Treatment Initiation, Substance Use Trajectories, and the Social Determinants of Health in Persons Living With HIV Seeking Medication for Opioid Use Disorder.

BACKGROUND: People living with HIV and opioid use disorder (OUD) are disproportionally affected by adverse socio-structural exposures negatively affecting health, which have shown inconsistent associations with uptake of medications for OUD (MOUD). This study aimed to determine whether social determinants of health (SDOH) were associated with MOUD uptake and trajectories of substance use in a clinical trial of people seeking treatment. METHODS: Data are from a 2018 to 2019 randomized trial comparing the effectiveness of different MOUD to achieve viral suppression among people living with HIV and OUD. SDOH were defined by variables mapping to Healthy People 2030 domains: education (Education Access and Quality), income (Economic Stability), homelessness (Neighborhood and Built Environment), criminal justice involvement (Social and Community Context), and recent SUD care (Health Care Access and Quality). Associations between SDOH and MOUD initiation were assessed with Cox proportional hazards models, and SDOH and substance use over time with generalized estimating equation models. RESULTS: Participants (N = 114) averaged 47 years old, 63% were male, 56% were Black, and 12% Hispanic. Participants reported an average of 2.3 out of 5 positive SDOH indicators (SD = 1.2). Stable housing was the most commonly reported SDOH (61%), followed by no recent criminal justice involvement (59%), having a high-school level education or greater (56%), income stability (45%), and recent SUD care (13%). Each additional favorable SDOH was associated with a 25% increase in the likelihood of MOUD initiation during the study period [adjusted HR = 1.25, 95% CI = (1.01, 1.55), P = .044]. Positive SDOH were also associated with a decrease in the odds of baseline opioid use and a greater reduction in opioid use during subsequent weeks of the study (P < .001 for a joint test of baseline and slope differences). CONCLUSIONS: Positive social determinants of health, in aggregate, may increase the likelihood of MOUD treatment initiation among people living with HIV and OUD.

Latino Invisibility in the Pandemic.

Devastating effects of COVID-19 among Latinos have not been adequately emphasized or addressed by media, public health experts, researchers, or government officials. Moreover, the underreporting of the crisis' effect on Latinos and the undercounting of cases continues even as programs, initiatives, and policies are designed and implemented to mitigate the spread of the virus; to allocate resources to lessen the economic, educational, housing, and nutritional consequences of COVID; and to direct recovery planning. The invisibility and systematic neglect of the Latino population has contributed to Latino individuals' disproportionately high rates of infection, hospitalization, and death. Changing the COVID-19 narrative is necessary in order to ensure appropriate and equitable responses to the pandemic's effect on Latinos.

Los efectos devastadores de la COVID-19 entre los latinos no han sido destacados ni abordados adecuadamente por los medios, expertos en salud pública, investigadores o funcionarios de gobierno. Por otra parte, el subregistro del efecto de la crisis en los latinos y el conteo incompleto de casos continúa, incluso mientras se diseñan e implementan programas, iniciativas y políticas para mitigar la propagación del virus; asignar recursos con el fin de atenuar las consecuencias económicas, educativas, habitacionales y nutricionales de la COVID y dirigir la planificación de la recuperación. La invisibilidad y el abandono sistemático de dicha población ha contribuido a tasas desproporcionadamente altas de infección, hospitalización y muerte de latinos. Es necesario cambiar la narrativa de la COVID-19 para garantizar respuestas adecuadas y equitativas al efecto de la pandemia en los latinos.

HIV clinic-based extended-release naltrexone versus treatment as usual for people with HIV and opioid use disorder: a non-blinded, randomized non-inferiority trial.

BACKGROUND AND AIM: Opioid agonist medications for treatment of opioid use disorder (OUD) can improve human immunodeficiency virus (HIV) outcomes and reduce opioid use. We tested whether outpatient antagonist treatment with naltrexone could achieve similar results. DESIGN: Open-label, non-inferiority randomized trial. SETTING: Six US HIV primary care clinics. PARTICIPANTS: A total of 114 participants with untreated HIV and OUD (62% male; 56% black, 12% Hispanic; positive for fentanyl (62%), other opioids (47%) and cocaine (60%) at baseline). Enrollment halted early due to slow recruitment. INTERVENTION: HIV clinic-based extended-release naltrexone (XR-NTX; n = 55) versus treatment as usual (TAU) with buprenorphine or methadone (TAU; n = 59). MEASUREMENTS: Treatment group differences were compared for the primary outcome of viral suppression (HIV RNA ≤ 200 copies/ml) at 24 weeks and secondary outcomes included past 30-day use of opioids at 24 weeks. FINDINGS: Fewer XR-NTX participants initiated medication compared with TAU participants (47 versus 73%). The primary outcome of viral suppression was comparable for XR-NTX (52.7%) and TAU (49.2%) [risk ratio (RR) = 1.064; 95% confidence interval (CI) = 0.748, 1.514] at 24 weeks. Non-inferiority could not be demonstrated, as the lower confidence limit of the RR did not exceed the pre-specified margin of 0.75 in intention-to-treat (ITT) analysis. The main secondary outcome of past 30-day opioid use was comparable for XR-NTX versus TAU (11.7 versus 14.8 days; mean difference = -3.1; 95% CI = -8.7, 1.1) in ITT analysis. Among those initiating medication, XR-NTX resulted in fewer days of opioid use compared with TAU in the past 30 days (6.0 versus 13.6, mean difference = -7.6; 95% CI = -13.8, -0.2). CONCLUSIONS: A randomized controlled trial found supportive, but not conclusive, evidence that human immunodeficiency virus clinic-based extended-release naltrexone is not inferior to treatment as usual for facilitating human immunodeficiency virus viral suppression. Participants who initiated extended-release naltrexone used fewer opioids than those who received treatment as usual.

Associations between fentanyl use and initiation, persistence, and retention on medications for opioid use disorder among people living with uncontrolled HIV disease.

BACKGROUND: Associations between fentanyl use and initiation and retention on medications for opioid use disorder (MOUD) are poorly understood. METHODS: Data were from a multisite clinical trial comparing extended-release naltrexone (XR-NTX) with treatment as usual (TAU; buprenorphine or methadone) to achieve HIV viral suppression among people with OUD and uncontrolled HIV disease. The exposure of interest was fentanyl use, as measured by urine drug screening. Outcomes were time to MOUD initiation, defined as date of first injection of XR-NTX, buprenorphine prescription, or methadone administration; MOUD persistence, the total number of injections, prescriptions, or administrations received over 24 weeks; and MOUD retention, having an injection, prescription, or administration during weeks 20-24. RESULTS: Participants (N = 111) averaged 47 years old and 62% were male. Just over half (57%) were Black and 13% were Hispanic. Sixty-four percent of participants tested positive for fentanyl at baseline. Participants with baseline fentanyl positivity were 11 times less likely to initiate XR-NTX than those negative for fentanyl (aHR = 0.09, 95% CI 0.03-0.24, p < .001), but there was no evidence that fentanyl use impacted the likelihood of TAU initiation (aHR = 1.50, 0.67-3.36, p = .323). Baseline fentanyl use was not associated with persistence or retention on any MOUD. CONCLUSIONS: Fentanyl use was a substantial barrier to XR-NTX initiation for the treatment of OUD in persons with uncontrolled HIV infection. There was no evidence that fentanyl use impacted partial/full agonist initiation and, once initiated, retention on any MOUD.

Illinois Unidos: A Community Demands Equity, Justice, and Inclusion.

At the onset of the COVID-19 pandemic, neither government officials nor members of the news media fully grasped what was happening in the Latino community. Underreporting of COVID-19 cases led to a systematic neglect of the Latino population and resulted in disproportionately high rates of infection, hospitalization, and death. Illinois Unidos was formed to engage in community mobilization, health communication, advocacy, and policy work in response to inequalities exacerbated by COVID-19 in Latino communities in Illinois. (Am J Public Health. 2021;111(S3):S204-S207. https://doi.org/10.2105/AJPH.2021.306407).

Care Facilitation Advances Movement Along the Hepatitis C Care Continuum for Persons With Human Immunodeficiency Virus, Hepatitis C, and Substance Use: A Randomized Clinical Trial (CTN-0064).

BACKGROUND: Direct-acting antivirals can cure hepatitis C virus (HCV). Persons with HCV/HIV and living with substance use are disadvantaged in benefiting from advances in HCV treatment. METHODS: In this randomized controlled trial, participants with HCV/HIV were randomized between February 2016 and January 2017 to either care facilitation or control. Twelve-month follow-up assessments were completed in January 2018.Care facilitation group participants received motivation and strengths-based case management addressing retrieval of HCV viral load results, engagement in HCV/HIV care, and medication adherence. Control group participants received referral to HCV evaluation and an offer of assistance in making care appointments. Primary outcome was number of steps achieved along a series of 8 clinical steps (eg, receiving HCV results, initiating treatment, sustained virologic response [SVR]) of the HCV/HIV care continuum over 12 months postrandomization. RESULTS: Three hundred eighty-one individuals were screened and 113 randomized. Median age was 51 years; 58.4% of participants were male and 72.6% were Black/African American. Median HIV-1 viral load was 27 209 copies/mL, with 69% having a detectable viral load. Mean number of steps completed was statistically significantly higher in the intervention group vs controls (2.44 vs 1.68 steps; χ 2 [1] = 7.36, P = .0067). Men in the intervention group completed a statistically significantly higher number of steps than controls. Eleven participants achieved SVR with no difference by treatment group. CONCLUSIONS: The care facilitation intervention increased progress along the HCV/HIV care continuum, as observed for men and not women. Study findings also highlight continued challenges to achieve individual-patient SVR and population-level HCV elimination. CLINICAL TRIALS REGISTRATION: NCT02641158.

Challenges and Barriers to HIV Care for Mexican Born Men Living in Chicago.

BACKGROUND: Latinx men are disproportionately impacted by HIV. Research often looks at Latinx people as a heterogeneous population. This paper describes baseline characteristics and barriers to HIV care among Mexican born men enrolled in an HIV care engagement intervention at a public health clinic in Chicago. METHODS: Survey and medical chart data were collected. RESULTS: 66 Mexican born men enrolled in the project. Over half (60%) were newly diagnosed; 40% were reengaging in care or establishing care for the first time. Participants reported significant pre and postmigration concerns including poverty, social stigma, late entry to care, and concurrent health concerns, including 47% screening positive for depression. Barriers to care and mental health concerns were significantly related to Stage 3 HIV. DISCUSSION: More prevention and intervention research is needed to ameliorate the negative socioeconomic and health ramifications of immigration and bolster mental and sexual health, reduce HIV transmission, and increase testing, linkage and care retention.

Proyecto Promover: Attempts to Roll Out an HIV Prevention and Testing Initiative Within a Mexican Immigrant Community.

Latinx immigrants and men, in particular, living in the US are disproportionally impacted by HIV. Despite these concerns, there is limited research on the development, implementation, and evaluation of community-based HIV education and HIV testing interventions. The current study describes such efforts within a historic Mexican immigrant enclave in Chicago. A mixed-methods case study was used to describe intervention development, as well as preliminary evaluation data. Community intervention components were refined through early focus groups, asset mapping, community networking and consultation with cultural advisors. We exceeded our activity goals. We were successful in reaching a segment of the population that is often overlooked and remains unaware of HIV and its risks. Incorporating social network approaches could facilitate reaching at-risk community groups. Demonstration projects require more time and resources (fiscal and technical) to develop, refine, evaluate and sustain community-level intervention components.

Feasibility and safety of extended-release naltrexone treatment of opioid and alcohol use disorder in HIV clinics: a pilot/feasibility randomized trial.

BACKGROUND AND AIMS: HIV-infected people with substance use disorders are least likely to benefit from advances in HIV treatment. Integration of extended-release naltrexone (XR-NTX) into HIV clinics may increase engagement in the HIV care continuum by decreasing substance use. We aimed to compare (1) XR-NTX treatment initiation, (2) retention and (3) safety of XR-NTX versus treatment as usual (TAU) for treating opioid use disorder (OUD) and/or alcohol use disorder (AUD) in HIV clinics. DESIGN: Non-blinded randomized trial of XR-NTX versus pharmacotherapy TAU. SETTING: HIV primary care clinics in Vancouver, BC, Canada and Chicago, IL, USA. PARTICIPANTS: Fifty-one HIV-infected patients seeking treatment for OUD (n = 16), AUD (n = 27) or both OUD and AUD (n = 8). MEASUREMENTS: Primary outcomes were XR-NTX initiation (receipt of first injection within 4 weeks of randomization) and retention at 16 weeks. Secondary outcomes generated point estimates for change in substance use, HIV viral suppression [HIV RNA polymerase chain reaction (pcr) < 200 copies/ml] and safety. FINDINGS: Two-thirds (68%) of participants assigned to XR-NTX initiated treatment, and 88% of these were retained on XR-NTX at 16 weeks. In comparison, 96% of TAU participants initiated treatment, but only 50% were retained on medication at 16 weeks. Mean days of opioid use in past 30 days decreased from 17.3 to 4.1 for TAU and from 20.3 to 7.7 for XR-NTX. Mean heavy drinking days decreased from 15.6 to 5.7 for TAU and 12.5 to 2.8 for XR-NTX. Among those with OUD, HIV suppression improved from 67 to 80% for XR-NTX and 58 to 75% for TAU. XR-NTX was well tolerated, with no precipitated withdrawals and one serious injection-site reaction. CONCLUSIONS: Extended-release naltrexone (XR-NTX) is feasible and safe for treatment of opioid use disorder and alcohol use disorder in HIV clinics. Treatment initiation appears to be lower and retention greater for XR-NTX compared with treatment as usual (clinicaltrials.gov NCT01908062).

Effect of Patient Navigation With or Without Financial Incentives on Viral Suppression Among Hospitalized Patients With HIV Infection and Substance Use: A Randomized Clinical Trial.

IMPORTANCE: Substance use is a major driver of the HIV epidemic and is associated with poor HIV care outcomes. Patient navigation (care coordination with case management) and the use of financial incentives for achieving predetermined outcomes are interventions increasingly promoted to engage patients in substance use disorders treatment and HIV care, but there is little evidence for their efficacy in improving HIV-1 viral suppression rates. OBJECTIVE: To assess the effect of a structured patient navigation intervention with or without financial incentives to improve HIV-1 viral suppression rates among patients with elevated HIV-1 viral loads and substance use recruited as hospital inpatients. DESIGN, SETTING, AND PARTICIPANTS: From July 2012 through January 2014, 801 patients with HIV infection and substance use from 11 hospitals across the United States were randomly assigned to receive patient navigation alone (n = 266), patient navigation plus financial incentives (n = 271), or treatment as usual (n = 264). HIV-1 plasma viral load was measured at baseline and at 6 and 12 months. INTERVENTIONS: Patient navigation included up to 11 sessions of care coordination with case management and motivational interviewing techniques over 6 months. Financial incentives (up to $1160) were provided for achieving targeted behaviors aimed at reducing substance use, increasing engagement in HIV care, and improving HIV outcomes. Treatment as usual was the standard practice at each hospital for linking hospitalized patients to outpatient HIV care and substance use disorders treatment. MAIN OUTCOMES AND MEASURES: The primary outcome was HIV viral suppression (≤200 copies/mL) relative to viral nonsuppression or death at the 12-month follow-up. RESULTS: Of 801 patients randomized, 261 (32.6%) were women (mean [SD] age, 44.6 years [10.0 years]). There were no differences in rates of HIV viral suppression versus nonsuppression or death among the 3 groups at 12 months. Eighty-five of 249 patients (34.1%) in the usual-treatment group experienced treatment success compared with 89 of 249 patients (35.7%) in the navigation-only group for a treatment difference of 1.6% (95% CI, -6.8% to 10.0%; P = .80) and compared with 98 of 254 patients (38.6%) in the navigation-plus-incentives group for a treatment difference of 4.5% (95% CI -4.0% to 12.8%; P = .68). The treatment difference between the navigation-only and the navigation-plus-incentives group was -2.8% (95% CI, -11.3% to 5.6%; P = .68). CONCLUSIONS AND RELEVANCE: Among hospitalized patients with HIV infection and substance use, patient navigation with or without financial incentives did not have a beneficial effect on HIV viral suppression relative to nonsuppression or death at 12 months vs treatment as usual. These findings do not support these interventions in this setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01612169.

HIV treatment outcomes among HIV-infected, opioid-dependent patients receiving buprenorphine/naloxone treatment within HIV clinical care settings: results from a multisite study.

BACKGROUND: Having opioid dependence and HIV infection are associated with poor HIV-related treatment outcomes. METHODS: HIV-infected, opioid-dependent subjects (N = 295) recruited from 10 clinical sites initiated buprenorphine/naloxone (BUP/NX) and were assessed at baseline and quarterly for 12 months. Primary outcomes included receiving antiretroviral therapy (ART), HIV-1 RNA suppression, and mean changes in CD4 lymphocyte count. Analyses were stratified for the 119 subjects not on ART at baseline. Generalized estimating equations were deployed to examine time-dependent correlates for each outcome. RESULTS: At baseline, subjects on ART (N = 176) were more likely than those not on ART (N = 119) to be older, heterosexual, have lower alcohol addiction severity scores, and lower HIV-1 RNA levels; they were less likely to be homeless and report sexual risk behaviors. Subjects initiating BUP/NX (N = 295) were significantly more likely to initiate or remain on ART and improve CD4 counts over time compared with baseline; however, these improvements were not significantly improved by longer retention on BUP/NX. Retention on BUP/NX for three or more quarters was, however, significantly associated with increased likelihood of initiating ART (ß = 1.34 [1.18, 1.53]) and achieve viral suppression (ß = 1.25 [1.10, 1.42]) for the 64 of 119 (54%) subjects not on ART at baseline compared with the 55 subjects not retained on BUP/NX. In longitudinal analyses, being on ART was positively associated with increasing time of observation from baseline and higher mental health quality of life scores (ß = 1.25 [1.06, 1.46]) and negatively associated with being homo- or bisexual (ß = 0.55 [0.35, 0.97]), homeless (ß = 0.58 [0.34, 0.98]), and increasing levels of alcohol addiction severity (ß = 0.17 [0.03, 0.88]). The strongest correlate of achieving viral suppression was being on ART (ß = 10.27 [5.79, 18.23]). Female gender (ß = 1.91 [1.07, 3.41]), Hispanic ethnicity (ß = 2.82 [1.44, 5.49]), and increased general health quality of life (ß = 1.02 [1.00,1.04]) were also independently correlated with viral suppression. Improvements in CD4 lymphocyte count were significantly associated with being on ART and increased over time. CONCLUSIONS: Initiating BUP/NX in HIV clinical care settings is feasible and correlated with initiation of ART and improved CD4 lymphocyte counts. Longer retention on BPN/NX was not associated with improved prescription of ART, viral suppression, or CD4 lymphocyte counts for the overall sample in which the majority was already prescribed ART at baseline. Among those retained on BUP/NX, HIV treatment outcomes did not worsen and were sustained. Increasing time on BUP/NX, however, was especially important for improving HIV treatment outcomes for those not on ART at baseline, the group at highest risk for clinical deterioration. Retaining subjects on BUP/NX is an important goal for sustaining HIV treatment outcomes for those on ART and improving them for those who are not. Comorbid substance use disorders (especially alcohol), mental health problems, and quality-of-life indicators independently contributed to HIV treatment outcomes among HIV-infected persons with opioid dependence, suggesting the need for multidisciplinary treatment strategies for this population.

Hepatic safety and lack of antiretroviral interactions with buprenorphine/naloxone in HIV-infected opioid-dependent patients.

BACKGROUND: The safety of buprenorphine/naloxone (bup/nx) in HIV-infected patients has not been established. Prior reports raise concern about hepatotoxicity and interactions with atazanavir. METHODS: We conducted a prospective cohort study of 303 opioid-dependent HIV-infected patients initiating bup/nx treatment. We assessed changes in aspartate aminotransferase (AST) and alanine aminotransferase (ALT) over time. We compared bup/nx doses in patients receiving the antiretroviral atazanavir to those not receiving atazanavir. We conducted surveillance for pharmacodynamic interactions. RESULTS: Median AST [37.0 vs. 37.0 units/liter (U/L) respective interquartile ranges (IQRs) 26-53 and 26-59] and ALT (33.0 vs. 33.0 U/L, respective IQRs 19-50 and 18-50) values did not change over time among 141 patients comparing pre-bup/nx exposure with post-bup/nx exposure measures. During bup/nx exposure, 207 subjects demonstrated no significant change in median AST (36.0 vs. 35.0 U/L, respective IQRs 25-57 and 25-61) and ALT (29.0 vs. 31.0 U/L, respective IQRs 19-50 and 18-50) values collected a median of 6 months apart. Analyses restricted to patients with hepatitis C and HIV co-infection yielded similar results, except a small but significant decrease in first to last AST, during treatment with bup/nx (P = 0.048). Mean bup/nx dose, ranging 16.0-17.8 mg, did not differ over time or with co-administration of atazanavir. No pharmacodynamic interactions were noted. CONCLUSIONS: Buprenorphine/naloxone did not produce measurable hepatic toxicity or pharmacodynamic interaction with atazanavir in HIV-infected opioid-dependent patients.

Metabolic syndrome and associated cardiovascular risk factors in the treatment of persons with human immunodeficiency virus and severe mental illness.

Over the past 15 years, novel pharmacologic treatments for the management of HIV/AIDS and severe mental illness have changed the prognosis and quality of life for millions of patients throughout the world. In HIV-infected patients, highly active antiretroviral therapy (HAART) has altered this epidemic in many countries and simpler, better-tolerated treatment regimens have resulted in many patients with HIV living longer and with an improved quality of life. In patients with severe mental illness, second generation antipsychotics (SGAs) or atypical antipsychotics have provided hope for many patients and families struggling with schizophrenia and bipolar disorder. Despite these advances in treatment, metabolic abnormalities, specifically the metabolic syndrome (MetS), are occurring at a greater incidence in both persons with HIV and persons with severe mental illness (SMI). Furthermore, patients with severe mental illness are becoming HIV-infected, and higher prevalence rates of severe mental illness are seen in HIV patients than the general population. This review examines the prevalence of metabolic abnormalities within each population and the impact of HAART and SGAs on the development of MetS. Overviewed are possible mechanisms for the development of MetS in these patients, standard monitoring protocols, and potential treatments for managing these metabolic issues. Finally, recommendations for monitoring and managing the intersecting, growing population of HIV/AIDS patients with severe mental illness are provided.