Improving the Delivery of Chronic Opioid Therapy Among People Living With Human Immunodeficiency Virus: A Cluster Randomized Clinical Trial.

BACKGROUND: Chronic pain is prevalent among people living with human immunodeficiency virus (PLWH); managing pain with chronic opioid therapy (COT) is common. Human immunodeficiency virus (HIV) providers often diverge from prescribing guidelines. METHODS: This 2-arm, unblinded, cluster-randomized clinical trial assessed whether the Targeting Effective Analgesia in Clinics for HIV (TEACH) intervention improves guideline-concordant care compared to usual care for PLWH on COT. The trial was implemented from 2015 to 2018 with 12-month follow-up at safety-net hospital-based HIV clinics in Boston and Atlanta. We enrolled 41 providers and their 187 patients on COT. Prescribers were randomized 1:1 to either a 12-month intervention consisting of a nurse care manager with an interactive electronic registry, opioid education, academic detailing, and access to addiction specialists or a control condition consisting of usual care. Two primary outcomes were assessed through electronic medical records: ≥2 urine drug tests and any early COT refills by 12 months. Other outcomes included possible adverse consequences. RESULTS: At 12 months, the TEACH intervention arm had higher odds of ≥2 urine drug tests than the usual care arm (71% vs 20%; adjusted odds ratio [AOR], 13.38 [95% confidence interval {CI}, 5.85-30.60]; P < .0001). We did not detect a statistically significant difference in early refills (22% vs 30%; AOR, 0.55 [95% CI, .26-1.15]; P = .11), pain severity (6.30 vs 5.76; adjusted mean difference, 0.10 [95% CI, -1.56 to 1.75]; P = .91), or HIV viral load suppression (86.9% vs 82.1%; AOR, 1.21 [95% CI, .47-3.09]; P = .69). CONCLUSIONS: TEACH is a promising intervention to improve adherence to COT guidelines without evident adverse consequences.

Chronic Opioid Therapy in People Living With Human Immunodeficiency Virus: Patients' Perspectives on Risks, Monitoring, and Guidelines.

Background: Chronic opioid therapy (COT) is common in people living with human immunodeficiency virus (PLHIV), but is not well studied. We assessed opioid risk behaviors, perceptions of risk, opioid monitoring, and associated Current Opioid Misuse Measure (COMM) scores of PLHIV on COT. Methods: COT was defined as ≥3 opioid prescriptions ≥21 days apart in the past 6 months. Demographics, substance use, COMM score, and perceptions of and satisfaction with COT monitoring were assessed among PLHIV on COT from 2 HIV clinics. Results: Among participants (N = 165) on COT, 66% were male and 72% were black, with a median age of 55 (standard deviation, 8) years. Alcohol and drug use disorders were present in 17% and 19%, respectively. In 43%, the COMM score, a measure of potential opioid misuse, was high. Thirty percent had an opioid treatment agreement, 66% a urine drug test (UDT), and 12% a pill count. Ninety percent acknowledged opioids' addictive potential. Median (interquartile range) satisfaction levels (1-10 [10 = highest]) were 10 (7-10) for opioid treatment agreements, 9.5 (6-10) for pill counts, and 10 (8-10) for UDT. No association was found between higher COMM score and receipt of or satisfaction with COT monitoring. Conclusions: Among PLHIV on COT, opioid misuse and awareness of the addictive potential of COT are common, yet COT monitoring practices were not guideline concordant. Patients who received monitoring practices reported high satisfaction. Patient attitudes suggest high acceptance of guideline concordant care for PLHIV on COT when it occurs.

Provider opioid prescribing practices and the belief that opioids keep people living with HIV engaged in care: a cross-sectional study.

We describe HIV providers' opioid prescribing practices and assess whether belief that chronic opioid therapy (COT) keeps people living with HIV (PLWH) engaged in care is associated with differences in these practices among providers from two HIV clinics. We conducted logistic regression to evaluate the association between the belief that COT keeps PLWH engaged in care and at least one component of guideline-recommended care (i.e., urine drug tests, treatment agreements, and/or prescription monitoring program use). The sample included 41 providers with a median age of 42 years, 63% female, 37% non-white. Routine adherence to guideline-recommended practices was: 34% urine drug tests, 27% treatment agreements, and 17% prescription monitoring program. Over half [54%] agreed that COT keeps PLWH engaged in care. There was no significant association between belief that COT keeps PLWH engaged in care and routinely providing any recommended COT care component (aOR 2.38; 95% CI 0.65-8.73). Most HIV providers do not routinely follow guidelines for opioid prescribing. We observed a positive association between belief that COT keeps PLWH engaged in care and following any guideline-recommended prescribing practices, although the result was not statistically significant. Interventions are needed to improve guideline-concordant care for COT by HIV providers.

Continuous Retention and Viral Suppression Provide Further Insights Into the HIV Care Continuum Compared to the Cross-sectional HIV Care Cascade.

BACKGROUND: The human immunodeficiency virus (HIV) care continuum has become an important tool for evaluating HIV care. Current depictions of the care continuum are often cross-sectional and evaluate retention and viral suppression (VS) in a single year, yet the National HIV/AIDS Strategy calls for programs with long-lasting outcomes. METHODS: Retrospective chart review of HIV-infected patients enrolled in a large, urban clinic in 2010 followed longitudinally for 36 months. McNemar comparisons and logistic regression analyses were conducted to evaluate covariate association with continuous retention and VS. Generalized estimating equation log-linear models were used to integrate time into the model. RESULTS: Among 655 patients (77% male, 83% black, 54% men who have sex with men (MSM), 78% uninsured) continuous retention/VS at 12 months (84%/64%), 24 months (60%/48%), and 36 months (49%/39%) showed significant attrition (P < .0001) over time. Continuous retention was associated with prevalent VS at the end of 36 months (adjusted prevalence ratio 3.12; 95% confidence interval [CI], 2.40, 4.07). 12-month retention for black (84%) and nonblack (85%) patients was equivalent, yet fewer blacks (46%) than nonblacks (63%) achieved 36-month continuous retention due to a significant interaction between race and time (aOR 0.75, 95% CI, .59, .95). CONCLUSIONS: Continuous retention is a critically important measure of long-term success in HIV treatment and the crucial component of successful treatment-as-prevention but is infrequently evaluated. Single cross-sections may overestimate successful retention and virologic outcomes. A longitudinal HIV care continuum provides greater insight into long-term outcomes and exposes disparities not evident with traditional cross-sectional care continua.

A collaborative care intervention to improve opioid prescribing among providers caring for persons with HIV: Impact on satisfaction, confidence, and trust.

BACKGROUND: HIV clinicians report low confidence and satisfaction prescribing chronic opioid therapy (COT). We hypothesized that the Targeting Effective Analgesia in Clinics for HIV (TEACH) intervention [a system-level improvement to increase guideline concordant care for COT] would improve satisfaction, confidence, and trust among PWH and their clinicians. METHODS: We conducted a two-arm, unblinded cluster randomized controlled trial (RCT) to assess the TEACH intervention. Clinicians were randomized in a 1:1 ratio to receive either the TEACH intervention (an IT-enabled nurse care manager, opioid education, academic detailing, and access to addiction specialists) or usual care. Outcomes were the following: clinician satisfaction (primary); confidence prescribing COT; patient satisfaction with COT; and trust in clinician. Intention-to-treat analyses were conducted using linear and logistic regression models. RESULTS: Clinicians (n = 41) were randomized and their 114 patients assessed. At 12 months, the adjusted mean difference in satisfaction with COT was 1.11 points for intervention vs control clinicians (Scale 1-10; 95% confidence interval [CI]: -0.04 to 2.26, p = 0.06). The adjusted mean confidence with prescribing COT was 1.01 points higher among intervention clinicians (Scale 1-10; 95% CI: 0.05-1.96, p = 0.04). There were no significant differences in patient satisfaction with COT (adjusted odds ratio (AOR) 1.17, 95% CI: 0.50-2.76, p = 0.72) or trust in provider (AOR 1.63, 95% CI: 0.65-4.09, p = 0.30). CONCLUSIONS: TEACH did not significantly affect prescriber satisfaction, patient satisfaction with pain management or patient trust; however, it did improve prescriber confidence. TEACH is a promising strategy to improve provider prescribing of COT for PWH without adverse patient satisfaction or trust in provider.

Study protocol for the targeting effective analgesia in clinics for HIV (TEACH) study - a cluster randomized controlled trial and parallel cohort to increase guideline concordant care for long-term opioid therapy among people living with HIV.

Background: People living with HIV (PLWH) frequently experience chronic pain and receive long-term opioid therapy (LTOT). Adherence to opioid prescribing guidelines among their providers is suboptimal. Objective: This paper describes the protocol of a cluster randomized trial, targeting effective analgesia in clinics for HIV (TEACH), which tested a collaborative care intervention to increase guideline-concordant care for LTOT among PLWH. Methods: HIV physicians and advanced practice providers (n = 41) were recruited from September 2015 to December 2016 from two HIV clinics in Boston and Atlanta. Patients receiving LTOT from participating providers were enrolled through a waiver of informed consent (n = 187). After baseline assessment, providers were randomized to the control group or the year-long TEACH intervention involving: (1) a nurse care manager and electronic registry to assist with patient management; (2) opioid education and academic detailing; and (3) facilitated access to addiction specialists. Randomization was stratified by site and LTOT patient volume. Primary outcomes (≥2 urine drug tests, early refills, provider satisfaction) were collected at 12 months. In parallel, PLWH receiving LTOT (n = 170) were recruited into a longitudinal cohort at both clinics and underwent baseline and 12-month assessments. Secondary outcomes were obtained through patient self-report among participants enrolled in both the cohort and the RCT (n = 117). Conclusions: TEACH will report the effects of an intervention on opioid prescribing for chronic pain on both provider and patient-level outcomes. The results may inform delivery of care for PLWH on LTOT for chronic pain at a time when opioid practices are being questioned in the US.

The Perilous Road from HIV Diagnosis in the Hospital to Viral Suppression in the Outpatient Clinic.

The HIV care continuum has received considerable attention in recent years, however, few care continua focus on the population of patients who are diagnosed during an inpatient hospital admission. We aimed to describe the HIV care continuum for patients newly diagnosed during hospitalization through 24-month follow-up. A retrospective chart review of HIV patients diagnosed at Grady Memorial Hospital from 2011 to 2012 was performed and records were matched to Georgia Department of Public Health HIV/AIDS surveillance data. Descriptive statistics and statistical tests of independence were utilized. Ninety-four new diagnoses were confirmed during the 2-year study period. Median age was 43 years (interquartile range [IQR] 30-51), 77% were male, 72% were non-Hispanic Black, 31% were men who have sex with men (MSM), and 77% were uninsured. Median CD4 count at diagnosis was 134 cells/µL (IQR 30-307). Eighty-four percent received their diagnosis before hospital discharge, 68% linked to care by 90 days, 73% were retained for 12 months, 48% were virologically suppressed by 12 months, 58% were retained for 24 continuous months, and 38% achieved continuous viral suppression (VS) during the initial 24 months after diagnosis. Late diagnosis is a persistent problem in hospitalized patients. Despite relative success with linkage to care and 12-month retention in care, a minority of patients maintained retention and VS for 24 continuous months.

Delivering a "dose of hope": a faith-based program to increase older african americans' participation in clinical trials.

BACKGROUND: Underrepresentation of older-age racial and ethnic minorities in clinical research is a significant barrier to health in the United States, as it impedes medical research advancement of effective preventive and therapeutic strategies. OBJECTIVE: The objective of the study was to develop and test the feasibility of a community-developed faith-based intervention and evaluate its potential to increase the number of older African Americans in clinical research. METHODS: Using a cluster-randomized design, we worked with six matched churches to enroll at least 210 persons. We provided those in the intervention group churches with three educational sessions on the role of clinical trials in addressing health disparity topics, and those in the comparison group completed surveys at the same timepoints. All persons enrolled in the study received ongoing information via newsletters and direct outreach on an array of clinical studies seeking participants. We evaluated the short-, mid-, and longer-term effects of the interventional program on clinical trial-related outcomes (ie, screening and enrollment). RESULTS: From 2012 to 2013, we enrolled a balanced cohort of 221 persons in the program. At a 3-month follow-up, mean intention to seek information about clinical trials was higher than baseline in both treatment (mu=7.5/10; sigma=3.1) and control arms (mu=6.6/10; sigma=3.3), with the difference more pronounced in the treatment arm. The program demonstrated strong retention at 3-month (95.4%, 211/221) and 6-month timepoints (94.1%, 208/221). CONCLUSIONS: The "Dose of Hope" program addressed an unmet need to reach an often overlooked audience of older African Americans who are members of churches and stimulate their interest in clinical trial participation. The program demonstrated its appeal in the delivery of effective messages and information about health disparities, and the role of clinical research in addressing these challenges.