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Understanding Medical Science Liaisons and Clinical Liaisons

Research organizations utilize a variety of medical professionals to conduct successful clinical trials. Two of those positions are a medical science liaison (MSL) and a clinical liaison. Both play a crucial role in keeping research organizations running smoothly, while taking on separate roles and responsibilities.

MSL Responsibilities

According to the Medical Liaison Science Society, a medical science liaison is a healthcare consulting professional within the pharmaceutical, biotechnology, medical device, contract research organization (CRO), and other healthcare industries.

The main purpose of their role is to establish and maintain a peer-to-peer relationship with leading physicians at academic medical centers (AMCs) and clinics. With a more outwardly focused role, MSLs typically deal with products utilized by physicians already on the market. The MSL will take the information the organization learned during the clinical development process and will share it with the physicians. This establishes the relationship and gives physicians an understanding of how this new product benefits their patients. They can also get the opinion of those physicians on the product, and take those ideas back to the clinical development organization to further improve their invention.

MSLs also work very closely with sales teams; since they are the ones promoting the new product to potential buyers, the MSL has to train and educate the sales team on the product’s functions and the benefits they can bring to patients. A MSL typically works with physicians on a more clinical academic level, while the salesperson deals with the day-to-day sales processes. They also help oversee clinical trials that showcase how the product works as safely and effectively as it was shown to work in the original trials.

Clinical Liaison Responsibilities

A clinical liaison is another great asset to a medical facility or healthcare organization. They handle a variety of tasks related to communications and general growth, and provide a range of services, from technical handling of new patient processes to more general community outreach. Clinical liaisons are typically registered nurses or licensed practice nurses with strong clinical experiences. They serve as an advocate for patients during the pre-admissions process, continuing until the patient is discharged from the facility. A clinical liaison is responsible for maintaining communication between the healthcare provider and the patient, as well as ensuring the patient understands and consents to the procedures conducted. They have a significant role in evaluating patients by conducting a thorough review of the patient’s medical records, medications, treatment plans, and insurance availability. The main goal of a clinical liaison is to ensure the patients understand procedures, the paperwork, and the entire clinical research process

Teaming Up to Deliver High-Quality Clinical Trials

Both medical science and clinical liaisons are important members of a clinical research organization. While they serve different roles, their primary focus is to provide patients with the most reliable and high-quality clinical trial experiences possible.

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Understanding the impact of the Clinical Trial Liaison (CTL) function

Conversation with Elizabeth Pash

In the past five years, ICON has reached its baseline recruitment milestone and helped sponsors bring nine new compounds to the market and two new indication approvals for already-approved medications with the support of CTLs. These successes show the significance of the fuction within clinical research.

Elizabeth Pash, PhD, Senior Director of Global Site Engagement Operations at ICON, spoke to leading pharmaceutical publication FirstWord about the CTL function, what this role is about, its value in developing and delivering optimal clinical trials and how it is expected to evolve in the future. She says, “ICON CTLs are doctorate-trained, clinical research professionals who engage in detailed scientific discussions with Principal Investigators and key site staff. CTLs are able to initiate these discussions at all stages of a clinical trial, supporting site identification, activation and recruitment.” According to Pash, CTLs are not only experts in their fields but they also impact recruitment, site engagement and partnerships with sponsors. With a substantial increase in clinical trials being conducted, professionals are needed who can identify the right sponsor for a clinical trial based on their domain knowledge. Medical Science Liaisons (MSLs) may be helpful in this area, but they might not know how clinical trials are conducted. That is where the CTLs’ come in. Their advanced educational qualifications in sciences and professional experience are an advantage because they have existing knowledge on clinical trials and trial sites, resulting in added impetus at supporting recruitment owing to their specialised knowledge and ability to identify appropriate professionals for a specific role.

Recruitment criteria also differ for centralised and decentralised clinical trials. Since decentralised trials do not follow the traditional mode of monitoring subjects in a central location and involve subjects commuting to sites, using telemedicine or availing services of local healthcare providers, personnel required to manage the recruitment of these trials also need to meet specific requirements. As Pash points out, “As more clinical trials begin to incorporate more decentralised approaches, the need for roles like CTLs is set to steadily increase in the industry, owing to the CTLs advanced knowledge of processes and technologies involved in decentralised trials to decide on the kind of personnel who should be employed in these environments.”

When asked how the CTLs differ from Clinical Research Associates (CRAs), Pash states that both are “protocol experts” but their roles with respect to sites are distinctly different. CRAs are required to know details of eligibility criteria and schedule of assessments to ensure proper conduct of trials and data monitoring during a recruitment drive, however CTLs know the scientific aspects of a protocol that will help with site engagement, indication investigation, determining the key eligibility criteria for a role, thereby ensuring trial success at participating sites. CRAs partner with study coordinators and supporting research staff whereas CTLs partner with principal investigators and site clinicians. Therefore, CTLs and CRAs need to work in tandem to ensure site staff are well-supported.

As Pash reiterates in her interview, the CTL’s role in site engagement and sponsor management is key to understanding the impact of the role in a clinical research environment when she says, “When sites are ready for activation, CTLs can support site training through discussion of the investigational product, review preclinical and early phase data, and provide the rationale for study design and key eligibility criteria.” Due to the unpredictable nature of research, unforeseeable issues may arise with planning, implementation or site selection for a clinical trial. With the CTLs existing knowledge in operationalisation of clinical trials at site level, they can provide valuable feedback to sponsors and study management teams on how to optimise recruitment at sites so that these issues can be avoided.

Data suggests that CTLs have benefitted ICON in increasing recruitment and introducing new drugs to the market since the introduction of the function in 2014. As observed, “Independent of therapeutic indication, ICON CTLs can contribute to a 20% average boost in the targeted recruitment rate and help approximately 70% of sites achieve their baseline recruitment goals.” When asked about the potential of this role beyond trials themselves, Pash suggests, the weekly meetings held during ongoing trials and the lessons that CTLs share during these discussions have helped ICON and sponsor operational teams to identify potential recruitment challenges and facilitate implementation of useful strategies to overcome them. In the end, Pash reinforces that ICON CTLs not only have the experience of supporting a number of clinical trials, but their engagement has allowed sponsors to adapt their study designs to “reflect how patients are presenting in the clinic and current treatment paradigms” leading to more engaged investigators and better recruitment.

Ultimately, CTLs help in accelerating the trial process. They identify and collaborate with sponsors much earlier, “support trial and protocol design, conduct targeted investigator interviews and apply relevant information in early stages of clinical development,” expediting clinical research and drug development.

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Clinical Trial Liaisons

Clinical Trial Liaisons (CTLs) are highly trained, experienced professionals, who provide clinical trial support and communications to thought leaders, study sites and referral centers during clinical drug development. CTLs can be a driving force to ensure sites are enrolling patients in key clinical trials.

CTLs Role Responsibilities:

• Point of contact for the sites for questions outside the scope of the CRA
• The face of the sponsor across multiple trials
• Raise awareness of the trial
• Keep sites motivated and engaged
• Reinforce the trial’s key messages

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Clinical trial liaison (ctl) value explained from three stakeholder perspectives:, patient perspective.

• CTLs will discuss customized strategies of patient access and recruitment
• Key messages for patients to understand the trial will be reviewed with the site staff

Investigator Perspective

• Personal CTL visits create a peer-to-peer relationship with Key Opinion Leaders
• CTLs will provide all details of the eligibility criteria, the scientific background of the drug and the trial rationale
• CTLs will also help to identify potential enrollment barriers and discuss solutions to overcome these barriers

Site Staff Perspective

• CTLs should provide maximum support as staff resources are limited at many sites
• CTLs will be open for site staff suggestions and discuss solutions with the sponsor

Clinical Trial Site Support

CTLs can conduct “Site Investigator Meetings” with each clinical trial site to ensure there is comprehension of the intricacies of the study and sustained enthusiasm throughout the enrollment period of the trial. Clinical Trial Liaisons can present the protocol, interim data, enrollment updates, and other information that is pertinent to the sites.

They can troubleshoot issues along with the contract research organization (CRO) and bring rapid feedback from the sites to the home office.

Insights generated by CTLs can help shape the clinical development program.

CTLs visiting clinical trial sites will typically visit them at least quarterly, and in some cases every 4-8 weeks. Site visit frequency is determined by the progress of enrollment and level of support needed by the sites.

Clinical Trial Referral Support

MSLs can ensure referral sites are aware of the clinical trial and refer potential patients to key clinical trials.

Case Study: Contract CTLs Supporting Clinical Trials

A large biotechnology company wanted to deploy a team of 30 CTLs and three managers in support of the launch of a novel oncology supportive care product.

The team was deployed in 6 weeks and trained and certified field ready in 3 weeks.

The team conducted quarterly Site Investigator Meetings to provide education, guidance and inspiration to the trial sites.

Those sites that were visited by a Clinical Trial Liaison enrolled 30-40% more patients than those that were not. The CTLs demonstrated a return on education after only a few months.

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TMAC offers a full range of clinical trial support service options focusing on patient recruitment & retention in support of investigative sites working in conjunction with clinical research associates.

CNEs foster the exchange of clinical information to raise disease state awareness and product education among healthcare professionals, patients and caregivers.

TMAC’s experienced healthcare professionals understand the importance of accuracy & compliance, with a focus on superior client service.

TMAC’s direct hire service, formerly known as TMAC Direct, is Pharma’s complete recruiting resource, helping companies scale from clinical development to medical affairs and commercialization across the globe.

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TMAC’s global Clinical Trial Liaisons (CTLs) are often PharmDs, PhDs, MDs and NPs and can be engaged throughout the life of a clinical trial, providing such services as scientific background, disease education, research rationale, protocol inclusion/exclusion criteria and pipeline support. CTLs may be involved in the identification and evaluation of trial sites and provide insight to the study teams on best practices for the identification and recruitment of trial subjects.

CTLs often work closely with the investigators, clinical research associates, and other study team personnel conducting the trials to ensure that they possess a thorough understanding of eligibility criteria and all relevant protocols and procedures. They may also be called upon to engage in peer-to-peer discussions with investigators and researchers about trial data and results.

TMAC CTLs can:

• Educate Investigators and site staff on clinical trials and their protocols
• Train Investigators and site staff on administration of the investigational product
• Accelerate enrollment of patients through referrals and awareness initiatives
• Attend Investigator meetings to provide education and/or training
• Identify new sites for consideration

TMAC CTLs are fully salaried and benefitted employees of TMAC and are 100% allocated to the clients they are hired to work on behalf of.  TMAC’s flexible model provides its clients with multiple hiring options; including internalization of all or some of the field medical team resources at the conclusion of the program.

Site Engagement Liaison

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• Categories Patient Recruitment
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About the role, this vacancy has now expired. please see similar roles below....

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Site Engagement Liaison (SEL) will develop relationships with clinical trial investigators and research site staff to facilitate recruitment of subjects in pharmaceutical industry clinical trials for which ICON serves as the contract research organization (CRO). The SEL will work in concert with ICON’s clinical research associates (CRAs) and the study team to ensure that investigators and site staff have a thorough understanding of the investigational agents being used in the study, the trial’s eligibility criteria, and all study procedures. Particular attention will be given to assessing the effectiveness of each site’s strategy used to identify potentially eligible subjects. The SEL must also understand how the trial fits into the site’s pattern of treatment for the condition and how any competing clinical trials or upcoming drug approvals may affect the progress of recruitment. Repeated interactions will be needed over the course of the trial to ensure that the trial remains “top of mind” with investigators and staff. The SEL will function as part of the study team and will interact frequently with sponsor companies and their field personnel. Furthermore, the SEL will serve as liaison with key investigators to help ensure that they receive prompt assistance with any queries and that any concerns they have are promptly transmitted to the trial’s sponsor.

Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.

• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Identify barriers to recruitment as well as solutions to those barriers
• Understand the scientific basis of assigned clinical trials
• Utilize educational materials to effectively communicate the science behind the clinical trial
• Be able to communicate the scientific basis of the trials to other team members, investigators and site staff
• Identify effective prescreening strategies for each trial and recommend improvements
• Provide detailed reports of interactions with investigators and site staff
• Serve as a therapeutic expert for internal ICON staff
• Participate in business development activities as assigned
• Exposure to the clinical research environment as a SEL, medical science liaison (MSL), study coordinator, Senior CRA or experience in a CRO
• Read, write and speak fluent English; fluent in host country language required
• PhD in biological science or related field, or PharmD preferred but not required
• Travel (approximately 60%) domestic and/or international.
• Other duties as assigned

To succeed you will need:

• You will possess a Bachelor’s Degree in a life-science, scientific discipline, medical and / or communication, marketing or business studies
• 3-5 years in CRO/Pharma; Minimum of 3 years’ experience in patient recruitment
• Highly developed organizational, problem solving and analytical skill, with the ability to prioritize
• time-sensitive tasks and work independently, and to make decision and to progress projects.
• Excellent communicator, both in written and spoken language, able to produce reports and project
• plans to a high standard
• Must have competent computer skills in MS Word, Excel and PowerPoint

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.  In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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The Site Engagement Liaison (SEL) will develop relationships with clinical trial investigators and research site staff to facilitate recruitment of subjects in pharmaceutical industry clinical trials

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Substance Use Disorders in Global Mental Health Delivery: Epidemiology, Treatment Gap, and Implementation of Evidence-Based Treatments

Substance use disorders (SUDs) account for substantial global morbidity, mortality, and financial and social burden, yet the majority of those suffering with SUDs in both low- and middle-income (LMICs) and high-income countries (HICs) never receive SUD treatment. Evidence-based SUD treatments are available, but access to treatment is severely limited. Stigma and legal discrimination against persons with SUDs continue to hinder public understanding of SUDs as treatable health conditions, and to impede global health efforts to improve treatment access and to reduce SUD prevalence and costs. Implementing SUD treatment in LMICs and HICs requires developing workforce capacity for treatment delivery. Capacity building is optimized when clinical expertise is partnered with regional community stakeholders and government in the context of a unified strategy to expand SUD treatment services. Workforce expansion for SUD treatment delivery harnesses community stakeholders to participate actively as family and peer supports, and as trained lay health workers. Longitudinal supervision of the workforce and appropriate incentives for service are required components of a sustainable, community-based model for SUD treatment. Implementation would benefit from research investigating the most effective and culturally adaptable models that can be delivered in diverse settings.

Substance use disorders (SUDs) are highly prevalent worldwide and are among the leading causes of morbidity and mortality globally. 1 , 2 Alcohol alone is a major cause of disease and injury, 3 with an estimated 95 million cases of alcohol use disorder (AUD) worldwide in 2010, 4 making it the ninth leading global risk factor for morbidity and premature death. 5 Furthermore, the global burden of disease related to alcohol use extends well beyond alcohol-attributable deaths because AUD poses a risk for other mental health disorders, 5 and alcohol-related harm extends to other individuals in the family and community—especially women and children—including alcohol-related injuries and violence, and fetal alcohol spectrum disorders.

In addition to the global burden of disease caused by harmful alcohol use and AUD, more than 250 million people worldwide between the ages of 15 and 64 years used illicit drugs in 2014, of whom 29 million had a drug use disorder. 6 Of these, 12 million injected drugs, and 14% of these individuals were living with HIV. 6 It is estimated that the drug-attributable disease burden accounts for approximately 1.5% of the global burden of disease overall. 1 In addition to this estimated disease burden, SUDs contribute to additional morbidity and mortality because they are associated with a myriad of medical conditions such as infectious diseases, including Hepatitis B and C, HIV, and tuberculosis (TB), as well as many cancers and chronic pulmonary, cardiovascular, and gastrointestinal disorders. 7 During the Covid-19 pandemic, it has also become clear that individuals with SUDs are vulnerable to this novel coronavirus both because of the presence of other medical comorbidities and because of the difficulty of extending necessary medical treatment to this population. 8

SUDs are also highly comorbid with other mental health disorders. 9 – 11 This comorbidity can complicate treatment course and recovery from both the SUD and other mental health disorders, especially anxiety, depression, personality disorders, and posttraumatic stress disorder. In addition, SUDs contribute significantly to intimate partner violence, family violence, overdose and suicide, and other accidental injury deaths (e.g., firearm, motor vehicle, and drowning). SUDs have a pro-foundly negative effect on overall mental health, and pose a significant risk for, and complicate the course of recovery from, co-occurring mental health conditions.

Given the significant morbidity and mortality associated with SUDs, it is fortunate that a broad range of evidence-based treatments for alcohol, tobacco, opioid, and other SUDs are available. These include brief behavioral therapies that can be delivered in individual and group formats, peer-led supportive treatments, family treatments, and mutual help programs, as well as medication treatment (also termed pharmacotherapy or medication-assisted treatment). 9 , 12 Yet despite these evidence-based treatments for SUDs and the overwhelming data demonstrating morbidity and mortality associated with SUDs, the vast majority of the world’s population affected by SUDs receives no treatment. Moreover, although many scientific advances in behavioral and pharmacologic interventions have been achieved in the last two decades, the treatment gap for SUDs globally remains among the widest of any and all medical and mental health disorders. The Organisation for Economic Co-operation and Development (OECD) estimated that increasing access to screening and advice within primary care settings for 30% of eligible heavy-drinking patients could decrease the overall prevalence of harmful use of alcohol by 10%–15% across OECD member countries and could reduce the incidence of AUD by 5%–14%. 13 In addition, if the proportion of patients with AUD who received behavioral and pharmacologic treatment doubled, the annual incidence of AUD would decrease to between 1% and 4% in the countries studied. 13 Another study demonstrated that in the European Union, if 60% of people with AUD were treated with effective alcohol pharmacotherapy, approximately 13% of male and 9% of female alcohol-attributable deaths would be averted in a 12-month period. 14 These data indicate that building capacity by training providers to implement these types of interventions for AUD could greatly reduce morbidity and mortality across both low- and middle-income countries (LMICs) and high-income countries (HICs). If we include tobacco-related disorders and the treatment of tobacco use disorders globally, all of these statistics grow exponentially. 15

Recent economic studies demonstrate the cost-effectiveness of investing up-front resources, especially in brief intervention and treatment programs for heavy drinking and AUD as well as in pharmacologic treatment for opioid use disorders (OUDs). 1 , 16 Why, then, do we not respond as a global community to narrow the treatment gap in LMIC and HIC health systems? The treatment gap in both LMICs and HICs may be explained by some combination of lack of (1) universal access to health and mental health care, (2) accessibility of evidence-based treatments, (3) clinical skills among health care providers, and (4) political will or financial resources. Additionally, each of these factors is magnified by historical stigma and discrimination of people with SUDs in all cultures.

Stigma and legal and economic discrimination toward people with alcohol and drug use disorders have contributed to marginalization of individuals with these disorders by societies and communities. These conditions contribute to self-stigma, with consequent avoidance of help seeking, to social isolation of people with SUDs and their families, to the ongoing lack of education among health care and governmental leaders about the availability of effective treatments, and to the lack of systematic education of health and mental health care providers about evidence-based treatments for patients with SUDs. It is therefore critical that clinicians, inclusive of mental health providers, in LMICs and HICs learn to integrate prevention, early intervention, treatment and recovery approaches and strategies, and evidence-based treatments into their work with patients with mental health disorders who have, or are at risk for, SUDs.

This selective review of the literature provides an overview of the global treatment gap for SUDs, including the historical roots of stigma and discrimination, the epidemiology of SUDs and the consequent global disease burden and costs, the availability of effective behavioral and medication treatments, specific models of SUD treatment implementation, and capacity building through training of mental health and primary care providers in community settings. Two case examples of implementation strategies to overcome specific challenges are also presented.

HISTORICAL ROOTS OF GLOBAL STIGMA AND DISCRIMINATION OF PEOPLE WITH SUBSTANCE USE DISORDERS

SUDs are complex mental health disorders that manifest in individuals in specific sociocultural contexts, including those characterized by individual disempowerment and discrimination. Although there are many barriers to providing care for patients with SUDs, stigma and discrimination are particularly important factors at both the provider and the health systems levels. 17 This stigma is fueled by ignorance and false beliefs regarding SUDs, including their etiology and the efficacy of treatments. 18 , 19 This stigma is powerfully reified in the language we use to describe those with SUDs. For example, in a study of mental health care practitioners attending professional conferences, when a person with an SUD was described as a “substance abuser,” rather than as “a person with a substance use disorder,” clinicians were less likely to believe that he or she deserved treatment. 20 Individuals with SUDs often do not recognize that they have a treatable condition; this lack of knowledge may in part reflect the surrounding society’s or community’s lack of awareness or knowledge. There is also a long-standing, well-documented disapproval of those with SUDs. 21 Self-stigma may reflect the individual’s perceived disapproval by others in one’s society or community, contributing to a sense of shame and fear of rejection, abandonment, or punishment. 22 In response to the considerable public misinformation about SUDs, the World Health Organization (WHO) published a fact sheet in multiple languages for policy makers entitled “What do people think they know about substance dependence,” dispelling eight myths about SUDs. 23

Stigma thus creates a significant barrier across many communities and societies in both LMICs and HICs. While legal and cultural conditions vary across countries and global regions, stigma is pervasive, including self-stigma, perceived stigma, and social and legal discrimination. One literature review of stigma and SUDs examined 20 published studies from the United Kingdom, United States, and Western Europe, and found that the public holds highly stigmatizing attitudes, including stereotyping, general emotional reactions, and consequent discrimination and loss of social status for individuals with SUDs. 24 A more recent review focused on the relationship between perceived social and self-stigma and SUD treatment outcomes, including alcohol and opioid use disorders, and examined studies across nine countries, including Australia, China, United Kingdom, United States, and several European countries. 25 This study found that individuals with SUDs across all these diverse countries and settings faced a large amount of stigma, often representing a significant barrier to seeking care. Countries such as China, Russia, and Ukraine, with mandatory registration systems. may present additional barriers for individuals who would benefit from SUD treatment. 25 Similar to studies in Western European countries and the United States, a population-based study in a rural Ethiopian district found that self-stigma and perceived social stigma are demonstrated barriers to seeking treatment for AUD. 26 The participants in this study endorsed feelings of being disappointed in themselves and feeling embarrassed and ashamed, as well as being taken less seriously or ignored by others because of their alcohol problem. 26 Religious beliefs and fear of legal prosecution can also be a barrier in some countries or regions. In one study of 612 male participants admitted to a psychiatric rehabilitation center in Saudi Arabia, barriers to seeking care also included strict observance of Islamic principles, with use of alcohol and drugs prohibited and punishable. 27 This study argues that there has nevertheless been an increase in SUDs and that social stigma, including fear of possible punishment, contributes to delay in seeking care from health professionals. 27

Stigmatizing attitudes of health care professionals can also impede diagnosis and treatment of individuals with SUDs. 25 , 28 Provision of treatment services that are culturally adapted and welcoming, and that simultaneously address biases among health care professionals, may also be effective in reducing perceived social stigma and self-stigma among patients with SUDs. Education and training of health providers and health systems leaders on evidence-based practices to reduce suffering, morbidity, and mortality from SUDs in the populations they serve is one necessary (even if not sufficient) step toward implementing screening, early interventions, and treatment for individuals with SUDs.

EPIDEMIOLOGY, DISEASE BURDEN, AND COSTS OF SUBSTANCE USE DISORDERS GLOBALLY

WHO held its first Forum on Alcohol, Drugs and Addictive Behaviours (FADAB) in June 2017. 1 FADAB reported that in 2008, 155–250 million people, or 3.5%–5.7% of the world’s population between ages 15 and 64 years, used substances such as cannabis, amphetamines, cocaine, opioids, and non-prescribed prescription medicines. Globally, cannabis is used by 129–290 million people, which is followed in prevalence of use by amphetamines, stimulants, cocaine, and opioids. WHO estimates that 0.7% of the global burden of disease in 2004 was due to cocaine and opioid use and that the social cost of illicit substance use was approximately 2% of the world’s gross domestic product. The 2008 data estimated that globally, 69,000 people die from opioid overdose annually and that more than 15 million have OUD with physiologic dependence. In spite of this, in 2008 only 30% of countries had effective medication available (in this study, narrowly defined as opioid agonist pharmacotherapy for maintenance treatment of opioid dependence) to treat this disorder. 1

As of March 2018, global alcohol consumption was equal to 6.4 liters of pure alcohol consumed per person per year for those 15 years and older, 29 which can be understood as a population average estimate of approximately one bottle or one liter of wine per week per person, with distribution of total quantity per individual non-randomly distributed and primarily concentrated in some individuals and not in others. 30 Almost 25% of alcohol consumed was illegally produced or sold. In 2016, 16% of drinkers 15 years and older engaged in heavy episodic drinking, with HICs having the highest alcohol consumption per capita. 1 Approximately 38% of individuals 15 years and older had consumed alcohol in the past 12 months, with more females being lifetime abstainers than males. Considerable variation of drinking and abstention rates in both women and men occurs, reflecting variations in cultural norms and prohibitions from region to region.

In 2016, daily tobacco smoking (consistent with nicotine use disorder) resulted in a staggering $2 trillion global economic burden associated with health care costs of tobacco-related illnesses and lost productivity due to premature morbidity and mortality. The majority of smoking-related deaths occur in LMICs, and men have substantially higher death rates than women in most countries. Regional variation in cigarette consumption continues to associate lower socioeconomic status with greater consumption, even in LMICs, and China has suffered sustained growth in consumption, consuming more cigarettes now than all other LMICs combined. 15 In addition, mental health disorders, including other SUDs, are associated with vulnerability to nicotine use disorder, 31 which therefore presents an opportunity for intervention in mental health treatment services.

Another measure by which to understand the global impact of SUDs is through disability-adjusted life years (DALYs). According to one study, in 2000, 4% of the global burden of disease measured in DALYs could be attributed to alcohol, 4% to tobacco, and 0.8% to illicit drugs. In countries with emerging economies, alcohol use was the most important of all risk factors in affected youth with respect to disability and mortality, exceeding even the importance of tobacco in this population. 32 In 2016, 31.8 million DALYs (1.3% of all DALYs) were attributable to drug use, and 99.2 million DALYs (4.2% of all DALYs) were attributable to alcohol use. 33

While these statistics capture global impact, they can obscure differences among regions and countries. For example, while alcohol accounted for 76% of substance use–attributable DALYs globally, drugs accounted for a greater percentage in two regions: high-income North America (53% of all substance-attributable DALYs) and North Africa and the Middle East (69% of total alcohol and drug–attributable DALYs). In addition, overall disease burden attributable to alcohol and drugs varies between countries. For example, the countries with the highest alcohol-attributable, age-standardized DALYs include Burundi, Central African Republic, Lesotho, Russia, and Ukraine. By contrast, Mongolia, Russia, and the United States, had the highest age-standardized DALYs attributable to drugs. 33 These differences in prevalence and health burden between regions and between countries provide important context for implementing interventions to reduce SUD morbidity and mortality in specific communities and countries.

The sex ratio of disease burden is approximately 4 to 1 (men to women) for most substances worldwide. This sex difference is most likely attributable to regional variation in social acceptability of drug and alcohol use and its impact on lifetime exposure. Cultural norms and prohibitions against drinking for women and men vary across regions. For example, according to WHO in 2016, the global prevalence of AUD varied widely by sex, with 46 million adult women (1.7%) and 237 million adult men (8.6%) having an AUD. For women, the greatest prevalence of AUD was in Europe (3.5% adult women) and in the Americas (5.1% adult women). For men, the highest prevalence rates for AUD were in the Americas (11.5% of adult men) and WHO’s European region (14.6% of adult men). 34 Most importantly, these statistics indicate that significant rates of death, disease, and disability could be avoided if consumption was modestly reduced. For example, in 2000, the attributable overall DALYs from alcohol were 713 million. If consumption had been cut by 25% in the intervening decade, the estimated avoidable disease burden by 2010 was 195 million DALYs, and by 2020, another 220 million DALYs. 32

Given the epidemiology and the clear population health burden, it is critical for practitioners of global mental health to appreciate that SUDs are rarely present on their own. Multiple epidemiologic studies confirm the high rates of co-occurring SUDs among individuals with other mental health disorders, including depression, anxiety, psychosis, and posttraumatic stress disorders. 35 , 36 Just as it is recommended that primary care medicine practitioners screen for SUDs and provide appropriate interventions for patients that have presented to them with co-occurring medical conditions, so it is also true that mental health practitioners can decrease the burden of disease and enhance clinical outcomes if they are able to provide screening and appropriate SUD interventions for their patients with depression, anxiety, psychotic, posttraumatic stress, and other related disorders.

Effective interventions for SUDs include behavioral and pharmacologic treatments, which are discussed in depth in the next section. The sections after that discuss the challenges and strategies for implementing evidence-based treatments for SUD in low-resource settings, along with efforts to build capacity through training of lay, community, and peer support persons. The final substantive section presents two case examples of implementing SUD treatments in low-resource settings. The first case demonstrates the effectiveness of using an existing delivery platform for TB treatment in Tomsk Oblast, Russia, to integrate AUD treatment. The second case demonstrates successful community engagement and input to appropriately and culturally adapt an intervention to lower risk for alcohol-exposed pregnancies in women with high-risk drinking in the Oglala Sioux Tribe community.

EVIDENCE-BASED TREATMENTS FOR SUDs AND ADAPTATION TO LOW-RESOURCE SETTINGS

Behavioral treatments.

Evidence-based behavioral treatments leverage techniques for modifying behavior, cognition, and motivation to target the key behavioral processes that maintain substance use, such as ambivalence about change and maladaptive strategies for coping with stress and environmental risk factors. Although not all behavioral treatments are equally effective, several types of treatments have demonstrated efficacy for SUDs, 37 including cognitive-behavioral therapies, 38 motivational interviewing, 39 and contingency-management approaches. 40 With increased recognition of the array of sex differences in SUDs, including treatment needs that are unique to, or that disproportionately affect, women, gender-specific treatment approaches for women have been developed. 41 For example, the Women’s Recovery Group—a manualized group therapy for women with SUDs—utilizes both gender-specific content and an all-women format that facilitates affiliation among group members. 42

Peer support can play an important role in treatment. Mutual support groups such as Alcoholics Anonymous (AA), along with other groups such as Narcotics Anonymous (NA) and SMART Recovery, are available globally and represent the most accessible form of SUD treatment in many regions. Although the specific focus varies across types of mutual help groups, these groups generally include both social support and recommended behavior-change strategies or other intervention components. Mutual help groups may be particularly helpful as a complement to traditional therapies; indeed, most of the available empirical data on mutual help focuses on the addition of mutual help to other interventions.

A recent Cochrane review found strong support for the efficacy of manualized interventions that encourage AA participation. 43 A significant benefit of mutual help is that it is both low-cost and widely available. In 2017, AA was active in 180 countries ( www.aa.org ). Although AA continues to be the most widely available mutual support group, there may be significant barriers to accessing this peer support in some countries, such as legal consequences (e.g., mandated treatment, termination of a driver’s license) for those who identify themselves with an AUD (for example) but for whom there is no protection of confidentiality. Recovery coaching is a rapidly expanding mutual support format that uses an individual mentorship model and can extend the reach of treatment supports beyond traditional settings. This approach may be helpful in LMIC settings, with the benefits of both expanding treatment capacity and leveraging local expertise (e.g., understanding of social support systems); however, this approach currently lacks empirical data, which are necessary to support the widescale implementation of this strategy. Nonetheless, the many benefits of mutual help should be tempered with the caution that little data are available on mutual help as a stand-alone treatment. Thus, building capacity in this particular domain without also considering formal treatments may do little to ease existing disparities in LMICs.

Behavioral therapies can be delivered in either individual or group formats, and the few trials that have compared these delivery methods have generally not supported the superiority of either format. 44 Group therapy has specific advantages in many treatment settings because it allows for more efficient allocation of therapist time. This delivery method may be particularly well suited to LMICs. For example, a study of group-delivered behavioral therapy for posttraumatic stress disorder for female sexual violence survivors in the Democratic Republic of Congo was associated with large symptom improvements and was superior to a comparison support condition. 45 Among the greatest challenges in improving access to behavioral therapies for SUDs is to train therapists—a challenge that has hampered the successful dissemination of behavioral therapies across psychiatric and behavioral health conditions. 46 Studies of clinician training in behavioral treatments have consistently found that a one-time workshop is insufficient to achieve successful training outcomes. 47 The gold standard for training in behavioral therapies is resource intensive and entails didactic training as well as practice-based learning followed by ongoing supervision and feedback. Such training can be especially challenging in LMIC settings.

Accordingly, efforts to make this process more efficient have been undertaken, including the consideration of “stepped” training approaches, in which more intensive training is only provided to those who do not quickly achieve competence. 48 Successful components of large-scale efforts to implement behavioral treatments include the availability of funding, program “champions,” and the ability to manage the unique challenges of each service setting through setting-specific adaptations. 49 Such setting-specific changes may include adapting the treatment to the available infrastructure (e.g., availability of mental health professionals) and adapting the treatment content to be culturally responsive while also maintaining the treatment’s core “active ingredients.” For example, studies of behavioral therapies leveraging community mental health workers have shown beneficial outcomes in settings with limited availability of specialized mental health professionals, such as communities in Iraq 50 and Afghanistan. 51 Adaptations of behavioral treatments to include culturally relevant content, such as the use of salient metaphors and consideration of local customs and values, have also demonstrated efficacy. 52

Technology-based treatment is another promising approach for delivering behavioral interventions. The use of computer-based administration of behavioral therapies has shown promise and may enable expanded access to high-quality behavioral interventions while requiring only minimal training for clinical support staff. 53 This reduced need for training may be particularly critical in view of the potential training burden associated with the various behavioral treatments that may be relevant in any given setting (e.g., contingency management, motivational interviewing, sex-specific treatments). 54 Development efforts are under way for other technologies, such as mobile phone applications 55 and various forms of telehealth (communication with a professional at a distance via video, voice, or text 56 ). These approaches offer substantial promise to expand evidence-based treatments to low-resource settings. The delivery of such advancements is subject, however, to barriers such as inconsistent or limited access to devices as well as to internet, cellular, and electric power services. Moreover, evaluation of the efficacy of these approaches will be critical, as this research agenda has at times been met with disappointing results. 57

Medication Treatment

Medication treatment for SUDs provides significant support for safety (e.g., detoxification and prevention of life-threatening withdrawal syndromes such as may occur with AUD; stabilization of alcohol and drug poisoning; reversal of opioid poisoning), comfort (e.g., opioid withdrawal), and relapse prevention (e.g., for nicotine, alcohol, and opioids). 58 All medication interventions for SUDs require patient and community health education on the biopsychosocial hazards of substance misuse and SUDs in order to achieve optimal public health prevention. Medication treatments directed at maintaining abstinence from addictive substances are optimally paired with individualized behavioral treatment and objective monitoring of progress (observed mental status stabilization, role performance improvement, toxico-logical evidence of abstinence or substance reduction, and self-reported improvements in quality of life).

In considering medication availability in lower-resourced regions, priority must be given to life-saving interventions and protocols, including benzodiazepine stabilization of alcohol and sedative withdrawal syndromes, drug poisoning reversal treatments (e.g., antagonist therapies such as naloxone for opioid overdose and flumazenil for benzodiazepine overdose), and nonspecific supportive medical interventions for substance-related delirium (e.g., thiamine and folate replacement, haloperidol for psychosis/delirium, hydration, and oxygenation). These treatments will save lives but do not prevent future substance misuse and must be considered emergency interventions rather than effective SUD treatments.

Evidence-based medications to treat SUDs are available with greatest demonstrated effectiveness for OUD, nicotine use disorder, and AUD. Only nicotine use disorder treatments have been assessed to be equally effective in those with or without co-occurring mental health disorders. 59 General principles of SUD maintenance therapies include using partial or full agonist therapies, in which the medication effectively replaces and stabilizes neural pathways destabilized by chronic substance use, as well as antagonist therapies, in which the medication blocks future substance access to receptors within affected, SUD-reinforcing neural pathways. Examples of the former include buprenorphine and methadone for OUD, nicotine replacement and varenicline for nicotine use disorder, and acamprosate, topiramate, and gabapentin for AUD. Examples of antagonist therapy include naltrexone for both OUD and AUD, and bupropion for nicotine use disorder. Some medications, such as the partial agonists buprenorphine and varenicline, provide unique pharmacological aspects of both agonist and antagonist prevention against future substance use. Disulfiram is an aversive medication used to treat AUD. Alcohol is metabolized to acetaldehyde, which is, in turn, metabolized by the enzyme acetaldehyde dehydrogenase. If alcohol is consumed, the inhibition by disulfiram of acetaldehyde dehydrogenase will cause a build-up of acetaldehyde, producing unpleasant side effects including flushing and nausea, and potential increased heart rate, hypotension, and chest pain. In resource-limited settings, prioritization may be considered for utilizing medications with low incidence of adverse effects and good tolerability (e.g., buprenorphine, varenicline, acamprosate) over medications with more serious adverse effects requiring laboratory monitoring (e.g., methadone, disulfiram) or with lower tolerability. It is also useful to caution against somatic treatments that may be in use and for which there is no empirical support.

Although sex differences in response to pharmacotherapies are largely unknown due to poor representation of women in many clinical trials, evidence is beginning to emerge suggesting that men and women may respond differently to a range of medications for SUDs. For example, a meta-analytic review identified superior treatment outcomes for nicotine-dependent women treated with varenicline relative to nicotine replacement therapy, a finding not observed for men. 60 Most studies have shown comparable clinical outcomes for women and men for buprenorphine/naloxone treatment for OUD. 61

One domain of sex-specific treatment is for pregnant and postpartum women with SUDs. Most addictive substances cross the placenta, and many are known or suspected teratogens. Accordingly, efforts to engage pregnant women with SUDs in prenatal and substance use care are critically important for both the health of the mother and the developing fetus. While behavioral therapies are important interventions for pregnant and postpartum women, 62 for pregnant women with OUD it is now considered standard of care to receive methadone or buprenorphine, two agonist medications with demonstrated efficacy for treating pregnant women with OUD. 63 , 64

CHALLENGES AND STRATEGIES FOR IMPLEMENTING EVIDENCE-BASED TREATMENTS FOR SUBSTANCE-RELATED DISORDERS IN LOW-RESOURCE SETTINGS

Bridging the treatment gap requires strategic choice, adaptation, and delivery of evidence-based treatments in LMICs, with special attention paid to local disease burden, existing health infrastructure, and cultural factors. Planning and implementation is an iterative, bidirectional process, involving mental health specialists and other health care providers. Multidisciplinary teams must include psychiatrists and psychologists, along with primary care providers and teams focused on co-occurring medical and other mental health conditions, as well as community-based health workers and peer and lay counselors, to arrive at the most effective model of training to implement evidence-based care for patients with SUDs. In many global health settings, robust delivery platforms that could potentially integrate SUD prevention and treatment—such as national programs in HIV, TB, and maternal-child health—also require strong buy-in from program administrators and political leaders. Getting such support is key since layering SUD treatment onto these existing health care platforms can optimize assets such as national treatment protocols, supply chains, and community health worker networks. 65

One large-scale set of studies that demonstrated these principles for mental health care is the Programme for Improving Mental Health Care (PRIME). This multi-country study demonstrated the effective development and piloting of mental health care plans at the district level in five LMICs. 66 With many effective and cost-effective interventions available, scaling up the implementation of these interventions in low-resource settings was the greatest challenge faced by the investigators participating in this study. While the settings for this implementation strategy were diverse socially, culturally, and economically, they nevertheless shared an overall framework for developing their particular mental health care plans. Five district plans developed in Ethiopia, India, Nepal, South Africa, and Uganda utilized strategies that included extensive consultations with local and national experts, as well as assessment tools to evaluate competency of primary care physicians to deliver basic mental health care. One significant finding from these studies is that differences among the countries were often resource driven, with disparities more prominent between low-income and middle-income countries. A number of challenges, however, were similar across low- and middle-income countries, including the existence of already overburdened primary care systems, the need for high levels of stakeholder participation and engagement, and the limited impact of training in the absence of referral pathways, improved medication supplies, and reorientation of health facility managers to integrate these mental health care interventions. Taken together, this study represents the first multi-country, detailed, district-level planning for integrating mental health treatment into primary care, 66 and it provides a roadmap of strategies that may be effective in integrating specific mental health interventions into primary care services. Notably, AUD was included as one of the mental health conditions in packages of interventions in the districts in all five countries. 67 – 71 With respect to AUD, these interventions were variable as to whether they emphasized screening and detection, referral to an alcohol rehabilitation center for treatment, behavioral treatment, or medication treatment.

The selection of appropriate evidence-based interventions is based upon consideration of the cultural context of providing care, availability of existing resources, and best opportunities to expand capacity in the specific context where the care will be delivered. For instance, pharmacologic treatment may not be ideal in settings where medication supply chains are weak, and the choice of behavioral treatments may depend on the size, skills, and oversight of health care providers who would deliver the intervention. In this respect, non–mental health practitioners can provide key information on acceptable and unacceptable interventions, and also on implications for delivery. Surveys or interviews with providers and patients can not only “paint the landscape” of mental health and SUD treatment needs, but also reduce stigma and build buy-in through open dialogue about concerns and treatment options.

Once interventions are identified, implementation processes should be created to address screening and referral, clarify provider roles and systems for inter-provider communication, and optimize patient engagement and retention. In the global context, treatment programs may require building out additional teams or delivery platforms as needed to reach those individuals who are not accessing health care systems. Iterative discussions are often needed to sensitize program directors and front-line providers to the relevance of treating SUDs as well as other co-occurring mental health conditions, and of embracing “program accountability” for individuals traditionally excluded from health care.

TRAINING HEALTH CARE WORKERS TO PROVIDE EVIDENCE-BASED SUD TREATMENT

Long-term, sustained training is the most effective means of building self-efficacy among providers who initially may be unfamiliar and uncomfortable with providing SUD care. 72 – 74 Although resource intensive, the up-front investment of a collaborative supervision model for adapting evidence-based SUD treatments to global health settings can provide significant gains in providing effective cultural innovations of evidence-based treatment that may be sustained locally. Several strategies have been successfully employed in such collaborative care models and are becoming increasingly affordable and accessible with expansion of virtual technologies and platforms to support global collaborations (see Text Box 1 ). These strategies harness the evidence-based treatment expertise of clinical/research teams paired with the cultural expertise of local health care leadership teams to adapt evidence-based treatment to local resources, training needs, delivery platforms, quality assessment, evidence-based treatment performance, and patient acceptance, leading to optimal local integration and outcomes (institutional pairing). Initial planning includes an intensive process of mutual engagement around targeted goals, training in all aspects of evidence-based treatment protocols, and implementing innovation needs of the region that may reflect regional resource gaps or cultural stigma (“train the trainer” models for disseminating evidence-based treatments). Next phases provide structured staff training, setup, and piloting of adapted evidence-based treatments for initial cultural acceptance and fit. Once achieved, a structured schedule of collaborative quality assessment of implementation and iterative feedback to optimize evidence-based treatment delivery and outcome can yield local sustainability and interim adaptability to changing trends, as well as medical updates to evidence-based treatments. The use of technology to bridge geographical training barriers, coupled with planned collaborative booster supervision, is essential to achieving these goals.

Collaborative Strategies Supporting Evidence-based SUD Treatment Dissemination 72 – 74

EBT, evidence-based treatment; SUD, substance use disorder.

Given the paucity of specialized SUD/mental health services broadly available in both LMICS and HICs, along with the strain on primary care in LMICs especially, dissemination of evidence-based treatments will of necessity include building a work force comprising nonmedical/nonclinical lay staff as well as supportive involvement of family, friends, and other community stakeholders to serve roles of extended care management. Mental health studies utilizing these approaches have demonstrated efficacy in LMIC regions, 45 , 75 with the data showing positive trends for efficacy in AUD. Global SUD peer support/recovery programs, typified by 12-step programs such as Alcoholics Anonymous also provide extended stabilization resources through the social networking of recovering peers actively assisting and engaging peers in early recovery phases of treatment. It has been noted, however, that these programs are effective only in culturally accepting regions and do not effectively engage SUD populations in regions having strong barriers of stigma and legal discrimination against SUDs, such as Russia, 74 or in regions lacking familiarity with 12-step programs, such as Brazil. 76

Care-management intervention studies generally offer mixed results, with strongest efficacy in patient engagement and retention in care, versus with other measured outcomes. 77 Therefore, in strategic planning for development of lay health worker and peer support services, a needs assessment should consider regional barriers to care in order of need priority/severity, and use this assessment to guide selection of their participatory services best suited to plug gaps in SUD care, while also incentivizing lay health workers to actively participate. For example, recruiting and reimbursing transportation services to health clinicians may in some cases be more urgently needed than training lay health workers to deliver mobile care remotely. These decision points are best collaboratively determined by a community-wide needs assessment process. Indeed, lessons learned from large-scale global mental health studies in LMICs aimed at integrating mental health and AUD care within primary care services confirm this approach, and further outline eight core considerations during implementation: (1) use participatory workshops during the design and planning phases, bringing together as many community stakeholders as possible to achieve unity in purpose and vision, (2) engage health providers in allowing non-stigmatized health services to be a point of contact in which to identify and engage individuals with more stigmatized mental health/SUD service needs, (3) use screening instruments that employ culturally appropriate concepts and case vignettes, (4) train lay health workers in the use of manualized treatment interventions, (5) provide longitudinal fidelity/adherence supervision support, along with assessment of progress in achieving intervention goals, (6) adequately compensate lay health workers for their services, (7) implement more robust mental health/SUD care when systems need to be rebuilt after natural disasters, and (8) rapidly respond to natural opportunities in which political will or funding is aligned with strengthening regional mental health/SUD care. 78

CASE EXAMPLES OF ADAPTATION AND IMPLEMENTATION OF EVIDENCE-BASED SUD TREATMENTS INTO LOW-RESOURCE SETTINGS

Incorporating tools for monitoring and evaluation is essential for tracking program goals. Because SUDs may be under-diagnosed, universal screening can help to quantify service needs, the association of SUDs with other health conditions, and treatment response to SUD care. Especially when providers are new to the delivery of behavioral interventions, monitoring treatment fidelity and providing ongoing, real-time feedback are critical to achieving competence in treatment delivery and to sustaining the adoption of these interventions. Programs should also incorporate algorithms to make iterative programmatic changes based on data.

Although the co-occurrence of SUDs with other medical conditions magnifies the impact of SUDs on global disease burden, this phenomenon also presents unique opportunities for treatment delivery: programs focused on specific health problems may offer a platform to reach those at greatest risk of SUDs, even where infrastructure for mental health and primary care is weak. Furthermore, because SUDs have such a profound impact on disease outcomes, programs targeting local disease burden (for example, HIV, TB, maternal-child health, depression, posttraumatic stress disorder) are most likely to achieve their desired outcomes if SUD treatment is integrated into their package of care. Cultural adaptation, stakeholder engagement, and community input to effectively adapt evidenced-based SUD treatment are also critical strategies for successful implementation. We present two case studies in diverse settings to illustrate these principles. The first uses an existing TB treatment-delivery platform to implement effective AUD screening and treatment in Tomsk Oblast, Russia. The second case study integrates community input to adapt an effective intervention to prevent alcohol-exposed pregnancies in the American Indian community in the United States.

IMPACT Trial in Tomsk Oblast, Russia, to Integrate AUD Treatment into TB Care

TB treatment involves daily, directly observed therapy (DOT) for at least six months, and therefore offers an ideal “delivery platform” for intensive alcohol and potentially other SUD care. To illustrate this integrated treatment model, a TB program in Tomsk Oblast, located in western Siberia, incorporated alcohol treatment into routine TB care. AUD was known to be highly prevalent among TB patients in this setting. 79 , 80 In response, a team of U.S.-based addictions and TB specialists collaborated with local leadership and physicians to incorporate three components of AUD care into their TB program: screening and referral; evidence-based treatments adapted to the local context; and delivery across a spectrum of care settings. First, the Alcohol Use Disorders Identification Test (AUDIT) was locally validated and implemented by TB physicians, with treatment algorithms based on AUDIT scores. 81 In addition to introducing universal screening and referral, the incorporation of this tool into the routine intake process began to normalize discussions of alcohol use with their patients. Pharmacologic and behavioral treatment options then were incorporated into TB care. Naltrexone was administered along with TB medications under DOT. Using the bidirectional approach described above, the cross-cultural team adapted a brief counseling intervention (BCI) for this population and setting; a key modification included scripted discussions designed to motivate patients to reduce their alcohol intake to improve their chance of TB cure. As patients recovered, they routinely transitioned from inpatient care to day hospitals and clinic posts. To ensure continuity of care, all DOT workers were trained to administer naltrexone and track naltrexone adherence on the patient’s “TB treatment card.” BCIs were incorporated into routine monthly TB follow-up evaluations; however, for patients who moved back to remote villages, sporadic follow-up resulted in fewer BCI encounters.

The clinical trial to evaluate this model found that naltrexone adherence was high, with 75% of planned doses achieved through DOT; among individuals who had previously attempted to quit, naltrexone improved TB treatment outcomes (92% versus 76% had favorable outcomes; p = .04). 82 BCIs proved more challenging to deliver, however, and did not improve outcomes, with patients receiving only 50% of planned BCI encounters. To improve continuity of care, a pilot program, Sputnik, was subsequently implemented. 83 Through home visits, trained nurses now work with patients to address alcohol use and other psychosocial issues, resulting in greater retention and improved TB outcomes. The experience described above suggests that treatment programs can overcome barriers of stigma and limited access to specialty services by folding SUD care into existing health care platforms in global health settings. 65

CHOICES (Changing High-Risk Alcohol Use and Increasing Contraception Effectiveness Study) in the Oglala Sioux Tribe

This program highlights the importance of community input to effectively adapt an evidenced-based treatment for use in an American Indian community. CHOICES (Changing High-Risk Alcohol Use and Increasing Contraception Effectiveness Study) was developed as a preconception intervention to reduce alcohol-exposed pregnancies among women engaged in risky drinking. 84 The brief motivational interviewing was originally designed to include four counseling sessions and one contraception consultation visit. CHOICES was shown to reduce risky drinking and increase contraception use among urban and suburban women in a multisite clinical trial. 85 The team then partnered with the Oglala Sioux Tribe to adapt the CHOICES curriculum with extensive community input from clinic staff and leadership. Tribal clinics were then allowed to tailor the intervention to their own preferences and needs (e.g., person who delivered the curriculum, number of sessions offered, recruitment strategies), and the program resulted in significantly reduced alcohol-exposed pregnancy risk. 86 A subsequent iteration has involved group delivery of the CHOICES intervention, 87 based on qualitative input from the Oglala community members on the importance of social support from relatives, elders, and community members through shared cultural practices and teachings. 88 This program highlights how an evidence-based treatment can be successfully transitioned from research to programmatic implementation through strong community engagement and program flexibility to build upon the varying strengths of local implementation sites.

For vulnerable populations who are marginalized from health care, these approaches can have synergistic positive effects on SUDs and other prevalent health outcomes. 89 , 90 Because of underlying risk factors for both SUDs and co-occurring conditions, integrated care may be ideal for delivering sex-specific interventions. 91 , 92 Systematic reviews and implementation research reinforce the importance of five core components for successfully integrated programs: political will; longitudinal training for front-line providers; standardized protocols for screening, treatment, and referral; patient-centered, holistic approaches to managing comorbid conditions; and service delivery that maximizes efficiency and retention. 72 , 73 , 93 – 96

Substance use disorders are highly prevalent globally resulting in great morbidity and mortality. In addition to high burden of disease, SUDs cause significant additional harm to others, especially women and children, through substance-related injuries, violence, adverse effects on fetal development, disruption in parenting, and other mental health effects through the complex interplay between SUDs and other conditions, including depression, anxiety, posttraumatic stress, and psychotic disorders. The additional costs to communities and societies include family and social disruption, financial costs, and economic burden. Despite the existence of evidence-based treatments, implementation of behavioral, pharmacologic, and community-based services in both LMICs and HICs remains severely limited; the treatment gap globally is vast; and most individuals never receive treatment specific to SUDs. Stigma and legal discrimination associated with SUDs continue to hinder public understanding of SUDs as treatable mental health conditions. Culturally appropriate adaptation of evidence-based treatments is a necessary step in implementing innovative systems of care and can be accomplished through community-wide needs assessments. Models of integration of SUD treatment into existing platforms of medical and mental health care can be culturally adapted and expanded through training primary care and mental health care providers, including lay health workers. Strategies can be successfully employed to build capacity through collaborative care models for mental health, including SUD care, train-the-trainer models, including booster sessions for clinicians for ongoing implementation, and clinician/researcher collaboration for adaptation of evidence-based treatments to specific settings. Innovations in the use of technology show promise in providing training, consultation, and extended recovery treatment support. Compelling evidence demonstrates that increasing access to SUD treatment in LMICs and HICs can substantially reduce morbidity and mortality, decrease economic burdens in multiple domains, and improve individual, family, and community health.

Acknowledgments

Supported , in part, by National Institute on Drug Abuse grant no. K23 DA035297 (Dr. McHugh).

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the article.

This article represents work that will be published, in part, in the chapter “Substance Use Disorders in Global Mental Health Training” in the forthcoming book A Framework for Training in Global Mental Health Delivery , edited by Bibhav Acharya and Anne E. Becker, to be published by Routledge/Taylor & Francis.

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