Melanie A. Thompson, MD; Michael J. Mugavero, MD, MHSc; K. Rivet Amico, PhD; Victoria A. Cargill, MD, MSCE; Larry W. Chang, MD, MPH; Robert Gross, MD, MSCE; Catherine Orrell, MBChB, MSc, MMed; Frederick L. Altice, MD; David R. Bangsberg, MD, MPH; John G. Bartlett, MD; Curt G. Beckwith, MD; Nadia Dowshen, MD; Christopher M. Gordon, PhD; Tim Horn, MS; Princy Kumar, MD; James D. Scott, PharmD, MEd; Michael J. Stirratt, PhD; Robert H. Remien, PhD; Jane M. Simoni, PhD; Jean B. Nachega, MD, PhD, MPH
Acknowledgment: The authors thank the following individuals, who were instrumental to the development of these guidelines: José M. Zuniga, PhD, MPH, and Angela Knudson (IAPAC; guideline conception, administrative support); Laura Bernard, MPH, and Kathryn Muessig, PhD (systematic review and evidence grading); Jennifer Johnsen, MD (systematic review); Anne McDonough, MPH (editing); and Adele Webb, PhD, RN (Chamberlain College of Nursing, Cleveland, Ohio; contribution to discussions of children and adolescents), and Morgan Dirlam (Georgetown University; contribution to future recommendations, concomitant medical conditions). The authors also thank the external reviewers, including Jane Anderson, PhD, and John Walsh, MBBS (British HIV Association); Carl Stein, MHS, PA-C, (Physician Assistant AIDS Network); Donna E. Sweet, MD (American Academy of HIV Medicine); Ann Deschamps, RN, MSN (European HIV Nurses Network); Robert T. Carroll, MN, RN (Association of Nurses in AIDS Care); and Donna Futterman, MD, and Brian Gazzard, MD, MA (individual reviewers). The HIV Medicine Association also provided input into these guidelines.
Grant Support: Development of the guidelines was jointly sponsored by IAPAC and the U.S. National Institutes of Health's Office of AIDS Research.
Potential Conflicts of Interest: Disclosures from authors and panel members can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-0061.
Requests for Single Reprints: International Association of Physicians in AIDS Care, 1640 Rhode Island Avenue NW, Suite 200, Washington, DC 20036; e-mail, firstname.lastname@example.org.
Current Author Addresses: Dr. Thompson: AIDS Research Consortium of Atlanta, 131 Ponce de Leon Avenue, Suite 130, Atlanta, GA 30308.
Dr. Mugavero: 1530 3rd Avenue South, Community Care Building 142, Birmingham, AL 35294-2050.
Dr. Amico: 5598 Mounting Road, Brighton, MI 48116.
Dr. Cargill: Office of AIDS Research, National Institutes of Health, 5635 Fishers Lane, Bethesda, MD 20892.
Dr. Chang: Johns Hopkins Center for Global Health, 1503 East Jefferson Street, Room 116, Baltimore, MD 21205.
Dr. Gross: Perelman School of Medicine, University of Pennsylvania, 804 Blockley Hall, 423 Guardian Drive, Pennsylvania, PA 19104-6021.
Dr. Orrell: University of Cape Town, Anzio Road, Observatory 7705, Cape Town, South Africa.
Dr. Altice: Yale University AIDS Program, 135 College Street, Suite 323, New Haven, CT 06510.
Dr. Bangsberg: MGH Center for Global Health, 104 Mt. Auburn Street, 3rd Floor, Cambridge, MA 02138.
Dr. Bartlett: Johns Hopkins School of Medicine, 615 North Wolfe Street, 1830 Building Room 437, Baltimore, MD 21205.
Dr. Beckwith: The Warren Alpert Medical School of Brown University, The Miriam Hospital, 164 Summit Avenue, Providence, RI 02906.
Dr. Dowshen: The Children's Hospital of Philadelphia, 34th Street and Civic Center Boulevard, 11 NW, Suite 10, Room 24, Philadelphia, PA 19104.
Dr. Gordon: National Institute of Mental Health, 6001 Executive Boulevard, Room 6212, Bethesda, MD 20892-9619.
Mr. Horn: AIDSmeds.com, 462 Seventh Avenue, 19th Floor, New York, NY 10018-7424.
Dr. Kumar: Georgetown University School of Medicine, 5PHC Building, 3800 Reservoir Road NW, Washington, DC 20007.
Dr. Scott: Western University of Health Sciences, College of Pharmacy, 309 East 2nd Street, Pomona, CA 91766.
Dr. Stirratt: National Institute of Mental Health, 6001 Executive Boulevard, MSC-9619, Room 6199, Bethesda, MD 20892.
Dr. Remien: Columbia University, 1051 Riverside Drive, Unit 15, New York, NY 10032.
Dr. Simoni: Department of Psychology, University of Washington, 3909 Stevens Way NE, Campus Box 351525, Seattle, WA 98195-1525.
Dr. Nachega: Johns Hopkins Bloomberg School of Public of Health, 615 North Wolfe Street, Room E5527, Baltimore, MD 21205.
Author Contributions: Conception and design: M.A. Thompson, M.J. Mugavero, K.R. Amico, V.A. Cargill, L.W. Chang, R. Gross, C. Orrell, F.L. Altice, D.R. Bangsberg, J.G. Bartlett, C.G. Beckwith, N. Dowshen, C.M. Gordon, T. Horn, P. Kumar, J.D. Scott, M.J. Stirratt, R.H. Remien, J.M. Simoni, J.B. Nachega.
Analysis and interpretation of the data: M.A. Thompson, M.J. Mugavero, K.R. Amico, V.A. Cargill, L.W. Chang, R. Gross, C. Orrell, F.L. Altice, D.R. Bangsberg, J.G. Bartlett, C.G. Beckwith, N. Dowshen, C.M. Gordon, T. Horn, P. Kumar, J.D. Scott, M.J. Stirratt, R.H. Remien, J.M. Simoni, J.B. Nachega.
Drafting of the article: M.A. Thompson, M.J. Mugavero, K.R. Amico, V.A. Cargill, L.W. Chang, R. Gross, C. Orrell, F.A. Altice, D.R. Bangsberg, J.G. Bartlett, C.G. Beckwith, N. Dowshen, C.M. Gordon, T. Horn, P. Kumar, J.D. Scott, M.J. Stirratt, R.H. Remien, J.M. Simoni, J.B. Nachega.
Critical revision of the article for important intellectual content: M.A. Thompson, M.J. Mugavero, K.R. Amico, V.A. Cargill, L.W. Chang, R. Gross, C. Orrell, F.L. Altice, D.R. Bangsberg, J.G. Bartlett, C.G. Beckwith, N. Dowshen, C.M. Gordon, T. Horn, P. Kumar, J.D. Scott, M.J. Stirratt, R.H. Remien, J.M. Simoni, J.B. Nachega.
Final approval of the article: M.A. Thompson, M.J. Mugavero, K.R. Amico, V.A. Cargill, L.W. Chang, R. Gross, C. Orrell, F.L. Altice, D.R. Bangsberg, J.G. Bartlett, C.G. Beckwith, N. Dowshen, C.M. Gordon, T. Horn, P. Kumar, J.D. Scott, M.J. Stirratt, R.H. Remien, J.M. Simoni, J.B. Nachega.
Statistical expertise: L.W. Chang, F.L. Altice.
Obtaining of funding: V.A. Cargill.
Administrative, technical, or logistic support: M.A. Thompson, M.J. Mugavero, V.A. Cargill.
Collection and assembly of data: M.A. Thompson, M.J. Mugavero, K.R. Amico, V.A. Cargill, L.W. Chang, R. Gross, C. Orrell, F.A. Altice, D.R. Bangsberg, J.G. Bartlett, C.G. Beckwith, N. Dowshen, C.M. Gordon, T. Horn, P. Kumar, J.D. Scott, M.J. Stirratt, R.H. Remien, J.M. Simoni, J.B. Nachega.
After HIV diagnosis, timely entry into HIV medical care and retention in that care are essential to the provision of effective antiretroviral therapy (ART). Adherence to ART is among the key determinants of successful HIV treatment outcome and is essential to minimize the emergence of drug resistance. The International Association of Physicians in AIDS Care convened a panel to develop evidence-based recommendations to optimize entry into and retention in care and ART adherence for people with HIV.
A systematic literature search was conducted to produce an evidence base restricted to randomized, controlled trials and observational studies with comparators that had at least 1 measured biological or behavioral end point. A total of 325 studies met the criteria. Two reviewers independently extracted and coded data from each study using a standardized data extraction form. Panel members drafted recommendations based on the body of evidence for each method or intervention and then graded the overall quality of the body of evidence and the strength for each recommendation.
Recommendations are provided for monitoring entry into and retention in care, interventions to improve entry and retention, and monitoring of and interventions to improve ART adherence. Recommendations cover ART strategies, adherence tools, education and counseling, and health system and service delivery interventions. In addition, they cover specific issues pertaining to pregnant women, incarcerated individuals, homeless and marginally housed individuals, and children and adolescents, as well as substance use and mental health disorders. Recommendations for future research in all areas are also provided.
Grading Scales for Quality of the Body of Evidence and Strength of Recommendations
Appendix Table 1.
Summary of Recommendations With Scores for Quality of the Body of Evidence and Strength of Recommendation
Appendix Table 2.
Evidence Base for Education and Counseling Recommendations
Recommendations for Future Research
Appendix Table 3.
Process for Evaluating the Body of Evidence
Appendix Table 4.
Factors Considered in Determining the Strength of the Recommendation
The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.
IsabelleArnet, Senior Researcher, Heiner C. Bucher, Kurt E. Hersberger
Pharmaceutical Care Research Group, University Basel, and Institute for Clinical Epidemiology, Unive
March 30, 2012
Polymedication Electronic Monitoring System (POEMS) in future research
The expert panel from the IAPAC proposed pioneering guidelines to improve entry into and retention in care, as well as adherence to HIV medications, the three pillars of HIV treatment success. We highly honour their article. We agree that the currently most used electronic drug monitors (a microchip embedded in a pill bottle cap) can not be recommended for routine use outside of studies because they only measure one single drug and not the whole regimen, they impede the use of pillboxes and because patients often remove pocket doses.
To overcome these shortcomings we developed a self-adhesive polymer film, with conductive wires that can be affixed to commercial multidose blister packs. The new technology allows recording of date, time and location of drug removed from a blister pack. Thus, we can track intake of an entire regimen with all solid oral drugs and the system can easily be combined with time reminder alarms. Furthermore, the visualization of individual intake behaviours with the entire medication, and not only with one drug, would permit to correlate adherence with eg drug-drug interactions, reasons of treatment failure and drug resistance, and guide decision making. We obtained first promising results with this new adherence tool in a study on aspirin resistance (ClinicalTrials.gov Identifier: NCT01039480) and are going to soon start a study with HIV- patients at the University Hospital Basel.
Therefore we would like to strengthen the recommendation for future research into electronic monitoring ART adherence and to overcome drawbacks of existing EDMs. We suggest as new strategy and as amendment to Table 2, the development of electronic monitoring technology with direct link to supporting drug reminder systems. Such tools should enable both, monitoring and patient support and they should be convenient for patients in daily life.
Lisa KFitzpatrick, Medical Epidemiologist, Daveda Hudson, Aurnell Dright
Howard University/United Medical Center
April 3, 2012
Peer navigation and Individual Patient Outreach for Entry to HIV Care: Reaching beyond the data
We commend Thompson and colleagues for the development and publication of Guidelines for Improving Entry Into and Retention in Care(1). These guidelines are important for consolidating best practices for the approach to this multi-dimensional and complex issue. However, while we understand the science gaps presented, we disagree with IIIC recommendations for the use of peer-navigators and intensive individual outreach. Based on our experiences in Washington DC, these strategies should be considered vital to engaging clients from impoverished and disadvantaged communities. Both peer navigation and intensive individual outreach have become anchors for successfully engaging and retaining both new and lost clients into HIV care, often in minutes rather than months. Therefore, these guidelines will serve as a minimum effort required to achieve and maintain entry and retention in care. In 2011, of 210 lost-to -care clients targeted by our outreach efforts, over 50% required unorthodox approaches that exceed parameters outlined or not mentioned in these guidelines. For example, successful outreach efforts included: 1. Seventeen phone calls to a single client, 2. An impromptu meeting on a street corner between a physician and client, 3. Twice weekly phone calls and monthly written notes for eleven months.
In an era of shrinking healthcare resources, we do not believe additional research on entry into care, particularly via randomized trials, should be prioritized over implementation of effective strategies highlighted in federally-funded observational studies2, 3. In addition, a wealth of data exist on barriers to engagement in care4,5. Similarly, among our clients, the most common explanations and barriers to care include: 1. depression and denial associated with a new diagnosis, 2. non- IDU substance use and 3. delays in securing health insurance. Given this, we believe the solutions to improving engagement in HIV care largely involve shifting resources to develop targeted policy and implementing structural interventions such as improving access to integrated mental health and substance use treatment, expanded clinic hours, improving community health literacy and dialogue about HIV and alleviating bureaucratic delays in securing health insurance.
Finally, the guidelines do not specifically address the integration of pharmacists within healthcare teams. The inclusion of a PharmD for treatment adherence counseling on our team has been invaluable for client retention. If more research is funded, we agree with the recommendation to conduct operational research to demonstrate the impact of interventions like this since doing so will provide evidence to justify funding for this service delivery model.
1. Thompson MA, Mugavero MJ, Amico KR, et al. Guidelines for Improving Entry Into and Retention in Care and Antiretroviral Adherence for Persons With HIV: Evidence-Based Recommendations From an International Association of Physicians in AIDS Care Panel. Annals of Internal Medicine. March 5, 2012 2012:E-419.
2. Gardner LI, Metsch LR, Anderson-Mahoney P, Loughlin AM, del Rio C, Strathdee S, et al; Antiretroviral Treatment and Access Study Study Group. Efficacy of a brief case management intervention to link recently diagnosed HIV-infected persons to care. AIDS. 2005;19:423-31.
3. Bradford JB, Coleman S, Cunningham W. HIV System Navigation: an emerging model to improve HIV care access. AIDS Patient Care STDS. 2007;21 Suppl 1:S49-58. [PMID: 17563290
4. Cavaleri MA, Kalogerogiannis K, McKay MM. Barriers to HIV care: an exploration of the complexities that influence engagement in and utilization of treatment. Soc Work Health Care. 2010;49(10):934-45.
5. Rumptz MH, Tobias C, Rajabiun S, Bradford J, Cabral H. Factors associated with engaging socially marginalized HIV-positive persons in primary care. AIDS Patient Care STDS. 2007;21 Suppl 1:S30-9.
We do not have competing interests.
EvanWood, Professor of Medicine, Julio S. G. Montaner
University of British Columbia
June 6, 2012
Drug Addiction, Incarceration and Entry and Retention in Care for Persons with HIV
1. Milloy MJ, Kerr T, Buxton J, et al. Dose-response effect of incarceration events on nonadherence to HIV antiretroviral therapy among injection drug users. J Infect Dis. May 1 2011;203(9):1215-1221.
2. Westergaard RP, Kirk GD, Richesson DR, Galai N, Mehta SH. Incarceration Predicts Virologic Failure for HIV-Infected Injection Drug Users Receiving Antiretroviral Therapy. Clinical Infectious Diseases. 2011;53(7):725-731.
3. Yirrell DL, Robertson P, Goldberg DJ, McMenamin J, Cameron S, Leigh Brown AJ. Molecular investigation into outbreak of HIV in a Scottish prison. BMJ. 1997;314(7092):1446-1450.
4. Wood E, Milloy MJ, Montaner JSG. HIV treatment as prevention among injection drug users. Current Opinion in HIV and AIDS. 2012.
5. Johnson R, Raphael S. The effects of male incarceration dynamics on acquired immune deficiency syndrome infection rates among African American women and men. Journal of Law and Economics. 2009;52(2):251-293.
Frederick A. Altice, MD, MA (Yale University), Curt G. Beckwith, MD (Brown University), Tim Horn (AIDSmeds.com), Jane M. Simoni, PhD (University of Washington)
On behalf of the International Association of Physicians in AIDS Care Panel on Guidelines for Improving Entry into and Retention in Care and Antiretroviral Adherence for Patients with HIV
September 20, 2012
Letters from Fitzpatrick, et al, and Wood and Montaner illustrate areas that were addressed by the panel but for which insufficient evidence limited the ability to make definitive recommendations. Given the assumptions needed for interpreting uncontrolled studies, we confined our evidence base to studies with either randomized or observational comparative data. We agree with Fitzpatrick, et al that peer-navigation and intensive individual outreach may be helpful in achieving successful entry into and retention in clinical care, particularly among individuals with co-morbid psychiatric and substance use disorders. Currently, the strength of evidence for such strategies is limited by a paucity of high quality published research. Similarly, Fitzpatrick and colleagues’ identification of pharmacist-led interventions as meriting a specific recommendation is constrained by a lack of literature on unique contributions of interventions led by pharmacists versus others. It is important to emphasize that while scientific evaluation requires resources, it remains the cornerstone of evidence-based practice and arguably produces cost-savings in the longer-term. Precisely because of shrinking healthcare resources, recommended approaches should be those that are effective, and determining effectiveness requires scientific investigation. We encourage those who are implementing interventions in practice or research settings to evaluate them with controlled observational studies or randomized trials and disseminate their results in order to inform the next version of these guidelines.We agree with Wood and Montaner that incarceration may lead to antiretroviral (ART) non-adherence, interruptions in care, and virologic failure for HIV-infected people who use drugs (PWUDs). Our guidelines presented evidence-based interventions (EBIs) that addressed barriers to HIV treatment outcomes among PWUDs and within criminal justice settings and did not seek to describe or weight the negative contributors themselves. Consistent with our guidelines methodology, only interventions with robust study designs were included. While the data appear incontrovertible that there are profound negative consequences on longitudinal HIV care associated with incarceration, currently there are no EBIs that reduce the negative health consequences of incarceration on PWUDs. It is provocative to speculate, however, that structural interventions that address increased community-based drug treatment, homelessness, unemployment, healthcare access, and legal reform could lead to alternatives to incarceration, thereby improving ART adherence, treatment and retention in care among HIV-infected PWUDs. We encourage the development and evaluation of methodologically sound, innovative interventions that improve HIV treatment outcomes through enhanced ART adherence and coordination of HIV care among PWUDs in criminal justice settings. Our guidelines further outline many research priorities for this population and we also refer readers to more detailed treatises on these issues that have been recently reviewed (1-3).
Frederick A. Altice, MD, MA (Yale University)
Curt G. Beckwith, MD (Brown University)
Tim Horn (AIDSmeds.com)
Jane M. Simoni, PhD (University of Washington)
On behalf of the International Association of Physicians in AIDS Care Panel on Guidelines for Improving Entry into and Retention in Care and Antiretroviral Adherence for Persons with HIV
1. Altice FL, Kamarulzaman A, Soriano VV, Schechter M, Friedland GH. Treatment of medical, psychiatric, and substance-use comorbidities in people infected with HIV who use drugs. Lancet. 2010;376(9738):59-79.
2. Wolfe D, Carrieri MP, Shepard D. Treatment and care for injecting drug users with HIV infection: a review of barriers and ways forward. Lancet. 2010;376(9738):355-66.
3. Binford MC, Kahana SY, Altice FL. A Systematic Review of Antiretroviral Adherence Interventions for HIV-Infected People Who Use Drugs. Curr HIV/AIDS Rep. 2012:In press. Authors
Thompson MA, Mugavero MJ, Amico KR, Cargill VA, Chang LW, Gross R, et al. Guidelines for Improving Entry Into and Retention in Care and Antiretroviral Adherence for Persons With HIV: Evidence-Based Recommendations From an International Association of Physicians in AIDS Care Panel. Ann Intern Med. 2012;156:817–833. doi: 10.7326/0003-4819-156-11-201206050-00419
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