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The COVID-19 pandemic exacerbated health challenges among people who use opioids (PWUO) and substance using men who have sex with men (SU-MSM) in Southeastern United States cities. Within the larger NIDA Clinical Trials Network Protocol 0082 PrEP attitudes and opioid use services implementation survey, N=171 PWUO and N=169 SU-MSM answered a COVID-19 vaccine attitudes survey, including measures of vaccine willingness and health beliefs. In mixed-effects linear models for PWUO and SU-MSM, respectively: (1) belief in vaccine protection from illness was positively correlated with vaccine willingness; and (2) sense of being “a guinea pig” was negatively correlated with vaccine willingness. Having previously used a COVID-19 antigen test was positively correlated with vaccine willingness in SU-MSM. This study aims to define vaccine willingness during the COVID-19 pandemic among people who use drugs and proposes the use of the Health Belief Model to conceptualize the correlation between health beliefs and intended behaviors.
Related protocols: CTN-0082
Background: American Indian and Alaska Native (AI/AN) communities experienced a disproportionate increase in opioid-related fatal and non-fatal poisonings during the COVID-19 pandemic. Access to treatment, such as medications for opioid use disorder (MOUD), became even more critical, although research among this population is limited. We completed qualitative interviews with substance use disorder (SUD) treatment providers (i.e., MOUD prescribers, non-prescribing clinicians, non-clinical support staff) to assess the impact of COVID-19 on MOUD care among AI/AN adults.
Methods: This research was completed in connection with two CTN studies: CTN-0096 and CTN-0118. Sixty-minute semi-structured interviews were completed with providers working in SUD treatment (N = 25). Eligible providers represented 6 programs serving rural Tribal and urban areas primarily in the Pacific Northwest United States. Transcripts were independently reviewed and analyzed for themes based upon the research aims.
Results: Nineteen female and six male providers completed interviews. Four themes were identified: (1) Beneficial policy changes for MOUD delivery; (2) Telehealth as the biggest policy shift; (3) Addressing complexity, and (4) Cultural services. Findings indicated providers viewed the introduction of telehealth, implementation of mobile services, and expanded take home dosing as positive and leading to increased treatment access. However, barriers related to the internet, transportation, and reimbursement of telehealth remain.
Conclusions: Providers highlighted the utility in the expansion and sustainment of telehealth. Flexible policies for MOUD were particularly beneficial during the height of COVID-19 to maintain and increase access to treatment. Providing a menu of treatment options, emphasizing cultural engagement and social support were deemed necessary to enhance AI/AN community driven solutions in curbing the opioid poisoning public health crisis.
Related protocols: CTN-0096, CTN-0118
This narrative review, which is not directly part of a CTN study but whose primary authors are funded by the CTN and are working on protocols related to this topic, addresses post-2020, specific, complex challenges for use of and adherence to pre-exposure prophylaxis (PrEP) for HIV prevention among out-of-treatment people who use drugs (PWUD) at syringe services programs (SSPs).
The COVID-19 pandemic and its associated changes to the provision of healthcare have significantly impacted HIV prevention, especially for PWUD. Through a synthesis of literature and clinical experience, we (1) characterize the operational changes imposed by the pandemic on SSPs that shaped the current HIV prevention landscape; (2) describe three levels of current challenges for PWUD, including consumer attitudes, non-medical and medical provider attitudes, and structural and scalability barriers; (3) characterize current models for PrEP in SSPs; and (4) offer practical recommendations for HIV prevention in harm reduction programs.
Conclusions: PrEP is a highly effective prevention tool if taken as prescribed. It has been enthusiastically promoted by members of the research, public health and provider communities. Despite its efficacy, PWUD struggle to engage with the PrEP care continuum. We highlight opportunities to advance HIV prevention for PWUD by enhancing tailored, whole-person approaches that may set aside PrEP in favor of other risk reduction routes. For most PWUD who receive services at SSPs, PrEP is a single tool and not realistic until other social and structural determinants of health are addressed.
COVID-19 exacerbated the opioid-related poisoning crisis among many American Indian/Alaska Native (AI/AN) communities. There is a lack of research examining the extent of the impact of the pandemic on the delivery of treatment for opioid use disorder (OUD) in this population. In collaboration with an Indigenous Collaborative Board, Tribal leadership and administration, this study, part of CTN-0118, explored AI/AN SUD-serving treatment providers’ experiences delivering treatment for OUD from 2020-2022. Eligible providers (N=25) represented 6 programs and organizations serving Tribal and urban areas primarily in the Pacific Northwest. Two members of the research team independently reviewed transcripts before reaching consensus on a finalized codebook and analysis was informed by a qualitative descriptive approach. Findings indicated providers viewed the changes to telemedicine, medication dosing, and the introduction of mobile services as a positive and increased access to care. Barriers remained, however, including when programs discontinued services and reverted to pre-pandemic policy (e.g., no longer mailing prescriptions). This study highlights the impact of the COVID-19 pandemic and what was perceived as effective in the delivery and sustainment of telemedicine, medications, as well as the continued necessity to provide a menu of treatment and social service options to meet the unique needs of AI/AN communities. Study results may inform future programmatic and organizational systems change among AI/AN communities to enhance access and SUD service engagement beyond emergency response efforts.
Related protocols: CTN-0118
Introduction: American Indian/Alaska Native (AI/AN) communities are more likely to suffer negative consequences related to substance misuse. The COVID-19 pandemic exacerbated the opioid poisoning crisis, in combination with ongoing treatment barriers resulting from settler-colonialism, systemic oppression and racial discrimination. AI/AN adults are at greatest risk of COVID-19 related serious illness and death. In collaboration with an Indigenous community advisory board and Tribal leadership, this study, supported by CTN-0118, explored AI/AN treatment provider perceptions of client-relatives’ (i.e., SUD treatment recipients) experiences during the pandemic from 2020 to 2022.
Methods: Providers who underwent screening and were eligible to participate (N = 25) represented 6 programs and organizations serving rural and urban areas in Washington, Utah, and Minnesota. Participants engaged in audio-recorded 60-90 min semi-structured individual interviews conducted virtually via Zoom. The interview guide included 15 questions covering regulatory changes, guidance for telemedicine, policy and procedures, staff communication, and client-relatives’ reactions to implemented changes, service utilization, changes in treatment modality, and perceptions of impact on their roles and practice. Interview recordings were transcribed and de-identified. Members of the research team independently reviewed transcripts before reaching consensus. Coding was completed in Dedoose, followed by analyses informed by a qualitative descriptive approach.
Results: Five main domains were identified related to client-relative experiences during the COVID-19 pandemic, as observed by providers: (1) accessibility, (2) co-occurring mental health, (3) social determinants of health, (4) substance use, coping, and harm reduction strategies, and (5) community strengths. Providers reported the distinctive experiences of AI/AN communities, highlighting the impact on client-relatives, who faced challenges such as reduced income, heightened grief and loss, and elevated rates of substance use and opioid-related poisonings. Community and culturally informed programming promoting resilience and healing are outlined.
Conclusion: Findings underscore the impact on SUD among AI/AN communities during the COVID-19 pandemic. Identifying treatment barriers and mental health impacts on client-relatives during a global pandemic can inform ongoing and future culturally responsive SUD prevention and treatment strategies. Elevating collective voice to strengthen Indigenous informed systems of care to address the gap in culturally-and community-based services, can bolster holistic approaches and long-term service needs to promote SUD prevention efforts beyond emergency response efforts.
Related protocols: CTN-0118
American Indian and Alaska Native (AI/AN) communities experienced a disproportionate increase in opioid-related poisonings during COVID-19. Availability of treatment, such as medications for opioid use disorder (MOUD) within AI/AN communities, is therefore imperative. We completed qualitative interviews with substance use disorder treatment providers providing services to AI/AN adults to assess the impact of COVID-19 related regulatory changes (e.g., medication dosing) and transitions in services (i.e., telemedicine) that aimed to enhance access to care. This project was supported by CTN-0118.
Related protocols: CTN-0118
The COVID-19 pandemic exacerbated the drug poisoning crisis in American Indian/Alaska Native communities, in combination with ongoing substance use disorder (SUD) treatment barriers resulting from settler-colonialism, systemic oppression and racial discrimination. For similar reasons, AI/AN adults also experienced increased risk of COVID-19 related serious illness and death. In collaboration with an AI/AN Collaborative Board and Tribal leadership and administration, this study, supported by CTN-0118, explored AI/AN SUD treatment providers’ perception of client-relatives’ (i.e., SUD treatment recipients) experiences (e.g. substance use) during the height of the pandemic (2020-2022).
Related protocols: CTN-0118
There is limited research examining factors impacting MOUD retention in rural settings, especially within the context of the COVID-19 pandemic. Using electronic health records data collected as part of a NIDA Clinical Trials Network study (CTN-0102), this study explored how the onset of the COVID-19 pandemic may have impacted MOUD retention in a sample of 563 rural primary care patients.
Cox regression model was applied to examine if COVID-19 was related to treatment retention, controlling for demographics, clinic, insurance type, and other diagnoses. The independent variable was the number of days between the patient’s first MOUD prescription date during the pre-COVID observation period (10/1/2019–3/13/2020) and the start of the COVID-19 pandemic. The dependent variable was retention on MOUD, defined as the time from the first MOUD prescription documented during the pre-COVID observation period to the first break in consecutive MOUD prescriptions (right censored at 180 days).
The findings demonstrated that there was a reduced risk of a prescription break for every 10-day increase in the time from the first documented MOUD prescription to the onset of the COVID-19 pandemic (HR = 0.96, 95% CI = 0.92–0.99; p = 0.011).
Conclusions: While the data did not include complete treatment histories to determine who was new to MOUD treatment, the findings suggest that patients whose first documented MOUD prescription in the dataset was closer to the onset of the pandemic had a greater likelihood of experiencing retention challenges. This underscores the importance for clinics to establish comprehensive contingency plans for future emergencies to ensure uninterrupted MOUD treatment and support, particularly for individuals in the early stabilization phase of their recovery.
Related protocols: CTN-0102
Recent data indicate rising opioid overdose deaths among African-American residents of Washington, DC. In this paper, researchers highlight a community-informed approach to assessing attitudes toward opioid use disorder (OUD) treatment among DC residents (February 2019 – March 2020). This paper is based on work conducted as part of CTN-0088.
A listening tour with trusted community leaders led to the formation of a Community Advisory Board (CAB). When the COVID-19 pandemic commenced in March 2020, community dialogues became exclusively virtual. The CAB partnered with academic leaders to co-create project mission and values and center the community’s concerns related to opioid use and its causes, treatment structure, and facilitators of effective engagement.
Interview guides were created for the engagement of community members, utilizing values highlighted by the CAB. The CAB underscored that in addition to opioid problems, effective engagement must address community experience, collective strengths/resilience, and the role of indigenous leadership.
Conclusions: Engaging community prior to project implementation and maintaining alignment with community values facilitated OUD assessments. Community-informed assessments may be critical to building community trust.
Related protocols: CTN-0088
The purpose of this study, part of NIDA-CTN-0117, was to examine changes in addiction medicine treatment utilization during the COVID-19 pandemic among adolescents (aged 13–17 years) and differences by race/ethnicity.
Researchers compared treatment initiation (overall and telehealth), engagement, and 12-week retention between insured adolescents with substance use problems during pre-COVID-19 (March to December 2019, n = 1,770) and COVID-19 (March to December 2020, n = 1,177) using electronic health record data from Kaiser Permanente Northern California.
Compared to pre-COVID-19, odds of treatment initiation, overall (adjusted odds ratio [95% confidence interval] = 1.42 [1.21–1.67]), and telehealth (5.98 [4.59–7.80]) were higher during COVID-19, but odds of engagement and retention did not significantly change. Depending on the outcome, Asian/Pacific Islander, Black, and Latino/Hispanic (vs. White) adolescents had lower treatment utilization across both periods. Changes in utilization over time did not differ by race/ethnicity.
Conclusions: Addiction medicine treatment initiation increased among insured adolescents during the pandemic, especially via telehealth. Although racial/ethnic disparities in treatment utilization persisted, they did not worsen.
Related protocols: CTN-0117
The COVID-19 pandemic strained the U.S. health care system, posing logistical challenges for community-based programs. This study surveyed 11 program directors in sexually transmitted infection (STI) clinics and syringe services programs (SSPs) that served people who use substances and are at risk for HIV in five southeastern U.S. states. The 11 sites were all participants in NIDA Clinical Trials Network (CTN) multisite protocol CTN-0082. Brief survey questions asked about programs’ use of in-person and telehealth services. Results indicated widespread reduction of in-person services and concomitant adoption of telehealth services. In STI clinics, telehealth replaced in-person visits for all but urgent treatment of active symptoms. In SSPs, in-person contact continued or increased from pre-pandemic volumes. In both programs, the most salient telehealth use barrier was limited device or internet access and limited technological ease. Services were sustained through innovative adaptations.
Conclusions: This snapshot of response to the early COVID-19 lockdown phase offers actionable guidance about service preparedness for future public health catastrophes in community-based programs serving vulnerable populations.
This is the Primary Outcomes Article for CTN-0119.
The impact of COVID-19-related healthcare changes on access to buprenorphine (BUP) nationwide in the US is unknown. We conducted an interrupted time series with the IQVIA LRx database. The study timeline included BUP prescriptions from 52 weeks before (2/23/19–2/21/20) to 52 weeks after (4/4/20–4/2/21) the initial pandemic period (2/22/20–4/3/20). Segmented regression estimated relative changes in total milligrams (MG) of BUP available per week nationwide at 1, 26, and 52 weeks post-initial-pandemic. We evaluated treatment disruptions in previously stable patients, defined as =6 months of BUP prescriptions.
A total of 31 617 849 prescriptions were included. Total MG BUP dispensed increased at 1 and 26 weeks and then returned to baseline trends at 52 weeks post-initial pandemic period (4.1% [95% CI: 3.7,4.5], 2.1% [1.5,2.6], 0.1% [-0.6,0.9]). Stably-treated patients saw a decrease in 7-, 14-, and 28-day treatment disruptions at 52 weeks post-initial-pandemic period (-21.6% [-25.6,-17.7]; -10.8% [-16.3,-5.3]; -27.3% [-33.0,-21.6]). Men retained an increase in MG BUP compared to women at 52 weeks (0.7% [0.01,1.4] versus -0.6% [-1.5,0.2]). Younger age groups (18–29 years and 30–39 years) had a decrease in MG BUP at 52 weeks compared to expected baseline trend (-16.6 [-24.2, -9.0]; -1.6 [-3.0, -0.1). Patients with Medicaid demonstrated an increase in MG BUP at 52 weeks (8.3% [6.3,10.3]). MG BUP prescribed by APP prescribing increased by over 140 000 mg per week prior to the pandemic and continued to increase.
Conclusions: Regulatory changes around buprenorphine prescribing facilitated patient access to buprenorphine during the pandemic.
Related protocols: CTN-0119
Addiction treatment rapidly transitioned to a primarily telehealth modality (telephone and video) during the COVID-19 pandemic, raising concerns about disparities in utilization. The objective of this study, part of CTN-0117, was to examine whether there were differences in overall and telehealth addiction treatment utilization after telehealth policy changes during the COVID-19 pandemic by age, race, ethnicity, and socioeconomic status.
This cohort study examined electronic health record and claims data from Kaiser Permanente Northern California for adults (age =18 years) with drug use problems before the COVID-19 pandemic (from March 1, 2019, to December 31, 2019) and during the early phase of the COVID-19 pandemic (March 1, 2020, to December 31, 2020; hereafter referred to as COVID-19 onset). Analyses were conducted between March 2021 and March 2023.
Generalized estimating equation models were fit to compare addiction treatment utilization during COVID-19 onset with that before the COVID-19 pandemic. Utilization measures included the Healthcare Effectiveness Data and Information Set of treatment initiation and engagement (including inpatient, outpatient, and telehealth encounters or receipt of medication for opioid use disorder [OUD]), 12-week retention (days in treatment), and OUD pharmacotherapy retention. Telehealth treatment initiation and engagement were also examined. Differences in changes in utilization by age group, race, ethnicity, and socioeconomic status (SES) were examined.
Among the 19 648 participants in the pre–COVID-19 cohort (58.5% male; mean [SD] age, 41.0 [17.5] years), 1.6% were American Indian or Alaska Native; 7.5%, Asian or Pacific Islander; 14.3%, Black; 20.8%, Latino or Hispanic; 53.4%, White; and 2.5%, unknown race. Among the 16 959 participants in the COVID-19 onset cohort (56.5% male; mean [SD] age, 38.9 [16.3] years), 1.6% were American Indian or Alaska Native; 7.4%, Asian or Pacific Islander; 14.6%, Black; 22.2%, Latino or Hispanic; 51.0%, White; and 3.2%, unknown race. Odds of overall treatment initiation increased from before the COVID-19 pandemic to COVID-19 onset for all age, race, ethnicity, and SES subgroups except for patients aged 50 years or older; patients aged 18 to 34 years had the greatest increases (adjusted odds ratio [aOR], 1.31; 95% CI, 1.22-1.40). Odds of telehealth treatment initiation increased for all patient subgroups without variation by race, ethnicity, or SES, although increases were greater for patients aged 18 to 34 years (aOR, 7.17; 95% CI, 6.24-8.24). Odds of overall treatment engagement increased (aOR, 1.13; 95% CI, 1.03-1.24) without variation by patient subgroups. Retention increased by 1.4 days (95% CI, 0.6-2.2 days), and OUD pharmacotherapy retention did not change (adjusted mean difference, -5.2 days; 95% CI, -12.7 to 2.4 days).
Conclusions: In this cohort study of insured adults with drug use problems, there were increases in overall and telehealth addiction treatment utilization after telehealth policies changed during the COVID-19 pandemic. There was no evidence that disparities were exacerbated, and younger adults may have particularly benefited from the transition to telehealth.
Related protocols: CTN-0117
Approximately 1800 opioid treatment programs (OTPs) in the US dispense methadone to upwards of 400,000 patients with opioid use disorder (OUD) annually, operating under longstanding highly restrictive guidelines. OTPs were granted novel flexibilities beginning March 15, 2020, allowing for reduced visit frequency and extended take-home doses to minimize COVID exposure with great variation across states and sites. We sought to use electronic health records to compare retention in treatment, opioid use, and adverse events among patients newly entering methadone maintenance in the post-reform period in comparison with year-ago, unexposed, controls.
This was a retrospective observational cohort study across 9 OTPs, geographically dispersed, in the National Institute of Drug Abuse (NIDA) Clinical Trials Network. Newly enrolled patients between April 15 and October 14, 2020 (post-COVID, reform period) v. March 15-September 14, 2019 (pre-COVID, control period) were assessed. The primary outcome was 6-month retention. Secondary outcomes were opioid use and adverse events including emergency department visits, hospitalizations, and overdose.
821 individuals were newly admitted in the post-COVID and year-ago control periods, average age of 38.3 (SD 11.1), 58.9% male. The only difference across pre- and post-reform groups was the prevalence of psychostimulant use disorder (25.7% vs 32.9%, p = 0.02). Retention was non-inferior (60.0% vs 60.1%) as were hazards of adverse events in the aggregate (X2 (1) = 0.55, p = 0.46) in the post-COVID period. However, rates of month-level opioid use were higher among post-COVID intakes compared to pre-COVID controls (64.8% vs 51.1%, p < 0.001). Moderator analyses accounting for stimulant use and site-level variation in take-home schedules did not change findings.
Conclusions: Policies allowing for extended take-home schedules were not associated with worse retention or adverse events despite slightly elevated rates of measured opioid use while in care. Relaxed guidelines were not associated with measurable increased harms and findings could inform future studies with prospective trials.
The COVID-19 pandemic has changed the landscape of healthcare service delivery. This review, supported by the Greater Southern California Node and the Telemedicine Special Interest Group (SIG) of the NIDA National Drug Abuse Treatment Clinical Trials Network (CTN), aims to describe telemedicine-delivered substance use disorder (SUD) treatments and services along the cascade of care in the U.S. after the start of the COVID-19 pandemic.
A literature review was conducted on PubMed, Embase, Web of Science, and Cochrane Library (Wiley). English-language articles that describe any healthcare services for patients with SUDs using telemedicine in the U.S. since the onset of the COVID-19 pandemic were identified (N = 33). We narratively summarized telemedicine-based service provision along the cascade of SUD care, such as screening/assessment, prescription, monitoring, recovery support, and other services.
Soon after the onset of COVID-19 and mandated restrictions, cadres of healthcare providers from different specialties mobilized to ramp up video- and audio-based services to remotely treat patients with SUDs. Medication prescription (48.5%) and individual counseling (39.4%) were the most frequently reported services delivered via telemedicine. Other steps of SUD care delivered by telemedicine characterized in our review included SUD screening and assessment (30.3%), induction (21.2%), medication management (27.3%), monitoring (27.3%), recovery support (15.2%), and referral (24.2%). Feasibility issues and challenges to implementing telemedicine included patients’ lack of access to technology and health insurance coverage, providers’ capacity limits and concerns, and clinics’ financial and office-space constraints.
Conclusions: The COVID-19 pandemic has offered a window of opportunity to advance telemedicine expertise by formalizing clinical guidance and routinizing provider in-service training in virtual SUD treatment. Findings suggest enhanced efforts to reduce disparities in telemedicine-based services.