Background. The aim of the study was to determine whether enhanced personal contact with human immunodeficiency virus (HIV)–infected patients across time improves retention in care compared with ...existing standard of care (SOC) practices, and whether brief skills training improves retention beyond enhanced contact. Methods. The study, conducted at 6 HIV clinics in the United States, included 1838 patients with a recent history of inconsistent clinic attendance, and new patients. Each clinic randomized participants to 1 of 3 arms and continued to provide SOC practices to all enrollees: enhanced contact with interventionist (EC) (brief face-to-face meeting upon returning for care visit, interim visit call, appointment reminder calls, missed visit call); EC + skills (organization, problem solving, and communication skills); or SOC only. The intervention was delivered by project staff for 12 months following randomization. The outcomes during that 12-month period were (1) percentage of participants attending at least 1 primary care visit in 3 consecutive 4-month intervals (visit constancy), and (2) proportion of kept/scheduled primary care visits (visit adherence). Results. Log-binomial risk ratios comparing intervention arms against the SOC arm demonstrated better outcomes in both the EC and EC + skills arms (visit constancy: risk ratio RR, 1.22 95% confidence interval {CI}, 1.09–1.36 and 1.22 95% CI, 1.09–1.36, respectively; visit adherence: RR, 1.08 95% CI, 1.05–1.11 and 1.06 95% CI, 1.02–1.09, respectively; all Ps < .01). Intervention effects were observed in numerous patient subgroups, although they were lower in patients reporting unmet needs or illicit drug use. Conclusions. Enhanced contact with patients improved retention in HIV primary care compared with existing SOC practices. A brief patient skill-building component did not improve retention further. Additional intervention elements may be needed for patients reporting illicit drug use or who have unmet needs. Clinical Trials Registration. CDCHRSA9272007.
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
Individuals living with HIV report disproportionately high levels of trauma exposure and PTSD symptoms, both which have been associated with suboptimal ART adherence. Often conflated, the question ...arises as to which construct is driving subsequent HIV self-care behavior. Given the HIV disparities among Black and Hispanic/Latinx individuals, and that Miami is a geographic region with a high racial/ethnic minority make up and a unique socioeconomic environment, it is important to explore factors related to HIV outcomes in Miami to mitigate its uncontrolled epidemic. This study aimed to examine the association of trauma exposure, PTSD symptoms, and relevant additional key factors with adherence to ART among a sample of majority Black and Hispanic/Latinx individuals who are economically marginalized receiving public HIV care in Miami, FL (
N
= 1237) via a cross-sectional survey. Sequential linear regression was used to examine the study aim in four blocks: (1) trauma, (2) PTSD symptoms, and key covariates of ART adherence including (3) depression and substance use (potential psychological covariates), and (4) indicators of socioeconomic status (potential structural covariates). In the first block, trauma exposure was associated with worse adherence. However, in the second block, the association with trauma dropped and PTSD was significantly associated with worse adherence. Of note, for those experiencing high levels of trauma exposure, adherence was negatively impacted regardless of PTSD. When other key factors associated with adherence were entered in the third and fourth blocks, neither trauma exposure nor PTSD were uniquely significant. In this final model, depression, substance use, and unstable housing were uniquely associated with worse adherence. Trauma-informed models of HIV care that holistically address co-occurring factors are warranted to cater to communities with HIV health disparities and keep them from falling off the HIV care continuum.
The HIV/AIDS epidemic remains a major public health concern since the 1980s; untreated HIV infection has numerous consequences on quality of life. To optimize patients’ health outcomes and to reduce ...HIV transmission, this study focused on vulnerable populations of people living with HIV (PLWH) and compared different predictive strategies for viral suppression using longitudinal or repeated measures. The four methods of predicting viral suppression are (1) including the repeated measures of each feature as predictors, (2) utilizing only the initial (baseline) value of the feature as predictor, (3) using the last observed value as the predictors and (4) using a growth curve estimated from the features to create individual-specific prediction of growth curves as features. This study suggested the individual-specific prediction of the growth curve performed the best in terms of lowest error rate on an independent set of test data.
Abstract
The concept of “undetectable = untransmittable (U = U)” has been revolutionary in both the prevention and treatment of persons with human immunodeficiency virus (HIV). Most studies proving ...the concept of U = U used an HIV RNA (viral load VL) cutoff of 200 copies/mL to define being undetectable. Since then, increasingly sensitive commercial VL assays, sometimes down to a lower limit of detection (LLD) of 20 copies/mL, lead to confusion about the definition of “undetectable” and when someone is truly considered untransmittable. VLs between the LLD and 200 copies/mL have been associated with future virologic failure; however, no data exist to suggest that intervening in those patients leads to any meaningful benefits. In the absence of a demonstrable benefit of reporting such low VLs, we view this practice as harmful. We suggest recommendations for adjusting VL reporting and improving provider counseling, and call for research designs to mitigate the harms of overly sensitive VL testing.
Overly sensitive HIV viral load assays complicate the straightforward, transformative concept of “U=U”. In the absence of demonstrable benefits of reporting low viral load values (<200 copies/mL), we consider this to be a harmful practice and suggest mitigation strategies.
Reply to Alvarez and Llibre Serota, David P; Rodriguez, Maria G; Syros, Alina ...
Open forum infectious diseases,
02/2024, Letnik:
11, Številka:
2
Journal Article
OBJECTIVE:We examined HIV transmission potential of patients in care by analyzing the amount of person-time spent above a viral load threshold that increases risk for transmission.
...DESIGN:Observational cohort and supplemental data.
METHODS:The cohort included HIV patients who received care at six HIV clinics in the United States, from 1 April 2009 to 31 March 2013, and had two or more viral load tests during this interval. Person-time (in days) above a viral load of 1500 copies/ml out of the total observation time was determined by inspecting consecutive pairs of viral load results and the time intervals between those pairs. The person-time rate ratios comparing demographic and clinical subgroups were estimated with Poisson regression.
RESULTS:The cohort included 14 532 patients observed for a median of 1073 days with a median of nine viral load records. Ninety percent of the patients had been prescribed antiretroviral therapy. On average, viral load exceeded 1500 copies/ml during 23% of the patients’ observation time (average of 84 days per year, per patient). Percentage of person-time above the threshold was higher among patients who had more than a fourth of their viral load pairs exceeding a 6-month interval (34% of observation time), patients not on antiretroviral therapy (58% of time), new/re-engaging patients (34% of time), patients 16–39 years of age (32% of time), and patients of black race (26% of time).
CONCLUSION:HIV patients in care spent an average of nearly a quarter of their time with viral loads above 1500 copies/ml, higher among some subgroups, placing them at risk for potentially transmitting HIV to others.
Miami is a Southeastern United States (U.S.) city with high health, mental health, and economic disparities, high ethnic/racial diversity, low resources, and the highest HIV incidence and prevalence ...in the country. Syndemic theory proposes that multiple, psychosocial comorbidities synergistically fuel the HIV/AIDS epidemic. People living with HIV/AIDS in Miami may be particularly affected by this due to the unique socioeconomic context. From April 2017 to October 2018, 800 persons living with HIV/AIDS in a public HIV clinic in Miami completed an interviewer-administered behavioral and chart-review cross-sectional assessment to examine the prevalence and association of number of syndemics (unstable housing, low education, depression, anxiety, binge drinking, drug use, violence, HIV-related stigma) with poor ART adherence, unsuppressed HIV viral load (≥ 200 copies/mL), and biobehavioral transmission risk (condomless sex in the context of unsuppressed viral load). Overall, the sample had high prevalence of syndemics (
M
= 3.8), with almost everyone (99%) endorsing at least one. Each syndemic endorsed was associated with greater odds of: less than 80% ART adherence (aOR 1.64, 95% CI 1.38, 1.98); having unsuppressed viral load (aOR 1.16, 95% CI 1.01, 1.33); and engaging in condomless sex in the context of unsuppressed viral load (1.78, 95% CI 1.30, 2.46). The complex syndemic of HIV threatens to undermine the benefits of HIV care and are important to consider in comprehensive efforts to address the disproportionate burden of HIV/AIDS in the Southern U.S. Achieving the 90-90-90 UNAIDS and the recent U.S. “ending the epidemic” targets will require efforts addressing the structural, social, and other syndemic determinants of HIV treatment and prevention.
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.
Hospitalizations for severe injection-related infections (SIRI), such as endocarditis, osteomyelitis, and skin and soft tissue infections (SSTI) are increasingly common. People who inject drugs ...(PWID) experiencing SIRIs often receive inadequate substance use disorder (SUD) treatment and lack of access to harm reduction services. This translates into lengthy hospitalizations with high rates of patient-directed discharge, readmissions, and post-hospitalization mortality. The purpose of this study was to describe the development of an integrated "SIRI Team" and its initial barriers and facilitators to success.
The Jackson SIRI Team was developed to improve both hospital and patient-level outcomes for individuals hospitalized with SIRIs at Jackson Memorial Hospital, a 1550-bed public hospital in Miami, Florida, United States. The SIRI Team provides integrated infectious disease and SUD treatment across the healthcare system starting from the inpatient setting and continuing for 90-days post-hospital discharge. The team uses a harm reduction approach, provides care coordination, focuses on access to medications for opioid use disorder (MOUD), and utilizes a variety of infection and addiction treatment modalities to suit each individual patient.
Over the initial 8-months of the SIRI Team, 21 patients were treated with 20 surviving until discharge. Infections included osteomyelitis, endocarditis, bacteraemia/fungemia, SSTIs, and septic arthritis. All patients had OUD and 95% used stimulants. All patients were discharged on MOUD and 95% completed their prescribed antibiotic course. At 90-days post-discharge, 25% had been readmitted and 70% reported taking MOUD.
A model of integrated infectious disease and SUD care for the treatment of SIRIs has the potential to improve infection and addiction outcomes. Providing attentive, patient-centered care, using a harm reduction approach can facilitate engagement of this marginalized population with the healthcare system.
KEY MESSAGES
Integrated infectious disease and addiction treatment is a novel approach to treating severe injection-related infections.
Harm reduction should be applied to treating patients with severe injection-related infections with a goal of facilitating antibiotic completion, remission from substance use disorder, and reducing hospital readmissions.
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