Validation of Two Diagnostic Assessments for Opioid and Stimulant Use Disorder for Use by Non-Clinicians.

Objective: The United States is in the fourth wave of the opioid epidemic marked by the increase in fentanyl and co-occurring stimulant use related overdose deaths. Measures are needed to quickly diagnose opioid and stimulant use disorders, yet current traditional diagnostic assessments pose barriers to providing rapid diagnoses. Methods: This study aimed to (1) validate an updated version of the Rapid Opioid Dependence Screen (RODS) from DSM-IV criteria for opioid dependence to the now DSM-5 moderate-to-severe opioid use disorder, the Rapid Opioid Use Disorder Assessment (ROUDA); and (2) create and validate the Rapid Stimulant Use Disorder Assessment to DSM-5 stimulant use disorder (RSUDA) when compared to the substance use disorder module from the DSM-5 version of the Mini International Neuropsychiatric Interview. Results: One-hundred and fifty adults completed study assessments, 122 reported opioid misuse and 140 reported stimulant misuse within their lifetime. The ROUDA had a sensitivity of 82.5% (95% confidence interval [CI] 75.7, 89.2), specificity of 100.0% (95% CI: 100, 100), and strong internal consistency α = 0.94. The RSUDA had similarly high sensitivity (83.8%, 95% CI: 77.7, 89.9), specificity (91.4%, 95% CI: 86.8, 96.1), and internal consistency α = 0.87. The ROUDA and RSUDA are efficient and valid measures that can be administered in various settings by non-clinical staff to rapidly diagnose opioid and stimulant use disorders and allow for immediate treatment and harm reduction interventions. Conclusions: The ROUDA and RSUDA are efficient and valid measures that can be administered by non-clinicians to rapidly diagnose opioid and stimulant use disorders.

The relationship between reincarceration and treatment of opioid use disorder with extended-release naltrexone among persons with HIV.

Background: In the United States, a disproportionate number of persons with HIV (PWH) and opioid use disorder (OUD) are involved in the justice system. Medications for OUD (MOUD) can reduce convictions and incarceration time in persons with OUD. Extended-release naltrexone (XR-NTX) has been shown to reduce craving of opioids, recurrence of use, and overdose and help achieve or maintain HIV viral suppression in PWH with OUD involved with the justice system. Objectives: This retrospective study aimed to describe factors associated with reincarceration and to evaluate if XR-NTX was associated with reduced reincarceration among PWH and OUD who were released to the community from incarceration. Methods: Data from participants released to the community from incarceration from a completed randomized controlled trial was analyzed using a generalized linear model to estimate odds ratios associated with reincarceration and a Kaplan-Meier survival analysis to determine time to reincarceration and non-reincarcerated individuals were compared. Results: Of the 77 participants, 41 (53.2%) were reincarcerated during the 12-month study period. The mean time to reincarceration was 190 days (SD=108.3). Compared with participants who remained in the community, reincarcerated participants were more likely to have major depressive disorder at study baseline, increased opioid cravings, longer mean lifetime incarceration, and a higher physical quality of life score. XR-NTX was not significantly associated statistically with reincarceration in this analysis. Conclusion: Reducing reincarceration is a public health priority, given the high proportion of PWH and OUD in the U.S. justice system as well as high degrees of persons returning to the community and having care interrupted due to reincarceration. This analysis determined that potentially identifying depression in recently released individuals could improve HIV outcomes, decrease recurrence of opioid use, and reduce reincarceration.

Evaluation of the Impact of HIV Serostatus on the Hepatitis C Virus Care Cascade and Injection Drug Use Among Persons Initiating Medication Treatment for Opioid Use Disorder.

Background: Persons who inject drugs are at increased risk for acquiring hepatitis C virus (HCV). Medications for opioid use disorder (MOUD) are associated with reduced injection drug use (IDU) frequency among persons with opioid use disorder (OUD). However, whether HCV treatment uptake or changes in IDU frequency differ by HIV serostatus among persons receiving MOUD is incompletely understood. Methods: A secondary analysis was performed of data collected from 2 prospective cohort studies of participants with (PWH) or without HIV with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition-diagnosed OUD who were initiated on methadone, buprenorphine, or naltrexone. Results: Of 129 participants, 78 (60.5%) were HCV antibody positive. PWH underwent increased HCV viral load testing (76.7% vs 43.3%; P = .028), but HCV treatment rates did not differ (17.6% vs 10.0%; P = .45) by HIV status. Participants without HIV reported a greater reduction in mean opioid IDU at 90 days (10.7 vs 2.0 fewer days out of 30; P < .001), but there were no group differences at 90 days. Stimulant use did not differ between groups. Urine opioid positivity declined from baseline to 90 days among the entire cohort (61.4% to 38.0%; P < .001) but did not differ by HIV serostatus. Conclusions: PWH who received MOUD underwent higher rates of follow-up HCV testing, but HCV treatment rates did not significantly differ by HIV serostatus. Participants without HIV on MOUD reported a greater reduction in opioid IDU. Improved integration of concomitant OUD with HCV and HIV screening, linkage to care, and treatment are needed for persons without HIV.

Maintenance on extended-release naltrexone is associated with reduced injection opioid use among justice-involved persons with opioid use disorder.

INTRODUCTION: Opioid use disorder (OUD) and injection drug use (IDU) place justice-involved individuals at increased risk for acquiring or transmitting HIV or hepatitis C virus (HCV). Methadone and buprenorphine have been associated with reduced opioid IDU; however, the effect of extended-release naltrexone (XR-NTX) on this behavior is incompletely studied. METHODS: This study examined injection opioid use and shared injection equipment behavior from a completed double-blind placebo-controlled trial of XR-NTX among 88 justice-involved participants with HIV and OUD. Changes in participants' self-reported daily injection opioid use and shared injection equipment was evaluated pre-incarceration, during incarceration, and monthly post-release for 6 months. The study also assessed differences in time to first opioid injection post-release. The research team performed intention to treat and "as treated" (high treatment versus low treatment) analyses. RESULTS: Fifty-eight of 88 participants (69.5 %) endorsed IDU and 26 (29.5 %) reported sharing injection equipment in the 30 days pre-incarceration; 2 participants (2.2 %) reported IDU during incarceration; 19 (21.6 %) reported IDU one month post-release from prison or jail. Fifty-four (61.4 %) participants had an HIV RNA below 200 copies/mL and 62 (70.5 %) were baseline HCV antibody positive. The 6-month follow-up rate was 49.5 % and 50.5 % for those who received XR-NTX and placebo, respectively, which was not significantly different (p = 0.822). Participants in the XR-NTX and placebo groups had similar low mean opioid injection use post-release and time to first injection opioid use in the Intention-to-treat analysis. In the as-treated analysis, participants in the high treatment group had significantly lower mean proportion of days injecting opioids (13.8 % high treatment versus 22.8 % low treatment, p = 0.02) by month 1, which persisted up to 5 months post-release (0 % high treatment vs 24.3 % low treatment, p < 0.001) and experienced a longer time to first opioid injection post-release (143.8 days high treatment vs 67.4 days low treatment, p < 0.001). CONCLUSIONS: Injection opioid use was low during incarceration and remained low post-release in this justice-involved population. Retention on XR-NTX was associated with reduced intravenous opioid use, which has important implications for reducing transmission of HIV and HCV.

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.

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.

Sexual Violence and Chemsex among Substance-Using Sexual and Gender Minorities in Texas.

Chemsex is the use of methamphetamine or other substances to enhance sexual experiences, and is most often associated with sexual minority men. Within the chemsex literature, questions of sexual violence emerge due, in part, to ambiguity about what constitutes consent within sexualized environments with co-occurring substance use.To understand the context in which sexual violence occurs, data from an online survey of sexual and gender minority Texans were analyzed using bivariate and logistic regression (N = 1273), and qualitative interviews with substance-using sexual minority men from a separate sample were thematically analyzed (N = 22).Among survey participants, 12.8% experienced a form of sexual violence (10.1% experienced intimate partner violence and 7.6% experienced sexual assault). When participants were categorized based on past year substance use and sex party attendance, 48.0% of participants who used drugs and attended sex parties (a proxy for chemsex) experienced sexual violence (41.6% experienced intimate partner violence and 41.0% experienced sexual assault). When variables statistically significant at the bivariate-level were entered into logistic regression models, participants in the chemsex category were 12.5 [95% CI: 6.9, 22.8] times more likely to experience sexual violence. Substance-using sexual minority men experiencing sexual violence describe situations in which consent is difficult to revoke and sexual exploitation is likely to occur.Studies which more deeply explore the relationship between sexual and relationship violence and chemsex among sexual and gender minorities are needed. Particularly, the notion of consent needs further conceptualization in the context of drug use and sex parties. HIGHLIGHTS: Measures of recent substance use and sex party attendance were combined to create a proxy measure for chemsex, which is the use of substances to enhance sexual experiences.Substance-using sexual and gender minorities engaging in chemsex were at increased risk of sexual violence.In addition to engaging in chemsex, variables associated with an increased odds of sexual violence among sexual and gender minorities were younger age, having a non-monosexual sexual identity, and receiving a mental health diagnoses.Studies on sexual and gender minorities engaging in chemsex should be developed to further explore sexual exploitation.

Covariates of hazardous alcohol use among sexual and gender minorities in Texas: Identifying the most vulnerable.

BACKGROUND: Information is limited on the prevalence of hazardous drinking and associated covariates among sexual and gender minority (SGM) persons. These analyses estimated the prevalence of hazardous drinking and identified associated covariates. METHODS: A total of 1273 SGM adolescents and adults living in Texas completed an online survey between March 2016 and January 2017. Variables associated with hazardous drinking at the bivariate-level (p < 0.10) were entered into multiple logistic regression models to estimate the strength of their association. RESULTS: More than a third (39.1%) of participants meet criteria for hazardous drinking. Compared to non-hazardous drinkers, hazardous drinkers were younger (x- = 20.7 [SD = 8.9] vs. x- = 26.5 [SD = 13.8]) and more likely to be Hispanic (41.5% vs. 26.2%). Hazardous drinkers were more likely to report using substances in past 12 months, including opioids (15.3% vs. 6.7%), stimulants (26.3% vs. 12.7%), and marijuana (37.6% vs. 21.2%). More hazardous drinkers reported injecting drugs (12.3% vs. 5.8%) and having a history of incarceration (14.1% vs. 7.3%). They were less likely to be diagnosed with depression (50.2% vs. 56.5%). When entered into a multivariate logistic regression model, hazardous drinkers were more likely to be younger (aOR = 0.97 [0.95, 0.98]), Hispanic (aOR = 1.5 [1.2, 2.0]), have a history of incarceration (aOR = 2.4 [1.5, 3.6]), and use a substance, not including marijuana (aOR = 1.7 [1.3, 2.3]). They were less likely to be diagnosed with depression (aOR = 0.73 [0.6, 0.9]). CONCLUSIONS: Our findings highlight the intersection of race and ethnicity, mental health, criminal justice involvement, and substance use and the need for tailored interventions that address underlying determinants.

A modeling framework to inform preexposure prophylaxis initiation and retention scale-up in the context of 'Getting to Zero' initiatives.

OBJECTIVE(S): 'Getting to Zero' (GTZ) initiatives aim to eliminate new HIV infections over a projected time frame. Increased preexposure prophylaxis (PrEP) uptake among populations with the highest HIV incidence, such as young Black MSM, is necessary to accomplish this aim. Agent-based network models (ABNMs) can help guide policymakers on strategies to increase PrEP uptake. DESIGN: Effective PrEP implementation requires a model that incorporates the dynamics of interventions and dynamic feedbacks across multiple levels including virus, host, behavior, networks, and population. ABNMs are a powerful tool to incorporate these processes. METHODS: An ABNM, designed for and parameterized using data for young Black MSM in Illinois, was used to compare the impact of PrEP initiation and retention interventions on HIV incidence after 10 years, consistent with GTZ timelines. Initiation interventions selected individuals in serodiscordant partnerships, or in critical sexual network positions, and compared with a controlled setting where PrEP initiators were randomly selected. Retention interventions increased the mean duration of PrEP use. A combination intervention modeled concurrent increases in PrEP initiation and retention. RESULTS: Selecting HIV-negative individuals for PrEP initiation in serodiscordant partnerships resulted in the largest HIV incidence declines, relative to other interventions. For a given PrEP uptake level, distributing effort between increasing PrEP initiation and retention in combination was approximately as effective as increasing only one exclusively. CONCLUSION: Simulation results indicate that expanded PrEP interventions alone may not accomplish GTZ goals within a decade, and integrated scale-up of PrEP, antiretroviral therapy, and other interventions might be necessary.

Extended-release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living with HIV and Alcohol use Disorders Transitioning to the Community: Results From a Double-Blind, Placebo-Controlled Trial.

OBJECTIVE: To determine whether extended-release naltrexone (XR-NTX) would improve or maintain viral suppression (VS) among incarcerated individuals with HIV and alcohol use disorders (AUDs) transitioning to the community. DESIGN: A randomized, double-blind, placebo-controlled trial was conducted among incarcerated individuals with HIV and AUDs transitioning to the community from 2010 through 2016. METHODS: Eligible participants (N = 100) were randomized 2:1 to receive 6 monthly injections of XR-NTX (n = 67) or placebo (n = 33) starting at release and continued for 6 months. The primary and secondary outcomes were the proportion that maintained or improved VS at <200 and <50 copies per milliliter from baseline to 6 months, respectively, using an intention-to-treat analysis. RESULTS: Participants allocated to XR-NTX improved VS from baseline to 6 months for <200 copies per milliliter (48.0%-64.2%, P = 0.024) and for <50 copies per milliliter (31.0%-56.7%, P = 0.001), whereas the placebo group did not (<200 copies/mL: 64%-42.4%, P = 0.070; <50 copies/mL: 42.0%-30.3%, P = 0.292). XR-NTX participants were more likely to achieve VS than the placebo group at 6 months (<200 copies/mL: 64.2% vs. 42.4%; P = 0.041; <50 copies/mL: 56.7% vs. 30.3%; P = 0.015). XR-NTX independently predicted VS [<200 copies/mL: adjusted odds ratio (aOR) = 2.68, 95% confidence interval (CI) = 1.01 to 7.09, P = 0.047; <50 copies/mL: aOR = 4.54; 95% CI = 1.43 to 14.43, P = 0.009] as did receipt of ≥3 injections (<200 copies/mL: aOR = 3.26; 95% CI = 1.26 to 8.47, P = 0.010; <50 copies/mL: aOR = 6.34; 95% CI = 2.08 to 19.29, P = 0.001). Reductions in alcohol consumption (aOR = 1.43, 95% CI = 1.03 to 1.98, P = 0.033) and white race (aOR = 5.37, 95% CI = 1.08 to 27.72, P = 0.040) also predicted VS at <50 copies per milliliter. CONCLUSIONS: XR-NTX improves or maintains VS after release to the community for incarcerated people living with HIV and AUDs.

Substance Use, Mental Health, HIV Testing, and Sexual Risk Behavior Among Men Who Have Sex With Men in the State of Maharashtra, India.

Among 433 men who have sex with men in Maharashtra, India who completed an online survey, 23% reported hazardous drinking, 12% illicit substance, and 9% polysubstance use. The overall prevalence of depression and intimate partner violence (IPV) were 58% and 56%, respectively. Participants engaging in hazardous drinking had more sexual partners and were less likely to be married to women. Participants reporting illicit substance use or polysubstance use were more likely to have been out, had more sexual partners, or experienced IPV. Those reporting illicit substance use were more likely to engage in condomless anal sex. Based on our findings, we suggest that public health interventions integrate HIV, substance use, and mental health services.

Extended-Release Naltrexone Improves Viral Suppression Among Incarcerated Persons Living With HIV With Opioid Use Disorders Transitioning to the Community: Results of a Double-Blind, Placebo-Controlled Randomized Trial.

OBJECTIVE: To determine whether extended-release naltrexone (XR-NTX) would improve or maintain viral suppression (VS) among prisoners or jail detainees with HIV and opioid use disorder (OUD) transitioning to the community. DESIGN: A 4-site, prospective randomized double-blind, placebo-controlled trial was conducted among prison and jail inmates with HIV and OUD transitioning to the community from September 2010 through March 2016. METHODS: Eligible participants (N = 93) were randomized 2:1 to receive 6 monthly injections of XR-NTX (n = 66) or placebo (n = 27) starting at release and observed for 6 months. The primary outcome was the proportion that maintained or improved VS (<50 copies/mL) from baseline to 6 months. RESULTS: Participants allocated to XR-NTX significantly improved to VS (<50 copies/mL) from baseline (37.9%) to 6 months (60.6%) (P = 0.002), whereas the placebo group did not (55.6% at baseline to 40.7% at 6 months P = 0.294). There was, however, no statistical significant difference in VS levels at 6 months between XR-NTX (60.6%) vs. placebo (40.7%) (P = 0.087). After controlling for other factors, only allocation to XR-NTX (adjusted odds ratio = 2.90; 95% confidence interval = 1.04 to 8.14, P = 0.043) was associated with the primary outcome. Trajectories in VS from baseline to 6 months differed significantly (P = 0.017) between treatment groups, and the differences in the discordant values were significantly different as well (P = 0.041): the XR-NTX group was more likely than the placebo group to improve VS (30.3% vs. 18.5%), maintain VS (30.3% vs. 27.3), and less likely to lose VS (7.6% vs. 33.3%) by 6 months. CONCLUSIONS: XR-NTX improves or maintains VS after release to the community for incarcerated people living with HIV with OUD.

Extended-release naltrexone reduces alcohol consumption among released prisoners with HIV disease as they transition to the community.

BACKGROUND: Alcohol use disorders (AUDs) are highly prevalent among persons living with HIV (PLH) within the criminal justice system (CJS). Extended-release naltrexone (XR-NTX) has not been previously evaluated among CJS-involved PLH with AUDs. METHODS: A randomized, double-blind, placebo-controlled trial was conducted among 100 HIV+ prisoners with AUDs. Participants were randomized 2:1 to receive 6 monthly injections of XR-NTX or placebo starting one week prior to release. Using multiple imputation strategies for data missing completely at random, data were analyzed for the 6-month post-incarceration period. Main outcomes included: time to first heavy drinking day; number of standardized drinks/drinking day; percent of heavy drinking days; pre- to post-incarceration change in average drinks/day; total number of drinking days; and a composite alcohol improvement score comprised of all 5 parameters. RESULTS: There was no statistically significant difference overall between treatment arms for time-to-heavy-drinking day. However, participants aged 20-29 years who received XR-NTX had a longer time to first heavy drinking day compared to the placebo group (24.1 vs. 9.5days; p<0.001). There were no statistically significant differences between groups for other individual drinking outcomes. A sub-analysis, however, found participants who received ≥4 XR-NTX were more likely (p<0.005) to have improved composite alcohol scores than the placebo group. Post-hoc power analysis revealed that despite the study being powered for HIV outcomes, sufficient power (0.94) was available to distinguish the observed differences. CONCLUSIONS: Among CJS-involved PLH with AUDs transitioning to the community, XR-NTX lengthens the time to heavy drinking day for younger persons; reduces alcohol consumption when using a composite alcohol consumption score; and is not associated with any serious adverse events.

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.

Correlates of retention on extended-release naltrexone among persons living with HIV infection transitioning to the community from the criminal justice system.

BACKGROUND: The acceptability of and retention on extended-release naltrexone (XR-NTX), an FDA-approved medication for the treatment of alcohol and opioid use disorders, among persons living with HIV disease (PLH) under criminal justice setting (CJS) supervision has not been evaluated to date. METHODS: Two double-blind placebo-controlled randomized trials of XR-NTX for inmates with HIV disease transitioning to the community with (1) alcohol use disorders (AUDs) or (2) opioid use disorders, are underway. Reasons for not accepting XR-NTX and an evaluation of differences in demographic features between those who were retained on study drug and those who did not return for their second injection post-release are discussed. RESULTS: 70% of eligible persons consented to participate; almost 90% received their first injection; and almost 60% returned for their first injection after release. Variables found to be associated (p<0.10) with returning for the second injection included: not meeting criteria for hazardous drinking (p=0.035; OR 0.424 (CI 0.191-0.941)); being prescribed antiretroviral therapy (p=0.068; OR 2.170 (CI 0.943-4.992)); expressing experiencing serious depression 30 days prior to incarceration (p=0.068; OR 1.889 (CI 0.955-3.737)); not having a positive cocaine urine screen on the day of release (DOR) (p=0.011; OR 0.258 (CI 0.091-0.729)); and not meeting criteria for an AUD plus any substance use disorder (p=0.068; OR 0.521 (CI 0.259-1.048)). Only positive cocaine urine test on DOR was statistically significant after multivariate regression analyses (p=0.005; OR 0.207 (CI 0.068-0.623)). CONCLUSION: CJS based XR-NTX programs are highly acceptable among PLH, however retention on XR-NTX after release is negatively impacted by relapse to cocaine use.

Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for HIV-infected, opioid dependent prisoners and jail detainees who are transitioning to the community.

BACKGROUND: People with opioid dependence and HIV are concentrated within criminal justice settings (CJS). Upon release, however, drug relapse is common and contributes to poor HIV treatment outcomes, increased HIV transmission risk, reincarceration and mortality. Extended-release naltrexone (XR-NTX) is an evidence-based treatment for opioid dependence, yet is not routinely available for CJS populations. METHODS: A randomized, double-blind, placebo-controlled trial of XR-NTX for HIV-infected inmates transitioning from correctional to community settings is underway to assess its impact on HIV and opioid-relapse outcomes. RESULTS: We describe the methods and early acceptability of this trial. In addition we provide protocol details to safely administer XR-NTX near community release and describe logistical implementation issues identified. Study acceptability was modest, with 132 (66%) persons who consented to participate from 199 total referrals. Overall, 79% of the participants had previously received opioid agonist treatment before this incarceration. Thus far, 65 (49%) of those agreeing to participate in the trial have initiated XR-NTX or placebo. Of the 134 referred patients who ultimately did not receive a first injection, the main reasons included a preference for an alternative opioid agonist treatment (37%), being ineligible (32%), not yet released (10%), and lost upon release before receiving their injection (14%). CONCLUSIONS: Study findings should provide high internal validity about HIV and opioid treatment outcomes for HIV-infected prisoners transitioning to the community. The large number of patients who ultimately did not receive the study medication may raise external validity concerns due to XR-NTX acceptability and interest in opioid agonist treatments. CLINICAL TRIAL NUMBER: NCT01246401.

An evaluation of hepatic enzyme elevations among HIV-infected released prisoners enrolled in two randomized placebo-controlled trials of extended release naltrexone.

Extended-release naltrexone (XR-NTX), an approved treatment for opioid or alcohol dependence, is a once-monthly injectable formulation of naltrexone. Hepatotoxicity concerns have limited its use, necessitating further investigation. This study aims to examine hepatic enzyme levels in participants of 2 randomized placebo-controlled trials (RCTs) of XR-NTX. Hepatic transaminases were measured in 85 patients enrolled in RCTs of XR-NTX among HIV-infected prisoners, transitioning to the community and receiving treatment for either dependence on alcohol (52.9%), opioids (44.7%) or both (16.5%). Baseline characteristics included HCV co-infection (55.7%), antiretroviral therapy (81%), mental illness (39%) and receiving psychiatric medications (34.1%). Levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma glutamyl transferase (GGT) were not statistically different between persons randomized to placebo (N=24) and XR-NTX (N=61) arms. These results confirm that XR-NTX is safe to use among opioid and alcohol dependent HIV-infected released prisoners receiving ART with high rates of co-morbid HCV infection and mental illness.