XR-NTX improves or maintains VS after release to the community for incarcerated people living with HIV with OUD.

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 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. 9.5 days; p <0.001). There were no statistically significant differences for other individual drinking outcomes. A sub-analysis 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 (.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.

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.

XR-NTX improves or maintains VS after release to the community for incarcerated people living with HIV and AUDs.

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 an 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.

The U.S. 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=1,270) 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 a 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.

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 second 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.

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