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BackgroundAntiretroviral pre-exposure prophylaxis (PrEP) is clinically efficacious and recommended for HIV prevention among people who inject drugs (PWID), but uptake remains low and intervention needs are understudied. To inform the development of PrEP interventions for PWID, we conducted a qualitative study in the Northeastern USA, a region where recent clusters of new HIV infections have been attributed to injection drug use.MethodsWe conducted qualitative interviews with 33 HIV-uninfected PWID (hereafter, "participants") and 12 clinical and social service providers (professional "key informants") in Boston, MA, and Providence, RI, in 2017. Trained interviewers used semi-structured interviews to explore PrEP acceptability and perceived barriers to use. Thematic analysis of coded data identified multilevel barriers to PrEP use among PWID and related intervention strategies.ResultsAmong PWID participants (n = 33, 55% male), interest in PrEP was high, but both participants and professional key informants (n = 12) described barriers to PrEP utilization that occurred at one or more socioecological levels. Individual-level barriers included low PrEP knowledge and limited HIV risk perception, concerns about PrEP side effects, and competing health priorities and needs due to drug use and dependence. Interpersonal-level barriers included negative experiences with healthcare providers and HIV-related stigma within social networks. Clinical barriers included poor infrastructure and capacity for PrEP delivery to PWID, and structural barriers related to homelessness, criminal justice system involvement, and lack of money or identification to get prescriptions. Participants and key informants provided some suggestions for strategies to address these multilevel barriers and better facilitate PrEP delivery to PWID.ConclusionsIn addition to some of the facilitators of PrEP use identified by participants and key informants, we drew on our key findings and behavioral change theory to propose additional intervention targets. In particular, to help address the multilevel barriers to PrEP uptake and adherence, we discuss ways that interventions could target information, self-regulation and self-efficacy, social support, and environmental change. PrEP is clinically efficacious and has been recommended for PWID; thus, development and testing of strategies to improve PrEP delivery to this high-risk and socially marginalized population are needed.

Background: Fentanyl is increasingly pervasive in the unregulated drug supply and is a driver of drug overdose deaths in the United States. The aims of this study were to characterize and identify correlates of fentanyl preference among people who use drugs (PWUD) in Rhode Island (RI)., Methods: Using bivariate analysis, we examined associations between fentanyl preference and sociodemographic and psychosocial characteristics at baseline among participants enrolled in the RI Prescription Drug and Illicit Drug Study from August 2020-February 2023. Fentanyl preference was operationalized based on responses to a five-point Likert scale: "I prefer using fentanyl or drugs that have fentanyl in them." Participants who responded that they "strongly disagree," "disagree," or were "neutral" with respect to this statement were classified as not preferring fentanyl, whereas participants who responded that they "agree" or "strongly agree" were classified as preferring fentanyl., Results: Among 506 PWUD eligible for inclusion in this analysis, 15% expressed a preference for fentanyl or drugs containing fentanyl as their drug of choice. In bivariate analyses, preference for fentanyl was positively associated with younger age, white race, lifetime history of overdose, history of injection drug use, past month enrollment in a substance use treatment program, past month treatment with medications for opioid use disorder, and preferences for heroin and crystal methamphetamine (all p < 0.05). Descriptive data yielded further insight into reasons for fentanyl preference, the predominant having to do with perceived effects of the drug and desire to avoid withdrawal symptoms., Conclusions: Only a relatively small subset of study participants preferred drugs containing fentanyl. Given the increased prevalence of fentanyl contamination across substances within the unregulated drug market, the result for PWUD is increasingly less agency with respect to choice of drug; for example, people may be forced to use fentanyl due to restricted supply and the need to mitigate withdrawal symptoms, or may be using fentanyl without intending to do so. Novel and more effective interventions for PWUD, including increased access to age-appropriate harm reduction programs such as fentanyl test strips and overdose prevention centers, are needed to mitigate fentanyl-related harms., (© 2024. The Author(s).)

Background: Over 107,000 people died in the United States (U.S.) from drug overdose in 2022, with over one million overdose deaths since 1999. The U.S. drug market is characterized by a highly toxic, unregulated, and rapidly changing supply. Understanding the extent of exposure to fentanyl among people who use drugs (PWUD) will guide public health interventions aimed to decrease overdose., Methods: We utilized baseline data from the Rhode Island Prescription and Illicit Drug Study, a randomized controlled trial of harm reduction-oriented interventions for PWUD in Rhode Island from 2020 to 2023. We evaluated sociodemographic and drug use-related covariates and examined fentanyl presence in urine drug testing (UDT). We built a classification and regression tree (CART) model to identify subpopulations with the highest likelihood of fentanyl presence in UDT., Results: Among 446 participants, those with fentanyl present in UDT tended to be younger, non-Hispanic white, and had recently injected drugs ( p <0.05 for all). The CART analysis demonstrated a large variation in sample sub-groups' likelihood of fentanyl presence in UDT, from an estimated probability of 0.09 to 0.90. Expected recent fentanyl exposure was the most important predictor of fentanyl in UDT., Conclusions: Univariate analyses and CART modeling showed substantial variation in the presence of fentanyl in UDT among PWUD. Harm reduction services for people actively injecting drugs and drug checking programs based on capacity-building, empowerment, and targeted towards those not yet engaged in services are urgently needed to support PWUD in navigating the current volatile drug supply., Competing Interests: We wish to confirm that there are no known conflicts of interest associated with this publication and there has been no significant financial support for this work that could have influenced its outcome., (© 2024 The Authors.)

Pre-exposure prophylaxis (PrEP) is effective in preventing HIV transmission, but uptake and adherence among young men who have sex with men (YMSM) remains suboptimal. New PrEP formulations may enhance PrEP use, but little is known about their acceptability. We enrolled 39 cis- and transgender YMSM (age 18-34) from Boston, MA; Jackson, MS; Birmingham, AL; and New Orleans, LA, who participated in video-based focus groups (n = 30) or in-depth interviews (n = 9) to examine how new PrEP products (e.g., injections, monthly pills, implants) are perceived and might be improved for YMSM. Focus groups were transcribed, coded, and analyzed using grounded theory and content analysis. Nearly half (46%) of participants were Black; 11% identified as Hispanic. Seventy-nine percent were PrEP experienced. Product preference was driven by the desire for flexible, safe, effective, and affordable PrEP options. A majority of participants preferred subcutaneous injections every 6 months or monthly pills dispersed in 3 or 4 doses. Subcutaneous injections and batched monthly pills were favored by those with demanding schedules and those who desired fewer provider visits; monthly pills were more appealing for those who feared needles. Despite broad preferences for longer-acting products for convenience, participants raised concerns regarding side effects and waning protection after missed doses. Participants felt that more education about safety and efficacy profiles of new products could influence their attitudes. These findings suggest that it is important to prioritize YMSM's dynamic lifestyles during product development, and that product safety and efficacy information should be accessible in youth-friendly language., (© 2024. Merck & Co., Inc., Rahway, NJ, USA and its affiliates & Jonathan HillRorie, Katie Biello, Meg Quint, Bernadette Johnson, Latesha Elopre, Kendra Johnson, Rebecca Lillis, Kaylee Burgan, Douglas Krakower, Kenneth H. Mayer.)

Men who have sex with men (MSM) are at increased risk for certain types of chronic diseases and mental health problems. Despite having extended survival in the highly active antiretroviral therapy (HAART) era, MSM living with HIV contend with aging-related diseases and complications with treatment. Consequent hospitalizations incur high costs, fear, low quality of life, and frailty. Unlike heterosexual men, MSM experience more structural violence and "syndemics" of psychosocial factors that not only accelerate HIV acquisition and transmission risk but also may increase morbidity, leading to greater rates of hospitalization. We aim to examine the impact of "syndemic" psychosocial factors on the incidence of hospitalization among geographically diverse MSM in the US. Participants were 1760 MSM from the Multicenter AIDS Cohort Study (MACS) between 2004 and 2019. We examined the relationship between six psychosocial factors (depression, stimulant use, smoking, heroin use, childhood sexual abuse, and intimate partner violence) and incident hospitalization (admission to a hospital for treatment). We found a positive dose-response relationship between the number of syndemic factors and hospitalization. MSM reporting five or more syndemic factors had over twice the risk of hospitalization compared to MSM without syndemic factors [aRR = 2.14 (95% CI = 1.56, 2.94)]. Psychosocial factors synergistically increased hospitalizations over time. The positive dose-response relationship between the number of syndemic factors and hospitalization and the synergistic effects of these factors underscore the need for interventions that disentangle the syndemics to reduce hospitalization and related costs and improve the quality of life among MSM., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: As in much of the United States, there have been significant increases in overdose deaths among non-Hispanic Black and Hispanic/Latinx populations in Rhode Island over the past decade. Given the shifting dynamics of the overdose epidemic, there is an urgent need for focused interventions that address the specific needs of diverse communities. This study explores differences in drug use patterns, harm reduction behaviors and types and barriers to treatment by race and ethnicity. Methods: This study utilized baseline data from the Rhode Island Prescription and Illicit Drug Study (RAPIDS). We assessed sociodemographic characteristics, drug use patterns, harm reduction practices, treatment type, and barriers to treatment in a cross-sectional analysis of people who use drugs (PWUD), stratified by race and ethnicity (non-Hispanic white, non-Hispanic Black, non-Hispanic other race, and Hispanic). Chi-square tests of independence and ANOVA tests were used to identify statistically significant differences by race and ethnicity. Results: Among 509 participants, the median age was 43, and the majority were men (64%). Non-Hispanic Black participants reported significantly less regular use of unregulated opioids, such as heroin (10%) and fentanyl (12%), as compared to non-Hispanic white participants (39% and 33%, respectively). Non-Hispanic Black participants reported significantly less experience responding to overdoses: only 39% had ever administered naloxone and 34% had ever performed rescue breathing, as compared to 67% and 57% among non-Hispanic white participants, respectively. Despite significant differences in drug use patterns, there were few differences in harm reduction practices by race and ethnicity. Current treatment enrollment was highest among those who were non-Hispanic white (38%) and lowest among those who were non-Hispanic Black (7%). Conclusions: These findings suggest that there are differences in overdose response experience and treatment exposure between non-Hispanic Black PWUD and those belonging to other racial and ethnic groups, indicating a need for enhanced investment in overdose response education, naloxone distribution and treatment access for non-Hispanic Black PWUD.

New HIV infections disproportionately affect young men who have sex with men (YMSM). PrEP is effective in preventing HIV acquisition; however, adherence is critical and is often suboptimal among YMSM. Interventions addressing the unique PrEP adherence challenges faced by YMSM are needed. We conducted qualitative interviews with 20 HIV-negative, YMSM (ages 15-24) with a PrEP indication and 11 healthcare professionals to inform adaption of a PrEP adherence intervention (Life-Steps for PrEP) for YMSM. We explored environmental, healthcare, and individual factors influencing uptake, adherence, attitudes, and perspectives (including desired modifications) on the Life-Steps intervention. Interviews were analyzed using content analysis. Of YMSM study participants (mean age 21.6) 55% were White, 15% Hispanic, and 5% Black. Most YMSM were PrEP-experienced (70%). Healthcare professionals (6 prescribers, 1 nurse, 2 health educators, 2 other/unspecified) averaged 6.9 years of experience caring for YMSM. All described stigma as a barrier to PrEP; YMSM expressed concern around being perceived as "risky" and concern about inadvertent PrEP disclosure if family/friends found their medication, or if parental insurance was used. Difficulty with planning for potential adherence challenges were identified by both groups. YMSM highlighted benefits of a nurse-led intervention (i.e., adding "legitimacy"), but stressed need for nonjudgmental, "savvy" interventionists. YMSM expressed a desire for comprehensive YMSM-specific sexual health information. These findings informed modification and expansion of Life-Steps content. Results highlight key potential barriers, many of which center around privacy. Content that addresses PrEP stigma, disclosing PrEP use, navigating insurance, and planning ahead in a nonjudgmental environment by trusted providers emerged as important components of a YMSM-focused delivery of Life-Steps for PrEP.

Background: Overdose prevention centers (OPCs) are being implemented in the United States as a strategy to reduce drug-related mortality and morbidity. Previous studies have suggested that people who use drugs (PWUD) with a history of criminal legal system (CLS) involvement (e.g. current probation/parole) are at greater risk of overdose but may also encounter significant barriers to OPC use. The objective of this study was to explore the association between willingness to use an OPC and probation/parole status in a sample of PWUD in Rhode Island., Methods: This study utilized data from the Rhode Island Prescription and Illicit Drug Study, which enrolled adult PWUD from August 2020 to February 2023. We used Pearson's chi-square and Wilcoxon rank-sum tests to assess bivariate associations between willingness to use an OPC and probation/parole status (current/previous/never), as well as other sociodemographic and behavioral characteristics. In multivariable Poisson analyses, we examined the association between willingness to use an OPC and probation/parole status, adjusting for key sociodemographic and behavioral characteristics., Results: Among 482 study participants, 67% were male, 56% identified as white, 20% identified as Hispanic/Latine, and the median age was 43 (IQR 35-53). Nearly a quarter (24%) had never been on probation/parole, 44% were not currently on probation/parole but had a lifetime history of probation and parole, and 32% were currently on probation/parole. Most participants (71%) reported willingness to use an OPC, and in both bivariate and multivariable analyses, willingness to use an OPC did not vary by probation/parole status. Crack cocaine use and lifetime non-fatal overdose were associated with greater willingness to use an OPC (all p < 0.05)., Conclusions: These data demonstrate high willingness to use OPC among PWUD in Rhode Island regardless of CLS-involvement. As OPCs begin to be implemented in Rhode Island, it will be imperative to engage people with CLS-involvement and to ensure access to the OPC and protection against re-incarceration due to potential barriers, such as police surveillance of OPCs., (© 2024. The Author(s).)

Background: Male sex workers (MSWs), specifically cisgender men who exchange sex for money, goods, drugs, or other items of value with other cisgender men, are at high risk for HIV infection. Compared to men not engaged in sex work, MSWs are more likely to engage in frequent condomless sex with paying and non-paying sexual partners. While MSWs are often included as a subgroup of gay and bisexual men, data show that a large proportion identify as heterosexual; additionally, most MSWs do not identify as "sex workers." This places MSWs in a unique position where they may not engage with traditional HIV prevention programs, and when they do, they may not feel comfortable, leading to poor retention. Thus, HIV prevention interventions that address MSWs' unique life circumstances and provide support in exploring their sexual health options are needed., Methods: In this protocol paper, we describe the design and procedures for a National Institute of Health-funded, randomized controlled trial testing the efficacy of "PrEPare for Work,"- a theory-based, manualized PrEP uptake and adherence intervention for MSW - using a 2-stage randomization design. Stage 1: MSWs are equally randomized to receive either the "PrEPare for Work Stage 1 intervention" (strength-based case management and facilitated PrEP linkage) or Standard of Care (SOC) to evaluate successful PrEP uptake (prescription filled) within two months post-randomization. Stage 2: Those who initiate PrEP are then equally re-randomized to receive either the "PrEPare for Work Stage 2 intervention" (1-on-1 skills training, problem-solving, and motivational interviewing adherence counseling and personalized, daily text message reminders) or SOC to assess adherence (Tenofovir concentrations in hair) over 12 months of follow up. Planned analyses will examine intervention efficacy, specific conceptual mediators, and hypothesized moderators., Discussion: Based on our extensive preliminary research, multi-component, theory-informed interventions targeting this subpopulation of MSWs' unique life circumstances are urgently needed. In this study, we are evaluating whether "PrEPare for Work" can improve PrEP uptake and adherence among MSWs. If this intervention is efficacious, it would be readily disseminated to diverse community organizations that serve MSWs and possibly other community or clinic-based settings., Trial Registration: ClinicalTrials.gov number NCT05736614, registered February 8, 2023., (© 2024. The Author(s).)

Background: International efforts have reduced the availability of methamphetamine precursors, but its distribution and use continue to rise. Methamphetamine use can lead to short- and long-term adverse effects, including addiction, physical and psychosocial health problems, socioeconomic troubles, incarceration, overdose, and death. Gay, bisexual, and other men who have sex with men (MSM) have been shown to have an elevated prevalence of methamphetamine use., Methods: We conducted a systematic review and meta-analysis to estimate the prevalence of methamphetamine use among MSM. We searched electronic databases, such as PubMed, for peer-reviewed literature published between 2011 and 2022. Data on methamphetamine use were extracted, including study features, location, study design, sampling method, recruitment period, specific MSM subgroups, prevalence period, and demographics. Employing a random-effects model, we computed the pooled prevalence of methamphetamine use among MSM across two prevalence periods: recent use (i.e., one month, three months, six months, one year) and lifetime use., Results: The systematic review included 56 studies with a total of 25,953 MSM who use methamphetamine. Most studies were conducted in Europe, with the highest prevalence reported in the United Kingdom. The studies primarily used cross-sectional or cohort study designs with convenience sampling. The pooled prevalence rates across recent use (i.e., past month, past three months, past six months, and past year) was 15% (95% CI [11-19%]). Additionally, we pooled lifetime use, which was 23% (95% CI [9-38%]). High heterogeneity (I 2 > 99%) was observed, indicating significant variation., Conclusion: This systematic review and meta-analysis provide a pooled prevalence of methamphetamine use among MSM. The analysis accounts for study design, prevalence period, specific MSM subgroups, and geographical areas to estimate methamphetamine use in diverse settings and populations. The review highlights the need for targeted interventions and harm reduction strategies focused on prevention, education, healthcare access, and stakeholder collaboration to address the multifaceted challenges of methamphetamine use among MSM., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023. Published by Elsevier B.V.)

HIV pre-exposure prophylaxis (PrEP) use is limited among male sex workers, who are at exceptionally high-risk for HIV infection. We developed a theory-informed, two-pronged intervention ("PrEPare-for-Work") to optimize PrEP initiation and adherence among male sex workers, which was preliminarily evaluated in a two-stage pilot randomized controlled trial of 110 male sex workers in the US Northeast. Individuals randomized to the Stage 1 PrEPare-for-Work Case Management arm were three times as likely as those in the standard of care (SOC) arm to initiate PrEP (RR = 2.95, 95% CI = 1.57-5.57). Participants who initiated PrEP and were randomized to the Stage 2 PrEPare-for-Work Adherence Counseling arm had higher rates of prevention-effective adherence (measured via tenofovir in hair) compared to those in the SOC arm (RR = 1.7, 95% CI 0.64-4.77; 55.6% vs. 28.6%, respectively); though not statistically significant. Given the need and the promise of this pilot RCT, further efficacy testing is warranted and should be prioritized., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Introduction: Pre-exposure prophylaxis (PrEP) has been available for young people for over a decade, yet only ∼15% of young people in the United States with indications for PrEP have a prescription for it. Next-generation PrEP modalities may address some of the challenges of daily oral PrEP. However, preferences for these products are unknown., Methods: From October 2020 to June 2021, we conducted an online survey of 737 cisgender, young men who have sex with men (age 15-24 years) without HIV across the United States who reported same-sex attraction or consensual sex with another man in the past 6 months. Participants completed a conjoint experiment comparing daily oral pills, event-driven oral pills, event-driven rectal douches, intramuscular injections, intravenous broadly neutralizing antibody (bnAb) infusions and subcutaneous implants. Participants ranked the products from most to least preferred. Exploded logit models examined the association between ranked preferences of PrEP modalities and socio-demographic and behavioural characteristics., Results: Participants' mean age was 21 years (SD = 2.3), and 56% identified as White. Nineteen percent were currently taking daily oral PrEP, and another 9% had previously taken it. Participants prioritized efficacy, absence of side effects and costs in the conjoint analyses. Daily oral PrEP had the highest preference ranking, followed by event-driven oral (OR = 0.89, p = 0.058), injectable (OR = 0.83, p = 0.005), implant (OR = 0.48, p < 0.0001), bnAb infusions (OR = 0.38, p < 0.0001) and rectal douches (OR = 0.24, p < 0.0001). There were differences in PrEP preferences across age, insurance status, sexual behaviour, PrEP use history, HIV and sexually transmitted infection (STI) testing history, and STI diagnoses (omnibus tests: p < 0.05). Participants also provided reasons for selecting their top product choice: ease of use for those who chose daily oral (99%) and daily event-driven (98.5%); feel more protected against HIV for those who chose injectable (95.4%) and implants (100%); not worrying about forgetting to take it for those who chose bnAbs (93.8%); and being able to stop taking it when they want for those who chose rectal douche (90.9%)., Conclusions: Next-generation modalities were less likely to be preferred over daily oral PrEP, with differences in the magnitude by socio-demographic and behavioural characteristics. Given the low uptake of daily oral PrEP, end-users' preferences for and concerns about PrEP products must be understood to ensure high acceptability and penetration., (© 2023 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Purpose: To examine readiness to provide oral and injectable pre-exposure prophylaxis (PrEP) for sexual and gender minority youth (SGMY) and to explore decision-making for HIV prevention strategies (e.g., condom use, daily and event-driven oral PrEP, and injectable PrEP) among healthcare providers., Methods: Between February and April 2022, we recruited 31 prescribing providers (M.Ds, D.Os, P.As, and N.Ps) practicing in primary care and specialized clinics in the U.S. Northeast for focus groups or individual interviews. Focus groups and interview transcripts were analyzed using thematic analysis., Results: Most providers specialized in Pediatrics (42%) or Adolescent Medicine (23%) and 58% had previously prescribed PrEP. Main barriers to PrEP readiness were low PrEP knowledge, limited time for visits, and competing clinical priorities. Organizational factors such as routine HIV/STI testing, PrEP-specific electronic health records templates, and specialized staff (e.g., PrEP navigators) promoted PrEP readiness. Providers held positive attitudes toward injectable PrEP to promote adherence among SGMY, yet barriers to implementation of this modality were identified (e.g., patient anxiety about needles, additional staffing needs). Providers described event-driven oral PrEP as an option for SGMY with episodic HIV risk. Assurances of conditional confidentiality, including preventing disclosure of sensitive information through insurance forms, and shared decision-making facilitated conversations about HIV prevention with SGMY., Discussion: Future PrEP implementation efforts for SGMY should consider combined efforts targeting provider knowledge about PrEP modalities (e.g., decision aids) and clinic organizational factors (e.g., routine HIV/STI testing, resources to assist providers and patients in navigating the multiple steps between prescription and adherence to PrEP)., (Copyright © 2022 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Pre-exposure prophylaxis (PrEP) is highly effective for prevention of HIV transmission and plays an important role in efforts to end the HIV epidemic within the next decade. However, disparities in access to PrEP might be fuelling disparities in the burden of HIV in the USA. The advent of next-generation PrEP formulations that do not involve daily regimens (eg, long-acting cabotegravir) holds potential to facilitate medication adherence, but if the roll-out of these formulations does not consider disparities in access, HIV disparities might be further widened. On the basis of US epidemiological data and informed by the Theory of Fundamental Causes of Health Disparities, we propose an equity-promoting framework to guide the implementation of daily oral and next-generation PrEP. Multilevel efforts to bolster equity in PrEP care include generating demand for next-generation PrEP formulations among marginalised groups, expanding the availability of health services providing oral and next-generation PrEP, and addressing structural and financial barriers to HIV prevention care. The aim of these strategies is to realise the potential of next-generation PrEP to provide people at high risk with effective options to prevent HIV acquisition, thereby helping to reduce both overall HIV transmission and health disparities in the USA., Competing Interests: Declaration of interests KBB received unrestricted research grants from Merck. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background: HIV incidence has recently increased among people who inject drugs (PWID) across the United States, with outbreaks occurring in states with long-standing syringe service programs (SSPs) including Massachusetts (MA). Antiretroviral pre-exposure prophylaxis (PrEP) is an evidence-based HIV prevention strategy recommended for PWID, but uptake in this marginalized population is extraordinarily low., Methods: We describe the design and procedures for a National Institute on Drug Abuse (NIDA)-funded (R01) randomized controlled trial (RCT) testing the efficacy of "PrEP for Health," a multicomponent behavioral intervention to increase PrEP uptake, adherence, and persistence among HIV-negative PWID attending SSPs in two areas of the U.S. Northeast that are heavily affected by injection-related HIV transmission. Participants are equally randomized to receive the "PrEP for Health" intervention (involving individually tailored HIV and PrEP education, motivational interviewing, problem-solving skills and planning, and ongoing navigation support) or an enhanced standard of care (eSOC) control condition involving a brief educational video on the utility of PrEP for HIV prevention. Co-primary outcomes are PrEP uptake (using medical/pharmacy records) and adherence (using tenofovir quantification in hair samples); a secondary outcome is PrEP persistence (using medical/pharmacy records) over 12 months. Major assessments occur at baseline, 1-, 3-, 6-, and 12-month follow-up visits. Planned analyses will examine intervention efficacy, specific hypothesized conceptual mediators of the intervention effect (e.g., self-perceived HIV risk; PrEP knowledge, interest in use, motivation, and behavioral skills) and epidemiologically linked moderators (e.g., age; gender; condomless vaginal or anal sex)., Discussion: Findings from our extensive preliminary research with the study population revealed that a multicomponent, theory-based intervention targeting PrEP knowledge, motivation, self-efficacy, behavioral skills, and structural barriers to PrEP access is urgently needed for PWID who are at risk of HIV acquisition. We also learned that SSPs represent a highly acceptable service setting for delivering such interventions. In this study, we are evaluating the efficacy of the "PrEP for Health" intervention. If efficacious, findings from our implementation evaluation could help guide its dissemination to diverse SSPs and possibly other community-based settings accessed by this population., Trial Registration: ClinicalTrials.gov number NCT04430257, registered June 12, 2020., (© 2023. The Author(s).)

Background: HIV outbreaks among people who inject drugs (PWID) and experience homelessness are increasing across the USA. Despite high levels of need, multilevel barriers to accessing antiretroviral pre-exposure prophylaxis (PrEP) for HIV prevention persist for this population. The Boston Health Care for the Homeless Program (BHCHP) initiated a low-threshold, outreach-based program to support engagement in PrEP services among PWID experiencing homelessness., Methods: To inform dissemination efforts, we explored patient and provider perspectives on key program components. From March to December 2020, we conducted semi-structured qualitative interviews with current and former BHCHP PrEP program participants and prescribers, patient navigators, and outreach workers (i.e., providers). Thematic analysis explored perspectives on key program components., Results: Participants (n = 21) and providers (n = 11) identified the following five key components of BHCHP's PrEP program that they perceived to be particularly helpful for supporting patient engagement in PrEP services: (1) community-driven PrEP education; (2) low-threshold, accessible programming including same-day PrEP prescribing; (3) tailored prescribing supports (e.g., on-site pharmacy, short-term prescriptions, medication storage); (4) intensive outreach and navigation; and (5) trusting, respectful patient-provider relationships., Discussion: Findings suggest that more patient-centered services formed the basis of BHCHP's innovative, successful PrEP program. While contextual challenges including competing public health emergencies and homeless encampment "sweeps" necessitate ongoing programmatic adaptations, lessons from BHCHP's PrEP program can inform PrEP delivery in a range of community-based settings serving this population, including syringe service programs and shelters., (© 2022. The Author(s).)

Background: Black and Latino sexual minority men in the Southern United States have the highest HIV infection rates in the country. Increased HIV testing can help decrease onward HIV transmission through detecting previously undiagnosed infections. HIV self-testing is an evidence-based strategy to increase HIV testing among sexual minority men, but the implementation of this intervention in the Southern United States is limited. One implementation barrier is the lack of knowledge of Black and Latino sexual minority men's preferences for various HIV self-testing program characteristics and their willingness to pay for these preferences. In addition, little is known about facilitators and barriers to initiating HIV self-testing programs from the perspectives of HIV prevention implementation decision-makers in this region., Methods: We will conduct an online discrete choice experiment among Black and Latino sexual minority men in the Southern United States (n = 300) to estimate this population's preferences for the following HIV self-testing program characteristics: delivery strategy (home delivery, peer delivery, clinic pickup); delivery speed (same day, next day, 3 days, and 5 days); support (instructions only, during test, and 1 week after delivery); and price ($0, $20, $40, $50, $60). We will also use this choice data to generate willingness-to-pay estimates for each program characteristic. Guided by the Consolidated Framework for Implementation Research, we will then conduct semi-structured interviews (n = 30) with HIV prevention program decision-makers at various health organizations serving Black and Latino sexual minority men in the region to further understand facilitators and barriers to implementation of the most preferred HIV self-testing program design., Discussion: By gaining perspectives on HIV self-testing implementation from patients and providers, this project will build a roadmap for the initiation of HIV self-testing programs to decrease HIV incidence among one of the most disproportionately impacted populations in the USA., (© 2023. The Author(s).)

Background: In the context of increasing injection-related HIV outbreaks across the United States, particularly among people who inject drugs (PWID) experiencing homelessness, there is an urgent need to expand access to pre-exposure prophylaxis (PrEP) for HIV prevention. Peer-based interventions for PrEP could be helpful for promoting PrEP uptake, yet the social experiences of using PrEP among PWID experiencing homelessness have not been thoroughly explored., Methods: To better understand social experiences surrounding PrEP use among PWID experiencing homelessness, we conducted qualitative interviews from March-December 2020 with current and former PrEP patients of an innovative, low-threshold program implemented by Boston Health Care for the Homeless Program (BHCHP) in Boston, MA. Thematic analysis of coded interview data explored participants' perspectives and experiences with PrEP disclosure and discussions within their social networks., Results: Among interviews with 21 participants, we identified the following four interrelated aspects of their social experiences using PrEP: (1) participants' were aware of increasing HIV transmission within their social networks, which motivated their PrEP use and disclosure; (2)  participants generally avoided disclosing their PrEP use within public spaces or casual conversations; (3)  participants expressed greater willingness to discuss PrEP with their close social contacts; and (4)  some participants self-identified as leaders or expressed interest in leading the dissemination of PrEP information within their social networks., Conclusions: Findings highlight the significance of PrEP disclosure and discussions within the social networks of PWID experiencing homelessness, suggesting a need for continued social network and intervention research-particularly to establish the feasibility and acceptability of peer-based interventions for promoting PrEP-with this marginalized population., (© 2023. The Author(s).)

Background: New HIV infections in the Philippines are increasing at an alarming rate. However, over three quarters of men who have sex with men (MSM) have never been tested for HIV. HIV self-testing (HIVST) may increase overall testing rates by removing barriers, particularly fear of stigmatization and mistrust of providers. This study aimed to determine if these factors are associated with preference for HIVST among Filipino cisgender MSM (cis-MSM), and whether there is an interaction between anticipated HIV testing stigma and provider mistrust on preference for HIVST., Methods: We conducted secondary analysis of a one-time survey of 803 cis-MSM who were recruited using purposive sampling from online MSM dating sites and MSM-themed bar locations in Metro Manila, Philippines. Summary statistics were computed to describe participant characteristics. Multivariable modified Poisson regression analyses were conducted to determine if anticipated HIV testing stigma and provider mistrust were associated with preference for HIVST among cis-MSM. Other variables such as age, education, monthly income, relationship status, HIV serostatus, and knowing where to get HIV testing were the minimal sufficient adjustment set in the analyses., Results: Average age of participants was 28.6 years (SD = 8.0); most had received college degrees (73%) and were employed (80%). Most respondents (81%) preferred facility-based testing, while 19% preferred HIVST. A high percentage of participants reported anticipated HIV testing stigma (66%) and provider mistrust (44%). Anticipated HIV testing stigma (aPR = 1.51; 95% CI = 1.01-2.25, p = 0.046) and provider mistrust (aPR = 1.49; 95% CI = 1.07-2.09, p = 0.020) were independently associated with a preference for HIVST. There was a positive, additive interaction between provider mistrust and anticipated HIV testing stigma on preference for HIVST (RERI = 1.13, 95% CI: 0.20-2.06; p = 0.017), indicating that the association between anticipated HIV testing stigma and preference for HIVST is greater among those with provider mistrust compared to those without provider mistrust., Conclusions: HIVST should be offered as a supplement to traditional facility-based HIV testing services in the Philippines to expand testing and reach individuals who may not undergo testing due to anticipated HIV testing stigma and provider mistrust., (© 2022. The Author(s).)

Young men who have sex with men (YMSM) remain at disproportionate risk for HIV acquisition in the United States (US), yet use of evidence-based prevention strategies, including routine HIV testing and pre-exposure prophylaxis (PrEP), remain low. Smartphones and mobile app usage are nearly ubiquitous in this population. Given the potential for scalability, a mobile app to increase HIV testing and PrEP use among YMSM has the potential to make an extraordinary public health impact if efficacious. Based on extensive formative, community-engaged research, we developed a theory-driven mobile app-MyChoices-to increase HIV testing and PrEP uptake among YMSM. In a pilot randomized controlled trial (RCT), participants (n = 60) were randomized 2:1 to receive MyChoices or standard of care (SOC). Data from 3 to 6-month post-baseline assessments demonstrate that the app was highly acceptable (System Usability Score; mean = 75.8, SD = 10.7) and feasible (94% used the MyChoices app at least once; mean = 15.3 sessions, SD = 9.8). While not powered to assess efficacy, those in the MyChoices arm had 22% higher prevalence of HIV testing over follow-up compared to those in the SOC arm (NS). There was no difference in PrEP uptake. A fully-powered efficacy trial is warranted; if efficacy is demonstrated, the MyChoices app could be easily scaled to reach YMSM across the US., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objectives: People who inject drugs (PWID) may experience high human immunodeficiency virus (HIV) risk and inadequate access to biomedical HIV prevention. Emerging data support integrating HIV post-exposure and pre-exposure prophylaxis (PEP, PrEP) into services already accessed by PWID. We describe PEP/PrEP eligibility and receipt in a low-barrier substance use disorder bridge clinic located in an area experiencing an HIV outbreak among PWID at the onset of the COVID-19 pandemic., Methods: Retrospective chart review of new patients at a substance use disorder bridge clinic in Boston, MA (January 15, 2020-May 15, 2020) to determine rates of PEP/PrEP eligibility and prescribing., Results: Among 204 unique HIV-negative patients, 85.7% were assessed for injection-related and 23.0% for sexual HIV risk behaviors. Overall, 55/204 (27.0%) met CDC criteria for HIV exposure prophylaxis, including 7/204 (3.4%) for PEP and 48/204 (23.5%) for PrEP. Four of 7 PEP-eligible patients were offered PEP and all 4 were prescribed PEP. Thirty-two of 48 PrEP eligible patients were offered PrEP, and 7/48 (14.6%) were prescribed PrEP. Additionally, 6 PWID were offered PrEP who lacked formal CDC criteria., Conclusions: Bridge clinics patients have high rates of PEP/PrEP eligibility. The majority of patients with identified eligibility were offered PEP/PrEP, suggesting that upstream interventions that increase HIV risk assessment may support programs in initiating PEP/PrEP care. Additional work is needed to understand why patients declined PEP/PrEP. PrEP offers to PWID who did not meet CDC criteria also suggested provider concern regarding the sensitivity of CDC criteria among PWID. Overall, bridge clinics offer a potential opportunity to increase biomedical HIV prevention service delivery., Competing Interests: The authors report no conflicts of interest., (Copyright © 2022 American Society of Addiction Medicine.)

Access to daily oral pre-exposure prophylaxis (PrEP) is suboptimal among young cisgender men who have sex with men (YMSM) in the United States. Next-generation modalities that do not involve daily oral regimens may mitigate some of the barriers to PrEP use. We identified latent classes of YMSM based on health care decision-making patterns and examined associations between latent classes and access to health care and PrEP modality preferences (i.e., daily and event-driven oral, rectal douches, broadly neutralizing antibodies, subcutaneous implants, and an injectable). Between October 2020 and June 2021, we administered an online survey to 737 YMSM. Latent class analysis (LCA) identified groups of YMSM based on communication with providers, stigma and mistrust in health care, and autonomy in sexual health decisions. Logistic regression examined associations between class membership and health care access, and exploded logit regression examined associations between class membership and ranked PrEP modality preferences. LCA identified three classes: shared decision-making (high communication with providers and high autonomy); provider-led decision-making (high communication and low autonomy); and patient-driven decision-making (low communication and high autonomy). Shared decision-making was associated with higher access to health care in comparison with the other classes. Across all classes, YMSM preferred daily oral PrEP over all next-generation PrEP modalities. Preferences for daily oral PrEP over next-generation PrEP modalities were particularly marked among the patient-driven decision-making class. Shared decision-making is associated with access to health care and HIV prevention and higher acceptability of next-generation PrEP modalities, and should be considered as part of future interventions to promote use of daily oral and next-generation PrEP.

Next generation pre-exposure prophylaxis (PrEP) modalities that do not require daily regimens may address some of the barriers to daily oral PrEP among young men who have sex with men (YMSM). We conducted online semi-structured interviews with 30 YMSM to examine experiences and preferences related to HIV prevention care that may inform implementation of next generation PrEP. Barriers to PrEP care included initiating conversations about sexuality with providers; confidentiality concerns regarding disclosure of sexual practices and PrEP use to family; gaps in access to healthcare; and limited availability of affordable health services. Future implementation of next generation PrEP may benefit from providers addressing confidentiality concerns when discussing PrEP with YMSM; PrEP programs accounting for discontinuities in healthcare access among YMSM while strengthening access to affordable services; and collaborations between generalist providers and specialized clinics and providers to address providers' education needs, which may increase as next generation PrEP becomes available. We have linked affiliation 9 to author name "Katie B. Biello". Please check and confirm. Okay!, (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

In India, male sex workers (MSW) are among the most vulnerable populations at higher risk for HIV and other sexually transmitted infections (STIs) and may seek health care services less frequently. A community-based sample of 100 MSW in Chennai, India, completed a baseline assessment as part of a behavioral intervention to reduce the acquisition and transmission of HIV. MSW reported an average of 12.2 ( SD = 17.7) condomless anal sex acts with male clients in the past month, yet only 48% accessed health care services in the past 3 months. In a multivariable model adjusted for relevant covariates, MSW who accessed health care services in the past 3 months were more likely to be tested for HIV/STIs and report routine HIV testing over the past 12 months. Future HIV prevention efforts among MSW in India should incorporate referrals for accessing general health care services and identify specific barriers to health care engagement among this group.

People who inject drugs (PWID) have extraordinarily low uptake of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) despite high levels of need. Long-acting PrEP modalities hold promise for HIV prevention among PWID, but product preferences remain poorly understood. From September to November 2021, we conducted qualitative interviews with 28 HIV-negative, adult (≥18 years) PWID in San Diego County, CA, to explore their perspectives on daily oral PrEP pills and long-acting PrEP modalities (i.e., injections, implants, intravaginal rings, and broadly neutralizing antibodies), which we explained using standard scripts. Thematic analysis identified variations in PrEP modality interest and acceptability. We identified three key factors across the 28 interviews that appeared to influence PrEP modality preferences: perceived convenience of use, invasiveness, and familiarity (based on past experience). Overall, most participants preferred injectable PrEP over other modalities because they viewed injectable medications as convenient, noninvasive, and familiar. While injectable PrEP was recently approved for use in the United States and was most the acceptable PrEP modality in this sample, our findings suggest that intervention and implementation research is urgently needed to improve our understanding of strategies that could support access, uptake, and sustained adherence to longer-acting PrEP for PWID.

Introduction: Coronavirus disease 2019 (COVID-19) has impacted researchers' ability to continue to deliver HIV prevention and treatment interventions face to face. Although telehealth has been an important strategy to maintain research operations during the current pandemic, participants at increased risk of or living with HIV are often at higher risk of also experiencing poverty, housing instability, and other challenges that may present obstacles to successful remote delivery. Methods: We provide descriptions of remote adaptations to two randomized controlled efficacy trials of behavioral interventions for primary and secondary HIV prevention with descriptive enrollment and retention data. Results and Conclusions: Best practices for implementing telemedicine and e-health procedures are discussed, including procedures for addressing remote participation barriers (economic, health literacy, etc.) and other challenges, such as building rapport and staff support (NCT03092531 and NCT03175159).

Next generation PrEP formulations may circumvent factors that impede daily oral pre-exposure prophylaxis (PrEP) use among young men who have sex with men (YMSM). We conducted video-based cognitive interviews with 20 YMSM (age 16-24) recruited in the US Northeast to assess participants' attitudes and comprehension of written descriptions of next generation PrEP modalities. Participants were predominately racial/ethnic minorities and half used daily oral PrEP. We identified four main areas for improvement of descriptions: defining scientific terms and balancing medical jargon and casual language; referencing more established products to contextualize PrEP formulations (e.g., hormonal implants); ensuring clarity and reducing redundancy; and including imagery (e.g., rectal douche applicator). The refined descriptions serve as exemplar text that may be used in future studies examining YMSM's preferences across next generation PrEP modalities. Accurate descriptions of next generation PrEP products strengthen measurement accuracy and can help roll-out products that become approved for clinical use., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background & Objectives: Transgender women (TGW) in India are at high risk of HIV infection. Despite behavioural interventions aimed at reducing HIV risk, no literature synthesis exists so far to evaluate their potential for reducing HIV incidence in India This review was aimed to identify and evaluate HIV-focussed behaviour change interventions for TGW in India., Methods: Literature from three databases were reviewed up to June 2, 2021, for studies describing behavioural interventions for HIV prevention among TGW in India. The inclusion criteria were studies that included TGW and reported intervention effects on HIV prevention-related behaviour. Data were analyzed descriptively., Results: Of the 146 articles screened, only three met the inclusion criteria. All three interventions were at the open pilot trial stage and included other high-risk groups (e.g. men who have sex with men). The interventions used behavioural counselling, increased sexually transmitted infection screening and sexual healthcare visits and leveraged community-based organizations to improve the outcomes. All these interventions showed modest improvements in health-seeking behaviour and access to services. However, none specifically targeted TGW., Interpretation & Conclusions: The scoping review highlights the need for behavioural interventions for HIV prevention tailored to TGW in India. This study emphasizes the need for research to move to the next stage of intervention development and testing utilizing more rigorous evaluation methods, such as a randomized controlled trial.

A large proportion of HIV infections among men who have sex with men occur within primary partnerships, however, there is a lack of research focused on serodiscordant male couples. We used baseline data collected as part of Project Stronger Together-a randomized controlled trial to improve treatment outcomes among 155 serodiscordant male couples. We described engagement in HIV care/prevention using the HIV treatment cascade and PrEP care continuum. Among partners living with HIV, 86.5% were linked to care, 77.4% retained in care, 81.3% prescribed ART, 60.7% adherent, and 67.7%virally suppressed. Among HIV-negative partners, 62.6% were willing to take PrEP, 48.4% had ever taken PrEP, and 26.5% were adherent to PrEP. Black partners living with HIV had lower odds of being virally suppressed compared to White partners. Our findings provide evidence to suggest designing programs to address the racial disparities in viral suppression, addressing barriers to HIV prevention/treatment, and improving PrEP education., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Nigerian gay, bisexual, and other men who have sex with men (GBMSM) experience social marginalisation, discrimination and violence due to their sexual orientation and same-sex attraction, which may affect mental health, substance use, and HIV sexual risk behavior. The goal of the current study was to conduct formative qualitative research to gain better understanding of these issues among GBMSM in Lagos, Nigeria. Face-to-face, semi-structured, in-depth interviews were conducted with 30 GBMSM in Lagos, Nigeria. Data were analysed using a deductive content analysis approach. We found that Nigerian GBMSM experienced both general life stressors as well as proximal and distal sexual minority identity stressors, including rejection by family members, harassment, and physical violence perpetrated by the general public and police officers. Participants described dealing with mental health problems within the context of family rejection, experienced stigma due to sexual orientation, and feelings of social isolation. Substance use was described as occurring within the context of social settings. Lastly, some participants mentioned that they engaged in risky sexual behaviour while under the influence of alcohol and drugs. These findings call for comprehensive and innovative, GBMSM-affirming behavioural healthcare, substance cessation services, and innovative HIV prevention interventions specifically designed and tailored for Nigerian GBMSM.

Background: In the United States, the criminalization and stigmatization of drug use and sex work contribute to infectious disease transmission and healthcare disengagement. People who inject drugs (PWID) and engage in sex work experience exacerbated HIV risk. In the context of the ongoing HIV and overdose epidemics little research describes why PWID engage in sex work and its relative HIV risk. To inform intervention needs, we aimed to create a typology of sex work among PWID with a focus on HIV risk and healthcare utilization behaviours., Methods: We drew from in-depth interviews conducted across Massachusetts and Rhode Island from 2016-2019. Participants were ≥18 years old and self-reported past-month injection drug use and HIV-negative status. Using data from individuals reporting sex work experience (n=33/78), we utilized the framework method to develop a typology of perspectives on sex work engagement and attributes pertaining to HIV risk and healthcare utilization behaviours., Results: We uncovered varying perspectives on sex work and associated HIV risks and prevention needs. A typology included three groups who viewed their sex work engagement as a (1) consistent job, (2) income supplement, or (3) survival method to abate withdrawal symptoms. The first group described more consistent sexual and injection behaviours to mitigate HIV risk than the second group. The third group appeared particularly vulnerable to HIV, describing inconsistent condom use and frequent sharing of injection equipment, low healthcare utilization, and limited disclosure of sex work and injection drug use to healthcare providers., Conclusion: Findings highlight distinct perspectives on sex work among PWID involved in it and corresponding perceptions of HIV risk and healthcare utilization behaviours. Understanding the nuances in sex work engagement among PWID can inform interventions to prevent infectious disease transmission, including efforts to further connect this marginalized population to harm reduction, health, and low barrier opioid treatment services., Competing Interests: Declarations of Interest No conflicts of interest., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Purpose of Review: Recent HIV outbreaks among people who use drugs (PWUD) necessitate additional HIV prevention tools. Pre-exposure prophylaxis (PrEP) is highly efficacious yet uptake among PWUD remains exceedingly low. To address multilevel, complex barriers to PrEP use among PWUD, a range of intervention strategies are needed., Recent Findings: The literature on interventions to optimize PrEP use among PWUD is nascent, comprising small pilots and demonstration projects in early phases of intervention development. Initial studies suggest that structural, healthcare, interpersonal, and individual-level interventions can improve PrEP use for PWUD, and a number of efficacy trials are underway. Future studies are needed to optimize the use of new PrEP modalities (e.g., injectable PrEP), simultaneously target multilevel challenges to PrEP use, and evaluate the integration of PrEP into other service settings and substance use treatment modalities., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Multilevel barriers to pre-exposure prophylaxis (PrEP) care among male sex workers (MSW) include aspects of interactions with health services and providers. We examined relationships between health service- and provider-level factors and PrEP care among MSW. Between 2017 and 2019, we enrolled 111 MSW in the Northeast United States who were not on PrEP, but expressed interest in potentially using PrEP, in a behavioral intervention to promote PrEP uptake and adherence. Using baseline data, we examined whether having a primary care provider, past year frequency of medical visits, comfort discussing sexual practices with providers, and transportation difficulties to accessing general health care were associated with PrEP use self-efficacy, anticipated barriers to PrEP uptake, adherence, and retention (linear regression), and intention to initiate PrEP (logistic regression). Models adjusted for age, race/ethnicity, sexual identity, education, and income. Participants' mean age was 34.2 [standard deviation (SD) = 8.5], and 47% were non-White. Three-quarters (76%) intended to initiate PrEP within the next month. Comfort discussing sexual practices with providers was associated with PrEP use self-efficacy ( b  = 0.41, p  = 0.008). Comfort discussing sexual practices with providers was negatively associated with anticipated barriers to PrEP uptake ( b  = -0.29, p  = 0.006). Transportation difficulties to accessing general health care were associated with barriers to PrEP uptake ( b  = 0.30, p  = 0.007) and barriers to PrEP adherence and retention ( b  = 0.57, p  < 0.001). No health service- and provider-level characteristics were associated with intention to initiate PrEP. PrEP programs targeting MSW may benefit from interventions to foster communication between MSW and providers about sexual practices and should consider structural barriers to accessing care, including lack of access to transportation.

Despite high need, HIV preexposure prophylaxis (PrEP) utilization among people who use drugs (PWUD) remains low. Boston Health Care for the Homeless Program implemented an innovative "low-threshold" PrEP Program for PWUD experiencing homelessness in Boston, Massachusetts. From October 1, 2018 to February 29, 2020, 239 clients were linked to PrEP services, and 152 were prescribed PrEP (mean = 8.9/month), over twice the number of PrEP prescriptions over the previous 12 months (n = 48; mean = 4/month). The cumulative probability of remaining on PrEP for 6 months was 44% (95% confidence interval = 36%, 52%).

Background: Substantial research gaps exist regarding the relationship between transgender-related discrimination and substance use outcomes for transgender adults, with few studies accounting for other experiences of victimization., Methods: Transgender adults (N = 600) from Massachusetts and Rhode Island completed a survey online or in-person. Multivariable linear and logistic regression models examined the association between lifetime experiences of transgender-related discrimination using the validated 11-item Everyday Discrimination Scale (theoretical range = 0-44) and substance use outcomes: past 12-month substance use frequency, lifetime substance use disorder (SUD) diagnosis, and substance use treatment (SUTx) history. All models were adjusted for age, gender identity, race, survey modality, childhood physical/sexual abuse, intimate partner violence, and discrimination attributable to other reasons than being transgender., Results: The mean transgender-related discrimination score was 20.8 (SD = 9.6, range = 0-44). Overall, 11.8 % of the sample had a SUD diagnosis and 11.0 % had received SUTx. In separate multivariable models adjusted for sociodemographic and victimization experiences, the highest quartile of transgender-related discrimination was significantly associated with higher past 12-month substance use (B = 1.44; aR 2 = 0.13; p = .009), SUD diagnosis (aOR = 3.64; 95 % CI = 1.46-9.07; p = .006), and lifetime treatment history (aOR = 3.93; 95 % CI = 1.50-10.21; p = .005)., Conclusions: There was a significant positive association between experiencing high levels of transgender-related discrimination and substance use outcomes among the transgender adults sampled. Longitudinal research is needed to understand the specific mediators driving these relationships and to address the implications of transgender-related discrimination on SUD treatment utilization., (Published by Elsevier B.V.)

Background: Limited research has explored risk factors for opioid pain medication misuse, concomitant substance misuse, and the unmet behavioral health treatment (BHTx) needs of transgender and gender diverse (TGD) adults., Methods: In 2019, TGD adults (N = 562) in Massachusetts and Rhode Island were purposively recruited and completed a psychosocial and behavioral health survey (95 % online; 5% in-person). Multivariable logistic regression was used to examine factors associated with past 12-month opioid pain medication misuse and unmet BHTx needs., Results: Overall, 24.4 % of participants were trans women; 32.0 % trans men; and 43.6 % were non-binary. Past-year substance misuse included: marijuana (56.8 %), hazardous drinking (37.5 %), hallucinogens (9.8 %), benzodiazepines (8.2 %), and opioid pain medication (8.0 %). Among participants with past-year substance misuse and BHtx need (n = 326), 81.3 % received BHtx and 18.7 % had unmet BHtx needs. Being a trans woman, having HIV, stigma in healthcare, and number of substances misused were associated with increased odds of past-year opioid pain medication misuse; high social connectedness was associated with decreased odds of opioid pain medication misuse (p-values<0.05). Younger age, stigma in healthcare, and misusing opioid pain medications were associated with increased odds of unmet BHTx needs; post-traumatic stress disorder and family support were associated with decreased odds of unmet BHtx needs (p-values<0.05)., Conclusions: Addressing disparities in opioid pain medication misuse among TGD people requires systematic improvements in healthcare access, including efforts to create TGD-inclusive BHtx environments with providers who are equipped to recognize and treat the social and structural drivers of TGD health inequities, including opioid pain medication misuse., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: U.S. sexual and gender minority youth experience individual, interpersonal, and structural-level barriers to HIV prevention and care. Innovative, youth-driven approaches to mobile and electronic interventions that support use of new biomedical prevention, testing, and treatment options may address these barriers. Adapting evidence-based interventions for youth must balance core intervention components with responsiveness to the distinct needs of end-users., Methods: The UNC/Emory Center for Innovative Technology (iTech) adapts and evaluates technology-based interventions for youth living with or at risk for HIV. We analyzed formative research (focus groups and individual usability sessions) across five iTech studies: two apps promoting HIV testing and pre-exposure prophylaxis (PrEP), one app promoting behavioral risk reduction and PrEP, one PrEP adherence app, and one mobile-optimized website for increasing viral suppression, with the aim of informing best practices for technology-based intervention development. Each study presented prototypes of adapted mHealth interventions to samples of their target end-user population for use and/or evaluation., Results: One hundred and thirty-eight youth across seven geographically diverse sites provided feedback during the intervention adaptation process. We found high interest in and acceptability of all five intervention prototypes. Cross-study themes included: (I) Desire for multiple privacy protections (e.g., password, fingerprint) to keep HIV status, sexual identity, and sexual behavior confidential. (II) Strong but varied preferences for the look and feel of platforms. Imagery should be discrete but representative. Participants valued customizable platforms and positive themes, motivational language, and humor. Youth wanted information presented using multiple modalities (e.g., text, video, image) to increase engagement. (III) Youth preferred engagement features and functions consistent with familiar platforms (e.g., Snapchat, Instagram). Gamification features that resulted in tangible versus virtual rewards were predicted to increase engagement. Intervention messaging functions were perceived as useful; customization was desired as a way to control frequency, mode (e.g., SMS, in-app message, push notification), and content. (IV) Youth voiced varied preferences for platform content including: featuring young role models from the lesbian, gay, bisexual, transgender, queer and/or questioning (LGBTQ) community, incorporating mental health resources, and maintaining a holistic health-focus (not HIV-centric)., Conclusions: We found high acceptability and consistent feedback in youths' evaluations of these mHealth interventions; divergence was most commonly found in preferred content versus features and functions. Identifying broadly accepted aspects of mHealth interventions for youth supports the feasibility of adaptation (versus de novo creation) and should guide the focus of future formative research phases. Continued research is needed to better understand how to balance usability preferences with finite resources for customization., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/mhealth-20-43). The series “Technology-based Interventions in HIV Prevention and Care Continuum among American Youth” was commissioned by the editorial office without any funding or sponsorship. LHW served as the unpaid Guest Editor of the series. DG, KEM, CH, KBB, AYL, KJH, JMG, CJR, and LHW report grants from National Institutes of Health, during the conduct of the study; AYL reports grants and other from Gilead Sciences and grants from Viiv Healthcare, outside the submitted work. The authors have no other conflicts of interest to declare., (2021 mHealth. All rights reserved.)

Background: Young men who have sex with men (YMSM) are disproportionately impacted by HIV and other sexually transmitted infections (STIs) in the United States (US) and have low rates of HIV/STI testing. Provision of HIV self-testing and STI self-collection can increase testing rates, and access to these kits through mobile applications (apps) could help facilitate YMSM using HIV self-testing and STI self-collection., Methods: Data for this study comes from two pilot randomized controlled trials (RCTs) of mobile apps within the Adolescent Trials Network-LYNX and MyChoices-aimed to increase HIV/STI testing among YMSM (age 15-24) who had not recently tested for HIV and were at high risk for HIV acquisition across five US cities. Both apps include the ability to order a HIV self-test with rapid results and a kit for STI self-collection and mailing of samples for syphilis, gonorrhea and chlamydia to a lab for testing. Using assessments of app users (n=80) at pre-randomization and at 3- and 6-months post-randomization and online interview data from a purposive sample of app users (n=37), we report on experiences and lessons learned with HIV self-testing and STI self-collection kits ordered via the apps., Results: Participants were on average 20.7 years of age (SD =2.4), and 49% were non-White or multiple race/ethnicity. Sixty-three percent had a prior HIV test. Over half (58%) had a prior STI test, but only 3% had tested within the past 3 months. Nearly two-thirds ordered an HIV self-testing kit; of whom, 75% reported using at least one self-test kit over the study period. STI self-collection kit ordering rates were also high (54%); however, STI self-collection kit return rates were lower (13%), but with a high positivity rate (5.3%). Both HIV self-testing and STI self-collection kits were highly acceptable, and 87% reported that it was extremely/very helpful to be able to order these kits through the apps. The most common reason for not ordering the HIV/STI kits was preferring to test at a clinic. In interviews, participants expressed feeling empowered by being able to test at home; however, they also raised concerns around STI sample collection., Conclusions: HIV self-testing and STI self-collection kit ordering via mobile apps is feasible, acceptable and may show promise in increasing testing rates among YMSM. The LYNX and MyChoices apps are currently being tested in a full-scale efficacy trial, and if successful, these innovative mobile apps could be scaled up to efficiently increase HIV/STI testing among youth across the US., Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/mhealth-20-70). The series “Technology-based Interventions in HIV Prevention and Care Continuum among American Youth” was commissioned by the editorial office without any funding or sponsorship. LHW served as the unpaid Guest Editor of the series. KBB, CH, KHM, SM, JD, JN, LHW, KB and DF reports grants from NICHD, during the conduct of the study. PS reports grants from NIH, during the conduct of the study; and grants and personal fees from NIH, CDC, and Gilead Sciences, personal fees from Merck, and Ontario HIV Research Network, outside the submitted work. SB reports grants from NICHD, during the conduct of the study; non-financial support from Gilead Sciences, outside the submitted work. AL reports grants from NICHD, during the conduct of the study; grants and other from Gilead Sciences, grants from Viiv Healthcare, outside the submitted work. The authors have no other conflicts of interest to declare., (2021 mHealth. All rights reserved.)

Background: Gender-based stigma contributes to increased HIV prevalence, but little is known about psychosocial mechanisms linking stigma and HIV risk among young transgender women (YTW)., Setting: This study uses data from Project LifeSkills, a randomized controlled efficacy trial of an empowerment-based HIV prevention intervention for YTW (N = 233). YTW were recruited in Boston, MA, and Chicago, IL, between 2012 and 2015 and completed study assessment visits at baseline and months 4 and 12., Methods: Using autoregressive structural equation modeling, we examined whether poor social support and psychological distress at 4 months mediate the prospective relationship between gender-based stigma at baseline and condomless anal and vaginal sex (CAVS) acts at 4 and 12 months; all models were adjusted for treatment arm, HIV serostatus, study site, and sociodemographics., Results: Gender-based stigma at baseline was directly associated with increased CAVS at 4 months [adjusted incidence rate ratio (aIRR) = 1.18, 95% confidence interval (CI): (1.05 to 1.33)] and 12 months [aIRR = 1.17, 95% CI: (1.02 to 1.34)]. Gender-based stigma was also associated with higher psychological distress at 4 months [b = 0.70, 95% CI: (0.13 to 1.27)], which in turn was marginally associated with increased CAVS at 12 months [aIRR = 1.03, 95% CI: (1.00 to 1.06)]. Contrary to expectations, poor social support at 4 months was associated with decreased CAVS at 12 months [aIRR = 0.40, 95% CI: (0.28 to 0.59)]., Conclusions: Future HIV prevention interventions with YTW should consider addressing experiences of gender-based stigma and the psychological distress that may ensue from gender-based stigma. More research is needed to understand the influence of poor social support on sexual behaviors in this population., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Harm reduction services, which typically provide overdose education and prevention with distribution of naloxone and other supplies related to safer drug use, help reduce opioid-related overdose and infectious disease transmission. However, structural stigma and the ongoing criminalization of drug use have limited the expansion of harm reduction services into many non-urban communities in the United States that have been increasingly affected by the health consequences of opioid and polysubstance use., Methods: We conducted qualitative interviews with 22 professionals working with people who use drugs in cities and towns across Rhode Island and Massachusetts to understand challenges and strategies for engaging communities in accepting harm reduction perspectives and services., Results: Our thematic analysis identified several interrelated challenges to implementing harm reduction services in non-urban communities, including: (1) limited understandings of harm reduction practice and preferential focus on substance use treatment and primary prevention, (2) community-level stigma against people who use drugs as well as the agencies supporting them, (3) data reporting and aggregating leading to inaccurate perceptions about local patterns of substance use and related health consequences, and (4) a "prosecutorial mindset" against drug use and harm reduction. From key informants' narratives, we also identified specific strategies that communities could use to address these challenges, including: (1) identifying local champions to advocate for harm reduction strategies, (2) proactively educating communities about harm reduction approaches before they are implemented, (3) improving the visibility of harm reduction services within communities, and (4) obtaining "buy-in" from a wide range of local stakeholders including law enforcement and local government., Conclusion: These findings carry important implications for expanding harm reduction services, including syringe service programs and safe injection sites, into non-urban communities that have a demonstrated need for evidence-based interventions to reduce drug-related overdose and infectious disease transmission., Competing Interests: Declarations of Interest None., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Background: Men who have sex with men (MSM) in India are extremely marginalised and stigmatised, and therefore experience immense psychosocial stress. As current HIV prevention interventions in India do not address mental health or resilience to these stressors, we aimed to evaluate a resilience-based psychosocial intervention in the context of HIV and sexually transmitted infection (STI) prevention., Methods: We did a multicity, randomised, clinical efficacy trial in Chennai (governmental tuberculosis research institute) and Mumbai (non-governmental organisation for MSM), India. Inclusion criteria were MSM, aged 18 years or older, who were at risk of HIV acquisition or transmission, defined as having any of the following in the 4 months before screening: anal sex with four or more male partners (protected or unprotected), diagnosis of an STI, history of transactional sex activity, or condomless anal sex with a man who was of unknown HIV status or serodiscordant. Participants were required to speak English, Tamil (in Chennai), or Hindi (in Mumbai) fluently. Eligible individuals were randomly assigned (1:1) to either a resilience-based psychosocial HIV prevention intervention, consisting of group (four sessions) and individual (six sessions) counselling alongside HIV and STI voluntary counselling and testing, or a standard-of-care control comprising voluntary counselling and testing alone. The primary outcomes were number of condomless anal sex acts with male partners during the past month (at baseline and 4 months, 8 months, and 12 months after randomisation), and incident bacterial STIs (at 12 months after randomisation). Resilience-related mediators included self-esteem, self-acceptance, and depression. Recruitment is now closed. This trial is registered with ClinicalTrials.gov, NCT02556294., Findings: Between Sept 4, 2015, and June 28, 2018, we enrolled 608 participants; 305 (50%) were assigned to the psychosocial intervention condition and 303 (50%) were assigned to the control condition. 510 (84%) of 608 men completed an assessment at 4 months after randomisation, 483 (79%) at 8 months, and 515 (85%) at 12 months. 512 (99%) of 515 men had STI data from the 12-month assessment. The intervention condition had a 56% larger reduction in condomless anal sex acts (95% CI 35-71; p<0·0001) from baseline to 4-month follow-up, 72% larger reduction (56-82; p<0·0001) from baseline to 8-month follow-up, and 72% larger reduction (53-83; p<0·0001) from baseline to 12-month follow-up, compared with the standard-of-care control condition (condition by time interaction; χ 2 =40·29, 3 df; p<0·0001). Improvements in self-esteem and depressive symptoms both mediated 9% of the intervention effect on condomless anal sex acts. Bacterial STI incidence did not differ between study conditions at 12-month follow-up., Interpretation: A resilience-based psychosocial intervention for MSM at risk of HIV acquisition or transmission in India was efficacious in reducing condomless anal sex acts, with evidence for mediation effects in two key target resilience variables. HIV prevention programmes for MSM in India should address mental health resilience to augment reductions in the risk of sexually transmitted HIV., Funding: National Institute of Mental Health., (Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: HIV disproportionately affects young men who have sex with men (YMSM) in the United States. Uptake of evidence-based prevention strategies, including routine HIV testing and use of pre-exposure prophylaxis (PrEP), is suboptimal in this population. Novel methods for reaching YMSM are required., Objective: The aim of this study is to describe the development and evaluate the feasibility and acceptability of the MyChoices app, a mobile app designed to increase HIV testing and PrEP use among YMSM in the United States., Methods: Informed by the social cognitive theory, the MyChoices app was developed using an iterative process to increase HIV testing and PrEP uptake among YMSM. In 2017, beta theater testing was conducted in two US cities to garner feedback (n=4 groups; n=28 YMSM). These findings were used to refine MyChoices, which was then tested for initial acceptability and usability in a technical pilot (N=11 YMSM). Baseline and 2-month postbaseline assessments and exit interviews were completed. Transcripts were coded using a deductive approach, and thematic analysis was used to synthesize data; app acceptability and use data were also reported., Results: The MyChoices app includes personalized recommendations for HIV testing frequency and PrEP use; information on types of HIV tests and PrEP; ability to search for nearby HIV testing and PrEP care sites; and ability to order free home HIV and sexually transmitted infection test kits, condoms, and lube. In theater testing, YMSM described that MyChoices appears useful and that they would recommend it to peers. Participants liked the look and feel of the app and believed that the ability to search for and be pinged when near an HIV testing site would be beneficial. Some suggested that portions of the app felt repetitive and preferred using casual language rather than formal or medicalized terms. Following theater testing, the MyChoices app was refined, and participants in the technical pilot used the app, on average, 8 (SD 5.0; range 2-18) times over 2 months, with an average duration of 28 (SD 38.9) minutes per session. At the 2-month follow-up, the mean System Usability Scale (0-100) score was 71 (ie, above average; SD 11.8). Over 80% (9/11) of the participants reported that MyChoices was useful and 91% (10/11) said that they would recommend it to a friend. In exit interviews, there was a high level of acceptability for the content, interface, and features., Conclusions: These data show the initial acceptability and user engagement of the MyChoices app. If future studies demonstrate efficacy in increasing HIV testing and PrEP uptake, the app is scalable to reach YMSM across the United States., Trial Registration: Clinicaltrials.gov NCT03179319; https://clinicaltrials.gov/ct2/show/NCT03179319., International Registered Report Identifier (irrid): RR2-10.2196/10694., (©Katie B Biello, Jonathan Hill-Rorie, Pablo K Valente, Donna Futterman, Patrick S Sullivan, Lisa Hightow-Weidman, Kathryn Muessig, Julian Dormitzer, Matthew J Mimiaga, Kenneth H Mayer. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 24.03.2021.)

Introduction: In Massachusetts, recent outbreaks of HIV have been fueled by injection and sexual exposures among people who inject drugs. Understanding pre-exposure prophylaxis need, knowledge, and use among people who inject drugs will help inform and evaluate interventions., Methods: In 2019, investigators analyzed 2018 National HIV Behavioral Surveillance data from people who inject drugs in Boston, MA, who met eligibility criteria. Proportions of people who inject drugs with U.S. Preventive Services Task Force-based pre-exposure prophylaxis indication were estimated by types of HIV acquisition risk in the past year: injection exposure only, sexual exposure only, and overlapping injection and sexual exposures. Investigators then evaluated pre-exposure prophylaxis awareness, conversations with healthcare providers about pre-exposure prophylaxis, and self-reported pre-exposure prophylaxis use among those with and without pre-exposure prophylaxis indications., Results: The prevalence of pre-exposure prophylaxis indication was 92% overall (389/423), with 290 (69%) participants indicated for injection exposures only, 3 (<1%) indicated for sexual exposures only, and 96 (23%) indicated for both injection and sexual exposures. Among those indicated for pre-exposure prophylaxis (n=389), 152 (39%) reported being aware of pre-exposure prophylaxis, 41 (11%) had discussed pre-exposure prophylaxis with a healthcare provider, and 8 (2%) had used pre-exposure prophylaxis in the past year. There were no statistically significant differences between pre-exposure prophylaxis‒indicated and ‒nonindicated people who inject drugs with respect to pre-exposure prophylaxis awareness, discussion with a healthcare provider, and pre-exposure prophylaxis use., Conclusions: Indication for pre-exposure prophylaxis was high, but awareness was low, conversations about pre-exposure prophylaxis with healthcare providers were uncommon, and pre-exposure prophylaxis use was extremely low. These findings highlight important areas for clinical and community-based interventions to improve pre-exposure prophylaxis uptake among and delivery to people who inject drugs., (Copyright © 2020 American Journal of Preventive Medicine. All rights reserved.)

Background: Male sex workers (MSW) are disproportionately affected by HIV/AIDS, with an estimated HIV prevalence in the United States of 19.3%. Existing research suggests that MSW are also at risk of adverse psychosocial problems. Cross-sectional studies of MSW have suggested that co-occurring epidemics or a "syndemic" of psychosocial problems may increase vulnerability to HIV acquisition/transmission by elevated sexual risk. To the best of our knowledge, there are no published studies examining this relationship longitudinally among MSW. This study examined how a syndemic of 6 psychosocial problems result in additive risk for condomless anal sex (CAS) with male clients among a multicity, longitudinal cohort of MSW., Setting: Community-based organization and health center in 2 Northeastern US cities., Methods: Between 2015 and 2017, 100 MSW from Boston, MA and Providence, RI completed behavioral/psychosocial surveys at baseline, 6 months, and 12months. Generalized estimating equation modeling was used to examine the prospective relationship of additive psychosocial problems and subsequent CAS with male clients, adjusting for age, site, race/ethnicity, MSW-type, and HIV serostatus., Results: Mean age = 34.7 (SD = 11.8); 62% racial/ethnic minority; and 20% HIV+. The prevalence of 6 psychosocial syndemic problems was substantial at baseline and remained high at each time point (all within the past 6 months): 74% problematic depressive symptoms, 27% polydrug use (3+ drugs, not including stimulants), 57% stimulant (methamphetamine/cocaine/crack) use, 44% hazardous drinking, 15% experienced client-specific physical/sexual violence, and 57% childhood sexual abuse. Looking at the number of psychosocial problems experienced, 7% had zero, 27% had 1, 24% had 2, 27% had 3, and 15% had 4 or more. We identified a statistically significant positive "dose-response" relationship between the number of psychosocial problems and CAS with male clients over time, with the greatest odds of engaging in CAS with a male client over follow-up among those with 4 or more psychosocial problems (adjusted odds ratio = 5.18, 95% CI: 1.61 to 16.62)., Conclusions: Internet escorts and street-based MSW are likely to experience psychosocial problems and engaging in HIV sexual risk with male clients. The accumulation of psychosocial problems additively predicted CAS with male clients in a prospective cohort of MSW. The specification of psychosocial problems presents distinct treatment targets for HIV prevention among MSW in the United States., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)

India has one of the largest numbers of men who have sex with men (MSM) globally; however, geographic data on sexually transmitted infection (STI) prevalence and associations with sexual behavior are limited. Six-hundred and eight MSM in Chennai and Mumbai underwent screening for a behavioral trial and were assessed for bacterial STIs (syphilis, chlamydia, gonorrhea), HIV, and past-month self-reported condomless anal sex (CAS). Mumbai (37.8%) had a greater prevalence of any STI than Chennai (27.6%) (prevalence ratio [PR] = 1.37, 95% CI: 1.09, 1.73). This pattern also emerged for gonorrhea and chlamydia separately but not syphilis. Conversely, Mumbai MSM reported lower rates of CAS (mean = 2.2) compared to Chennai MSM (mean = 14.0) (mean difference = -11.8, 95% CI: -14.6, -9.1). The interaction of city by CAS on any STI prevalence (PR = 2.09, 95% CI: 1.45, 3.01, p < .0001) revealed that in Chennai, higher rates of CAS were not associated with STI prevalence, but in Mumbai they were (PR = 2.49, 95% CI: 1.65, 3.76, p < .0001). The higher prevalence of bacterial STIs but lower frequency of CAS in Mumbai (versus Chennai), along with the significant interaction of CAS with city on STI rates, suggests that there are either differences in disease burden or differences by city with respect to self-reported assessment of CAS. Regardless, the high prevalence rates of untreated STIs and condomless sex among MSM suggest the need for additional prevention intervention efforts for MSM in urban India.

Background: The estimated 2.2 million people who inject drugs (PWID) in the USA experience significant gaps in preventive healthcare and a high burden of infectious, psychiatric, and other chronic diseases. Many PWID rely on emergency medical services, which are costly and not designed to deliver preventive services, manage chronic conditions, or address social needs., Objective: The objective of this study was to explore barriers and facilitators to primary care utilization from the perspectives of PWID in New England, a region highly affected by the overdose crisis., Design: Participants completed semi-structured qualitative interviews exploring substance use and healthcare utilization patterns., Participants: We recruited 78 PWID through community-based organizations (e.g., syringe service programs) in 16 urban and non-urban communities throughout Massachusetts and Rhode Island., Approach: Thematic analysis identified barriers and facilitators to primary care utilization at the individual, interpersonal, and systemic levels., Key Results: Among 78 PWID, 48 described recent primary care experiences; 33 had positive experiences and 15 described negative experiences involving discrimination or mistrust. Individual-level barriers to primary care utilization included perceived lack of need and competing priorities (e.g., avoiding opioid withdrawal, securing shelter beds). Interpersonal-level barriers included stigma and perceived low quality of care for PWID. Systemic-level barriers included difficulty navigating healthcare systems, inadequate transportation, long wait times, and frequent provider turnover. Participants with positive primary care experiences explained how appointment reminders, flexible hours, addiction medicine-trained providers, case management services, and transportation support facilitated primary care utilization and satisfaction., Conclusions: Findings regarding the multilevel barriers and facilitators to accessing primary care among PWID identify potential targets for programmatic interventions to improve primary care utilization in this population. Based on these findings, we make recommendations for improving the engagement of PWID in primary care as a means to advance individual and public health outcomes.

Background: Opioid overdose deaths involving synthetic opioids, particularly illicitly manufactured fentanyl, remain a substantial public health concern in North America. Responses to overdose events (e.g., administration of naloxone and rescue breathing) are effective at reducing mortality; however, more interventions are needed to prevent overdoses involving illicitly manufactured fentanyl. This study protocol aims to evaluate the effectiveness of a behavior change intervention that incorporates individual counseling, practical training in fentanyl test strip use, and distribution of fentanyl test strips for take-home use among people who use drugs., Methods: Residents of Rhode Island aged 18-65 years who report recent substance use (including prescription pills obtained from the street; heroin, powder cocaine, crack cocaine, methamphetamine; or any drug by injection) (n = 500) will be recruited through advertisements and targeted street-based outreach into a two-arm randomized clinical trial with 12 months of post-randomization follow-up. Eligible participants will be randomized (1:1) to receive either the RAPIDS intervention (i.e., fentanyl-specific overdose education, behavior change motivational interviewing (MI) sessions focused on using fentanyl test strips to reduce overdose risk, fentanyl test strip training, and distribution of fentanyl test strips for personal use) or standard overdose education as control. Participants will attend MI booster sessions (intervention) or attention-matched control sessions at 1, 2, and 3 months post-randomization. All participants will be offered naloxone at enrolment. The primary outcome is a composite measure of self-reported overdose in the previous month at 6- and/or 12-month follow-up visit. Secondary outcome measures include administratively linked data regarding fatal (post-mortem investigation) and non-fatal (hospitalization or emergency medical service utilization) overdoses., Discussion: If the RAPIDS intervention is found to be effective, its brief MI and fentanyl test strip training components could be easily incorporated into existing community-based overdose prevention programming to help reduce the rates of fentanyl-related opioid overdose., Trial Registration: ClinicalTrials.gov NCT04372238 . Registered on 01 May 2020.