Guideline:
Bibliographic Source(s)
- New York State Department of Health. Adherence to antiretroviral therapy among substance users. New York (NY): New York State Department of Health; 2005 Jun. 11 p. [38 references]
Guideline Status
This is the current release of the guideline.
Guideline Category
Counseling
Management
Intended Users
Advanced Practice Nurses
Health Care Providers
Physician Assistants
Physicians
Public Health Departments
Substance Use Disorders Treatment Providers
Guideline Objective(s)
To provide recommendations for adherence to antiretroviral therapy among human immunodeficiency virus (HIV)-infected substance users
Target Population
Human immunodeficiency virus (HIV)-infected patients using illicit substances
Interventions and Practices Considered
- Establishing a strong patient-provider relationship including trust and engagement with the provider
- Identifying and addressing potential barriers to adherence before initiating highly active antiretroviral therapy (HAART) reassessing barriers to adherence at least every 3 to 4 months discussing with patients the known interactions between prescribed medications and illicit substances
- Educating patients about the safety and efficacy of methadone and buprenorphine and assessing potential interactions between HAART and methadone before and during therapy
- Counseling patients about the need for strict adherence and the risk of viral drug resistance when adherence is compromised
- Performing a thorough adherence assessment and obtaining antiretroviral resistance assays prior to changing a failing regimen
- Assessing adherence using the following methods or a combination:
- Self-report
- Pill count
- Pharmacy records
- Electronic pill bottle monitors
- Therapeutic drug monitoring
- Directly observed therapy (DOT)
- Modified directly observed therapy (MDOT)
- Computer-assisted self interview (CASI) assessment
- Improving adherence using the following intervention strategies:
- Education and motivation
- Simplifying the regimen and tailoring it to the patient's lifestyle
- Management of side effects
- Identification and treatment of depression
- Substance use treatment
- Involving an adherence team or monitor
- Referring the patient to social services and mental health providers
Major Outcomes Considered
- Predictors of adherence to antiretroviral therapy
- Antiretroviral resistance
- The advantages and disadvantages of adherence measures
Methods Used to Collect/Select Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods used to Collect/Select the Evidence
Not stated
Number of Source Documents
Not stated
Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus (Committee)
Rating Scheme for the Strength of the Evidence
Not applicable
Methods Used to Analyze the Evidence
Review
Description of the Methods Used to Analyze the Evidence
Not stated
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
The Human Immunodeficiency Virus (HIV) Guidelines Program works directly with committees composed of HIV Specialists to develop clinical practice guidelines. These specialists represent different disciplines associated with HIV care including infectious diseases family medicine obstetrics and gynecology among others. Generally committees meet in person 3 to 4 times per year and otherwise conduct business through monthly conference calls.
Committees meet to determine priorities of content review literature and weigh evidence for a given topic. These discussions are followed by careful deliberation to craft recommendations that can guide HIV primary care practitioners in the delivery of HIV care. Decision making occurs by consensus. When sufficient evidence is unavailable to support a specific recommendation that addresses an important component of HIV care the group relies on their collective best practice experience to develop the final statement. The text is then drafted by one member reviewed and modified by the committee edited by medical writers and then submitted for peer review.
Rating Scheme for the Strength of the Recommendations
Not applicable
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
Peer Review
Description of Method of Guideline Validation
Not stated
Major Recommendations
Introduction
Clinicians should consider substance users candidates for highly active antiretroviral therapy (HAART) if they meet the medical eligibility criteria for HAART and demonstrate readiness to begin therapy by attending the majority of their appointments and expressing interest in antiretroviral therapy (ARV) treatment.
Key Point:
History of substance use or current substance use should not be the sole factor in withholding HAART from eligible patients. Decisions about when to prescribe HAART for eligible drug-using patients should be made on a case-by-case basis.
Predictors of Adherence
Key Point:
A strong patient-provider relationship including trust and engagement with the provider has been associated with improved ARV adherence.
Addressing Potential Barriers to Adherence before Initiating HAART
Clinicians should identify and address potential barriers to adherence before initiating HAART in human immunodeficiency virus (HIV)-infected substance users (see the Table 1 below). If clinicians elect to defer prescribing HAART while addressing potentially modifiable barriers to adherence they should discuss this decision with the patient.
Clinicians should reassess potential barriers to adherence at least every 3 to 4 months and whenever adherence problems are identified.
Clinicians should discuss with patients the known interactions between prescribed medications and illicit substances.
| Table 1 Potential Barriers to Adherence |
|---|
|
Additional Barriers to Address with Patients Receiving Concurrent Opioid Pharmacotherapy
Clinicians should educate patients who receive concurrent opioid pharmacotherapy and ARV therapy about the safety and efficacy of methadone and buprenorphine because these patients may have misconceptions regarding the safety of concurrent opioid pharmacotherapy and ARV therapy.
Clinicians should assess potential interactions between HAART and methadone before and during therapy by inquiring about oversedation and opioid withdrawal symptoms. If withdrawal symptoms are present the primary care clinician should conduct a detailed history and facilitate a dose increase by educating the patient and communicating with the methadone provider.
Adherence and Antiretroviral Resistance
Clinicians should counsel patients before initiating ARV therapy and at routine monitoring visits during therapy concerning the need for strict adherence and the risk of viral drug resistance when adherence is compromised.
Clinicians should perform a thorough adherence assessment and obtain antiretroviral resistance assays prior to changing regimens in patients who are receiving a failing regimen (failure to demonstrate >1.5-log drop in viral load within 3 months of initiating treatment and more importantly failure to achieve a viral load <50 copies/mL within 6 months of initiating treatment).
Measurement of Adherence
Clinicians should assess adherence at every routine monitoring visit.
Clinicians should use finite time intervals when inquiring about and quantifying the patient's self-report. Clinicians should average responses across visits to obtain a more accurate estimate of adherence.
When assessing adherence clinicians should use precise language that the patient can understand. In addition clinicians should verify that patients are taking the medications as prescribed specifically correct medications correct number of pills per dose and correct number of doses per day.
Key Points:
- Adherence measurements averaged from repeated adherence assessments will yield a more accurate calculation of adherence than one-time assessments.
- Clinicians' estimates of patient adherence have been shown to be inaccurate and should not be substituted for a thorough adherence assessment.
Interventions to Improve Adherence
Clinicians should refer patients to substance use treatment programs to optimize patients' ability to successfully utilize and adhere to HAART and other medical therapies (Samet Friedmann & Saitz 2001; Sorenson et al. 1998).
Adherence intervention strategies should include the following elements:
- Education and motivation including treatment readiness should be part of every visit
- If medically feasible simplifying the regimen and tailoring it to the patient's lifestyle
- Preparation for and management of side effects
- Identification and treatment of depression and other psychiatric conditions
- Substance use treatment
- Involving an adherence team or monitor
- Referring the patient to social services and mental health providers for assistance in dealing with (or resolving) issues that are barriers to adherence
Clinicians and substance-using patients should work together to develop a plan to decrease or stabilize substance use in preparation for initiating ARV therapy.
Key Point:
Behavioral skills and motivation are crucial factors for promoting behavior change.
| Table 2 Interventions to Improve Adherence |
|
|---|---|
| Determinant | Action to improve Adherence |
| Beliefs and knowledge (of HIV medications) Self-efficacy and adherence Memory (difficulty remembering doses) |
Educate patient; provide information Enhance motivation Offer patient visual aids to help remember daily regimen; use beepers pillboxes and other reminders |
Clinical Algorithm(s)
None provided
References Supporting the Recommendations
- Samet JH Friedmann P Saitz R. Benefits of linking primary medical care and substance abuse services: patient provider and societal perspectives. Arch Intern Med 2001 Jan 8;161(1):85-91. PubMed
- Sorensen JL Mascovich A Wall TL DePhilippis D Batki SL Chesney M. Medication adherence strategies for drug abusers with HIV/AIDS. AIDS Care 1998 Jun;10(3):297-312. PubMed
Type of Evidence supporting the Recommendations
The type of supporting evidence is not specifically stated for each recommendation.
Potential Benefits
- Improve the adherence to antiretroviral therapy among human immunodeficiency virus (HIV)-infected substance users
- Refer to Appendix A in the original guideline document for information on advantages of adherence measures.
Potential Harms
Refer to Appendix A in the original guideline document for information on disadvantages of adherence measures.
Description of Implementation Strategy
Following the development and dissemination of guidelines the next crucial steps are adoption and implementation. Once practitioners become familiar with the content of guidelines they can then consider how to change the ways in which they take care of their patients. This may involve changing systems that are part of the office or clinic in which they practice. Changes may be implemented rapidly especially when clear outcomes have been demonstrated to result from the new practice such as prescribing new medication regimens. In other cases such as diagnostic screening or oral health delivery however barriers emerge which prevent effective implementation. Strategies to promote implementation such as through quality of care monitoring or dissemination of best practices are listed and illustrated in the companion document to the original guideline (HIV clinical practice guidelines New York State Department of Health; 2003) which portrays New York's HIV Guidelines Program. The general implementation strategy is outlined below.
- Statement of purpose and goal to encourage adoption and implementation of guidelines into clinical practice by target audience
- Define target audience (providers consumers support service providers).
- Are there groups within this audience that need to be identified and approached with different strategies (e.g. HIV Specialists family practitioners minority providers professional groups rural-based providers)?
- Define implementation methods.
- What are the best methods to reach these specific groups (e.g. performance measurement consumer materials media conferences)?
- Determine appropriate implementation processes.
- What steps need to be taken to make these activities happen?
- What necessary processes are internal to the organization (e.g. coordination with colleagues monitoring of activities)?
- What necessary processes are external to the organization (e.g. meetings with external groups conferences)?
- Are there opinion leaders that can be identified from the target audience that can champion the topic and influence opinion?
- Monitor progress.
- What is the flow of activities associated with the implementation process and which can be tracked to monitor the process?
- Evaluate.
- Did the processes and strategies work?
- Were the guidelines implemented?
- What could be improved in future endeavors?
Implementation Tools
Personal Digital Assistant (PDA) Downloads
For information about availability see the "Availability of Companion Documents" and "Patient Resources" fields below.
IOM Care Need
Living with Illness
IOM Domain
Effectiveness
Patient-centeredness
Bibliographic Source(s)
- New York State Department of Health. Adherence to antiretroviral therapy among substance users. New York (NY): New York State Department of Health; 2005 Jun. 11 p. [38 references]
Adaptation
Not applicable: The guideline was not adapted from another source.
Source(s) of Funding
New York State Department of Health
Guideline Committee
Substance Use Committee
Composition of Group that Authored the Guideline
Committee Chair: Marc N. Gourevitch MD MPH Director Division of General Internal Medicine New York University School of Medicine
Committee Members: Bruce Agins MD MPH Medical Director AIDS Institute New York State Department of Health; Julia H. Arnsten MD MPH Associate Professor Medicine Epidemiology and Population Health and Psychiatry and Behavioral Sciences Albert Einstein College of Medicine Montefiore Medical Center; Steven L. Batki MD Director Addiction Psychiatry Clinic Crouse Chemical Dependency Treatment Services; Interim Associate Chief of Staff for Research Syracuse VA Medical Center; Professor and Director of Research Department of Psychiatry SUNY Upstate Medical University; Lawrence S. Brown Jr. MD MPH Clinical Associate Professor of Public Health Weill Medical College Cornell University; President American Society of Addiction Medicine; Senior Vice President Division of Medical Services Evaluation and Research Addiction Research and Treatment Corporation; Brenda Chabon PhD Assistant Professor Dept. of Psychiatry and Behavioral Sciences Montefiore Medical Center/Albert Einstein College of Medicine; Barbara Chaffee MD MPH Clinical Associate Professor of Medicine Upstate Medical Center Clinical Campus at Binghamton Binghamton New York; Medical Director Internal Medicine Binghamton Family Care Center United Health Services Hospitals; Steven Kipnis MD FACP FASAM Medical Director New York State Office of Alcoholism & Substance Abuse Services; Nancy Murphy NP HIV Primary Care Provider Center for Comprehensive Care Room 14A36 St Luke's Roosevelt Hospital Center; David C. Perlman MD Chief Infectious Diseases Beth Israel Medical Center -- Singer Division; Professor of Medicine Albert Einstein College of Medicine; Director AIDS Inpatient Unit Beth Israel Medical Center; Benny Primm MD Executive Director Division of Medical Services Evaluation and Research Addiction Research and Treatment Corporation; Sharon Stancliff MD Medical Director Harlem East Life Plan; Medical Consultant NYSDOH AIDS Institute; Robert Whitney MD Erie County Medical Center
AIDS Institute: Diane Rudnick Director Substance Abuse Section New York State Department of Health
Financial Disclosures/Conflicts of Interest
Not stated
Guideline Status
This is the current release of the guideline.
Guideline Availability
Electronic copies: Available from the New York State Department of Health AIDS Institute Web site.
Print copies: Available from Office of the Medical Director AIDS Institute New York State Department of Health 5 Penn Plaza New York NY 10001; Telephone: (212) 268-6108
Availability of Companion Documents
This guideline is available as a Personal Digital Assistant (PDA) download from the New York State Department of Health AIDS Institute Web site.
Patient Resources
None available
NGC STATUS
This NGC summary was completed by ECRI on July 18 2005.
COPYRIGHT STATEMENT
This NGC summary is based on the original guideline which is copyrighted by the guideline developer. See the New York State Department of Health AIDS Institute Web site for terms of use.
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