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.

Design and methods of a double blind randomized placebo-controlled trial of extended-release naltrexone for alcohol dependent and hazardous drinking prisoners with HIV who are transitioning to the community.

BACKGROUND: HIV-infected prisoners have a high prevalence of alcohol use disorders and commonly relapse to alcohol soon after release to the community which is linked to high morbidity, poor antiretroviral therapy (ART) adherence and increased sexual risk-taking behaviors. Extended-release naltrexone (XR-NTX) effectively reduces relapse to alcohol in alcohol dependent persons, yet it remains unexamined among criminal justice system (CJS) populations transitioning to the community. METHODS: A randomized double-blind, placebo-controlled trial of XR-NTX to improve HIV treatment outcomes via reducing relapse to alcohol use after prison release for HIV-infected hazardous drinking and alcohol dependent prisoners is discussed. RESULTS: Acceptability of study participation is high with 86% of those referred who met eligibility criteria and 85% of those who were able to receive injections prior to release accepted injections, yet important implementation issues are identified and addressed during the study and are discussed in this paper. CONCLUSION: Medication-assisted therapies for prevention of relapse to alcohol use for CJS populations transitioning to the community, especially for HIV-infected patients, are urgently needed in order to reduce alcohol relapse after release and improve HIV treatment outcomes and contribute to improved individual and public health.

Understanding the revolving door: individual and structural-level predictors of recidivism among individuals with HIV leaving jail.

Incarceration, particularly when recurrent, can significantly compromise the health of individuals living with HIV. Despite this, the occurrence of recidivism among individuals with HIV has been little examined, particularly among those leaving jail, who may be at especially high risk for return to the criminal justice system. We evaluated individual- and structural-level predictors of recidivism and time to re-incarceration in a cohort of 798 individuals with HIV leaving jail. Nearly a third of the sample experienced at least one re-incarceration event in the 6 months following jail release. Having ever been diagnosed with a major psychiatric disorder, prior homelessness, having longer lifetime incarceration history, having been charged with a violent offense for the index incarceration and not having health insurance in the 30 days following jail release were predictive of recidivism and associated with shorter time to re-incarceration. Health interventions for individuals with HIV who are involved in the criminal justice system should also target recidivism as a predisposing factor for poor health outcomes. The factors found to be associated with recidivism in this study may be potential targets for intervention and need to be further explored. Reducing criminal justice involvement should be a key component of efforts to promote more sustainable improvements in health and well-being among individuals living with HIV.

Rationale, study design and sample characteristics of a randomized controlled trial of directly administered antiretroviral therapy for HIV-infected prisoners transitioning to the community - a potential conduit to improved HIV treatment outcomes.

BACKGROUND: HIV-infected prisoners experience poor HIV treatment outcomes post-release. Directly administered antiretroviral therapy (DAART) is a CDC-designated, evidence-based adherence intervention for drug users, yet untested among released prisoners. METHODS: Sentenced HIV-infected prisoners on antiretroviral therapy (ART) and returning to New Haven or Hartford, Connecticut were recruited and randomized 2:1 to a prospective controlled trial (RCT) of 6 months of DAART versus self-administered therapy (SAT); all subjects received case management services. Subjects meeting DSM-IV criteria for opioid dependence were offered immediate medication-assisted treatment. Trained outreach workers provided DAART once-daily, seven days per week, including behavioral skills training during the last intervention month. Both study groups were assessed for 6 months after the intervention period. Assessments occurred within 90 days pre-release (baseline), day of release, and then monthly for 12 months. Viral load (VL) and CD4 testing was conducted baseline and quarterly; genotypic resistance testing was conducted at baseline, 6 and 12 months. The primary outcome was pre-defined as viral suppression (VL<400 copies/mL) at 6 months. RESULTS: Between 2004 and 2009, 279 participants were screened, of which 202 met eligibility criteria and 154 were ultimately enrolled in the study; 103 subjects were randomized to DAART and 51 to SAT. Subjects were mostly male (81.2%), people of color (87.0%), had an alcohol use disorder (39.7%), had underlying depression (54.2%), were virally suppressed (78.8%) and had a mean CD4=390.7 cells/mL. CONCLUSIONS: Outcomes from this RCT will contribute greatly to HIV treatment outcomes after release from prison, a period associated with adverse HIV and other medical consequences.

Comparison of tuberculin skin testing reactivity in opioid-dependent patients seeking treatment with methadone versus buprenorphine: policy implications for tuberculosis screening.

BACKGROUND: Buprenorphine's availability in primary care settings offers increased access to treatment and linkage to primary care for opioid-dependent patients. Currently, tuberculin skin testing (TST) is recommended for patients enrolling in methadone maintenance treatment (MMT), but not for those enrolling in buprenorphine maintenance treatment (BMT). OBJECTIVES: To compare TST screening results in enrollees in BMT and MMT programs and assess the correlates of TST positivity among these subjects. METHODS: A cross-sectional analysis of a retrospective cohort study was conducted to compare concurrent TST results among contemporaneously matched groups of MMT and BMT patients in the same community. RESULTS: TST positivity was approximately 9% in both MMT and BMT settings (p = .27). Increased TST positivity was associated with being Black (AOR = 3.53, CI = 1.28-9.77), Hispanic (AOR = 3.11, CI = 1.12-8.60), and having higher education (AOR = 3.01, CI = 1.20-7.53). CONCLUSIONS: These results confirm a similar high prevalence of TST positivity in opioid-dependent patients enrolling in MMT and BMT programs. Racial and ethnic health disparities remain associated with TST positivity, yet a relationship between higher education and tuberculosis requires further investigation. SCIENTIFIC SIGNIFICANCE: These data suggest the importance of incorporating TST screening in emerging BMT programs as a mechanism to provide increased detection and treatment of tuberculosis infection in opioid-dependent patient populations.