 components plus a system to refer smokers to a community health worker (CHW) for more intensive counseling (4As + R). Provider surveys were conducted at baseline, 6 months, and 12 months to assess the hypothesized effect of the strategies on provider and organizational-level factors. The primary outcome was provider adoption of the 4As. RESULTS: Adoption of the 4As increased significantly across both study arms (all p < .001). Perceived organizational priority for TDT, compatibility with current workflow, and provider attitudes, norms, and self-efficacy related to TDT also improved significantly across both arms. In Arm 2 sites, 41% of smokers were referred to a CHW for additional counseling. CONCLUSIONS: The study demonstrated the effectiveness of a multicomponent and multilevel strategy (ie, provider and system) for implementing evidence-based TDT in the Vietnam public health system. Combining provider-delivered brief counseling with opportunities for more in-depth counseling offered by a trained CHW may optimize outcomes and offers a potentially scalable model for increasing access to TDT in health care systems like Vietnam. IMPLICATIONS: Improving implementation of evidence-based TDT guidelines is a necessary step toward reducing the growing burden of noncommunicable diseases and premature death in LMICs. The findings provide new evidence on the effectiveness of multilevel strategies for adapting and implementing TDT into routine care in Vietnam and offer a potentially scalable model for meeting Framework Convention on Tobacco Control Article 14 goals in other LMICs with comparable public health systems. The study also demonstrates that combining provider-delivered brief counseling with referral to a CHW for more in-depth counseling and support can optimize access to evidence-based treatment for tobacco use.Clinical trials number: NCT01967654.

Using the multiphase optimization strategy (MOST) framework to optimize an intervention to increase COVID-19 testing for Black and Latino/Hispanic frontline essential workers: A study protocol.

BACKGROUND: Among those at highest risk for COVID-19 exposure is the large population of frontline essential workers in occupations such food service, retail, personal care, and in-home health services, among whom Black and Latino/Hispanic persons are over-represented. For those not vaccinated and at risk for exposure to COVID-19, including frontline essential workers, regular (approximately weekly) COVID-19 testing is recommended. However, Black and Latino/Hispanic frontline essential workers in these occupations experience serious impediments to COVID-19 testing at individual/attitudinal- (e.g., lack of knowledge of guidelines), social- (e.g., social norms), and structural-levels of influence (e.g., poor access), and rates of testing for COVID-19 are insufficient. METHODS/DESIGN: The proposed community-engaged study uses the multiphase optimization strategy (MOST) framework and an efficient factorial design to test four candidate behavioral intervention components informed by an integrated conceptual model that combines critical race theory, harm reduction, and self-determination theory. They are A) motivational interview counseling, B) text messaging grounded in behavioral economics, C) peer education, and D) access to testing (via navigation to an appointment vs. a self-test kit). All participants receive health education on COVID-19. The specific aims are to: identify which components contribute meaningfully to improvement in the primary outcome, COVID-19 testing confirmed with documentary evidence, with the most effective combination of components comprising an "optimized" intervention that strategically balances effectiveness against affordability, scalability, and efficiency (Aim 1); identify mediators and moderators of the effects of components (Aim 2); and use a mixed-methods approach to explore relationships among COVID-19 testing and vaccination (Aim 3). Participants will be N = 448 Black and Latino/Hispanic frontline essential workers not tested for COVID-19 in the past six months and not fully vaccinated for COVID-19, randomly assigned to one of 16 intervention conditions, and assessed at 6- and 12-weeks post-baseline. Last, N = 50 participants will engage in qualitative in-depth interviews. DISCUSSION: This optimization trial is designed to yield an effective, affordable, and efficient behavioral intervention that can be rapidly scaled in community settings. Further, it will advance the literature on intervention approaches for social inequities such as those evident in the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05139927 ; Registered on 11/29/2021. Protocol version 1.0. May 2, 2022, Version 1.0.

Recurrent Injecting Drug Use as a Mediator between Psychiatric Disorder and Non-Fatal Overdose.

BACKGROUND: Unintentional drug overdose has increased markedly in the United States. Studies document an association between psychiatric disorder and unintentional overdose; we extend this research through a preliminary test of a causal model of recurrent injection drug use mediating this relationship. METHODS: In a cross-sectional study of 241 adults in New York City with a possible current substance use disorder, we conducted conventional and Imai's mediation analyses to examine if psychiatric disorder is associated with increased prevalence of ever overdosing and if recurrent injection drug use mediates this association. Our cross-sectional data permit the first step of assessing causal models: testing if statistical associations are consistent with the model. RESULTS: Fifty-eight percent of the sample endorsed previous psychiatric disorder diagnosis and 35.7% reported ever overdosing. Imai's mediation analysis showed that, adjusting for covariates, the total association between psychiatric diagnosis and ever overdosing (adjusted prevalence difference [aPD] = 0.16, 95% CI 0.04-0.28) was composed of a direct effect (aPD = 0.09, 95% CI -0.03 - 0.21, p = 0.136) and an indirect effect (aPD = 0.07, 95% CI 0.02-0.13). Recurrent injecting drug use contributed to 42% (ratio of indirect effect to total effect; 95% CI 12 - 100%, p = 0.02) of the association between psychiatric diagnosis and ever overdosing. Conventional mediation analysis produced similar results. CONCLUSIONS: Our results provide a warrant for taking the necessary next step for assessing a causal model using longitudinal data, potentially providing a strong rationale for intervening on psychiatric disorders to stem overdose.

Concerts, bars, parties, and raves: Differential risk for drug use among high school seniors according to venue attendance.

Background: Nightlife attendance is an established risk factor for drug use, but studies have not focused on adolescent general population samples or compared risk according to type(s) of venues attended. We examined whether attendance of various types of venues was associated with drug use. Methods: Data were examined from an annual nationally representative survey of high school seniors in the US (2014-2019, N = 11,565). We determined whether past-year attendance of parties, concerts, bars or nightclubs, and raves or dance music events was associated with past-year drug use using mixed-effects logistic regression. Mall and movie attendance were examined as negative controls. Results: Compared to those who reported not attending specific venues, attending parties was associated with higher odds of using alcohol in particular (aOR = 5.03, 95% CI: 3.92-6.44). Attending concerts was associated with higher odds for use of alcohol, cannabis, ecstasy, and nonmedical use of prescription stimulants and opioids. All drugs examined were concentrated among those who attend bars, nightclubs, raves, and dance parties. Rave or dance party attendance was associated with higher odds for use of ecstasy (aOR = 3.71, 95% CI: 2.50-5.50) and methamphetamine (aOR = 4.92, 95% CI: 2.43-9.96) in particular, and bar or nightclub attendance was associated with higher odds of use of cocaine (aOR = 6.49, 95% CI: 4.37-9.63), ecstasy (aOR = 6.49, 95% CI: 4.54-9.27), and methamphetamine (aOR = 5.49, 95% CI: 2.57-11.72) in particular. Attending movies was associated with lower odds for use of cocaine and nonmedical prescription stimulant use. Conclusion: We determined differential risk of drug use depending on types of venues attended by adolescents.

Leveraging technology to address unhealthy drug use in primary care: Effectiveness of the Substance use Screening and Intervention Tool (SUSIT).

Background: Screening for unhealthy drug use is now recommended for adult primary care patients, but primary care providers (PCPs) generally lack the time and knowledge required to screen and deliver an intervention during the medical visit. To address these barriers, we developed a tablet computer-based 'Substance Use Screening and Intervention Tool (SUSIT)'. Using the SUSIT, patients self-administer screening questionnaires prior to the medical visit, and results are presented to the PCP at the point of care, paired with clinical decision support (CDS) that guides them in providing a brief intervention (BI) for unhealthy drug use. Methods: PCPs and their patients with moderate-risk drug use were recruited from primary care and HIV clinics. A pre-post design compared a control 'screening only' (SO) period to an intervention 'SUSIT' period. Unique patients were enrolled in each period. In both conditions, patients completed screening and identified their drug of most concern (DOMC) before the visit, and completed a questionnaire about BI delivery by the PCP after the visit. In the SUSIT condition only, PCPs received the tablet with the patient's screening results and CDS. Multilevel models with random intercepts and patients nested within PCPs examined the effect of the SUSIT intervention on PCP delivery of BI. Results: 20 PCPs and 79 patients (42 SO, 37 SUSIT) participated. Most patients had moderate-risk marijuana use (92.4%), and selected marijuana as the DOMC (68.4%). Moderate-risk use of drugs other than marijuana included cocaine (15.2%), hallucinogens (12.7%), and sedatives (12.7%). Compared to the SO condition, patients in SUSIT had higher odds of receiving any BI for drug use, with an adjusted odds ratio of 11.59 (95% confidence interval: 3.39, 39.25), and received more elements of BI for drug use. Conclusions: The SUSIT significantly increased delivery of BI for drug use by PCPs during routine primary care encounters.

African American/Black and Latino Adults with Detectable HIV Viral Load Evidence Substantial Risk for Polysubstance Substance Use and Co-occurring Problems: A Latent Class Analysis.

Substance use problems are highly prevalent among persons living with (PLWH) in the United States and serve as serious barriers to engagement in HIV care. Yet, in contrast to studies of single substances, little is known about patterns of polysubstance use in this population. Moreover, other risk factors (e.g., financial hardship, incarceration, homelessness, and mental health distress) are also prevalent and complicate HIV management. The present study drew on a cross-sectional survey with African American/Black and Latino (AABL) adult PLWH from low socioeconomic status backgrounds in New York City who were insufficiently engaged in HIV care and evidenced detectable HIV viral load (N = 512). We used latent class analysis (LCA) to explore patterns of polysubstance use and their relationships to financial hardship, incarceration, homelessness, and mental health. LCA yielded three substance use classes: Class 1, a high polysubstance use/high-risk substance use class (9%); Class 2, a polysubstance use/moderate substance use risk class (18%); and Class 3, a moderate polysubstance use/moderate-to-low-risk substance use class (74%). Mental health symptoms were prevalent in all classes, but Class 1 had greater mental health distress than the other two classes. Current homelessness was more prevalent in Classes 1 and 2. We cannot end the HIV epidemic without engaging and treating AABL PLWH who have serious barriers to engagement along the HIV care continuum, and who evidence polysubstance use along with co-occurring risk factors. Clinical settings can develop outreach and engagement approaches to bring this subpopulation of PLWH into care settings, and further, specialized services are needed to successfully screen, treat, and retain them.