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Barriers and facilitators to recruitment and enrollment of HIV-infected individuals with opioid use disorder in a clinical trial.

ABSTRACT: BACKGROUND:The CTN-0067 CHOICES trial tests implementation of extended-release naltrexone (XR-NTX) versus treatment-as-usual (TAU) for opioid use disorders (OUD) in HIV clinics to improve HIV viral suppression. The study team investigated recruitment strategies to elucidate the barriers and facilitators to recruitment and enrollment in the study. MAIN TEXT:Methods: Semi-structured, in-depth, digitally recorded interviews were completed with study recruitment-related staff and medical providers (n =?26) from six participating HIV clinics in the fall of 2018. Interviews probed 1) factors that might prevent prospective participants from engaging in study recruitment and enrollment procedures and 2) strategies used by study staff that encourage eligible patient participation. Interviews were transcribed and thematically analyzed using a content analysis approach. RESULTS:All respondents reported that barriers to recruitment and enrollment included challenging patient social and structural factors (e.g., homelessness or living environments with high substance use, criminal justice involvement), difficulty locating patients with unsuppressed HIV viral load and OUD within the HIV clinic, time-consuming study enrollment processes, and stigma around HIV and OUD which inhibited treatment seeking. Some respondents observed that distrust of research and researchers impeded recruitment activities in the community. A specific medication-related barrier was patient fear of opioid abstinence required prior to XR-NTX induction. Facilitators of recruitment included use of trusted peer outreach/recruitment workers in the community, hospitalizations that offered windows of opportunities for screening and XR-NTX induction, providing participant transportation, and partnerships with harm reduction organizations for referrals. CONCLUSIONS:Though study personnel encountered barriers to recruitment in the CHOICES study, persons with untreated HIV and OUD can be enrolled in multisite clinical trials by using enhanced recruitment strategies that extend outside of the HIV clinic. Employing peer outreach workers and collaborating with syringe service programs may be especially helpful in facilitating recruitment and merit inclusion in similar study protocols.

SUBMITTER: Hoffman KA

PROVIDER: S-EPMC6868733 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Barriers and facilitators to recruitment and enrollment of HIV-infected individuals with opioid use disorder in a clinical trial.

Hoffman Kim A KA Baker Robin R Kunkel Lynn E LE Waddell Elizabeth Needham EN Lum Paula J PJ McCarty Dennis D Korthuis P Todd PT

BMC health services research 20191121 1

<h4>Background</h4>The CTN-0067 CHOICES trial tests implementation of extended-release naltrexone (XR-NTX) versus treatment-as-usual (TAU) for opioid use disorders (OUD) in HIV clinics to improve HIV viral suppression. The study team investigated recruitment strategies to elucidate the barriers and facilitators to recruitment and enrollment in the study.<h4>Main text</h4>Methods: Semi-structured, in-depth, digitally recorded interviews were completed with study recruitment-related staff and medi ...[more]

PMID: 31752905

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Project description:BackgroundDespite evidence that medications to treat opioid use disorder (OUD) are effective, most people who could benefit from this treatment do not receive it. This rapid review synthesizes evidence on current barriers and facilitators to buprenorphine/naloxone and naltrexone at the patient, provider, and system levels to inform future interventions aimed at expanding treatment.MethodsWe systematically searched numerous bibliographic databases through May 2020 and selected studies published since 2014. Study selection, data abstraction, coding of barriers and facilitators, and quality assessment were first completed by one reviewer and checked by a second.ResultsWe included 40 studies of buprenorphine (5 also discussed naltrexone). Four types of patient and provider-level barriers to OUD medication use emerged-stigma related to OUD medications, treatment experiences and beliefs (positive or negative), logistical issues (time and costs as well as insurance and regulatory requirements), and knowledge (high or low) of OUD and the role of medications. Stigma was the most common barrier among patients, while logistical issues were the most common barriers among providers. Facilitators for both patients and providers included peer supports. Most administrator-identified or system-level barriers and facilitators fit into the category of logistical issues. We have moderate confidence in buprenorphine findings but low confidence in naltrexone findings due to the small number of studies.DiscussionStigma, treatment experiences, logistical issues, and knowledge gaps are the main barriers associated with low utilization of OUD medications. These barriers can overlap and mutually reinforce each other, but given that, it is plausible that reducing one barrier may lead to reductions in others. The highest priority for future research is to evaluate interventions to reduce stigma. Other priorities for future research include better identification of barriers and facilitators for specific populations, such as those with OUD related to prescription opioids, and for naltrexone use.Protocol registrationPROSPERO; CRD42019133394.

Project description:BackgroundPreventing HIV transmission among people who inject drugs (PWID) is a key element of the US Ending the HIV Epidemic strategy and includes both pre-exposure prophylaxis (PrEP) and medications for opioid use disorder (MOUD). While both lead to decreases in HIV transmission, MOUD has other social and health benefits; meanwhile, PrEP has additional HIV prevention advantages from sexual risk and the injection of stimulants. However, these medications are often prescribed in different settings and require multiple visits before initiation. Strategies to integrate these services (i.e., co-prescription) and offer same-day prescriptions may reduce demands on patients who could benefit from them.MethodsNominal group technique, a consensus method that rapidly generates and ranks responses, was used to ascertain barriers and solutions for same-day delivery of PrEP and MOUD as an integrated approach among PWID (n = 14) and clinical (n = 9) stakeholders. The qualitative portion of the discussion generated themes for analysis, and the ranks of the proposed barriers and solutions to the program are presented.ResultsThe top three barriers among PWID to getting a same-day prescription for both PrEP and MOUD were (1) instability of insurance (e.g., insurance lapses); (2) access to a local prescriber; and (3) client-level implementation factors, such as lack of personal motivation. Among clinical stakeholders, the three greatest challenges were (1) time constraints on providers; (2) logistics (e.g., coordination between providers and labs); and (3) availability of providers who can prescribe both medications. Potential solutions identified by both stakeholders included pharmacy delivery of the medications, coordinated care between providers and health care systems (e.g., case management), and efficiencies in clinical care (e.g., clinical checklists), among others.ConclusionsImplementing and sustaining a combined PrEP and MOUD strategy will require co-training providers on both medications while creating efficiencies in systems of care and innovations that encourage and retain PWID in care. Pilot testing the co-prescribing of PrEP and MOUD with quality performance improvement is a step toward new practice models.

Project description:ImportanceGabapentin prescriptions have drastically increased in the US due to off-label prescribing in settings such as opioid use disorder (OUD) treatment to manage a range of comorbid conditions and withdrawal symptoms, despite a lack of evidence.ObjectiveTo assess the purpose and associated risks of off-label gabapentin use in OUD treatment.Design, setting, and participantsThis retrospective recurrent-event case-control study with a crossover design used administrative claims data from MarketScan Commercial and Multi-State Medicaid databases from January 1, 2006, to December 31, 2016. Individuals aged 12 to 64 years with an OUD diagnosis and filling buprenorphine prescriptions were included in the primary analysis conducted from July 1, 2022, through June 1, 2023. Unit of observation was the person-day.ExposuresDays covered by filled gabapentin prescriptions.Main outcomes and measuresPrimary outcomes were receipt of gabapentin in the 90 days after initiation of buprenorphine treatment and drug-related poisoning. Drug-related poisonings were defined using codes from International Classification of Diseases, Ninth Revision, and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision.ResultsA total of 109 407 patients were included in the analysis (mean [SD] age, 34.0 [11.2] years; 60 112 [54.9%] male). Among the 29 967 patients with Medicaid coverage, 299 (1.0%) were Hispanic, 1330 (4.4%) were non-Hispanic Black, 23 112 (77.1%) were non-Hispanic White, and 3399 (11.3%) were other. Gabapentin was significantly less likely to be prescribed to Black or Hispanic patients, and more likely to be prescribed to female patients, those with co-occurring substance use or mood disorders, and those with comorbid physical conditions such as neuropathic pain. Nearly one-third of persons who received gabapentin (4336 [31.1%]) had at least 1 drug-related poisoning after initiating buprenorphine treatment, compared with 13 856 (14.5%) among persons who did not receive gabapentin. Adjusted analyses showed that days of gabapentin use were not associated with hospitalization for drug-related poisoning (odds ratio, 0.98 [95% CI, 0.85-1.13]). Drug-related poisoning risks did not vary based on dosage.Conclusions and relevanceGabapentin is prescribed in the context of a myriad of comorbid conditions. Even though persons receiving gabapentin are more likely to have admissions for drug-related poisoning, these data suggest that gabapentin is not associated with an increased risk of drug-related poisoning alongside buprenorphine in adjusted analyses. More data on the safety profile of gabapentin in OUD settings are needed.

Project description:BackgroundPolicies aimed at addressing the high rates of opioid overdose have prioritized increasing access to medications for treatment of opioid use disorder (MOUD). Numerous barriers exist to providing MOUD within the criminal justice system and/or to justice-involved populations. The aim of this study was to conduct a scoping review of the peer-reviewed literature on implementation of MOUD within criminal justice settings and with justice-involved populations.MethodsA systematic search process identified 53 papers that addressed issues pertaining to implementation barriers or facilitators of MOUD within correctional settings or with justice-involved populations; these were coded and qualitatively analyzed for common themes.ResultsOver half of the papers were published outside of the U.S. (n = 28); the most common study designs were surveys or structured interviews (n = 20) and qualitative interviews/focus groups (n = 18) conducted with correctional or treatment staff and with incarcerated individuals. Four categories of barriers and facilitators were identified: institutional, programmatic, attitudinal, and systemic. Institutional barriers typically limited capacity to provide MOUD to justice-involved individuals, which led to programmatic practices in which MOUD was not implemented following clinical guidelines, often resulting in forcible withdrawal or inadequate treatment. These programmatic practices commonly led to aversive experiences among justice-involved individuals, who consequently espoused negative attitudes about MOUD and were reluctant to seek treatment with MOUD following their release to the community. Facilitators of MOUD implementation included increased knowledge and information from training interventions and favorable prior experiences with individuals being treated with MOUD among correctional and treatment staff. Few systemic facilitators to implementing MOUD with justice-involved individuals were evident in the literature.ConclusionBarriers to implementing MOUD in criminal justice settings and/or with justice-involved populations are pervasive, multi-leveled, and inter-dependent. More work is needed on facilitators of MOUD implementation.

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Barriers and facilitators to recruitment and enrollment of HIV-infected individuals with opioid use disorder in a clinical trial.

Publications

Barriers and facilitators to recruitment and enrollment of HIV-infected individuals with opioid use disorder in a clinical trial.

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