This study is the first experimental trial to evaluate the effectiveness of a web-based behavioral intervention when deployed in a model where it partially substituted for standard counseling in a community-based specialty addiction treatment program. New opioid-dependent intakes in methadone maintenance treatment (n=160) were randomly assigned for 12 months to either: (1) standard treatment or (2) reduced standard treatment plus a web-based psychosocial intervention, the Therapeutic Education System (TES). Results demonstrated that replacing a portion of standard treatment with TES resulted in significantly greater rates of objectively measured opioid abstinence (48% vs. 37% abstinence across all study weeks; F(1,158)=5.90, p<.05 and 59% vs. 43% abstinence on weeks participants provided urine samples for testing; F(1,158)=8.81, p<.01). This result was robust and was evident despite how opioid abstinence was operationally defined and evaluated. The potential implications for service delivery models within substance abuse treatment programs and other healthcare entities are discussed.
Background While people who inject drugs (PWID) are vulnerable to the adverse outcomes of events like COVID-19, little is known regarding the impact of the current pandemic on PWID. We examine how COVID-19 has affected PWID in New York City across four domains: substance use, risk behaviors, mental health, and service utilization. Methods As part of a randomized trial to improve access to HCV treatment for PWID, we recruited 165 participants. Eligibility criteria included detectable HCV RNA and recent drug injection. The present cross-sectional analysis is based on a subsample of 106 participants. We compared responses between two separate samples: 60 participants interviewed prior to the pandemic (pre-COVID-19 sample) and 46 participants interviewed during the pandemic (COVID-19 sample). We also assessed differences by study group [accessible care (AC) and usual care (UC)]. Results Compared to the pre-COVID-19 sample, those interviewed during COVID-19 reported higher levels of mental health issues, syringe reuse, and alcohol consumption and greater reductions in syringe-service programs and buprenorphine utilization. In the analysis conducted by study group, the UC group reported significantly higher injection risk behaviors and lower access to buprenorphine treatment during COVID-19, while during the same period, the AC group reported lower levels of substance use and injection risk behaviors. Conclusion The current study provides insight on how COVID-19 has negatively affected PWID. Placing dispensing machines of harm-reduction supplies in communities where PWID live and increasing secondary exchange, mobile services, and mail delivery of supplies may help maintain access to lifesaving supplies during big events, such as COVID-19. Trial registration ClinicalTrials.gov NCT03214679. Registered July 11 2017. https://clinicaltrials.gov/ct2/show/NCT03214679.
Despite the recent explosion of behavioral health interventions delivered on mobile devices, little is known about factors that make such applications practical, engaging and useful to their target audience. This study reports on the feasibility, acceptability and preliminary efficacy of a prototype of a novel, interactive mobile psychosocial intervention to reduce problematic drug use among clients in methadone maintenance treatment (MMT). A mixed-methods pilot study with new MMT clients (n=25) indicated that the mobile intervention approach was feasible, and that participants found the intervention highly acceptable and useful. On 100-point visual analog scale (VAS) items, participants reported high levels of liking the program (M=75.6), and endorsed it as useful (M=77.5), easy to use (M=80.7), and containing a significant amount of new information (M=74.8). When compared with 25 study participants who received standard MMT alone, pilot participants rated their treatment significantly higher in interestingness and usefulness, and were significantly more satisfied with their treatment. In qualitative interviews, participants reported using the mobile intervention in a range of settings, including during times of heightened risk for substance use, and finding it helpful in managing drug cravings. Additionally, pilot participants showed evidence of increased treatment retention and abstinence from illicit opioids (in terms of effect size) over a 3-month period relative to those in standard MMT, suggesting the application’s potential to enhance treatment outcomes. These promising findings suggest that an evidence-based mobile therapeutic tool addressing substance use may appeal to drug treatment clients and have clinical utility as an adjunct to formal treatment.
IMPORTANCETo achieve hepatitis C elimination, treatment programs need to engage, treat, and cure people who inject drugs.OBJECTIVE To compare a low-threshold, nonstigmatizing hepatitis C treatment program that was colocated at a syringe service program (accessible care) with facilitated referral to local clinicians through a patient navigation program (usual care). DESIGN, SETTING, AND PARTICIPANTSThis single-site randomized clinical trial was conducted at the Lower East Side Harm Reduction Center, a syringe service program in New York, New York, and included 167 participants who were hepatitis C virus RNA-positive and had injected drugs during the prior 90 days. Participants enrolled between July 2017 and March 2020. Data were analyzed after all patients completed 1 year of follow-up (after March 2021).INTERVENTIONS Participants were randomized 1:1 to the accessible care or usual care arm. MAIN OUTCOMES AND MEASURESThe primary end point was achieving sustained virologic response within 12 months of enrollment. RESULTS Among the 572 participants screened, 167 (mean [SD] age, 42.0 [10.6] years; 128 (77.6%) male, 36 (21.8%) female, and 1 (0.6) transgender individuals; 8 (4.8%) Black, 97 (58.5%) Hispanic, and 53 (32.1%) White individuals) met eligibility criteria and were enrolled, with 2 excluded postrandomization (n = 165). Baseline characteristics were similar between the 2 arms. In the intention-to-treat analysis, 55 of 82 participants (67.1%) in the accessible care arm and 19 of 83 participants (22.9%) in the usual care arm achieved a sustained virologic response (P < .001). Loss to follow-up (12.2% [accessible care] and 16.9% [usual care]; P = .51) was similar in the 2 arms. Of the participants who received therapy, 55 of 64 (85.9%) and 19 of 22 (86.3%) achieved a sustained virologic response in the accessible care and usual care arms, respectively (P = .96). Significantly more participants in the accessible care arm achieved all steps in the care cascade, with the greatest attrition in the usual care arm seen in referral to hepatitis C virus clinician and attending clinical visit. CONCLUSIONS AND RELEVANCEIn this randomized clinical trial, among people who inject drugs with hepatitis C infection, significantly higher rates of cure were achieved using the accessible care model that focused on low-threshold, colocated, destigmatized, and flexible hepatitis C care compared with facilitated referral. To achieve hepatitis C elimination, expansion of treatment programs that are specifically geared toward engaging people who inject drugs is paramount.
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