S P N S

Special Projects of National Significance
2005 Report to CARE Act Grantees

Buprenorphine Initiative

An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care

Background

A growing number of HIV infections are related to the abuse of heroin and other opioids. Recent data estimate that approximately three million adults have used heroin at least once, while from 166,000 to 403,000 use it annually. Additionally, over two and a half million people use prescription opioid drugsprimarily oxycodone (OxyContin) and hydromorphone (Dilaudid)for non-medical purposes each year. Many different drugs of abuse can be injected, and heroin is most commonly taken as injected. While it may be smoked or sniffed as well, injecting heroin has the greatest risk in terms of HIV transmission. Sharing of needles, syringes and other injection paraphernalia facilitate HIV transmission, but unsafe sexual activity under the influence of opioids taken by any route can spread the virus as well.

By the end of 2001, 288,905 AIDS cases, nearly 36% of the cumulative total, were related to injection drug use, according to the Centers for Disease Control and Prevention (CDC). This number includes injection drug users and the sexual partners they infected, children born to people in either category, as well as HIV-positive men who both have sex with men and use injection drugs. Injection drug use is disproportionately the route of HIV transmission among women, African Americans, and Hispanic Americans.

Regular opioid use is very difficult to stop due to two phenomena: addiction and dependence. Although methadone has been the primary medical treatment for opioid

abuse, due to requirements on patients and difficulty in reaching these treatment centers, few substance users are in methadone treatment. Despite this, a recent change in the law allows certain physicians to prescribe to substance abusers a controlled substance for detoxification or maintenance purposes. The change in the law comes about through the Drug Addiction and Treatment Act of 2000 (DATA 2000). Specifically, this law allows physicians who meet certain requirements to treat opioid addiction with FDA approved narcotic medications. Thus, people with substance abuse problems now have the option to obtain treatment from primary care physicians in the clinical or office-based settings, as opposed to methadone clinics. This law, along with the availability of buprenorphine, an FDA approved office-based treatment for opioid addiction, potentially has positive implications for the HIV-infected individual who also has substance abuse issues.

The availability of office-based treatment creates the potential for increasing the availability of substance abuse treatment services and enables HIV primary care providers to integrate substance abuse treatment into their existing clinical services. HRSA's HIV/AIDS Bureau is partnering with the Substance Abuse and Mental Health Services Administration (SAMHSA) to enhance the role of HIV physicians and clinics in providing integrated buprenorphine and HIV treatment. This SPNS initiative seeks to support the development and evaluation of models to integrate buprenorphine opioid abuse treatment into existing HIV primary care.

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2005 REPORT buprenorphine initiative

The Buprenorphine Initiative

Based on new legislation and the availability of buprenorphine treatment, the Buprenorphine Initiative was designed to determine the effectiveness of integrating buprenorphine opioid abuse treatment into HIV primary care settings. This initiative, which began in September 2004, is comprised of 10 demonstration sites coordinated by a technical assistance/evaluation center.

Awardees work collaboratively with SPNS staff and the Center to:

· refine planned interventions;

· address state-of-the-art treatment and policy issues relating to the use of buprenorphine opioid abuse treatment in HIV primary care settings;

· conduct a local and multi-site evaluation;

· disseminate findings.

The initiative is directed towards persons with HIV in the primary care setting who also have substance abuse issues.

As a demonstration project, this initiative seeks to determine the feasibility and/or effectiveness of integrating buprenorphine opioid abuse treatment into HIV primary care settings. The ultimate goal is to improve the health of HIV-positive substance abusers.

Contact Information

The Evaluation and Support Center

The New York Academy of Medicine
1216 Fifth Avenue
New York, NY 10029

Ruth Finkelstein, ScD, Principal Investigator
Phone:212-822-7266

HRSA Project Officers

Special Projects of National Significance
5600 Fishers Lane, Room 7C-07
Rockville, MD 20857

Lois Eldred, DrPH, MPH
Phone: 301-443-3327

Adan Cajina, MS
Phone: 301-443-3180

Pamela Belton
Phone:301-443-9481

Grantees

Brown University, Miriam Hospital Immunology Center (Providence, RI)

Integrating Buprenorphine Opioid Treatment with HIV Primary Care

Target Population: HIV-infected patients with a focus on women, substance abusers, and persons being released from prison

Goal: 1. To evaluate the effectiveness of integrating buprenorphine treatment into HIV primary care; 2. To decrease HIV risk behaviors, increase adherence to HIV medications and/or substance abuse treatment, and improve quality of life

Strategies: 1. Initiation of an opioid use/abuse screening program; 2. Educational session on all forms of opioid treatment in addition to individualized evaluation for development of a treatment plan; 3. Buprenorphine team to include a nurse who will dispense buprenorphine and clinic staff who will provide comprehensive HIV and

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2005 REPORT buprenorphine initiative

substance abuse care; 4. Near-peer outreach worker to work with participants in the community to improve substance abuse treatment adherence

Evaluation: Assessment of substance abuse, HIV risk behaviors, adherence to HIV medications, quality of life, patient satisfaction, and follow-up with primary care and substance abuse treatment visits will take place at one, three, six, and 12 months; HIV viral load and CD4 data will also be obtained through chart review

Contact Information:

Timothy P. Flanigan, MD, Principal Investigator
164 Summit Avenue
Providence, RI 02906
Phone: 410-793-7152

El Rio Santa Cruz Neighborhood Health Center (Tucson, AZ)

Buprenorphine Opioid Abuse Treatment

Target Population: Opioid dependent HIV-positive patients in a primary care setting

Goal: 1. Improve patient adherence with primary HIV treatment including HAART therapy; 2. Reduce substance abuse behaviors including syringe-mediated risks; 3. Maintain or enhance health status of individuals; 4. Improve quality of life for individuals receiving the buprenorphine intervention

Strategies: 1. Training and certification of primary care providers in buprenorphine administration and management in the treatment of opioid abuse, dependence, and addiction; 2. Office-based nutritional, mental health, and substance abuse counseling

Evaluation: Measure data related to the goals stated above in addition to HIV health status markers including patients' CD4 counts and viral loads.

Contact Information:

Kevin Carmichael, MD, Principal Investigator
839 W. Congress
Tucson, AZ 85745
Phone: 520-629-2880

The Hektoen Institute, LLC/CORE Center (Chicago, IL)

Buprenorphine at CORE: An HIV Primary Care Program Demonstration

Target Population: Opioid dependent HIV-positive patients

Goal: To determine the effectiveness of a clinical/psychiatric model including buprenorphine treatment, as indicated by patient acceptance, improved health outcomes, and/or retention in care

Strategies: 1. Identification of opioid dependent patients during assessment in primary care clinics; 2. A clinical/psychiatric model consisting of a tightly linked team of a psychiatrist and a chemical dependency counselor who will be able to administer buprenorphine treatment to appropriate patients

Evaluation: Comparison of subjects enrolled in the current model of care (HIV/Cognitive-Behavioral Model including detox, residential treatment, and/or methadone) with those in the new clinical/psychiatric model, with respect to health outcomes and retention in care

Contact Information:

Jeffrey D. Watts, MD, Principal Investigator
The CORE Center
2020 W Harrison St.
Chicago, IL 60612
Phone: 312-572-4550

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THE SPNS MANDATE

The purpose of the Special Projects of National Significance (SPNS) program is to advance knowledge and skills through the support, development and evaluation of innovative models of HIV care for financially disadvantaged and medically underserved populations. The SPNS program, administered by the Health Resources and Services Administration (HRSA) HIV/AIDS Bureau (HAB), is part of the Ryan White Comprehensive AIDS Resources Emergency Act, also known as the CARE Act.

SPNS models of innovative care for HIV-positive patients have been designed to respond to the needs of the HIV epidemic. Currently, it is estimated that about 650,000 to 950,000 persons are infected with HIV and approximately 40,000 new infections occur every year in the United States. Only about one-third of HIV-infected adults are currently receiving regular or ongoing medical care for HIV infection. The most affected populations are traditionally underserved and hard-to-reach groups, particularly women, injection drug users and their heterosexual partners, gay and bisexual men of color and youth. HIV/AIDS is now most heavily impacting minority communities and individuals living in poverty.

SPNS response to the epidemic began in 1991 with some of the first Federal grants to target adolescents and women living with HIV. Today, a portfolio of 72 grants funded either solely by the HIV/AIDS Bureau or in partnership with other Federal agencies addresses the cutting-edge issues in HIV care.

The SPNS program is an integral link to all CARE Act programs. While it provides an opportunity to develop and evaluate new services, the program places great emphasis on the dissemination of these services. SPNS promotes the dissemination and replication of effective models of care relevant to the present challenges of the epidemic. These models include the integration of HIV primary care services to the needs of individuals who present with multiple diagnoses such as substance abuse, mental health, and other psycho-social burdens that complicate the effective delivery of health care.

As CARE Act grantees develop innovative services, the SPNS program will provide the funding and technical assistance for grantees to evaluate innovations and disseminate findings to the HIV community.

Within each multi-site SPNS initiative, grantees focus their interventions on a specific population or treatment issue, either by implementing components of existing interventions or designing new models. These models are evaluated for effectiveness, efficiency, and replicability. An important corollary is an examination of the contextual issues that contribute to the success or failure of an intervention in a particular setting or with a particular population.

Evaluation of Models

The structure of most of the multi-site initiatives is designed to collect data and evaluate interventions across sites. The projects are grouped by type of intervention or topic (e.g., outreach, prevention) with the guidance of an evaluation center, whose tasks include:

· facilitating cross-site evaluation, with technical assistance provided

· developing standardized data collection instruments

· assuring data quality

· disseminating findings

· and assessing policy implications of study findings.

Each grantee is required to participate in development of the evaluation plan for the overall initiative and most collect uniform data that can be analyzed and compared across programs. The SPNS initiatives have demonstrated that collaboration for multi-site evaluation of care programs is possible and rewarding, and that it requires time and effort on the part of all stakeholders: the evaluation centers, HRSA/SPNS, and the projects.

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Current SPNS Initiatives

To date, SPNS sponsors a variety of demonstration programs, each with a set of unique, yet initiative specific goals and strategies designed to have the greatest impact on their respective targets. While SPNS has funded numerous innovative programs over the past decade, the table below summarizes eight initiatives that are currently funded through 2009.

Lessons learned from these and other initiatives are helping the HIV/AIDS Bureau develop effective strategies for addressing the demand for HIV services among underserved infected populations.

Current priorities include:

US-Mexico Border: Demonstrating and evaluating models that advance HIV service innovation along the US-Mexico Border

Outreach: Evaluating effective outreach strategies for bringing individuals into HIV primary care treatment

Information Technology: Assessing and evaluating the use of information technology to improve HIV medical care

American Indian/Alaska Native: Supporting the coordination and integration of existing services for Native Americans/Alaska Natives living with HIV and other co-morbidities

Caribbean: Improving care and treatment of HIV-infected persons of Caribbean descent through culturally appropriate strategies

Prevention with Positives: Assessing prevention strategies in primary care settings for HIV-positive persons

Buprenorphine: Developing, implementing and evaluating innovative methods for integrating Buprenorphine Opioid Abuse Treatment in HIV primary care settings

Young MSM of Color: Implementing and evaluating models of outreach, care and prevention targeted to young HIV seropositive men who have sex with men (YMSM) of color

Initiative Topic Grantees Funding Period
Demonstration and Evaluation Models that Advance HIV Service Innovation Along the US-Mexico Border US-Mexico Border 6 2000-2005
Targeted HIV Outreach and Intervention Model Development and Evaluation for Underserved HIV-Positive Populations Not in Care Outreach 11 2001-2006
Evaluating the Impact of Information Technology on Improving Delivery and Quality of Care for HIV-Seropositive Individuals Information Technology 6 2002-2006
American Indian/Alaska Native (AI/AN) Initiative AI/AN 7 2002-2007
Models of Peer Support for Caribbeans Living in the U.S. Caribbean 6 2003-2007
Prevention with HIV-Infected Persons Seen in Primary Care Settings Prevention
w/ Positives		 16 2003-2007
An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care Settings Buprenorphine 11 2004-2009
Outreach, Care, and Prevention to Engage HIV-Seropositive Young MSM of Color Young MSM of Color 9 2004-2009
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Johns Hopkins School of Medicine (Baltimore, MD)

Randomized Trial of HIV Clinic Based Buprenorphine versus Referred Substance Abuse Care

Target Population: Treatment-seeking opioid-dependent patients who receive primary medical care in the Johns Hopkins HIV Clinic

Goal: The determine the impact of clinic-based buprenorphine treatment on HIV care utilization, changes in health status and immunological markers, and HIV transmission risk behaviors

Strategies: Incorporation of a clinic-based buprenorphine substance abuse treatment model

Evaluation: A randomized controlled trial of clinic-based buprenorphine treatment versus traditional substance abuse care, with a focus on evaluating the variables stated above in addition to patient characteristics associated with positive outcomes; costs, administrative changes, and acceptance of the new model will also be evaluated

Contact Information:

Gregory M. Lucas, MD, Principal Investigator
1830 E. Monument Street, Room 421
Baltimore, MD 21287
Phone: 410-614-0560

Montefiore Medical Center
(Bronx, NY)

The Development and Evaluation of Integration of Buprenorphine into HIV Primary Care in Bronx Community Health Centers

Target Population: Patients of Bronx HIV primary care community health centers

Goal: 1. To integrate buprenorphine substance abuse treatment into the primary care setting; 2. To improve access to and retention in treatment

Strategies: 1. Develop formal linkages between primary care providers and substance abuse/buprenorphine treatment experts and providers and community pharmacies dispensing buprenorphine; 2. Help facilitate certification of providers in buprenorphine treatment administration; 3. A substance abuse treatment team (HIV primary care physicians, substance abuse expert physicians, an HIV pharmacist, and a nurse clinical coordinator) to provide education and training, support, and consultation for providers

Evaluation: The evaluation will focus on clinical and psychosocial changes among participants treated with buprenorphine in comparison to those receiving usual care; the analysis will focus on drug use, HIV-related health status, mental and physical health and well-being, health service utilization, and patient satisfaction

Contact Information:

Chinazo Cunningham, MD, Principal Investigator
3544 Jerome Ave
Bronx, NY 10467
Phone: 718-515-5416

Organization to Achieve Solutions in Substance-Abuse, Inc (OASIS) (Oakland, CA)

Target Population: HIV-exposed heroin users in the Oakland region

Goal: To improve medical, psychosocial, and addiction outcomes

Strategies: Integration of buprenorphine therapy into medical services at an existing site of HIV primary care

Evaluation: Evaluation will compare the impact of a 2-year enhanced group intervention for HIV-exposed heroin users referred for outside substance abuse treatment to a similar enhanced intervention combined with 2-years of medically integrated buprenorphine

Contact Information:

Diane Sylvestre, MD, Principal Investigator
2862 Telegraph Ave.
Oakland, CA 94609
Phone: 510-834-5442

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Oregon Health and Science University
(Portland, OR)

Portland Integrates Care for Opioid Dependent AIDS Patients

Target Population: Opioid addicted patients in primary care HIV clinics

Goal: To integrate buprenorphine treatment and substance abuse counseling with HIV care, with anticipated improvements in medication adherence, attendance in substance abuse counseling, and health outcomes

Strategies: 1. Establishing teams composed of a physician, nurse, physician assistant, counselor and patient advocate to both coordinate and make decisions about buprenorphine integration at their clinic; 2. This team will also monitor patients and assure that individual services provided for them are appropriate

Evaluation: The evaluation will compare outcomes of participants involved in the model where buprenorphine treatment is integrated with HIV care, to those of participants who receive buprenorphine treatment according to federal guidelines for methadone

Contact Information:

P. Todd Korthuis, MD, MPH, Principal Investigator
3181 SW Sam Jackson Park Rd, L 475
Division of Internal Medicine
Portland, OR 97239
Phone: 503-494-6551

UCSF Positive Health Program
(San Francisco, CA)

Integrating Buprenorphine into the SFGH AIDS Program

Target Population: Patients in a comprehensive HIV primary care setting in San Francisco

Goal: To deliver new services for HIV-infected patients by enabling primary care providers to integrate substance abuse treatment into their existing clinical services

Strategies: A multidisciplinary collaboration with the Division of Substance Abuse and Addiction Medicine and the Community Behavioral Health Services agency to: 1. Provide physician education and training on addiction treatment, integrated services, and the use of buprenorphine; 2. Develop the policies and procedures to deliver buprenorphine treatment in HIV clinical settings

Evaluation: Process and outcome evaluation will focus on the efficacy of the buprenorphine treatment intervention with a diverse, low income, and often homeless population of persons living with HIV/AIDS

Contact Information:

Paula J. Lum, MD, MPH, Principal Investigator
995 Potrero Avenue, Building 80, Ward 84
San Francisco, CA 94110
Phone: 415-476-4082

University of Miami AIDS Clinical Research Unit (Miami, FL)

Miami Integration Project

Target Population: HIV-positive opioid users

Goal: To determine the feasibility and effectiveness of integrating buprenorphine substance abuse treatment with HIV primary care

Strategies: Subjects will be randomized to receive the new integrated treatment or the current standard of care


Evaluation: Baseline and follow-up measures will document demographics as well as changes in health, psychiatric needs, support and legal status, family health, social relationships, drug/alcohol use, ART use, and treatment adherence among the two groups

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Contact Information:

Margaret A. Fischl, MD, Principal Investigator
1800 NW 10th Avenue
Miami, FL 33136
Phone: 305-243-3847

Yale University AIDS Program (New Haven, CT)

Integrating Buprenorphine into HIV Clinical Care Settings

Target Population: HIV-infected opioid dependent patients in an HIV treatment setting

Goal: To determine the best model of substance abuse treatment for HIV-infected patients, with a focus on the site of induction and stabilization, the type of counseling, adherence and health outcomes, and cost effectiveness

Strategies: Three separate models will be implemented, which include: 1. On-site Addiction Treatment Model comparing standard and enhanced levels of counseling by a trained addiction specialist team; 2. HIV Primary Care Model with induction and stabilization performed on-site by the patients' primary care providers; 3. Induction/Stabilization Model with induction and eight week stabilization performed in an off-site substance abuse treatment facility

Evaluation: A control group of HIV-infected patients enrolled in a methadone treatment clinic will be used as the comparison for each of the models, and evaluation will be conducted with respect to retention in therapy, illicit drug use, adherence to HAART, and the impact on HIV transmission behaviors

Contact Information:

Frederick L. Altice, MD, Principal Investigator
135 College Street, Suite 323
New Haven, CT 06510
Phone: 203-737-2883

The New York Academy of Medicine (New York, NY)

Center for the Evaluation and Support of Integrated Buprenorphine Treatment and HIV Care

Goal: Working with the Buprenorphine grantees, the goals include: 1. To enhance the development of model demonstration programs that integrate buprenorphine treatment and HIV primary care; 2. To conduct a multi-site process, outcome, impact and cost evaluation of these programs; 3. To disseminate the findings to providers, administrators, and policy makers

Strategies: 1. Assemble a staff of experts and a National Advisory Committee to provide training and technical support to the demonstration sites; 2. Provide ongoing technical assistance and support in program design, clinical training and consultation, and the development of policy and procedures that address regulatory, ethical, and clinical concerns; 3. Translate the results of the evaluation into peer-reviewed publications, training materials, briefing papers, reports, and fact sheets

Evaluation: The Center will conduct a multi-site evaluation utilizing client, provider, and program data to determine the processes necessary to develop integrated HIV and buprenorphine programs, and their feasibility, effectiveness, impact, and cost

Contact Information:

Ruth Finkelstein, ScD, Principal Investigator
1216 Fifth Avenue
New York, NY 10029
Phone: 212-822-7266

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