Improving the Delivery of Chronic Opioid Therapy Among People Living With Human Immunodeficiency Virus: A Cluster Randomized Clinical Trial (original) (raw)
Related papers
HIV Research & Clinical Practice, 2019
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-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). Conclusion: 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.
Toward Safer Opioid Prescribing in HIV care (TOWER): a mixed-methods, cluster-randomized trial
Addiction Science & Clinical Practice, 2022
Background: The 2016 U.S. Centers for Disease Control Opioid Prescribing Guideline (CDC Guideline) is currently being revised amid concern that it may be harmful to people with chronic pain on long-term opioid therapy (CP-LTOT). However, a methodology to faithfully implement the CDC guideline, measure prescriber adherence, and systematically test its effect on patient and public health outcomes is lacking. We developed and tested a CDC Guideline implementation strategy (termed TOWER), focusing on an outpatient HIV-focused primary care setting. Methods: TOWER was developed in a stakeholder-engaged, multi-step iterative process within an Information, Motivation and Behavioral Skills (IMB) framework of behavior change. TOWER consists of: 1) a patient-facing opioid management app (OM-App); 2) a progress note template (OM-Note) to guide the office visit; and 3) a primary care provider (PCP) training. TOWER was evaluated in a 9-month, randomized-controlled trial of HIV-PCPs (N = 11) and their patients with HIV and CP-LTOT (N = 40). The primary outcome was CDC Guideline adherence based on electronic health record (EHR) documentation and measured by the validated Safer Opioid Prescribing Evaluation Tool (SOPET). Qualitative data including one-on-one PCP interviews were collected. We also piloted patient-reported outcome measures (PROMs) reflective of domains identified as important by stakeholders (pain intensity and function; mood; substance use; medication use and adherence; relationship with provider; stigma and discrimination). Results: PCPs randomized to TOWER were 48% more CDC Guideline adherent (p < 0.0001) with significant improvements in use of: non-pharmacologic treatments, functional treatment goals, opioid agreements, prescription drug monitoring programs (PDMPs), opioid benefit/harm assessment, and naloxone prescribing. Qualitative data demonstrated high levels of confidence in conducting these care processes among intervention providers, and that OM-Note supported these efforts while experience with OM-App was mixed. There were no intervention-associated safety concerns (defined as worsening of any of the PROMs).
The Association of Chronic Pain and Long-Term Opioid Therapy with HIV Treatment Outcomes
Journal of acquired immune deficiency syndromes (1999), 2018
Chronic pain occurs in up to 85% of persons living with HIV (PLWH) and is commonly treated with long-term opioid therapy (LTOT). We investigated the impact of chronic pain and LTOT on HIV outcomes. This was prospective cohort study conducted between 7/2015-7/2016 in five HIV primary care clinics. Chronic pain was defined as ≥moderate pain for ≥3 months on the Brief Chronic Pain Questionnaire and ≥4/10 on the Pain Enjoyment of life and General activity (PEG) questionnaire. Chronic pain and LTOT were assessed at an index visit. Suboptimal retention, defined as at least one "no-show" to primary care, and virologic failure were measured over the subsequent year. Multivariable logistic regression models were built for each outcome adjusting for site. Among 2334 participants, 25% had chronic pain, 27% had suboptimal retention, 12% had virologic failure, and 19% were prescribed LTOT. Among individuals not on LTOT, chronic pain was associated with increased odds of suboptimal rete...
Ongoing Pain Despite Aggressive Opioid Pain Management Among Persons With HIV
The Clinical Journal of Pain, 2010
Background: Chronic pain is a common problem among persons living with HIV and opioids are frequently used in its treatment. However, data on the variables associated with opioids use and the efficacy of this practice are lacking. Methods: We performed a cross-sectional cohort study of selfreported pain during the year 2005 in our clinic. Patients were grouped into 3 cohorts: those receiving daily opioid therapy for chronic pain (cohort 1, n = 115), those with a chronic pain diagnosis but not on daily opioid therapy (cohort 2, n = 209), and those without a chronic pain diagnosis (cohort 3, n = 796). Results: In multivariate analysis comparing cohorts 1 and 2, patients in cohort 1 were significantly more likely to be on a benzodiazepine or gamma-aminobutyric receptor agonist [odds ratio (OR) = 15.2], have injection drug use as a HIV risk factor (OR = 4.27), lack private insurance (OR = 3.51), have been abused (OR = 3.08), have a history of AIDS (OR = 2.21), and be seen more frequently (OR = 1.18). Patients in cohort 1 reported significantly more pain [mean pain scores (0 to 10): 4.3 cohort 1; 1.9 cohort 2; 0.7 cohort 3], and were more likely to have pain that was of moderate or greater severity (58.6% cohort 1; 15.5% cohort 2; 4.9% cohort 3). Conclusions: Psychosocial variables and a history of AIDS were associated with opioid use in our clinic. Persons on opioids continued to experience significantly more pain than other patients in our clinic.
BMC Infectious Diseases, 2011
Background: HIV-infected drug users are at higher risk of non-adherence and poor treatment outcomes than HIVinfected non-drug users. Prior work from our group and others suggests that directly administered antiretroviral therapy (DAART) delivered in opioid treatment programs (OTPs) may increase rates of viral suppression. Methods/Design: We are conducting a randomized trial comparing DAART to self-administered therapy (SAT) in 5 OTPs in Baltimore, Maryland. Participants and investigators are aware of treatment assignments. The DAART intervention is 12 months. The primary outcome is HIV RNA < 50 copies/mL at 3, 6, and 12 months. To assess persistence of any study arm differences that emerge during the active intervention, we are conducting an 18-month visit (6 months after the intervention concludes). We are collecting electronic adherence data for 2 months in both study arms. Of 457 individuals screened, a total of 107 participants were enrolled, with 56 and 51 randomly assigned to DAART and SAT, respectively. Participants were predominantly African American, approximately half were women, and the median age was 47 years. Active use of cocaine and other drugs was common at baseline. HIV disease stage was advanced in most participants. The median CD4 count at enrollment was 207 cells/mm 3 , 66 (62%) had a history of an AIDS-defining opportunistic condition, and 21 (20%) were antiretroviral naïve.
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2018
Chronic opioid therapy (COT) is common in people living with HIV (PLHIV), but 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. COT was defined as ≥3 opioid prescriptions ≥21 days apart in the past 6 months. Demographics, substance use history, COMM™ score, and perceptions of and satisfaction with COT monitoring were assessed among PLHIV on COT from two HIV clinics. Participants (n=166) on COT were 66% male, 72% Black with median age of 54 (SD ±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. In their current clinic experience, 30% had an opioid treatment agreement, 66% a urine drug test (UDT), and 12% a pill count. Ninety percent acknowledged opioids can be addictive. Median (IQR) satisfaction levels (1-10, 10=highest), were 10 (7, 10) for opioid treatment ag...
Receipt of Opioid Analgesics by HIV-Infected and Uninfected Patients
Journal of General Internal Medicine, 2013
BACKGROUND: Opioids are increasingly prescribed, but there are limited data on opioid receipt by HIV status. OBJECTIVES: To describe patterns of opioid receipt by HIV status and the relationship between HIV status and receiving any, high-dose, and long-term opioids. DESIGN: Cross-sectional analysis of the Veterans Aging Cohort Study. PARTICIPANTS: HIV-infected (HIV+) patients receiving Veterans Health Administration care, and uninfected matched controls. MAIN MEASURES: Pain-related diagnoses were determined using ICD-9 codes. Any opioid receipt was defined as at least one opioid prescription; high-dose was defined as an average daily dose ≥120 mg of morphine equivalents; long-term opioids was defined as ≥90 consecutive days, allowing a 30 day refill gap. Multivariable models were used to assess the relationship between HIV infection and the three outcomes. KEY RESULTS: Among the HIV+ (n = 23,651) and uninfected (n=55,097) patients, 31 % of HIV+ and 28 % of uninfected (p<0.001) received opioids. Among patients receiving opioids, HIV+ patients were more likely to have an acute pain diagnosis (7 % vs. 4 %), but less likely to have a chronic pain diagnosis (53 % vs. 69 %). HIV+ patients received a higher mean daily morphine equivalent dose than uninfected patients (41 mg vs. 37 mg, p=0.001) and were more likely to receive high-dose opioids (6 % vs. 5 %, p<0.001). HIV+ patients received fewer days of opioids than uninfected patients (median 44 vs. 60, p<0.001), and were less likely to receive long-term opioids (31 % vs. 34 %, p< 0.001). In multivariable analysis, HIV+ status was associated with receipt of any opioids (AOR 1.40, 95 % CI 1.35, 1.46) and high-dose opioids (AOR 1.22, 95 % CI 1.07, 1.39), but not long-term opioids (AOR 0.94, 95 % CI 0.88, 1.01).
Open Forum Infectious Diseases, 2021
Background People who inject drugs (PWID) living with HIV experience inadequate access to antiretroviral treatment (ART) and medication for opioid use disorders (MOUD). HPTN 074 showed that an integrated intervention increased ART use and viral suppression over 52 weeks. To examine durability of ART, MOUD, and HIV viral suppression, participants could re-enroll for an extended follow-up period, during which standard-of-care (SOC) participants in need of support were offered the intervention. Methods Participants were recruited from Ukraine, Indonesia and Vietnam and randomly allocated 3:1 to SOC or intervention. Eligibility criteria included: HIV-positive; active injection drug use; 18-60 years of age; ≥1 HIV-uninfected injection partner; and viral load ≥1,000 copies/mL. Re-enrollment was offered to all available intervention and SOC arm participants, and SOC participants in need of support (off-ART or off-MOUD) were offered the intervention. Results The intervention continuation gr...
AIDS and Behavior
for your work collecting and analyzing the data used, as well as your expertise in research and scientific writing. I am extremely grateful to Sarah Dobbins for her unwavering encouragement and confidence in my abilities. Many thanks to my partner, close friends, and family for their continued support and patience as I embark on my new career as a Nurse Practitioner. Lastly, I would like to thank the individuals I have been honored to treat as my patients in clinic and work with as clients in syringe access, their stories, strength, and resilience is what has ultimately inspired me to a lifelong career of serving vulnerable populations as a nurse.