HIV status and substance use disorder treatment need and utilization among adults in the United States, 2015-2019: Implications for healthcare service provision and integration.

INTRODUCTION: Substance use disorders (SUD) are associated with HIV acquisition and care disruptions. Most research focuses on clinical samples; however, we used a nationally representative, community-based sample to estimate SUD treatment need and utilization by HIV status. METHODS: We included participants from the 2015-2019 National Survey on Drug Use and Health aged 18 and older who met past-year DSM-IV SUD criteria (n = 22,166). Participants self-reported whether a healthcare professional ever told them they had HIV or AIDS [i.e., people with HIV (PWH), non-PWH, HIV status unknown]. Outcomes included past-year: 1) any SUD treatment use; 2) any specialty SUD treatment use; and 3) perceived SUD treatment need. Survey weighted multivariable logistic regression models estimated the likelihood of each outcome by HIV status, adjusting for age, sex, race/ethnicity, education, survey year, health insurance status, and household income. RESULTS: Overall, 0.5 % were PWH and 0.8 % had an HIV unknown status. Any past-year SUD treatment utilization was low across all groups (10.3 % non-PWH, 24.2 % PWH, and 17.3 % HIV status unknown respondents). Specialty SUD treatment utilization was reported by 7.2 % of non-PWH, 17.8 % PWH, and 10.9 % HIV status unknown respondents. Perceived treatment need was reported by 4.9 % of non-PWH, 12.4 % of PWH, and 3.7 % of HIV status unknown respondents. In adjusted models, PWH were more likely than non-PWH to report any past-year SUD treatment utilization (aOR = 2.06; 95 % CI = 1.08-3.94) or past-year specialty SUD treatment utilization (aOR = 2.07; 95 % CI = 1.07-4.01). Among those with a drug use disorder other than cannabis, respondents with HIV-unknown status were less likely than HIV-negative individuals to report past-year perceived treatment need (aOR = 0.39; 95 % CI = 0.20-0.77). CONCLUSIONS: Despite high SUD treatment need among PWH, more than three quarters of PWH with SUD reported no past-year treatment. Compared to non-PWH, PWH had higher treatment utilization and higher specialty treatment utilization, but SUD treatment was low across all groups. As SUD is associated with adverse HIV outcomes, our findings highlight the need for the integration of SUD treatment with HIV testing and care. Increasing access to SUD treatment could help reduce negative SUD-related outcomes along the HIV care continuum.

Interest in and Preference for Long-acting Injectable Antiretroviral Therapy in the Era of Approved Cabotegravir/Rilpivirine among Reproductive-aged Women in the U.S. South.

Among 103 reproductive-aged women with HIV in the U.S. South surveyed post-approval of long-acting injectable (LAI) cabotegravir/rilpivirine, nearly two-thirds reported willingness to try LAI antiretroviral therapy (ART). Most expressed preference for LAI over daily oral ART and had minimal concerns over potential LAI-ART use impacting reproductive health.

Gender(ed) science: How the institutionalization of gender continues to shape the conduct and content of women's health research.

Gender refers to the socially constructed roles, behaviors, and attributes that a particular society considers appropriate for men and women based on assumptions about biological sex. It also operates as a major social organizing principle that confers unequal power, status, and resources to men and women, with direct consequences for health. Historic patriarchal and misogynistic beliefs and values are reinforced through social institutions, including health science, which reify gender inequities. This commentary examines two key domains in which the social organization and institutionalization of gender in scientific research affect the conduct of women's health research and, by extension, women's health outcomes. These domains are: 1) decisions about which topics are prioritized, researched, and funded and 2) the dissemination of research findings. Using the National Institutes of Health (NIH) as a case study to illustrate broader patterns in scientific research, we present evidence of gender-based inequities in what is prioritized, deemed fundable, and disseminated, and how this affects knowledge production and attention to women's health. We highlight efforts and progress made by the NIH and call for additional attention to further address gender-based inequities and their impact on women's health research. We conclude with a call for critical social science analyses-ideally supported by the NIH-of the social organization of health science research to identify points of intervention for redressing deep-seated obstacles to advancing research on women's health.

Structural heteropatriarchy and maternal cardiovascular morbidities.

The United States has some of the poorest maternal health outcomes of any developed nation. Existing research on maternal cardiovascular morbidities has focused predominantly on individual- and clinic-level drivers, but we know little about community- and structural-level factors that shape these outcomes. We use a composite measure of "structural heteropatriarchy" which includes measures of structural sexism and structural LGB-stigma to examine the relationship between structural heteropatriarchy and three cardiovascular-related maternal morbidities using the National Longitudinal Study of Adolescent to Adult Health (n = 3928). Results using multivariate regressions show that structural heteropatriarchy is associated with increased risk of reporting maternal morbidities. Our findings provide further evidence that sexuality- and gender-based stigma operate together to shape health disparities, including maternal health.

"Being Queer, It Was Really Isolating": Stigma and Mental Health Among Lesbian, Gay, Bisexual, Transgender, and Queer (LGBTQ+) Young People During COVID-19.

Lesbian, Gay, Bisexual, Transgender, Queer, and other sexual and gender minority (LGBTQ+) youth and young adults (YYAs) have poorer mental health outcomes than their cisgender, heterosexual peers in large part due to multilevel stigmatization and minority stress. This was exacerbated by psychological stressors stemming from the COVID-19 pandemic; these experiences intersected with YYA unique developmental stage. Here we explored LGBTQ+ YYA's pandemic-related experiences, focusing on intersections between stigma and belonging, developmental processes, and their relationship to mental health. We conducted qualitative interviews from August to November 2021 with 34 LGBTQ+ YYA ages 14 to 24; interviews were nested within a quantitative study on YYA experiences during COVID-19. Interviews were transcribed and coded using thematic analysis. YYA described how pandemic impacts like quarantine and isolation directly impacted their mental health; these coalesced around four types of thematic shifts: shifts in (1) time, (2) living situations, (3) community supports, and (4) social and political climate. Multilevel stigmatization also created new mechanisms of norm enforcement for LGBTQ+ YYA. Interviews demonstrated how the pandemic also impacted key developmental processes including identity formation and autonomy seeking. The potential consequences of these pandemic-related shifts largely depended on YYA's experiences of stigma and/or belonging throughout the pandemic. Findings suggested that isolation from the COVID-19 pandemic intersected with existing socio-ecological structures in LGBTQ+ young people's lives. Efforts to investigate longitudinal impacts of the pandemic, as well as to intervene to reduce the stigmatization experienced by LGBTQ+ YYA, remain urgent.

Patient Education and Decision Support for Long-Acting Injectable HIV Antiretroviral Therapy: Protocol for Tool Development and Pilot Testing with Ryan White HIV/AIDS Program Medical Case Management Programs in New York.

BACKGROUND: Long-acting injectable (LAI) HIV antiretroviral therapy (ART) presents a major opportunity to facilitate and sustain HIV viral suppression, thus improving health and survival among people living with HIV and reducing the risk of onward transmission. However, realizing the public health potential of LAI ART requires reaching patients who face barriers to daily oral ART adherence and thus can clinically benefit from alternative treatment modalities. Ryan White HIV/AIDS Program Part A medical case management (MCM) programs provide an array of services to address barriers to HIV care and treatment among economically and socially marginalized people living with HIV. These programs have demonstrated effectiveness in improving engagement along the continuum of care, but findings of limited program impact on durable viral suppression highlight the need to further innovate and hone strategies to support long-term ART adherence. OBJECTIVE: This study aims to adapt and expand Ryan White MCM service strategies to integrate LAI ART regimen options, with the larger goal of improving health outcomes in the populations that could most benefit from alternatives to daily oral ART regimens. METHODS: In 3 phases of work involving patient and provider participants, this study uses role-specific focus groups to elicit perceptions of LAI versus daily oral ART; discrete choice experiment (DCE) surveys to quantify preferences for different ART delivery options and related supports; and a nonrandomized trial to assess the implementation and utility of newly developed tools at 6 partnering Ryan White HIV/AIDS Program Part A MCM programs based in urban, suburban, and semirural areas of New York. Findings from the focus groups and DCEs, as well as feedback from advisory board meetings, informed the design and selection of the tools: a patient-facing, 2-page fact sheet, including frequently asked questions and a side-by-side comparison of LAI with daily oral ART; a patient-facing informational video available on YouTube (Google Inc); and a patient-provider decision aid. Implementation outcomes, measured through provider interviews, surveys, and service reporting, will guide further specification of strategies to integrate LAI ART options into MCM program workflows. RESULTS: The study was funded in late April 2021 and received approval from the institutional review board in May 2021 under protocol 20-096. Focus groups were conducted in late 2021 (n=21), DCEs ran from June 2022 to January 2023 (n=378), and tools for piloting were developed by May 2023. The trial (May 2023 through January 2024) has enrolled >200 patients. CONCLUSIONS: This study is designed to provide evidence regarding the acceptability, feasibility, appropriateness, and utility of a package of patient-oriented tools for comparing and deciding between LAI ART and daily oral ART options. Study strengths include formative work to guide tool development, a mixed methods approach, and the testing of tools in real-world safety-net service settings. TRIAL REGISTRATION: Clinicaltrials.gov NCT05833542; https://clinicaltrials.gov/study/NCT05833542. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56892.

Long-Acting Injectable Antiretrovirals for HIV Treatment: A Multi-Site Qualitative Study of Clinic-Level Barriers to Implementation in the United States.

Long-acting injectable antiretroviral therapy (LAI ART) has the potential to address adherence obstacles associated with daily oral ART, leading to enhanced treatment uptake, adherence, and viral suppression among people living with HIV (PLWH). Yet, its potential may be limited due to ongoing disparities in availability and accessibility. We need a better understanding of the organizational context surrounding the implementation of LAI ART, and to inform its widespread rollout, we conducted 38 in-depth interviews with medical and social service providers who offer HIV care at private and hospital-based clinics across six US cities. Our findings highlight real-world implementation barriers outside of clinical trial settings. Providers described ongoing and anticipated barriers across three stages of LAI ART implementation: (1) Patient enrollment (challenges registering patients and limited insurance coverage), (2) medication delivery (insufficient personnel and resources), and (3) leadership and management (lack of interprofessional coordination and a lack of programming guidelines). Providers described how these barriers would have a disproportionate impact on under-resourced clinics, potentially exacerbating existing disparities in LAI ART access and adherence. Our findings suggest strategies that clinic leadership, policymakers, and other stakeholders can pursue to promote rapid and equitable LAI ART implementation in clinics across the United States. Resource and staffing investments could support clinics to begin, sustain, and scale up LAI ART delivery; additionally, the establishment of guidelines and tools could facilitate wider adoption of LAI ART across clinical settings. These efforts are crucial to promote resourced, standardized, and equitable implementation of LAI ART and maximize its potential to help end the HIV epidemic.

"This Is Actually a Really Unique Moment in Time": Navigating Long-Acting HIV Treatment and HIV Cure Research with Analytical Treatment Interruptions-A Qualitative Interview Study in the United States.

Advancements in long-acting (LA) HIV treatment and cure research with analytical treatment interruptions (ATIs) have generated important scientific and implementation questions. There is an urgent need to examine challenges navigating the evolving HIV treatment and cure research landscape. From August to October 2022, we conducted 26 semistructured interviews with biomedical researchers and community members representing a predominantly woman demographic to explore the complexity of navigating the rapidly evolving HIV therapeutic and HIV cure research landscape. We purposively sampled individuals recruited from the AIDS Clinical Trials Group and the Martin Delaney Collaboratories for HIV Cure Research. Audio files were transcribed verbatim and analyzed through a thematic approach, using an inductive and iterative process. Among 26 participants, 10 were biomedical researchers and 16 community members, including 11 were people with HIV. Three main themes emerged: (1) We are at a pivotal moment in the evolving landscape of HIV therapeutics and LA HIV treatment and HIV cure research should not be siloed but considered together; (2) There are challenges with engagement in HIV cure research and in switching between oral daily antiretroviral treatment and LA formulations and, mainly, the prolonged pharmacokinetic tail of these compounds matched with limited patient education about their impacts; and (3) There are unique opportunities as a result of this evolving therapeutic landscape, including the key role of decision support for people with HIV, centering around patient autonomy, and the need to learn from the lived experiences of people with HIV who choose LA treatment and/or participation in HIV cure research. Despite a bias toward the woman gender, our study identifies key considerations for navigating concurrent LA HIV treatment and HIV cure research with ATIs from both community members and biomedical researchers' perspectives. Achieving optimal HIV control remains a formidable challenge, necessitating robust interdisciplinary collaborations and engagement with key stakeholders.

Increasing the meaningful involvement of women in HIV cure-related research: a qualitative interview study in the United States.

BACKGROUND: Cisgender women represent over half of people living with HIV globally. However, current research efforts toward a cure for HIV focus predominantly on cisgender men. The under-representation of women in HIV cure clinical studies is particularly problematic given data suggesting that sex-dependent phenotypes limit scientific discovery. OBJECTIVE: We aimed to generate considerations to increase the meaningful involvement of women in HIV cure-related research. MATERIALS AND METHODS: We conducted in-depth interviews with biomedical researchers and community members to better understand factors that could increase the meaningful involvement of women in HIV cure clinical trials. Participants were affiliated with academia, industry, community advisory boards, and community-based organizations, and were identified using listings from the AIDS Clinical Trials Group and the Martin Delaney Collaboratories. We used conventional content analysis to analyze the qualitative data. RESULTS: We recruited 27 participants, of whom 11 were biomedical researchers and 16 were community members. Participants included 25 cisgender women, 1 transgender woman, and 1 cisgender man. Key considerations emerged, including the need to ensure that HIV cure studies reflect HIV epidemiologic trends and having accurate representation by sex and gender in HIV cure research. To increase the meaningful involvement of women, recommendations included instituting intentional enrollment goals, frequent and mandatory reporting on enrollment, and incentives for sites to enroll women. Additional themes included the need for agency and self-determination, attention to lived experiences, trauma and healing, and adequate support for women (e.g. logistical, psychosocial, mental, emotional, and physical). Participants noted that women would be willing to participate in HIV cure trials, related procedures (e.g. biopsies), and analytical treatment interruptions. They also expressed a desired for women-centered and holistic clinical trial designs that account for intersectionality. CONCLUSIONS: Our empirical inquiry extends recent calls to action to increase diversity of people involved in HIV cure research. Redressing the under-inclusion of women in HIV cure research is an urgent imperative. The entire field must mobilize and reform to achieve this goal. Meaningfully involving women across the gender spectrum in HIV cure research is needed to ensure that interventions are safe, effective, scalable, and acceptable for all people with HIV.

Structural-Level Racial-, Sexual Orientation-, and HIV-Related Discrimination and Subsequent Criminal Justice Involvement Among Young, Black, Men Who Have Sex With Men in North Carolina.

Multiple aspects of Black young men who have sex with men's (YMSM) identities cause them to be differentially targeted for arrest and incarceration. However, limited research has explored structural drivers of Black YMSM' criminal justice involvement, particularly co-occurring forms of discrimination. This article examines the temporal relationship between perceived racial discrimination, perceived sexual orientation discrimination, and community-level HIV discrimination and criminal justice involvement among Black YMSM in North Carolina. The study followed 465 Black YMSM from November 2013 to October 2016 who were recruited for a randomized controlled trial to test an internet-based intervention for Black YMSM living with, and at risk for HIV; participants completed online surveys at baseline, 3, 6, and 12 months. Logistic regression was used to explore the relationship between the three predictors at baseline (i.e., perceived racism and sexual orientation discrimination and community-level HIV discrimination) and criminal justice involvement at follow-up. All three predictor variables were significantly associated with subsequent criminal justice involvement in separate regression models that adjusted for other covariates: HIV discrimination (aOR = 1.06 [1.01-1.11]), perceived sexual orientation discrimination (aOR = 1.12 [1.00-1.27]), and perceived racism (aOR = 1.26 [1.12-1.42]). Perceived racism remained significant in the model with all three predictors (aOR = 1.29 [1.07-1.55]). Racism did not modify the relationship between HIV discrimination and perceived sexual orientation discrimination and criminal justice involvement. This study expands existing research by exploring racism as a structural driver of criminal justice involvement; we subsequently examined whether racism modified the effect of the two other predictors. It also contributes to research on co-occurring discrimination by examining their impact on an underrepresented population.

Prenatal exposure to opioids and neurodevelopment in infancy and childhood: A systematic review.

Aim: This systematic review aims to estimate the relationship between prenatal exposure to opioids and neurodevelopmental outcomes and examines potential sources of heterogeneity between the studies. Methods: We searched four databases through May 21st, 2022: PubMed, Embase, PsycInfo and the Web of Science according to a specified search strings. Study inclusion criteria include: (1) cohort and case-control peer-reviewed studies published in English; (2) studies comparing neurodevelopmental outcomes among children with prenatal opioid-exposure (prescribed or used non-medically) vs. an unexposed group. Studies investigating fetal alcohol syndrome or a different primary prenatal exposure other than opioids were excluded. Two main performed data extraction using "Covidence" systematic review platform. This systematic review was conducted in accordance with PRISMA guidelines. The Newcastle-Ottawa-Scale was used for quality assessment of the studies. Studies were synthesized based on the type of neurodevelopmental outcome and the instrument used to assess neurodevelopment. Results: Data were extracted from 79 studies. We found significant heterogeneity between studies due to their use of different instruments to explore cognitive skills, motor, and behavioral outcomes among children of different ages. The other sources of heterogeneity included: procedures to assess prenatal exposure to opioids; period of pregnancy in which exposure was assessed; type of opioids assessed (non-medical, medication used for opioid use dis-order, prescribed by health professional), types of co-exposure; source of selection of prenatally exposed study participants and comparison groups; and methods to address lack of comparability between exposed and unexposed groups. Cognitive and motor skills as well as behavior were generally negatively affected by prenatal opioid exposure, but the significant heterogeneity precluded a meta-analysis. Conclusion: We explored sources of heterogeneity in the studies assessing the association between prenatal exposure to opioids and neurodevelopmental outcomes. Sources of heterogeneity included different approaches to participant recruitment as well as exposure and outcome ascertainment methods. Nonetheless, overall negative trends were observed between prenatal opioid exposure and neuro-developmental outcomes.

Past-year medical and non-medical opioid use by HIV status in a nationally representative US sample: Implications for HIV and substance use service integration.

AIM: In the context of the continued overdose epidemic, recent population estimates of opioid use in highly affected groups, such as people at risk for or people living with HIV (PLWH), are essential for service planning and provision. Although nonmedical opioid use is associated with HIV transmission and with lowered adherence and care engagement, most studies rely on clinic-based samples and focus on medical use of opioids only. We examine associations between opioid-related outcomes by HIV status in a community-based nationally representative sample. METHODS: The 2015-2019 National Survey on Drug Use and Health included 213,203 individuals aged 18 and older. Respondents self-reported whether a health care professional ever told them they had HIV/AIDS (i.e., HIV-positive/PLWH, HIV-negative, HIV-unknown). Opioid-related outcomes included past-year medical opioid use and past-year nonmedical (i.e., prescription opioid and heroin) use. Multinomial logistic regression estimated adjusted relative risk ratios between past-year opioid-related outcomes and HIV status, controlling for age, gender, race/ethnicity, income, population density, and year. RESULTS: In 2015-2019, 0.2 % of respondents were PLWH and 0.3 % self-reported an HIV-unknown status. Past-year medical opioid use was 37.3 % among PLWH, 30.4 % among HIV-negative and 21.9 % among HIV-unknown individuals. Past-year nonmedical use was 11.1 % among PLWH, 4.2 % among HIV-negative and 7.2 % among HIV-unknown individuals. Compared to HIV-negative individuals, PLWH had 3.21 times higher risk of past-year nonmedical use vs. no use (95 % CI:2.02-5.08) and 2.02 times higher risk of past-year nonmedical vs. medical opioid use only (95 % CI:1.24-2.65). CONCLUSION: Nonmedical opioid use prevalence was almost three times higher among PLWH than HIV-negative individuals. Because opioid use and its related harms disproportionately burden PLWH, integrating HIV and substance use prevention and treatment services may improve both HIV-related and opioid-related outcomes, including overdose.

The perspectives of street-involved youth who use drugs regarding the acceptability and feasibility of HIV pre-exposure prophylaxis: a qualitative study.

Street-involved youth who use drugs (YWUD) face an elevated risk of HIV acquisition and represent a key population for HIV prevention initiatives, including pre-exposure prophylaxis (PrEP). However, little is known regarding the acceptability and feasibility of PrEP uptake and adherence among this multiply-marginalized population. Semi-structured qualitative interviews were conducted with 24 street-involved YWUD (ages 17-24) to examine their perspectives toward PrEP; youth were recruited through a longitudinal prospective cohort study in Vancouver, Canada. Youth reported high levels of ambivalence toward PrEP despite engagement in HIV-related risk behaviors. This ambivalence was driven by misperceptions regarding HIV transmission, including stigmatizing associations between HIV transmission and personal hygiene. Such misperceptions led participants to enact strategies that were ineffective in preventing HIV transmission. Participants contested their inclusion as a "key population" for PrEP, which limited their enthusiasm for PrEP uptake and adherence. Participants also highlighted that wider social-structural inequities (e.g., housing vulnerability, poverty) that produced HIV-related risks were likely to undermine sustained PrEP use. Findings demonstrate the need for tailored implementation strategies to increase PrEP acceptability, including targeted education and anti-stigma interventions to increase awareness about HIV transmission. Interventions should also target structural inequities in order to fully address HIV risk and PrEP ambivalence.

How social policies shape the health and well-being of sexual- and gender-minority youth: Pathways of influence, social side effects and implications for life course trajectories.

Recent research has documented the harmful health consequences of structural-level stigma that targets sexual and gender minority (SGM) individuals. In the case of sexual and gender minority youth (SGMY), life trajectories are shaped not only by targeted, SGM-focused policies, but also by social policies more broadly which may have unique impacts on SGMY given their social position. However, little work has explored the pathways that connect both targeted and universal social policies and the health and well-being of SGMY. In this study, we conducted 68 qualitative interviews with SGMY in New York City (n = 30) and community stakeholders across the US (n = 38) and used the constant comparative method to identify the pathways through which social policies affect SGMY health and well-being. We propose three pathways that are shaped by specific inter-related social policies in ways that contribute to health inequities among SGMY: 1) access to social inclusion in educational settings; 2) housing-related regulations and subsequent (in)stability; and 3) access to material resources through labor market participation. We also highlight ways that SGMY, and organizations that support them, engage in agency and resistance to promote inclusion and wellbeing. Drawing on ecosocial theory, we demonstrate how policies work across multiple domains and levels to influence cycles of vulnerability and risk for SGMY. We close by discussing the implications of our findings for future research and policy.

Age-related patterns of cocaine and methamphetamine use across the life course in the United States: Disparities by gender and sexual identity among adults.

PURPOSE: Research showing substance use decreases over the life course has focused primarily on heterosexual adults. We examined how age-related patterns of cocaine and methamphetamine use vary by sexual identity and gender among a national sample. METHODS: We included 191,954 adults aged 18-64 from the 2015-2019 National Survey on Drug Use and Health. We described the weighted prevalence of past-year cocaine and methamphetamine use and used logistic regressions to estimate relative odds of past-year cocaine and methamphetamine use by age, stratified by gender and sexual identity (heterosexual, gay/lesbian, bisexual). RESULTS: Cocaine and methamphetamine use was highest among lesbian, gay, and bisexual (LGB) adults compared to their heterosexual counterparts. Gay/lesbian men and women and bisexual men were also more likely to use cocaine at later ages. Heterosexual adults ages 26-34 (adjusted odds ratio [aOR] = 0.73; confidence interval [CI] = 0.65-0.83) were less likely than those 21-25 to report past-year cocaine use, but there were no differences between those ages 26-34 and 21-25 among any LGB sub-group. Heterosexual (aOR = 1.62; CI = 1.28-2.04) and gay (aOR = 2.93; CI = 1.26-6.80), men ages 26-34 were more likely to report past-year methamphetamine use than their counterparts ages 21-25. There were no age-related differences in past-year methamphetamine use between bisexual men and gay/lesbian women. CONCLUSIONS: Patterns of cocaine and methamphetamine use across the life course for LGB individuals differ from those of heterosexuals. This has implications for targeted prevention efforts to address stimulant use among minoritized populations.

How Black and Latino young men who have sex with men in the United States experience and engage with eligibility criteria and recruitment practices: implications for the sustainability of community-based research.

Research recruitment, eligibility, and who chooses to participate shape the resulting data and knowledge, which together inform interventions, treatment, and programming. Patterns of research participation are particularly salient at this moment given emerging biomedical prevention paradigms. This paper explores the perspectives of Black and Latino young men who have sex with men (BL-YMSM) regarding research recruitment and eligibility criteria, how their experiences influence willingness to enroll in a given study, and implications for the veracity and representativeness of resulting data. We examine inclusion and recruitment as a complex assemblage, which should not be reduced to its parts. From April-July 2018, we conducted in-depth interviews with 30 BL-YMSM, ages 18-29, in New York City. Interviews were recorded, transcribed, and analyzed using the constant comparative method. Black and Latino YMSM's responses unveiled tensions between researchers', recruiters', and participants' expectations, particularly regarding eligibility criteria (e.g., age, sex frequency), assumptions about 'risky behaviors,' and the 'target' community. Men preferred peer-to-peer recruitment, noting that most approaches miss key population segments. Findings highlight the need to critically examine the selected 'target' community, who sees themselves as participants, and implications for data comprehensiveness and veracity. Study eligibility criteria and recruitment approaches are methodological issues that shape knowledge production and the policies and programs deployed into communities. These findings can inform how future research studies frame recruitment and eligibility in order to better meet the needs of participants and ensure future engagement.

A Patient Decision Aid (i.ARTs) to Facilitate Women's Choice Between Oral and Long-Acting Injectable Antiretroviral Treatment for HIV: Protocols for its Development and Randomized Controlled Pilot Trial.

BACKGROUND: Many women with HIV (WWH) have suboptimal adherence to oral antiretroviral therapy (ART) due to multilevel barriers to HIV care access and retention. A long-acting injectable (LAI) version of ART was approved by the US Food and Drug Administration in January 2021 and has the potential to overcome many of these barriers by eliminating the need for daily pill taking. However, it may not be optimal for all WWH. It is critical to develop tools that facilitate patient-provider shared decision making about oral versus LAI ART modalities to promote women's adherence and long-term HIV outcomes. OBJECTIVE: This study will develop and pilot test a web-based patient decision aid called i.ART+support (i.ARTs). This decision aid aims to support shared decision making between WWH and their providers, and help women choose between oral and LAI HIV treatment. METHODS: The study will occur in 3 phases. In phase 1, we will utilize a mixed methods approach to collect data from WWH and medical and social service providers to inform i.ARTs content. During phase 2, we will conduct focus groups with WWH and providers to refine i.ARTs content and develop the web-based decision aid. In phase 3, i.ARTs will be tested in a randomized controlled trial with 180 women in Miami, Florida, and assessed for feasibility, usability, and acceptability, as well as to evaluate the associations between receiving i.ARTs and viral suppression, ART pharmacy refills, and clinic attendance. RESULTS: This study was funded in March 2021. Columbia University's IRB approved the study protocols (approval number IRB-AAAT5314). Protocols for phase 1 interviews have been developed and interviews with service providers started in September 2021. We will apply for Clinicaltrials.gov registration prior to phase 3, which is when our first participant will be enrolled in the randomized controlled trial. This is anticipated to occur in April 2023. CONCLUSIONS: This study is the first to develop a web-based patient decision aid to support WWH choices between oral and LAI ART. Its strengths include the incorporation of both patient and provider perspectives, a mixed methods design, and implementation in a real-world clinical setting. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35646.

Long-Acting Injectable Human Immunodeficiency Virus Pre-Exposure Prophylaxis Preferred Over Other Modalities Among People Who Inject Drugs: Findings from a Qualitative Study in California.

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.

Daily cannabis use, cannabis use disorder, and any medical cannabis use among US adults: Associations within racial, ethnic, and sexual minoritized identities in a changing policy context.

Differences in cannabis use patterns among racial, ethnic and sexual minoritized identity subgroups have been attributed to marginalized identity stressors. However, associations at the intersection of these minoritized identities remain underexplored in a changing medical cannabis law (MCL) context. We estimated medical cannabis and daily cannabis use, and cannabis use disorder (CUD) by intersecting racial, ethnic and sexual minoritized identity subgroups. We included 189,800 adults in the 2015-2019 National Survey on Drug Use and Health identifying as non-Hispanic white, non-Hispanic Black, or Hispanic and self-reported heterosexual, gay/lesbian, or bisexual sexual identity. We estimated the adjusted odds of past-year: (a) any medical cannabis, (b) daily cannabis use (i.e., 300 + days/year), and (c) DSM-5-proxy CUD by sexual identity, stratified by race and ethnicity. Cannabis measures were higher among sexual minoritized groups than heterosexual adults across racial and ethnic subgroups. Bisexual adults had higher odds of any medical cannabis use than their heterosexual counterparts: non-Hispanic white (6.4% vs. 1.8%; aOR = 2.6, 95% CI = [2.5-3.5]), non-Hispanic Black (4.1% vs. 1.7%; aOR = 2.7, 95% CI = [1.6-4.5]), and Hispanic adults (5.3% vs. 1.8 %; aOR = 2.6, 95% CI = [1.9-3.3]). We found heterogeneous associations with state MCL status across subgroups stratified by race and ethnicity. Bisexual adults in MCL states had higher odds of any medical cannabis use among non-Hispanic white (aOR = 2.0, 95% CI = [1.4-2.9]) and Hispanic (aOR = 3.6, 95% CI = [1.2-10.2]) adults compared to their non-MCL counterparts, but this was marginal among non-Hispanic Black bisexual adults (aOR = 1.6, 95% CI = [1.0-2.6]). Studies should assess intended and unintended cannabis policy effects among racial, ethnic, and sexual identity subgroups.