The impact of emergency guidance to the COVID-19 pandemic on treatment entry, retention and mortality among patients on methadone in Ukraine.

BACKGROUND AND AIMS: Ukraine's Ministry of Health released urgent COVID-19 guidelines, allowing for early implementation of take-home dosing (THD) for opioid agonist therapies (OAT) such as methadone. Enrollment in OAT and retention in the program are the most effective HIV prevention strategies for people who inject drugs (PWID). This study aimed to evaluate the impact of Ukraine's COVID-19 emergency guidance on OAT treatment enrollment, retention on treatment and mortality. DESIGN AND SETTING: Using Ukraine's national OAT registry for 252 governmental clinics across 25 regions, we conducted a 12-month comparative prospective cohort survival analysis. This study compared newly enrolled methadone patients within the initial 6 months following the COVID-19 guidance (COVID) with patients from the preceding year (pre-COVID) in a country with high adult HIV prevalence (1.2%) that is concentrated in PWID. PARTICIPANTS: In the nation-wide sample of newly enrolled PWID in Ukraine, comprising 2798 individuals, 1423 were in the COVID cohort and 1375 were in the pre-COVID cohort. The majority were male (86.7%), with an average age of 39.3 years. MEASUREMENTS: Primary outcomes were average monthly enrollment per cohort, treatment retention and mortality, with internal time-dependent predictors, including THD and optimal (> 85 mg) methadone dosing. RESULTS: Relative to the pre-COVID period, the monthly average patient enrollment was statistically significantly higher during the COVID period (283.7 versus 236.0; P < 0.0001), where patients were more likely to transition to THD and achieve optimal dosing earlier. Significant differences were observed in the proportions of person-months on THD (41 versus 13%, P < 0.0001) and optimal dosing (38 versus 31%, P < 0.0001) between the COVID and pre-COVID cohorts. Predictors of treatment retention, expressed as adjusted hazard ratios (aHR), included early THD [aHR = 1.90, 95% confidence interval (CI) = 1.47-2.45], early optimal dosing (aHR = 1.71, 95% CI = 1.37-2.13) and prior methadone treatment (aHR = 1.39, 95% CI = 1.15-1.68). These factors persisted, respectively, in the pre-COVID (aHR = 2.28, 95% CI = 1.41-3.70; aHR = 1.84, 95% CI = 1.32-2.56; and aHR = 1.36, 95% CI = 1.06-1.74) and COVID (aHR = 1.91, 95% CI = 1.40-2.59; aHR = 1.61, 95% CI = 1.20-2.16; and aHR = 1.49, 95% CI = 1.08-1.94) cohorts. Survival did not differ significantly between the two prospective cohorts. CONCLUSION: Ukraine's prompt adoption of early take-home dosing for opioid agonist therapies, such as methadone, following the emergency COVID-19 guidance appears to have increased enrollment into methadone and improved treatment retention for people who inject drugs without adverse effects on patient survival.

Aligning public health and public safety: Probation as a touchpoint to identify and link patients with opioid use disorder to opioid agonist treatment.

BACKGROUND: People in criminal justice settings (CJS) have high rates of opioid use disorder (OUD) and HIV. Probation is part of the CJS and congregates many individuals with high rates of mental health and substance use disorders relative to the general population; nevertheless, probation remains a major improvement to incarceration. As a steppingstone to full decarceration efforts, community supervision settings like probation can be leveraged as "touchpoints" to identify and link people with OUD (and other co-morbid conditions) to treatment and reduce criminal activity. METHODOLOGY: To determine the feasibility of a modified screening, brief intervention and referral to treatment (SBIRT) strategy to link probationers to opioid agonist therapies (OAT) in the newly created probation system in Ukraine, we conducted a single-arm SBIRT intervention in eight probation centers in four Ukrainian administrative regions. For those screening positive for OUD, interest in OAT was assessed before and after a brief intervention. Those interested in OAT were referred to community OAT services. Participants with OUD also underwent HIV testing. PRINCIPAL FINDINGS: Of the 1,298 consecutive individuals screened, 208 (16.0%) met criteria for opioid dependence. Of these, 122 (58.7%) enrolled in brief intervention, of which 54 (44.3%) had HIV and 14 (25.9%) of these were newly diagnosed. After the brief intervention, interest in starting OAT increased significantly from a median of 7.0 to 8.0 (P = <0.001) using a 10-point scale. Thirty (N = 30; 24.6%) of the enrolled participants initiated OAT and 21 of these (70%) were retained in treatment for 6 months. SIGNIFICANCE: The prevalence of OUD (and HIV) is high among people in probation in Ukraine. SBIRT can identify a large number of people eligible for OAT, many of whom were willing to initiate and remain on OAT. Integrating SBIRT into probation can potentially assist with OAT scale-up and help address HIV prevention efforts.

Viral Suppression Levels in Men Who Have Sex With Men and Transgender Women With Newly Diagnosed HIV and Alcohol Use Disorder in Peru: Results From a Randomized, Double-Blind, Placebo-Controlled Trial Using Oral Naltrexone.

BACKGROUND: Alcohol use disorders (AUDs) are common in men who have sex with men (MSM) and transgender women (TGW) in Peru and undermine antiretroviral therapy (ART) adherence. Oral naltrexone (NTX) is an evidence-based treatment for AUD that has not been assessed in cotreating AUD in MSM/TGW with HIV. SETTING AND DESIGN: A multi-site, randomized, double-blind, placebo-controlled trial among MSM/TGW with AUD and newly diagnosed with HIV in Lima, Peru. METHODS: Newly diagnosed MSM/TGW with HIV and AUD were prescribed a single-treatment regimen of EFV/TDF/FTC from 2014 to 2015 and randomized 2:1 to oral NTX (N = 103) or placebo (N = 53) for 24 weeks. The primary and secondary outcomes were proportion achieving viral suppression (VS: HIV-1 RNA < 400 copies/mL) or maximal viral suppression (MVS: HIV-1 RNA < 40 copies/mL) at 24 weeks. RESULTS: There were no significant differences between the arms in VS (81.6% NTX arm vs 75.5% placebo arm; P = 0.37) or MVS (61.2% NTX arm vs 66.0% placebo arm; P = 0.48). Adherence to study medication was low (mean = 34.6%) overall with only 21.4% of participants meeting recommended adherence levels (≥80% daily doses/month). Participants allocated to NTX had significantly lower adherence compared with placebo for both the first and second 12-week study periods, respectively (44.0% vs 35.2%, P = 0.04; 31.4% vs 35.2%, P = 0.03). CONCLUSIONS: Findings are inconclusive regarding the use of NTX for treatment of AUD in MSM/TGW newly diagnosed with HIV. VS and MVS levels were high irrespective of allocation. Adherence to study medication was low, requiring further exploration of strategies to optimize adherence to NTX as AUD treatment.

Preliminary analysis of self-reported quality health indicators of patients on opioid agonist therapy at specialty and primary care clinics in Ukraine: A randomized control trial.

International agencies recommend integrating addiction treatment into primary care for people who inject drugs (PWID) with opioid use disorder (OUD). Empirical data supporting integration that incorporates comprehensive health outcomes, however, are not known. For this randomized controlled trial in Ukraine, adult PWID with OUD were randomized to receive opioid agonist therapy (OAT) in specialty addiction treatment clinics (SATC) or to primary care clinics (PCCs). For those randomized to PCC, they were subsequently allocated to PCCs where clinicians received pay-for-performance (P4P) incentives (PCC with P4P) or not (PCC without P4P). Participating cities had one of each of the three intervention sites to control for geographic variation. Ongoing tele-education specialty training (OAT, HIV, tuberculosis) was provided to all PCCs. While the primary outcome for the parent trial focuses on patient medical record data, this preliminary analysis focuses on assessment of self-reported achievement of nationally recommended quality health indicators (QHIs) which is summed as a composite QHI score. Secondary outcomes included specialty and primary care QHI subscores. This study occurred from 01/20/2018-11/1/2020 with 818 of 990 randomized participants having complete self-reported data for analysis. Relative to SATC (treatment as usual), the mean composite QHI score was 12.7 (95% CI: 10.1-15.3; p<0.001) percentage points higher at PCCs; similar and significantly higher scores were observed in PCCs compared to SATCs for both primary care (PCC vs SATC: 18.4 [95% CI: 14.8-22.0; p<0.001] and specialty (PCC vs SATC: 5.9 [95% CI: 2.6-9.2; p<0.001] QHI scores. Additionally, the mean composite QHI score was 4.6 (95% CI: 2.0-7.2; p<0.001) points higher in participants with long term (>3 months) experience with OAT compared to participants newly initiating OAT. In summary, PWID with OUD receive greater primary care and specialty healthcare services when receiving OAT at PCCs supported by tele-education relative to treatment as usual provided in SATCs. Clinical trial registration: This trial was registered at clinicaltrials.gov and can be found using the following registration number: NCT04927091.

Responding to health policy recommendations on managing opioid use disorder during Russia's invasion of Ukraine: Divergent responses from the frontline to the west.

Russia's invasion of Ukraine on February 24, 2022, followed by Ukraine's Martial law, has disrupted the routine delivery of healthcare services, including opioid agonist treatment (OAT) programs. Directors (chief addiction treatment physicians) of these programs in each region had flexibility with implementing a series of adaptations to their practice to respond to war disruptions like mass internal displacement and legislation updates allowing more flexibility with OAT distribution policies and take-home dosing regulations. We conducted 8 in-depth interviews with directors from seven regions of Ukraine to describe their experiences providing OAT during a specific time during the war and the local crisis-response approach under the emergency policy updates. We categorized their experiences according to the level of exposure to conflict in each region and displacement of patients across the country, which may provide future guidance for OAT provision during the conflict.

Implementation opportunities for scaling up methadone maintenance treatment in Kyrgyzstan: Methadone dosage and retention on treatment over two years.

Background: Methadone maintenance treatment (MMT) is the most effective and cost-effective strategy to control HIV in Central Asian countries, where the epidemic is concentrated among people who inject drugs (PWID) who use opioids. Methods: Using data from a prospective observational database of all people initiated on MMT in Kyrgyzstan since 2008, we analyzed a more contemporary subset of data for all persons receiving MMT from January 2017 through June 2021 after the national treatment guidelines were changed. Retention on MMT was assessed at 1, 6, 12, and 24 months and predictive variables included were dosage levels, HIV status, and type of clinical setting using survival analysis. Predictors of treatment dropout were estimated using Cox multivariate regression models. Results: Among the 940 MMT patients, the proportion receiving low (<40mg), medium (40-85mg), and high (>85mg) dosage levels was 37.9%, 42.2%, and 19.9%, respectively. Increasing MMT dosage level was significantly (p<0.0001) correlated with retention at 1 (90%, 98%, 100%), 6 (42%, 63%, 95%), 12 (33%, 55%, 89%), and 24 (16%, 45%, 80%) months, respectively, with no differences between community and correctional settings. Significant predictors of dropout at 12 months included low (aHR=8.0; 95%CL=5.8-11.0) and medium (aHR=3.5; 95%CL=2.5-4.9) methadone dosage level relative to high dose, receiving MMT in three administrative regions relative to the capital Bishkek, and lower in the tuberculosis-specialized clinic in Bishkek. Clients with HIV receive higher average MMT doses (79.5mg vs 63.1mg; p<0.0001), but MMT retention did not differ after controlling for dosage in this group. Conclusions: The proportion of patients receiving optimal dosage was low (19.9%). An implementation strategy that focused on getting a larger proportion of MMT on the optimal dosage to promote retention could potentially improve the quality of existing treatment and promote further scale-up of MMT in Kyrgyzstan.

Rapid transitional response to the COVID-19 pandemic by opioid agonist treatment programs in Ukraine.

On March 16, 2020, Ukraine's Ministry of Health issued nonspecific interim guidance to continue enrolling patients in opioid agonist therapies (OAT) and transition existing patients to take-home dosing to reduce community COVID-19 transmission. Though the number of OAT patients increased modestly, the proportion receiving take-home dosing increased from 57.5% to 82.2%, which translates on average to 963,952 fewer clinic interactions annually (range: 728,652-1,016,895) and potentially 80,329 (range: 60,721-84,741) fewer hours of in-person clinical encounters. During the transition, narcologists (addiction specialists) expressed concerns about overdoses, the guidance contradicting existing legislation, and patient dropout, either from incarceration or inadequate public transportation. Though clinicians did observe some overdoses, short-term overall mortality remained similar to the previous year. As the country relaxes the interim guidance, we do not know to what extent governmental guidance or clinical practice will change to adopt the new guidance permanently or revert to pre-guidance regulations. Some future considerations that have come from COVID-19 are should dosing schedules continue to be flexible, should clinicians adopt telehealth, and should there be more overdose education and naloxone distribution? OAT delivery has improved and become more efficient, but clinicians should plan long-term should COVID-19 return in the near future. If the new efficiencies are maintained, it will free the workforce to further scale up OAT.