Social Research Center

Research Projects

A Randomized Controlled Trial of HIV Testing and Linkage to Care at Community Corrections

Principal Investigator: Michael S. Gordon, D.P.A. (Primary Contact)
Joisah D. Rich, M.D. (Brown University Medical School, The Miriam Hospital)
Co-Investigator(s): Michelle S. McKenzie, M.P.H. (Brown University Medical School, The Miriam Hospital)
Funded by: National Institute on Drug Abuse
Grant Number: R01 DA030771
Total Project Period: 9/10 – 6/17

This five-year study has two aims: 1) To determine the willingness of the community corrections population to undergo HIV testing (Seek), 1a) To compare a strategy of rapid HIV testing on site in community corrections to referral to an off site community HIV testing location with a randomized control study (Test). 2) To determine whether people with HIV (both known and newly diagnosed) can be identified in community corrections; 2a) To determine if a promising, theory driven, case management based strategy (Project Bridge), will be utilized by individuals with HIV recruited through community corrections; and 2b) To determine the impact of Project Bridge compared to Treatment as Usual on individuals with HIV recruited through community corrections on : 1) engagement in care; 2) retention in care; and 3) proportion of those prescribed Highly Active Antiretroviral Therapy (HAART) who are undetectable at 6 and 12 months using a pre-post analysis (Treat). A total of 6,000 male and female probationers and parolees in Baltimore City, Maryland (n=3,000) and Providence, Rhode Island (n=3,000) will be randomly assigned (within location and gender) either to one of two treatment conditions: 1) On-site rapid testing conducted by research staff co-located for the purposes of this study at the probation/parole office; or: 2) Referral by the research staff for rapid HIV testing off site at a community HIV testing site or community health center. The second study is a randomized trial of linkage to HIV care for HIV+ adults recruited through community corrections (probation and parole). All individuals identified by testing positive for HIV or self-reporting themselves as HIV-positive at community corrections will be offered enrollment in a one-year intervention study to examine the ability to improve linkage from no treatment into HIV care. A total of 240 HIV-positive participants (120 in Baltimore and 120 in Providence) will be randomly assigned to one of two conditions: 1) Project Bridge [PB] for 12 months; or 2) Treatment as Usual [TAU] (standard level of care/referral for treatment). Those HIV-positive participants randomized to treatment as usual that fail to engage in treatment (failure to engage in treatment during the three months previous to the 6-month assessment) will be offered a “rescue” opportunity to cross over to the Project Bridge intervention at their 6-month follow-up assessment. Those participants in TAU who refuse the “rescue” option of PB at 6 months will still be eligible for 12-month research follow-up assessments. All participants will be followed up at 3,6, and 12-months.

Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth

Principal Investigator: Shannon Gwin Mitchell, Ph.D.
Co-Investigator(s): Robert P. Schwartz, M.D.; Marc J. Fishman, M.D.; Laura J. Dunlap, Ph.D.; Gary Zarkin, Ph.D.
Project Manager: Elizabeth Buttrey
Funded by: National Institute on Drug Abuse
Grant Number: 1R01DA033391-01A1
Total Project Period: 01/13 – 12/18

This study is a 6-month, two-group random assignment comparative effectiveness trial of XR-NTX v. Treatment as Usual (TAU) for 340 opioid-dependent youth ages 15-21. TAU will consist of the typical treatment approach provided to opioid-dependent youth in the US, namely buprenorphine for the treatment of opioid withdrawal followed by counseling with or without continued buprenorphine. The study’s aims are: (1) to determine the relative effectiveness of XR-NTX compared to TAU for opioid-dependent youth in terms of the following 3- and 6-month outcomes: a) days in treatment; b) opioid use; c) other drug (cocaine and marijuana) and alcohol use; d) criminal behavior and arrests; and e) relapse to DSM-IV defined opioid dependence; (2) to examine the impact of XR-NTX on HIV drug- and sex-risk behaviors at 3- and 6-month follow-up and HIV infection status at 6-months; and (3) to evaluate the cost, cost-effectiveness, and cost-benefit of XR-NTX v. TAU among opioid-dependent youth.

HIV Care Cascade in Community Corrections: Implications for HIV treatment outcomes among criminal justice involved populations

Principal Investigators: Nicholas Zaller, Ph.D., The Miriam Hospital
Michael S. Gordon, D.P.A.
Co-Investigator: Curt Beckwith, M.D., The Miriam Hospital
Project Manager: Monique Wilson, Dr.PH
Funded by: National Institute of Allergy and Infectious Diseases
Grant Number:  
Total Project Period: 1/14 – 1/15

This is an observational study of HIV positive community corrections participants in Baltimore (total N= 200). The study will consist of a one-time computer administered survey and a one-time blood specimen for a HIV plasma viral load (PVL). Expected outcomes will be framed in terms of the HIV care cascade: 1) proportion of HIV positive participants who are actively engaged in care (self-report, chart review); 2) proportion of HIV positive participants in care who are prescribed ART (self-report, chart review, if available); 3) proportion of HIV positive participants in care and prescribed ART who are adherent to ART (self-report, PVL, chart review, if available); and 4) proportion of HIV positive participants prescribed ART who have undetectable PVL (PVL and chart review, if available).

NIDA Clinical Trials Network, Mid Atlantic Node

Principal Investigator: Maxine Stitzer, Ph.D. (Johns Hopkins School of Medicine)
Co-Principal Investigator: Robert Schwartz, M.D.
Co-Investigator(s): Jerome H. Jaffe, M.D., Shannon Gwin Mitchell, Ph.D., Frank Vocci, Ph.D.
Funded by: National Institute on Drug Abuse
Grant Number: U10 DA13034
Total Project Period: 9/10 – 8/15

The NIDA Clinical Trials Network (CTN) was founded in 1999 with six participating groups; it now has 16 participating groups, called Nodes, distributed throughout the US. Each node is comprised of a consortium of university-based researchers and directors of community-based drug abuse treatment clinics. The Mid Atlantic Node is led by Dr. Maxine Stitzer at the Johns Hopkins University and Dr. Robert Schwartz at Friends Research Institute and includes collaborations with Virginia Commonwealth University and Friends Research Institute, as well as a group of community treatment providers in Baltimore, Virginia and Washington, DC. This configuration is designed to promote and advance the three missions of the CTN: 1) to promote bi-directional communication between researchers and community treatment providers; 2) to conduct research on evidence-based interventions at community-based clinical sites to identify interventions with effectiveness in real world settings; and, 3) to promote dissemination and adoption of new evidence-based practices in order ultimately to improve treatment services nationwide. The CTN has now successfully conducted over 20 studies. Some have examined new medications such as buprenorphine for the treatment of opioid dependence; others have examined behavior therapies including motivational interviewing, contingency management and family-based therapy for adolescents. The results of completed studies can be found at: Further, to address the dissemination agenda, CTN and the national network of ATTC’s jointly sponsor a Blending Initiative to develop dissemination training packages for use of buprenorphine, motivational interviewing and contingency management (also called Motivational Incentives). These packages can be found on the ATTC website, www.

Prevention of Relapse to Opioid Addiction using Long-acting Injectable Naltrexone

Principal Investigator: Timothy W. Kinlock, Ph.D.
Co-Investigator(s): Michael Gordon, D.P.A., Marc J. Fishman, M.D.
Funded by: National Institute on Drug Abuse
Grant Number: R01 DA024550-01A1
Total Project Period: 7/08 – 5/14

The purpose of this study is to determine whether a monthly injection of naltrexone is practical and useful in the prevention of relapse and when compared to treatment as usual. This collaborative project will take place in five treatment sites where there is a large population of parolees with a history of opiate addiction: 1) University of Pennsylvania, Philadelphia, PA: 2) Rhode Island Hospital, Providence, RI; 3) New York University/Bellevue, New York, NY; 4) Columbia University, New York, NY; and 5) Friends Research Institute, Baltimore, MD.

After determining that all volunteers are opiate free by urine test results and not currently opiate dependent using a naloxone test, they will be randomized to depot naltrexone or Treatment as Usual (TAU. Participants in both groups will be given identical follow up assessments monthly for six months with measures of opiate use by self-report, urine test and hair analysis. An additional random urine test will take place each month between monthly visits. Both groups will be re-evaluated six and 12 months later. The University of Pennsylvania will be the coordinating site and each site will have a randomization goal of 20 new patients per year over 3.5 to 4 years to accrue a total of 360 to 400 participants. Treatment outcome will be measured by urine tests, hair analysis, self-report and continuation in treatment. Both naltrexone and comparison groups will receive equivalent cash incentives to remain in the program. A benefit-cost analysis will be conducted to compare the costs of the treatment with the quantifiable benefits in terms of reduced crime, re-incarceration and medical services and increased employment.

Reengineering Methadone Treatment: A Clinical Trial

Principal Investigator: Robert Schwartz, M.D.
Co-Investigator(s): Jerome H. Jaffe, M.D., Shannon Gwin Mitchell, Ph.D.
Funded by: National Institute on Drug Abuse
Grant Number: 2 RO1 DA 015842
Total Project Period: 3/1/11 – 2/28/15

Premature discontinuation from methadone treatment programs (MTP) is a frequent occurrence and is associated with continued illicit drug use, HIV infection, overdose death, and crime. This NIDA-funded study builds on the findings of our parent grant (5R01DA 015842) in which nearly half of over 350 newly admitted MTP were no longer in treatment at 12-month follow-up, in large part because of the powerful influence of program rules and the role of the counselor as enforcer of the rules. Our goal is to test the impact of a fundamental re-engineering of MTPs, based on the conceptual model of patient-centered care in order to avoid premature drop-out and to improve patient outcomes.

The Patient-Centered Methadone Program (PC-MTP) will reorganize the staff roles and MTP rules such that counselors will not be responsible for enforcing the clinics’ rules for their patients, patients will be encouraged but not required to participate in counseling, and most clinic rule infractions will result in consequences short of “administrative” discharge. This two-site randomized clinical trial with 300 participants will compare, on an intent-to-treat basis, the relative effectiveness of PC-MTP to treatment-as-usual MTP over the course of 12 months of treatment.

SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers

Principal Investigator: Shannon Gwin Mitchell, Ph.D.
Co-Investigator(s): Robert P. Schwartz, M.D.; Barry S. Brown, Ph.D.; Laura J. Dunlap, Ph.D.; Carolina Barbosa, Ph.D.; Arethusa S. Kirk, M.D.; Marla Oros, M.A.
Project Manager: Kristi Dusek, M.A.
Funded by: National Institute on Drug Abuse
Grant Number: 1R01DA034258-01
Total Project Period: 07/12 – 06/15

Guided by Proctor’s conceptual model of implementation research, this cluster randomized trial will compare two principal strategies of SBIRT delivery within adolescent medicine. In the Generalist Strategy, the primary care provider delivers brief intervention (BI) for substance misuse. In the Specialist Strategy, BIs are delivered by behavioral health counselors. The 7 study sites, primary care clinics operated by a large, urban Federally Qualified Health Center in Baltimore, will be randomly assigned to implement SBIRT for adolescents using either the Generalist or Specialist strategies. Staff at each site will be trained in the assigned implementation strategy, and quarterly booster trainings will be provided during the implementation period. Implementation outcomes, including: penetration, costs/cost-effectiveness, acceptability, timeliness, fidelity/adherence, and patient satisfaction will be assessed during the 18-month-long implementation period using a complementary combination of administrative service encounter data, provider and patient surveys, and qualitative interviews. At the end of the active implementation period, all training and technical support activities will cease for 12 months in order to measure relative sustainability. The proposed study will also examine the effectiveness of integrating adolescent HIV risk screening within an SBIRT model. Specific Aims are: (1) to examine the relative effectiveness of the Generalist v. the Specialist implementation strategies in terms of penetration of (i) BI for those adolescents for whom it is indicated and (ii) referral to specialty substance abuse treatment when indicated; (2) To determine the (iii) cost and (iv) cost-effectiveness of the two strategies; (3)  to compare the two strategies in terms of key implementation factors, including (v) acceptability; (vi) timeliness; (vii) fidelity/adherence; (viii) patient satisfaction; and (ix) sustainability; and (4) to examine the feasibility and acceptability of integrating HIV risk behavior screening into adolescent primary care as part of an SBIRT program.

SBIRT in New Mexico

Principal Investigator: Robert Schwartz, M.D.
Co-Investigator(s): Shannon Gwin Mitchell, Ph.D., Jan Gryczynski, M.A.
Project Manager: Jan Gryczynski, M.A.
Funded by: National Institute on Drug Abuse
Grant Number: R01 DA026003
Total Project Period: 9/09 – 7/14

Rigorous research is needed to test the effectiveness of screening and brief interventions that can easily be scaled-up to reduce illegal drug use and HIV risk behaviors. The few existing clinical trials of SBIRT for illicit drug use have not examined SBIRT’s impact on HIV risk behavior. The presently proposed study will address this gap in scientific knowledge through a partnership between Friends Research Institute and the Sangre de Cristo Community Health Partnership, the organization responsible for implementing the SAMHSA-funded Screening, Brief Intervention, Referral, and Treatment (SBIRT) Initiative throughout New Mexico since 2003. The study will use a randomized controlled trial to compare the effectiveness of a standardized interpersonal brief intervention (IBI) based on motivational interviewing (currently used in the New Mexico SBIRT initiative) with a promising computerized brief intervention (CBI) in reducing illegal drug use and HIV risk behaviors and their associated health consequences. In addition, the study will assess whether participants’ computer experience differentially moderates the effectiveness of the two interventions. The study will take place at two large primary care clinics in New Mexico. All patients will complete a screening for substance use via the Alcohol, Tobacco, and Substance Involvement Screening Tool (ASSIST) as part of regular clinical care. Patients who score in a moderate-risk category for illegal drug use (n = 360, 180 at each site) will be randomly assigned within their respective clinics to the IBI or CBI condition. Patients with high-risk drug use will be referred for more intensive services as per standard clinical practice. Primary outcomes include drug use levels for major substances of abuse as measured by analysis of hair samples, global illicit drug risk ASSIST scores, and HIV risk behaviors. Secondary outcomes include self-reported frequency of hospitalizations, emergency room utilization, injuries, psychological distress, arrests, missed work days, and earned income. Data analysis will be conducted using a Generalized Linear Mixed Model approach. An effective computerized brief intervention has the potential to make a substantial impact on public health by reducing drug use and HIV risk behaviors because it can be easily scaled up and implemented throughout the health care system.

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