HIV Risk and Interest in Preexposure Prophylaxis in Justice-Involved Persons.

Preexposure prophylaxis (PrEP) is underused in persons who use drugs and justice-involved persons. In an ongoing randomized controlled trial in 4 US locations comparing patient navigation versus mobile health unit on time to initiation of HIV medication or PrEP for justice-involved persons who use stimulants or opioids and who are at risk for or living with HIV, we assessed HIV risk factors, perceived HIV risk, and interest in PrEP. Participants without HIV (n = 195) were 77% men, 65% White, 23% Black, and 26% Hispanic; 73% reported a recent history of condomless sex, mainly with partners of unknown HIV status. Of 34% (67/195) reporting injection drug use, 43% reported sharing equipment. Despite risk factors, many persons reported their risk for acquiring HIV as low (47%) or no (43%) risk, although 51/93 (55%) with PrEP indications reported interest in PrEP. Justice-involved persons who use drugs underestimated their HIV risk and might benefit from increased PrEP education efforts.

Integrated Care Models: HIV and Substance Use.

PURPOSE OF REVIEW: Behaviors and practices associated with substance use contribute to lack of HIV virologic suppression and onward transmission. In the USA, many recent HIV outbreaks have been connected with substance use. Evidence-based strategies for integrating care of those at risk for and living with HIV and who use substances continue to evolve. This review, based on scientific and medical literature through March 2023, provides an overview and evaluation of initiatives for integrated care aimed to serve patients at risk for and with HIV and a substance use disorder. RECENT FINDINGS: Integrated care services can improve health outcomes for patients at risk for and with HIV and a substance use disorder; for instance, treatment for an opioid use disorder can help improve HIV viral suppression. Brick-and-mortar facilities can provide successful care integration with appropriate clinic leadership to support multidisciplinary care teams, up-to-date provider training, and sufficient pharmacy stock for substance use treatment. Delivering healthcare services to communities (e.g., mobile healthcare clinics and pharmacies, telehealth) may prove to be an effective way to provide integrated services for those with or at risk of HIV and substance use disorders. Incorporating technology (e.g., mobile phone applications) may facilitate integrated care. Other venues, including harm reduction programs and carceral settings, should be targets for integrated services. Venues providing healthcare should invest in integrated care and support legislation that increases access to services related to HIV and substance use.

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2022 Recommendations of the International Antiviral Society-USA Panel.

Importance: Recent advances in treatment and prevention of HIV warrant updated recommendations to guide optimal practice. Objective: Based on a critical evaluation of new data, to provide clinicians with recommendations on use of antiretroviral drugs for the treatment and prevention of HIV, laboratory monitoring, care of people aging with HIV, substance use disorder and HIV, and new challenges in people with HIV, including COVID-19 and monkeypox virus infection. Evidence Review: A panel of volunteer expert physician scientists were appointed to update the 2020 consensus recommendations. Relevant evidence in the literature (PubMed and Embase searches, which initially yielded 7891 unique citations, of which 834 were considered relevant) and studies presented at peer-reviewed scientific conferences between January 2020 and October 2022 were considered. Findings: Initiation of antiretroviral therapy (ART) is recommended as soon as possible after diagnosis of HIV. Barriers to care should be addressed, including ensuring access to ART and adherence support. Integrase strand transfer inhibitor-containing regimens remain the mainstay of initial therapy. For people who have achieved viral suppression with a daily oral regimen, long-acting injectable therapy with cabotegravir plus rilpivirine given as infrequently as every 2 months is now an option. Weight gain and metabolic complications have been linked to certain antiretroviral medications; novel strategies to ameliorate these complications are needed. Management of comorbidities throughout the life span is increasingly important, because people with HIV are living longer and confronting the health challenges of aging. In addition, management of substance use disorder in people with HIV requires an evidence-based, integrated approach. Options for preexposure prophylaxis include oral medications (tenofovir disoproxil fumarate or tenofovir alafenamide plus emtricitabine) and, for the first time, a long-acting injectable agent, cabotegravir. Recent global health emergencies, like the SARS-CoV-2 pandemic and monkeypox virus outbreak, continue to have a major effect on people with HIV and the delivery of services. To address these and other challenges, an equity-based approach is essential. Conclusions and Relevance: Advances in treatment and prevention of HIV continue to improve outcomes, but challenges and opportunities remain.

A Qualitative Exploration of the Potential Role of Using Online Social Media Support Communities to Increase Initiation of Medications for Opioid Use Disorder (MOUD).

Objectives: This study sought to explore the potential role of peer-led online communities to increase use of medications for opioid use disorder. Methods: From January through March 2020, participants with opioid use disorder and their family members/friends were recruited from paid Facebook ads; public health key stakeholders were recruited from referrals from the study team and opioid experts. Thirty participants from California were interviewed; 23 persons reporting opioid misuse, 3 family members/friends of persons misusing opioids, and 4 public health key stakeholders. We conducted semi-structured interviews asking about preferences, barriers and facilitators of treatment options for opioid use disorder, and perspectives around the use of digital/online communities. The categories of participants interviewed were each asked slightly different questions depending upon their role. Results: Results suggest that participants who misuse opioids (1) may prefer to engage in online communities rather than in-person meetings to discuss their opioid use, (2) generally prefer to receive opioid-related information from other patients with opioid use disorder and/or those in recovery rather than from health providers or other individuals, and (3) thought that an online community could be beneficial for helping address their opioid use. Conclusion: Results suggest an openness and interest in a peer-led online community to discuss opioid use and treatment among people who misuse opioids.

Study protocol of a randomized controlled trial comparing two linkage models for HIV prevention and treatment in justice-involved persons.

BACKGROUND: Persons involved in the justice system are at high risk for HIV and drug overdose upon release to the community. This manuscript describes a randomized controlled trial of two evidence-based linkage interventions for provision of HIV prevention and treatment and substance use disorder (SUD) services in four high risk communities to assess which is more effective at addressing these needs upon reentry to the community from the justice system. METHODS: This is a 5-year hybrid type 1 effectiveness-implementation randomized controlled trial that compares two models (Patient Navigation [PN] or Mobile Health Unit [MHU] service delivery) of linking justice-involved individuals to the continuum of community-based HIV and SUD prevention and treatment service cascades of care. A total of 864 justice-involved individuals in four US communities with pre-arrest histories of opioid and/or stimulant use who are living with or at-risk of HIV will be randomized to receive either: (a) PN, wherein patient navigators will link study participants to community-based service providers; or (b) services delivered via an MHU, wherein study participants will be provided integrated HIV prevention/ treatment services and SUD services. The six-month post-release intervention will focus on access to pre-exposure prophylaxis (PrEP) for those without HIV and antiretroviral treatment (ART) for people living with HIV (PLH). Secondary outcomes will examine the continuum of PrEP and HIV care, including: HIV viral load, PrEP/ ART adherence; HIV risk behaviors; HCV testing and linkage to treatment; and sexually transmitted infection incidence and treatment. Additionally, opioid and other substance use disorder diagnoses, prescription, receipt, and retention on medication for opioid use disorder; opioid and stimulant use; and overdose will also be assessed. Primary implementation outcomes include feasibility, acceptability, sustainability, and costs required to implement and sustain the approaches as well as to scale-up in additional communities. DISCUSSION: Results from this project will help inform future methods of delivery of prevention, testing, and treatment of HIV, HCV, substance use disorders (particularly for opioids and stimulants), and sexually transmitted infections for justice-involved individuals in the community. TRIAL REGISTRATION: Clincialtrials.gov NCT05286879 March 18, 2022.

Gender differences among persons entering medication treatment for opioid use disorder in the community.

BACKGROUND AND OBJECTIVES: We evaluated gender differences among persons initiating medications for opioid use disorder (MOUD). METHODS: Analyses of baseline assessments for a study evaluating the impact of MOUD on outcomes included: demographics, DSM-5 diagnoses, depression severity, quality of life (QoL), and medication history (N = 125). RESULTS: When compared to men, women had a greater prevalence of generalized anxiety and posttraumatic stress disorders; and worse psychological QoL. Women were less likely to be prescribed psychiatric medications. DISCUSSION AND CONCLUSIONS: Women may benefit from tailored multidisciplinary programs with MOUD. SCIENTIFIC SIGNIFICANCE: This study identified that women with OUD seeking MOUD in the community had greater sedative hypnotic nonprescribed medication use and psychiatric comorbidity than men, all of which can contribute to poorer retention on MOUD and higher risk of morbidity and mortality. Thus, concurrent psychiatric disorder screening and treatment integrated with MOUD may improve retention on MOUD, opioid relapse and overdose for women.

Gender differences among criminal justice-involved persons living with HIV interested in extended-release naltrexone treatment.

Background: Previous research has shown gender differences with respect to entry into medication treatment of substance use disorders (SUDs), yet few have examined gender differences among participants consented to be treated with extended-release naltrexone (XR-NTX). Understanding gender differences is critical to developing interventions to overcome barriers to initiation of and retention on medication treatment for SUDs. Methods: Data from two double-blind placebo-controlled trials of XR-NTX among persons with HIV and alcohol or opioid use disorders leaving the criminal justice system (CJS) were analyzed for gender differences among clinical characteristics, mental health, drug use severity, and other domains. The study that recruited persons with alcohol use disorder (AUD) was conducted from September 2010-February 2016 at two sites in Connecticut (CT), and the opioid use disorder (OUD) study was conducted from September 2010-March 2016 at three sites in CT and one site in Massachusetts. Results: Baseline data were analyzed from 193 participants consented to be randomized to XR-NTX or placebo; 40 women and 153 men. Women were younger, had worse mental health severity, and were more likely to be diagnosed with cocaine use disorder. There were no statistical differences between men and women in the prescription of antiretroviral therapy (ART) or ART adherence. Conclusions: Women had greater mental health severity and a higher prevalence of cocaine use as compared to men, both of which are known to be barriers to engagement and retention on medication treatment for alcohol and opioid use disorders. For women with CJS involvement and living with HIV and SUDs, understanding factors that may affect initiation and retention on medication treatment of SUDs are necessary to improve treatment outcomes in women.

Federal and State Action Needed to End the Infectious Complications of Illicit Drug Use in the United States: IDSA and HIVMA's Advocacy Agenda.

In response to the opioid crisis, IDSA and HIVMA established a working group to drive an evidence- and human rights-based response to illicit drug use and associated infectious diseases. Infectious diseases and HIV physicians have an opportunity to intervene, addressing both conditions. IDSA and HIVMA have developed a policy agenda highlighting evidence-based practices that need further dissemination. This paper reviews (1) programs most relevant to infectious diseases in the 2018 SUPPORT Act; (2) opportunities offered by the "End the HIV Epidemic" initiative; and (3) policy changes necessary to affect the trajectory of the opioid epidemic and associated infections. Issues addressed include leveraging harm reduction tools and improving integrated prevention and treatment services for the infectious diseases and substance use disorder care continuum. By strengthening collaborations between infectious diseases and addiction specialists, including increasing training in substance use disorder treatment among infectious diseases and addiction specialists, we can decrease morbidity and mortality associated with these overlapping epidemics.

Infectious Complications of Addiction: A Call for a New Subspecialty Within Infectious Diseases.

Infectious diseases (ID) physicians are increasingly responsible for the management of infectious consequences of substance use disorders (SUD). While we are often consulted for diagnosis and treatment of the infectious disease, it is clear that successful management of these infections requires a holistic approach, including acknowledgement and treatment of the underlying SUD. As we have learned through years of treating human immunodeficiency virus and hepatitis C virus infections, ID physicians have unique expertise in addressing both the infection and the complex biopsychosocial factors that underpin the infection. Many ID physicians have incorporated the management of addiction as part of their scope of practice, and here we seek to give a name and define the role of these ID/addiction dual specialists. We define the potential role of ID/addiction physicians in clinical care, health administration, and research, as well as provide recommendations to bolster the supply and reach of this burgeoning subspecialty.

Impact of Abstinence and of Reducing Illicit Drug Use Without Abstinence on Human Immunodeficiency Virus Viral Load.

BACKGROUND: Substance use is common among people living with human immunodeficiency virus (PLWH) and a barrier to achieving viral suppression. Among PLWH who report illicit drug use, we evaluated associations between HIV viral load (VL) and reduced use of illicit opioids, methamphetamine/crystal, cocaine/crack, and marijuana, regardless of whether or not abstinence was achieved. METHODS: This was a longitudinal cohort study of PLWH from 7 HIV clinics or 4 clinical studies. We used joint longitudinal and survival models to examine the impact of decreasing drug use and of abstinence for each drug on viral suppression. We repeated analyses using linear mixed models to examine associations between change in frequency of drug use and VL. RESULTS: The number of PLWH who were using each drug at baseline ranged from n = 568 (illicit opioids) to n = 4272 (marijuana). Abstinence was associated with higher odds of viral suppression (odds ratio [OR], 1.4-2.2) and lower relative VL (ranging from 21% to 42% by drug) for all 4 drug categories. Reducing frequency of illicit opioid or methamphetamine/crystal use without abstinence was associated with VL suppression (OR, 2.2, 1.6, respectively). Reducing frequency of illicit opioid or methamphetamine/crystal use without abstinence was associated with lower relative VL (47%, 38%, respectively). CONCLUSIONS: Abstinence was associated with viral suppression. In addition, reducing use of illicit opioids or methamphetamine/crystal, even without abstinence, was also associated with viral suppression. Our findings highlight the impact of reducing substance use, even when abstinence is not achieved, and the potential benefits of medications, behavioral interventions, and harm-reduction interventions.

A Literature Review Examining Primary Outcomes of Medication Treatment Studies for Opioid Use Disorder: What Outcome Should Be Used to Measure Opioid Treatment Success?

BACKGROUND AND OBJECTIVES: Medications for opioid use disorder (MOUD) reduce opioid use and overdose; however, MOUD clinical trials have used varying primary outcomes to document treatment success. We conducted a literature review to assess and critically examine the methodologies used in MOUD treatment studies. METHODS: Published studies in English that examined MOUD (buprenorphine, methadone, or extended-release naltrexone) were included (N = 20). The methods and frequencies of measuring primary opioid outcomes, including urine drug tests (UDTs) and self-report of opioid use were compared among studies. RESULTS: A total of 20 studies fit the inclusion criteria. Each study assessed opioid use; only 12 had opioid use as a primary outcome. Other primary outcomes included retention in treatment (N = 6), and two had other primary outcomes (death and opioid withdrawal symptoms). Opioid use was assessed through both self-report and UDTs in 15 studies. Two studies did not use UDTs. Differences were found in the methods used for how opioid use, retention in treatment, self-report of opioid use, and UDTs were measured. DISCUSSION AND CONCLUSIONS: The different primary outcomes used and operational definitions in each study make comparisons between studies difficult. The use of both self-report and UDTs for opioid use has several advantages, and if possible, researchers should use both measures. SCIENTIFIC SIGNIFICANCE: This is the first review critically examining outcome measures from MOUD treatment studies. Creating a standard for opioid treatment outcomes in MOUD studies will allow for generalizable results that can inform both researchers and clinicians to better care for those with OUD. (Am J Addict 2020;00:00-00).

Medications for Treatment of Opioid Use Disorder among Persons Living with HIV.

PURPOSE OF REVIEW: Recent HIV outbreaks have occurred as a result of the current US opioid epidemic. Providing medications for opioid use disorder (MOUD) with methadone, buprenorphine, and extended-release naltrexone is essential to achieving optimal HIV treatment outcomes including viral suppression and retention in treatment. This review describes the pharmacology of MOUD with specific attention to interactions with antiretroviral therapy, and to the effect of MOUD on HIV treatment outcomes. RECENT FINDINGS: Methadone and buprenorphine both improve HIV viral suppression, adherence to antiretroviral therapy, and overall mortality for persons with opioid use disorder (OUD). Extended-release naltrexone has been most extensively studied in persons with HIV leaving incarcerated settings, and improves HIV viral suppression in that context. Strategies that integrate MOUD and HIV treatment are crucial to optimize viral suppression. The differing pharmacokinetic and delivery characteristics of these MOUD offer diverse options. Given the chronic and relapsing nature of both HIV and OUD, long-term approaches are required.

Self-reported antiretroviral therapy adherence and viral load in criminal justice-involved populations.

BACKGROUND: Self-reported antiretroviral therapy (ART) adherence measures that are associated with plasma viral load (VL) are valuable to clinicians and researchers, but are rarely examined among groups vulnerable to dropping out of care. One-seventh of all those living with HIV pass through incarceration annually and criminal-justice (CJ) involved people living with HIV (PLH) are vulnerable to falling out of care. We examined the association of self-reported ART adherence with VL in a criminal-justice sample compared to a routine-care sample. METHODS: Samples: We examined data from a multisite collaboration of studies addressing the continuum of HIV care among CjJ involved persons in the Seek, Test, Treat, and Retain cohort. Data pooled from seven CJ- studies (n = 414) were examined and compared with the routine-care sample from the Centers for AIDS Research Network of Integrated Clinical Systems' seven sites (n = 11,698). MEASURES: In both samples, data on self-reported percent ART doses taken were collected via the visual analogue scale adherence measure. Viral load data were obtained by blood-draw. ANALYSIS: We examined the associations of adherence with VL in both cohorts using mixed effects linear regression of log-VL, and mixed effects logistic regression of binary VL (≥ 200 copies/mL) outcomes. Interactions by CD4 count and self-reported health status were also tested. RESULTS: Among the CJ sample, the coefficient for log-VL was - 0.31 (95% CI = - 0.43, - 0.18; P < 0.01) and that in the routine-care sample was - 0.42 (95% CI = - 0.45, - 0.38; P < 0.01). For the logistic regression of binary detectable VL on 10% increments of adherence we found the coefficient was - 0.26 (95% CI = - 0.37, - 0.14; P < 0.01) and in the routine-care sample it was - 0.38 (95% CI = - 0.41, - 0.35; P < 0.01). There was no significant interaction by CD4 count level in the CJ sample, but there was in the routine-care sample. Conversely, there was a significant interaction by self-reported health status level in the criminal-justice sample, but not in the routine-care sample. CONCLUSIONS: The visual analogue scale is valid and useful to measure ART adherence, supporting treatment for CJ- involved PLH vulnerable to falling out of care. Research should examine adherence and VL in additional populations.

Prevalence, Diagnosis, and Treatment Rates of Mood Disorders among Opioid Users under Criminal Justice Supervision.

BACKGROUND: Individuals involved in the criminal justice system have disproportionately high rates of psychiatric disorders when compared to the general U.S. POPULATION: If left untreated, the likelihood of subsequent arrest increases and risk for adverse health consequences is great, particularly among opioid users. OBJECTIVES: To explore the prevalence, characteristics, and treatment of mood disorders among justice involved opioid-dependent populations. METHODS: The current study enrolled 258 treatment-seeking opioid-dependent individuals under community-based criminal justice supervision (e.g., probation, parole) screened from the larger parent study, Project STRIDE, a seek/test/treat randomized control trial (RCT) examining HIV and opioid use treatment. During baseline, individuals were screened for depression using the Patient Health Questionnaire-9 (PHQ-9) and screened for bipolar disorder using the Mood Disorder Questionnaire (MDQ) tool. RESULTS: Overall, 78 (30%) participants screened positive for moderate to severe depression and 54 (21%) screened positive for bipolar disorder. Participants self-reported mood disorders at higher rates than they screened positive for these conditions. Participants screening positive for these conditions experienced significantly greater family, legal, and medical problems on the Addiction Severity Index-Lite (ASI-Lite) than those who did not screen positive. Incidence of a lifetime suicide attempt was found to be associated with a positive screen for both mood disorders. Prescribed psychotropic treatment utilization was similar among those who screened positive for depression or bipolar disorder with approximately 38% reporting taking medication. IMPORTANCE: Findings suggest universal mood disorder screening to improve comprehensive psychiatric care and treatment of opioid-dependent justice-involved individuals.

Gender Differences in HIV Risk Behaviors Among Persons Involved in the U.S. Criminal Justice System and Living with HIV or at Risk for HIV: A "Seek, Test, Treat, and Retain" Harmonization Consortium.

The U.S. female criminal justice (CJ) population is rapidly growing, yet large-scale studies exploring gender-specific HIV risk behaviors in the CJ population are lacking. This analysis uses baseline data on adults with a CJ history from eight U.S. studies in an NIH-funded "Seek, Test, Treat, Retain" harmonization consortium. Data were collected using a standardized HIV risk behavior assessment tool and pooled across studies to describe participants' characteristics and risk behaviors. Multilevel mixed-effects logistic regression models were used to test for gender-based behavior differences. Among 784 HIV-positive (21.4% female) and 5521 HIV-negative (8.5% female) participants, HIV-positive women had higher odds than HIV-positive men of engaging in condomless sexual intercourse (AOR 1.84 [1.16-2.95]) with potentially sero-discordant partners (AOR 2.40 [1.41-4.09]) and of sharing injection equipment (AOR 3.36 [1.31-8.63]). HIV risk reduction interventions targeting CJ-involved women with HIV are urgently needed as this population may represent an under-recognized potential source of HIV transmission.

Co-calibration of two self-reported measures of adherence to antiretroviral therapy.

Adherence to antiretroviral therapy (ART) is an important determinant of clinical success assessed in many HIV studies. Harmonizing adherence data from studies that use different measures is difficult without a co-calibration equation to convert between validated instruments. Our purpose was to co-calibrate two commonly used adherence measures: the AIDS Clinical Trials Group (ACTG) questionnaire and the Visual Analog Scale (VAS). We used robust linear regression to develop a co-calibration equation in a clinical care cohort. The outcome was the 30-day VAS percentage of ART taken and the predictors were ACTG questions. We evaluated the equation's goodness of fit in five STTR (Seek, Test, Treat, Retain) consortium studies where individuals completed both measures: 2 criminal justice; 2 international; and 1 other high-risk vulnerable population. We developed a three-phase decision rule to convert ACTG to VAS in 1045 participants. First, when the last missed dose on the ACTG was reported as >30 days ago, the VAS was set to 100% (N = 582). Second, if "doses missed" was zero for all items, VAS was 100% (N = 104). Third, among remaining participants (N = 359), VAS was estimated as 96.8% minus 2.9% times the number of missed doses ("doses per day" was non-significant). Correlation between predicted and reported VAS was r = 0.80 in the criminal justice group (N = 446), r = 0.46 in the international group (N = 311), r = 0.32 in the other vulnerable population (N = 63), and r = 0.66 overall. When outliers due to inversion of the VAS scale were excluded (n = 25), these correlations were 0.88, 0.78, 0.80, and 0.86, respectively. We concluded that a simple decision rule and equation allowed us to co-calibrate between two widely used adherence measures thus combining data from studies with different instruments. This study highlighted issues with VAS inversions and its limitations as a single item. Combining studies using different instrument facilitates larger pooled datasets to address key research questions.

HIV-infected men who have sex with men, before and after release from jail: the impact of age and race, results from a multi-site study.

The US HIV/AIDS epidemic is concentrated among men who have sex with men (MSM). Black men are disproportionately affected by incarceration and Black MSM experience higher infection rates and worse HIV-related health outcomes compared to non-Black MSM. We compared HIV treatment outcomes for Black MSM to other HIV-infected men from one of the largest cohorts of HIV-infected jail detainees (N = 1270) transitioning to the community. Of the 574 HIV-infected men released, 113 (19.7%) self-identified as being MSM. Compared to other male subgroups, young Black MSM (<30 years old, N = 18) were significantly less likely: (1) before incarceration, to have insurance, access to an HIV healthcare provider, and use cocaine; (2) during incarceration, to receive a disease management intervention; and (3) in the 6 months post-release, to link to HIV care. Interventions that effectively link and retain young HIV-infected Black MSM in care in communities before incarceration and post-release from jail are urgently needed.