Research

The Alcohol Research Center on HIV (ARCH) is a multidisciplinary program project grant focused on reducing the impact of alcohol on the breadth and depth of the HIV epidemic. Research Component 3 was specifically designed to apply implementation science methods to promote integrated alcohol-HIV care in South Africa, a country at the epicenter of the global HIV epidemic.

South Africa is at the epicenter of the global HIV pandemic and has alarming rates of alcohol use, which pose a significant challenge to the HIV care cascade. Integrated alcohol-HIV care is the gold standard, but delivery of integrated care in South Africa is extremely rare. Recognizing the detrimental effects of risky alcohol use on the HIV care cascade, and in response to a needs assessment of national stakeholders and policy-makers, this research component evaluates a highly scalable train-the-trainer initiative on Screening, Brief Intervention and Referral to (SBIRT) for risky alcohol use. Using a novel task-sharing approach, we will provide SBIRT implementation support to over 900 health professionals and lay workers embedded within HIV treatment organizations. Study activities address three specific aims:

1. Develop a SBIRT train-the-trainer manual and suite of resources suitable for lay counselors.
2. Evaluate the effectiveness of the SBIRT train-the-trainer model on key implementation science outcomes measured at the trainer (e.g., fidelity, knowledge), provider (e.g., attitudes, self-efficacy, acceptability) and patient encounter levels (e.g., proportion of patients who receive each component of SBIRT – screening, brief intervention and referral to treatment).
3. Examine the relationship among trainer-, provider- and patient encounter-level outcomes.

Results of this study will advance knowledge of key implementation science questions, while promoting the integration of alcohol and HIV care, in a global priority setting.

Dates: September 2020 – May 2025

Funding source: National Institute on Alcohol Abuse and Alcoholism

Grant number: P01AA019072

Contact

Co-investigators: Kira DiClemente, PhD

Most oral health professionals advise patients who smoke to quit, but few connect patients directly to smoking cessation medication, which is an essential component of evidence-based smoking cessation treatment. Based on findings from previous trials, this cluster randomized, hybrid type 1 implementation-effectiveness trial will test whether combining brief advice with nicotine replacement therapy (NRT) sampling, which refers to providing patients who smoke with free samples of over-the-counter nicotine patches and nicotine lozenges, during a routine dentist visit increases rates of abstinence, quit attempts, and use of NRT. The results of the proposed research have potential for important clinical and policy significance with regard to reducing tobacco-related morbidity and mortality.

Cigarette smoking has profound negative effects on oral health. Smoking cessation decreases the incidence and progression of oral health problems. Most smokers attempt to quit, but the majority of quit attempts are unaided by smoking cessation medications and end in relapse. The American Dental Hygienists Association recommends that all oral health professionals Ask patients if they smoke, Advise smokers to quit, and Refer smokers to quitlines for counseling (Ask-Advise-Refer; AAR). AAR connects patients directly to counseling but not to medication, which can double cessation rates independent of counseling. Indeed, few dentists prescribe cessation medications. Failure to connect smokers to medication is a critical missed opportunity to prevent disease and save lives. Nicotine Replacement Therapy Sampling (NRTS) refers to providing all smokers, regardless of current interest in quitting, with free samples of over-the-counter NRT products and brief use instructions. NRTS has been shown to increase quit attempts and smoking abstinence rates. Dental settings are an ideal fit for NRTS because NRTS could easily be combined with AAR and providing samples of oral care products is routine and universal in dental care settings. This 5-year project will test the effectiveness of NRTS in dental practices. In the 2-year Clinical Trial Planning Phase (completed July 2022), we will establish feasibility and acceptability of study protocols. In the 3-year Clinical Trial Implementation Phase, activities will include stakeholder interviews to evaluate initial acceptability and feasibility of proposed study interventions and procedures, pilot testing, protocol refinement, and recruitment of practitioners for the UH3 trial. We propose to conduct a cluster randomized, hybrid type 1 implementation-effectiveness trial comparing AAR + NRTS (NRTS) to enhanced usual care (ET; AAR + electric toothbrush; N = 50 practitioners, limited to 1 per practice; N = 1200 patients) recruited from the Northeast and Midwest Regions of the National Dental Practice-Based Research Network. Study interventions will be delivered within the practices by trained practice staff. Our central hypothesis is that NRTS will produce greater abstinence rates than ET. Our primary outcome will be biologically verified, 7-day point prevalence abstinence at 6-months post-intervention. We also predict that compared to ET, NRTS will increase rates of quit attempts, reduce smoking heaviness, and increase NRT utilization. We will conduct a multi-stakeholder process evaluation of the feasibility and acceptability of the NRTS intervention and a cost-effectiveness analysis to aid future implementation efforts. Overall, we expect that, as a result of this project, we will establish the feasibility, acceptability, and effectiveness of NRTS in dental practices and determine that NRTS has high potential for translation to clinical practice.

Dates: October 2022 – July 2025

Funding source: National Institute of Dental & Craniofacial Research

Grant number: UH3DE029973

Contact

Principal investigator: Sarah Helseth, PhD, (Site PI) and Sandra Japuntich, PhD (Hennepin Healthcare)

Project staff: TBA Postdoctoral Fellow

This early-career development award is evaluating the preliminary effectiveness and implementation of measurement-based care (MBC) as a means to enhance the quality of care in opioid treatment programs (OTPs). In phase one of the research plan, Principal Investigator (PI) Kelli Scott, PhD, will work with eight opioid treatment programs (OTPs) to develop community-engaged research partnerships, complete site visits, and engage OTP staff and patients in qualitative interviews and quantitative surveys. Phase one outcomes will be used to inform site selection for MBC implementation and to facilitate adaptation of an MBC assessment protocol. Phase two will involve a pilot type 1 hybrid effectiveness-implementation study with four OTPs. The PI will work with the OTPs to integrate MBC into electronic medical record documentation procedures. Treatment providers will also receive MBC training and ongoing support, and preliminary MBC effectiveness and implementation data will be collected.

Results of this rigorous, mixed methods study will set the stage for future research focused on scaling up MBC to enhance the quality of care in OTPs. To conduct this high impact study, the PI requires training in four key areas:

1. Development and management of community-engaged partnerships to support effectiveness and implementation trials in addiction treatment
2. Evidence-based assessment and intervention methods for OUD
3. Mixed methods data collection using rapid ethnography
4. Measure design and adaptation

These training aims are supported by the Center for Dissemination & Implementation Science as well as by the candidate’s mentorship team. The mentorship team is led by primary mentor Sara Becker, PhD, and supported by Francesca Beaudoin, MD, PhD, MS; Lawrence Palinkas, PhD; and Melissa Clark, PhD.

Dates: April 2021 – February 2026

Funding source: National Institute on Drug Abuse

Grant number: K23DA050729

Contact

Principal investigator: Kelli Scott, PhD

Contingency management (i.e., motivational incentives for achieving pre-defined treatment goals) is one of the most effective behavioral interventions for persons with opioid use disorder, but its uptake in community opioid treatment programs is extremely low. This type 3 hybrid effectiveness-implementation trial evaluates whether two multi-level strategies can promote contingency management implementation within opioid treatment programs. The control condition is the staff-training strategy used by the SAMHSA-funded network of Addiction Technology Transfer Centers (ATTC), i.e., didactic workshop plus performance feedback plus staff coaching. The experimental condition is the ATTC strategy enhanced by two theory-driven components designed to sustain and accelerate change: implementation sustainment facilitation (ISF) and pay-for-performance, which we refer to as E-ATTC. Using a cluster randomized design, 30 opioid treatment programs across New England will be randomized to one of the two implementation conditions (ATTC versus E-ATTC).

The project addresses three specific aims:

• Compare the effect of the two implementation strategies on implementation outcomes (primary aim).
• Compare the effect of the two implementation strategies on patient outcomes (secondary aim).
• Test whether implementation climate and leadership engagement partially mediate the relationship between implementation strategy and the key study outcomes.

Achievement of the study aims will address a critical public health problem (the lack of effective strategies to improve the quality of opioid treatment), while advancing knowledge about why and how implementation strategies work.

Dates: September 2018 – July 2023

Funding source: National Institute on Drug Abuse

Grant number: R01DA046941

ClinicalTrials.gov identifier: NCT03931174

Contact

Principal investigators: Sara Becker, PhD, (contact PI); Bryan Garner, PhD

Project staff: Kimberly Yap (lead coordinator), Nick Correia, Fariha Hasan, Sarah Salino, Kira DiClemente, PhD

MIMIC2 is part of a NIDA Center of Excellence focused on advancing equitable access to effective addiction treatment. The project addresses one of the largest evidence-to-practice gaps in the addiction treatment field: the gap between the wealth of evidence supporting contingency management for stimulant use and its lack of availability in community settings.

Contingency management (CM) is the most effective intervention for stimulant use, but its uptake in specialty addiction programs is notoriously low. This type 3 hybrid effectiveness-implementation trial evaluates whether a multi-level, well-specified implementation strategy (Science to Service Laboratory [SSL]) can promote the uptake of CM for stimulant use in specialty addiction treatment. Utilizing a stepped wedge design, a regional cohort of 10 public sector clinics will be randomized to receive the SSL at five distinct time points. At six intervals, each of the 10 clinics will provide data from all available patient charts on CM delivery and patient outcomes. In addition, staff from each clinic will report on contextual determinants of implementation outcomes. The study will advance the scientific aims of the Center of Excellence by specifying and closely tracking delivery of the implementation strategy, while exploring the mediating influence of contextual determinants on implementation outcomes.  

Dates: July 2022 – May 2027

Funding source: National Institute on Drug Abuse

Grant number: P50DA054072

Contact

Principal investigator: Sara Becker, PhD

Co-investigators: Kelli Scott, PhD; Kira DiClemente, PhD

Project staff: Kimberly Yap (lead coordinator), Nick Correia, Fariha Hasan, Sarah Salino

The New England Addiction Technology Transfer Center (ATTC) is one of 10 regional training and technical assistance centers dedicated to supporting the front-line addiction treatment and recovery workforce. The New England ATTC is part of the national ATTC Network, comprised of 10 domestic regional centers, four special focus area centers and a network coordinating office. Together the Network serves the 50 U.S. states, the District of Columbia, Puerto Rico, the U.S. Virgin Islands and several Pacific Islands. The New England ATTC supports the mission of the national network to:

• Accelerate the adoption and implementation of evidence-based and promising addiction treatment and recovery-oriented practices and services,
• Heighten the awareness, knowledge and skills of the workforce that addresses the needs of people with substance use or other behavioral health disorders and
• Foster regional and national alliances among culturally diverse practitioners, researchers, policy makers, funders and the recovery community.

Dates: September 2017 – September 2023

Funding source: Substance Abuse and Mental Health Services Administration

Grant number: UR1TI080209

Contact

Principal investigators: Rosemarie Martin, PhD (contact PI/director), Sara Becker, PhD (co-director, former contact PI 2017-2022)

Co-investigator: Kelli Scott, PhD

Project staff: Mika Kearns

Adolescents in residential substance use (SU) treatment have high risk of relapse after discharge, but very few parents and teens engage in any continuing care. This study aims to improve the outcomes of adolescents following discharge from residential SU treatment by offering their parents a technology-assisted continuing care intervention. Such interventions have the potential to change existing treatment paradigms by extending the reach, duration and scalability of evidence-based care.

Parenting practices, including parental monitoring and parent-adolescent communication, have been established as key predictors of adolescent substance use outcomes following residential treatment. Yet parents face systemic and structural barriers to accessing traditional continuing care. Building upon our successful National Institute on Drug Abuse (NIDA)-funded R34, this study evaluates a technology-assisted parenting intervention called Parent SMART (Substance Misuse in Adolescents in Residential Treatment) as an adjunct to short-term residential treatment as usual (TAU). Adolescent-parent dyads (n=220 dyads; 440 in total) will be randomized to receive either TAU only or Parent SMART plus TAU. Multi-method follow-up assessments (i.e., self-report parent and adolescent measures, parent-adolescent in vivo interaction task, 8-panel urine screens) will be conducted six, 12, and 24 weeks post-discharge. The study addresses the following objectives:

• Assess the incremental benefit of Parent SMART on parenting skills, adolescent substance use and adolescent problem behaviors.
• Test whether improvements in parenting skills partially mediate reductions in adolescent SU.

The proposed research serves a high-need, underserved population during a vital treatment juncture. If found effective, the methods used in this study could help address barriers to continuing care and inform the development of a highly scalable intervention model for adolescents in residential treatment.

Dates: August 2021 – May 2026 

Funding source: National Institute on Drug Abuse

Grant number: R37DA052918

ClinicalTrials.gov identifier: NCT05169385

Contact

Principal investigator: Sara Becker, PhD (contact PI)

Co-investigator: Sarah Helseth, PhD

Project staff: Mika Kearns (lead coordinator), Nick Correia, Miranda Olson, Zabin Patel, Hannah Schiller, Clarisa Wijaya, Kira DiClemente, PhD

Due to juvenile justice (JJ) capacity constraints, court-involved, non-incarcerated (CINI) youth are often referred out for treatment and encounter multiple barriers to community care. Technology-assisted interventions would enable the JJ system to treat CINI youth in-house, without overextending its workforce or resources.

Smartphone apps are an ideal treatment platform for teens, yet the potential of smartphone apps as a means of reducing marijuana use in high-risk youth has not been realized. In this project, the principal investigator aims to establish the needs and preferences of CINI youth ages 14-17 for an adjunctive smartphone app, examine the app’s feasibility and acceptability, and establish its preliminary efficacy. The Teen Empowerment through Computerized Health (TECH) app, which targets putative intrapersonal and interpersonal mechanisms to promote marijuana-related behavior change, will serve as an adjunct to treatment-as-usual in the local family court. Following the Behavior Intervention Theory model, qualitative interviews with key stakeholders (n=30) will inform how clinical goals (knowledge, skills, motivation) will map on to TECH usage goals (goal-setting, peer networking), features (expert-moderated forum, notifications) and workflow. Next, 10 CINI youth will beta test the TECH prototype for one month, to guide its refinement. Finally, a pilot randomized control trial with 60 CINI youth will test the app for six months as an adjunct to treatment as usual on MJ and other SU-related outcomes, putative mechanisms of change (i.e., intrapersonal and interpersonal factors) and high-risk behaviors.

Principal investigator Sarah Helseth, PhD, will work with an accomplished, multidisciplinary mentorship team (Anthony Spirito, PhD; Nancy Barnett, PhD; Sara Becker, PhD; and Melissa Clark, PhD) to master four relevant areas of training:

1. Effective MJ and SU interventions for CINI youth
2. Interpersonal mechanisms of adolescent SU
3. Development of technology-assisted behavioral interventions
4. Qualitative methods for treatment development

Completion of this study has the potential to advance the field by demonstrating the feasibility, acceptability and preliminary efficacy of an adjunct technology-assisted intervention to improve outcomes among high-risk, marijuana-using CINI youth.

Dates: March 2020 – February 2025

Funding source: National Institute on Drug Abuse

Grant number: K23DA048062

Contact

Principal investigator: Sarah Helseth, PhD

Project staff: Hiring in spring 2023