Study design and participant characteristics of a randomized controlled trial of directly administered antiretroviral therapy in opioid treatment programs (original) (raw)
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Clinical Infectious Diseases, 2020
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 recor...
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.
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...
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).
Clinical Infectious Diseases, 2016
Background. Human immunodeficiency virus (HIV)-infected people who inject drugs (PWID) frequently encounter barriers accessing and remaining on antiretroviral therapy (ART). Some studies have suggested that opioid substitution therapy (OST) could facilitate PWID's engagement with HIV services. We conducted a systematic review and meta-analysis to evaluate the impact of concurrent OST use on ART-related outcomes among HIV-infected PWID. Methods. We searched Medline, PsycInfo, Embase, Global Health, Cochrane, Web of Science, and Social Policy and Practice databases for studies between 1996 to November 2014 documenting the impact of OST, compared to no OST, on ART outcomes. Outcomes considered were coverage and recruitment onto ART, adherence, viral suppression, attrition from ART, and mortality. Meta-analyses were conducted using random-effects modeling, and heterogeneity assessed using Cochran Q test and I 2 statistic. Results. We identified 4685 articles, and 32 studies conducted in North America, Europe, Indonesia, and China were included. OST was associated with a 69% increase in recruitment onto ART (hazard ratio [HR], 1.69; 95% confidence interval [CI], 1.32-2.15), a 54% increase in ART coverage (odds ratio [OR], 1.54; 95% CI, 1.17-2.03), a 2-fold increase in adherence (OR, 2.14; 95% CI, 1.41-3.26), and a 23% decrease in the odds of attrition (OR, 0.77; 95% CI, .63-.95). OST was associated with a 45% increase in odds of viral suppression (OR, 1.45; 95% CI, 1.21-1.73), but there was limited evidence from 6 studies for OST decreasing mortality for PWID on ART (HR, 0.91; 95% CI, .65-1.25). Conclusions. These findings support the use of OST, and its integration with HIV services, to improve the HIV treatment and care continuum among HIV-infected PWID.
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...
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2016
People who inject drugs are at high risk of HIV infection but often face barriers in accessing medical care including access to antiretroviral therapy (ART). Evidence is available about the effectiveness of opioid agonist therapy on drug dependency and risk behaviors. However, it remains scattered regarding access to ART among HIV-positive people who inject drugs. We conducted a systematic review to examine the association of opioid agonist therapy with ART initiation among HIV-positive people who inject drugs. We searched the literature for evidence from seven databases. We conducted a narrative synthesis and meta-analysis to examine the association of opioid agonist therapy with ART initiation. Five out of 2,901 identified studies met the inclusion criteria. Three out of five studies reported that, HIV-positive people receiving opioid agonist therapy initiated ART more than those not receiving opioid agonist therapy. In meta-analysis, opioid agonist therapy was associated with ART...