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Abstract Background In the United States, most (~ 70%) annual newly diagnosed HIV infections are among substance-using sexual minority men (SMM) and gender minority transgender women (trans women). Trans women and SMM are more likely to report or be diagnosed with a substance use disorder (SUD) than their cisgender or heterosexual counterparts and the presence of an SUD substantially increases the risk of HIV infection in both groups. Although Pre-Exposure Prophylaxis (PrEP) is highly effective, initiation, adherence, and persistence are exclusively behavioral outcomes; thus, the biomedical benefits of PrEP are abrogated by substance use. SUD is also associated with reduced quality-of-life, and increased overdose deaths, utilization of high-cost healthcare services, engagement in a street economy, and cycles of incarceration. Objective To determine the optimal (considering efficacy and cost-effectiveness) strategy for advancement along the PrEP Care Continuum among trans women and SMM with an SUD. Methods This study will implement a randomized controlled trial, evaluating two Stepped Care approaches involving A.S.K.-PrEP vs. standard of care (SOC) to determine optimal intervention strategies for trans women and SMM with an SUD (N = 250; n = 83 trans women; n = 167 SMM) for advancement along the PrEP Care Continuum. Participants will be randomized (3:1) to Stepped Care (n = 187) or SOC (n = 63). Participants in the Stepped Care arm will be assessed at 3-months for intervention response; responders will be maintained in A.S.K.-PrEP, while non-responders will receive added attention to their SUD via Contingency Management (CM). Non-responders will be re-randomized (1:1) to either (a) receive A.S.K.-PrEP + CM, or (b) shift the primary focus to their SUD (CM alone). Results Recruitment and enrollment began in May 2023. Recruitment will span approximately 36 months. Data collection, including all follow-up assessments, is expected to be completed in April 2027. Discussion Trans women and SMM with an SUD have the two highest HIV prevalence rates in the United States, which underscores the urgent need for effective measures to develop scalable behavioral interventions that can encourage advancement along the PrEP Care Continuum. To improve public health, researchers must identify scalable and cost-effective behavioral interventions to promote PrEP initiation, adherence, and persistence among trans women and SMM who use substances. Trial registration This trial has been registered at ClinicalTrials.gov under the number NCT05934877.

Abstract Background\Objectives Concomitant with low rates of pharmacotherapy for incarcerated individuals with OUD, there is a high rate of opioid overdose following re-entry into the community. Our research objective was to develop a better understanding of the factors that influence health-related quality-of-life (HRQoL) among this population during the high-risk transition period from incarceration to community. Few studies have assessed health-related quality-of-life (HRQoL) among individuals with OUD who are involved with the criminal-legal system, let alone over the period directly surrounding release from incarceration. Methods Secondary longitudinal analysis of data from a clinical trial where participants were randomized 1:1 to pre-release extended-release naltrexone (XR-NTX) + referral to community XR-NTX, vs. referral only. We conducted individual, multivariable regressions of EQ-5D domains (mobility, pain/discomfort, anxiety/depression; usual activities and self-care were excluded due to insufficient variation in scores), and the overall preference/utility score. HRQoL data were subset to timepoints immediately before release (baseline) and 12 weeks post-release; treatment groups were collapsed across condition. Multiple imputation by chained equations was conducted to handle missing 3-month data in the dependent variables and covariates, ad hoc. Results Greater severity in the psychiatric composite score was associated with substantially lower HRQoL, across all measures, following release from incarceration. Greater severity in the medical composite score was associated with lower pain/discomfort-related HRQoL. Conclusions Our findings highlight the importance of ensuring individuals with OUD are linked not only to MOUD, but also treatment for their comorbid conditions upon release from incarceration.

Background: Naloxone distributed to people at risk for opioid overdose has been associated with reduced overdose death rates; however, associations of retail pharmacy-distributed naloxone with overdose mortality have not been evaluated. Methods: Our analytic cohort uses retail pharmacy claims data; three health departments’ community distribution data; federal opioid overdose data; and American Community Survey data. Data were analyzed by 3-digit ZIP Code and calendar quarter-year (2016Q1–2018Q4), and weighted by population. We regressed opioid-related overdose mortality on retail-pharmacy and community naloxone distribution, and community-level demographics using a linear model, hypothesizing that areas with high overdose rates would have higher current levels of naloxone distribution but that increasing naloxone distribution from one quarter to the next would be associated with lower overdose. Results: From Q1–2016 to Q4–2018, the unadjusted naloxone distribution rate increased from 97 to 257 kits per 100,000 persons, while the unadjusted opioid overdose mortality rate fell from 8.1 to 7.2 per 100,000 persons. The concurrent level of naloxone distribution (both pharmacy and community) was positively and significantly associated with fatal opioid overdose rates. We did not detect associations between change in naloxone distribution rates and overdose mortality. Conclusion: Naloxone distribution volumes were correlated with fatal opioid overdose, suggesting medication was getting to communities where it was needed most. Amid high rates of overdose driven by fentanyl in the drug supply, our findings suggest additional prevention, treatment, and harm reduction interventions are required—and dramatically higher naloxone volumes needed—to reverse the opioid overdose crisis in the US.