Standard care impact on effects of highly active antiretroviral therapy adherence interventions: A meta-analysis of randomized controlled trials.

BACKGROUND Poor adherence to medication limits the effectiveness of treatment for human immunodeficiency virus. Systematic reviews can identify practical and effective interventions. Meta-analyses that control for variability in standard care provided to control groups may produce more accurate estimates of intervention effects. METHODS To examine whether viral load and adherence success rates could be accurately explained by the active content of highly active antiretroviral therapy (HAART) adherence interventions when controlling for variability in care delivered to controls, databases were searched for randomized controlled trials of HAART adherence interventions published from 1996 to January 2009. A total of 1342 records were retrieved, and 52 articles were examined in detail. Directly observed therapy and interventions targeting specific patient groups (ie, psychiatric or addicted patients, patients <18 years) were excluded, yielding a final sample of 31 trials. Two coders independently retrieved study details. Authors were contacted to complete missing data. RESULTS Twenty studies were included in the analyses. The content of adherence care provided to control and intervention groups predicted viral load and adherence success rates in both conditions (P < .001 for all comparisons), with an estimated impact of optimal adherence care of 55 percentage points. After controlling for variability in care provided to controls, the capacity of the interventions accurately predicted viral load and adherence effect sizes (R(2) = 0.78, P = .02; R(2) = 0.28, P < .01). Although interventions were generally beneficial, their effectiveness reduced noticeably with increasing levels of standard care. CONCLUSIONS Intervention and control patients were exposed to effective adherence care. Future meta-analyses of (behavior change) interventions should control for variability in care delivered to active controls. Clinical practice may be best served by implementing current best practice.

[1]  C Inch,et al.  Patient support and education for promoting adherence to highly active antiretroviral therapy for HIV/AIDS. , 2006, The Cochrane database of systematic reviews.

[2]  A. Carballo-Diéguez,et al.  Couple-focused support to improve HIV medication adherence: a randomized controlled trial , 2005, AIDS.

[3]  R. Crosby,et al.  Emerging theories in health promotion practice and research , 2002 .

[4]  Loren G. Miller,et al.  A prospective study of predictors of adherence to combination antiretroviral medication , 2002, Journal of General Internal Medicine.

[5]  J. Simoni,et al.  A randomized controlled trial of a peer support intervention targeting antiretroviral medication adherence and depressive symptomatology in HIV-positive men and women. , 2007, Health psychology : official journal of the Division of Health Psychology, American Psychological Association.

[6]  Blair T. Johnson,et al.  Efficacy of Antiretroviral Therapy Adherence Interventions: A Research Synthesis of Trials, 1996 to 2004 , 2006, Journal of acquired immune deficiency syndromes.

[7]  M. Otto,et al.  Two strategies to increase adherence to HIV antiretroviral medication: life-steps and medication monitoring. , 2001, Behaviour research and therapy.

[8]  K. Squires,et al.  A randomized trial of directly administered antiretroviral therapy and adherence case management intervention. , 2006, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[9]  M. Borenstein,et al.  Publication Bias in Meta-Analysis: Prevention, Assessment and Adjustments , 2006 .

[10]  Gerjo Kok,et al.  Standard care quality determines treatment outcomes in control groups of HAART-adherence intervention studies: implications for the interpretation and comparison of intervention effects. , 2009, Health psychology : official journal of the Division of Health Psychology, American Psychological Association.

[11]  Maria E. Fernandez,et al.  Planning Health Promotion Programs: An Intervention Mapping Approach , 2006 .

[12]  A. Bandura Self-Efficacy: The Exercise of Control , 1997, Journal of Cognitive Psychotherapy.

[13]  G. V. van Servellen,et al.  Effects of a treatment adherence enhancement program on health literacy, patient-provider relationships, and adherence to HAART among low-income HIV-positive Spanish-speaking Latinos. , 2005, AIDS patient care and STDs.

[14]  J. Cramer,et al.  Cue-dose training with monetary reinforcement , 2000, Journal of General Internal Medicine.

[15]  Jeffrey D Fisher,et al.  Information-motivation-behavioral skills model-based HIV risk behavior change intervention for inner-city high school youth. , 2002, Health psychology : official journal of the Division of Health Psychology, American Psychological Association.

[16]  Justin C McArthur,et al.  A programmable prompting device improves adherence to highly active antiretroviral therapy in HIV-infected subjects with memory impairment. , 2005, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[17]  S. Boswell,et al.  Use of an on-line pager system to increase adherence to antiretroviral medications , 2003, AIDS care.

[18]  R. Remien,et al.  Effects of a Behavioral Intervention on Antiretroviral Medication Adherence Among People Living With HIV: The Healthy Living Project Randomized Controlled Study , 2007, Journal of acquired immune deficiency syndromes.

[19]  J. Cramer,et al.  Cue-dose training with monetary reinforcement: pilot study of an antiretroviral adherence intervention. , 2000, Journal of general internal medicine.

[20]  D. Urada,et al.  Erratum to “The effectiveness of drug abuse treatment: a meta-analysis of comparison group studies” [Drug Alcohol Depend. 67 (2002) 53–72] , 2006 .

[21]  Eunice Chang,et al.  The effectiveness of drug abuse treatment: a meta-analysis of comparison group studies. , 2002, Drug and alcohol dependence.

[22]  Scott R. Smith,et al.  Telephone Support to Improve Antiretroviral Medication Adherence: A Multisite, Randomized Controlled Trial , 2008, Journal of acquired immune deficiency syndromes.

[23]  L. Koenig,et al.  Randomized controlled trial of an intervention to prevent adherence failure among HIV-infected patients initiating antiretroviral therapy. , 2008, Health psychology : official journal of the Division of Health Psychology, American Psychological Association.

[24]  Traci Mann,et al.  Effects of future writing and optimism on health behaviors in HIV-infected women , 2001, Annals of behavioral medicine : a publication of the Society of Behavioral Medicine.

[25]  C. Farthing,et al.  Efficacy of an Individualized Adherence Support Program with Contingent Reinforcement Among Nonadherent HIV-Positive Patients , 2006, Journal of the International Association of Physicians in AIDS Care.

[26]  D. Moher,et al.  Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. , 2008, Annals of internal medicine.

[27]  D. Paterson,et al.  Measurement of Adherence to Antiretroviral Medications , 2002, Journal of acquired immune deficiency syndromes.

[28]  Evelyn P Whitlock,et al.  Evidence-based behavioral medicine: What is it and how do we achieve it? , 2003, Annals of behavioral medicine : a publication of the Society of Behavioral Medicine.

[29]  Theo Stijnen,et al.  Advanced methods in meta‐analysis: multivariate approach and meta‐regression , 2002, Statistics in medicine.

[30]  E. Morse,et al.  Sustained Benefit From a Long-Term Antiretroviral Adherence Intervention: Results of a Large Randomized Clinical Trial , 2006, Journal of acquired immune deficiency syndromes.

[31]  Scott R. Smith,et al.  A medication self-management program to improve adherence to HIV therapy regimens. , 2003, Patient education and counseling.

[32]  U. Ehlert,et al.  Effects of cognitive behavioral stress management on HIV-1 RNA, CD4 cell counts and psychosocial parameters of HIV-infected persons , 2008, AIDS.

[33]  J. Tobin,et al.  Efficacy of a Group Medication Adherence Intervention Among HIV Positive Women: The SMART/EST Women’s Project , 2006, AIDS and Behavior.

[34]  Dean Wantland,et al.  Testing a Nurse-Tailored HIV Medication Adherence Intervention , 2006, Nursing research.

[35]  John T. Cacioppo,et al.  The Elaboration Likelihood Model of Persuasion , 1986, Advances in Experimental Social Psychology.

[36]  A. Wu,et al.  Interventions to Improve Adherence to Antiretroviral Therapy , 2002, Journal of acquired immune deficiency syndromes.

[37]  W. Marelich,et al.  Results of a pilot intervention trial to improve antiretroviral adherence among HIV-positive patients. , 2002, The Journal of the Association of Nurses in AIDS Care : JANAC.

[38]  Cathie M Scott,et al.  Health Promotion Planning: An Educational and Ecological Approach (3rd ed) , 2001 .

[39]  John C. Norcross,et al.  In Search of How People Change: Applications to Addictive Behaviors , 1993 .

[40]  Heather Ribaudo,et al.  A randomized study of serial telephone call support to increase adherence and thereby improve virologic outcome in persons initiating antiretroviral therapy. , 2005, The Journal of infectious diseases.

[41]  Gary Marks,et al.  Efficacy of Interventions in Improving Highly Active Antiretroviral Therapy Adherence and HIV-1 RNA Viral Load: A Meta-Analytic Review of Randomized Controlled Trials , 2006, Journal of acquired immune deficiency syndromes.

[42]  S. Rabe-Hesketh,et al.  Systematic review and meta-analysis of randomised controlled trials of psychological interventions to improve glycaemic control in patients with type 2 diabetes , 2004, The Lancet.

[43]  Judith Chwalow,et al.  Impact of a patient education program on adherence to HIV medication: a randomized clinical trial. , 2003, Journal of acquired immune deficiency syndromes.

[44]  J. Tolson,et al.  Impact of an educational program on efficacy and adherence with a twice-daily lamivudine/zidovudine/abacavir regimen in underrepresented HIV-infected patients. , 2003, Journal of acquired immune deficiency syndromes.

[45]  Milton C Weinstein,et al.  Projecting the cost-effectiveness of adherence interventions in persons with human immunodeficiency virus infection. , 2003, The American journal of medicine.

[46]  Susan Swindells,et al.  Adherence to Protease Inhibitor Therapy and Outcomes in Patients with HIV Infection , 2000, Annals of Internal Medicine.

[47]  John B. Willett,et al.  Another Cautionary Note about R 2: Its Use in Weighted Least-Squares Regression Analysis , 1988 .

[48]  J. Harman,et al.  Attrition and related trends in scientific rigor: A score card for ART adherence intervention research and recommendations for future directions , 2008, Current HIV/AIDS reports.

[49]  S. Noar,et al.  Does tailoring matter? Meta-analytic review of tailored print health behavior change interventions. , 2007, Psychological bulletin.

[50]  P. Cuijpers,et al.  Psychological treatment of social anxiety disorder: a meta-analysis , 2008, Psychological Medicine.

[51]  C. Kemper,et al.  Effect of a Brief Antiretroviral Adherence Intervention Delivered by HIV Care Providers , 2005, Journal of acquired immune deficiency syndromes.

[52]  Ross J. Harris,et al.  Life expectancy of individuals on combination antiretroviral therapy in high-income countries: a collaborative analysis of 14 cohort studies , 2008, The Lancet.

[53]  R. Petty,et al.  The Elaboration Likelihood Model of persuasion: Developing health promotions for sustained behavioral change. , 2009 .

[54]  Gerjo Kok,et al.  Decoding health education interventions: The times are a-changin’ , 2009 .

[55]  K. Farmer,et al.  Impact of an adherence clinic on behavioral outcomes and virologic response in treatment of HIV infection: a prospective, randomized, controlled pilot study. , 2005, Clinical therapeutics.

[56]  C. Porter,et al.  A 2-Arm, Randomized, Controlled Trial of a Motivational Interviewing-Based Intervention to Improve Adherence to Antiretroviral Therapy (ART) Among Patients Failing or Initiating ART , 2006, Journal of acquired immune deficiency syndromes.

[57]  K. Resnicow,et al.  Using motivational interviewing to promote adherence to antiretroviral medications: a pilot study. , 2003, The Journal of the Association of Nurses in AIDS Care : JANAC.

[58]  F. Wit,et al.  Virologic and Immunologic Response to Highly Active Antiretroviral Therapy in Indigenous and Nonindigenous HIV-1–Infected Patients in The Netherlands , 2004, Journal of acquired immune deficiency syndromes.

[59]  K. Melbourne,et al.  Medication adherence in patients with HIV infection: a comparison of two measurement methods. , 1999, The AIDS reader.

[60]  Gerjo Kok,et al.  The Impact of Computer-Tailored Feedback and Iterative Feedback on Fat, Fruit, and Vegetable Intake , 1998, Health education & behavior : the official publication of the Society for Public Health Education.

[61]  Julio S. G. Montaner,et al.  A simple, dynamic measure of antiretroviral therapy adherence predicts failure to maintain HIV-1 suppression. , 2006, The Journal of infectious diseases.

[62]  D. Kanouse,et al.  Assessing usual care in clinical trials of adherence interventions for highly active antiretroviral therapy. , 2003, Journal of acquired immune deficiency syndromes.

[63]  J. Bartlett Association between adherence to antiretroviral therapy and human immunodeficiency virus drug resistance , 2004 .

[64]  C. Farthing,et al.  Results of an Antiretroviral Adherence Intervention: STAR (Staying Healthy: Taking Antiretrovirals Regularly) , 2007, Journal of the International Association of Physicians in AIDS Care.

[65]  J. Casado,et al.  Validation of a simplified medication adherence questionnaire in a large cohort of HIV-infected patients: the GEEMA Study , 2002, AIDS.

[66]  K. Resnicow,et al.  Using motivational interviewing to promote adherence to antiretroviral medications: A randomized controlled study , 2008, AIDS care.

[67]  A. Bayoumi,et al.  Clinical and Economic Implications of Non-Adherence to HAART in HIV Infection , 2002 .

[68]  C. Abraham,et al.  A taxonomy of behavior change techniques used in interventions. , 2008, Health psychology : official journal of the Division of Health Psychology, American Psychological Association.

[69]  R. Haubrich,et al.  Cognitive-behavioral intervention to enhance adherence to antiretroviral therapy: a randomized controlled trial (CCTG 578) , 2006, AIDS.

[70]  B. Laurence,et al.  Efficacy of an Educational and Counseling Intervention on Adherence to Highly Active Antiretroviral Therapy: French Prospective Controlled Study , 2003 .

[71]  R. Hays,et al.  A Comparison Study of Multiple Measures of Adherence to HIV Protease Inhibitors , 2001, Annals of Internal Medicine.

[72]  J. Prochaska,et al.  Stages and processes of self-change of smoking: toward an integrative model of change. , 1983, Journal of consulting and clinical psychology.

[73]  P D Mullen,et al.  Clinical trials of patient education for chronic conditions: a comparative meta-analysis of intervention types. , 1985, Preventive medicine.

[74]  M. Kreuter,et al.  Applications workbook to accompany health promotion planning : an educational and ecological approach , 1999 .

[75]  H. Günthard,et al.  Effect of Individual Cognitive Behaviour Intervention on Adherence to Antiretroviral Therapy: Prospective Randomized Trial , 2004, Antiviral therapy.

[76]  N. Schneiderman,et al.  Influencing medication adherence among women with AIDS , 2003, AIDS care.