1. Education and Counseling to Support Adherence with general population of PLWH Guidelines and Recommendations for Implementation K. Rivet Amico, PhD University of Connecticut On behalf of Guidelines Panel July 2012www.iapac.org No conflicts to report

2. Education and Counseling Guidelines for general clinic population  Individual one-on-one ART education is recommended (II A).  Providing one-on-one adherence support to patients through 1 or more adherence counselling approaches is recommended (II A).  Group education and group counselling are recommended; however, the type of group format, content, and implementation cannot be specified on the basis of the currently available evidence (II C).  Multidisciplinary education and counselling intervention approaches are recommended (III B).  Offering peer support may be considered (III C).

3. INDIVIDUAL ONE-ON-ONE ART EDUCATION IS RECOMMENDED (II A) High (II)Strong evidence with important limitations; Strong evidence from observational studies Strong (A)Almost all patients should receive the recommended course of action Brock et al. 2007 Collier et al. 2005 Fairley et al. 2003 Golin et al. 2006 Goujard et al. 2003 Holzemer et al. 2006 Johnson et al. 2007 Kalichman et al. 2005 Murphy et al. 2007 Rawlings et al. 2003 Safren et al. 2001 Smith et al. 2003 Tuldra et al. 2000 Williams et al. 2006 14 intervention studies 10 + effects on adherence 1 study (of 8) + effects on biomarkers

4. INDIVIDUAL ONE-ON-ONE ART EDUCATION IS RECOMMENDED (II A) Content should include: Common side-effects Role of adherence in treatment success Role of non-adherence in resistance Additionally… Medication management skills Review of common barriers Framing of adherence as challenging for many From this evidence base

5. INDIVIDUAL ONE-ON-ONE ART EDUCATION IS RECOMMENDED (II A) From this evidence base Targets knowledge acquisition Discussion Exploration Activities Goes beyond Information Provision (e.g., booklets, information providing without conversation or information checks). Diversity Clinicians, nurses, pharmacists, counselors, health workers. Timing in relation to ART Education often combined with Counseling

6. INDIVIDUAL ONE-ON-ONE ART EDUCATION IS RECOMMENDED (II A) Implementation challenges? Sufficient resources to provide education individually General education messages need to be tailored to local community and culture Common mis-information must be identified Need to determine timing, duration, and deliverer and plan for monitoring Confirm that approach goes beyond info delivery Most providers/agencies surveyed in IAPAC web survey report providing some kind of education (85%*)

7. PROVIDING ONE-ON-ONE ADHERENCE SUPPORT TO PATIENTS THROUGH 1 OR MORE ADHERENCE COUNSELLING APPROACHES IS RECOMMENDED (II A). High (II)Strong evidence with important limitations; Strong evidence from observational studies Strong (A)Almost all patients should receive the recommended course of action Brock et al. 2007 Collier et al. 2005 Fairley et al. 2003 Golin et al. 2006 Goujard et al. 2003 Holzemer et al. 2006 Johnson et al. 2007 Kalichman et al. 2005 Murphy et al. 2007 Safren et al. 2001 Smith et al. 2003 Tuldra et al. 2000 Williams et al. 2006 Dilorio et al, 2003 Dilorio et al, 2008 Johnson et al, 2011 Knobel et al, 1999 Parsons et al, 2005 Pradier et al, 2003 Reynolds et al, 2008 Weber et al, 2004 Mann, 2001 Wagner et al, 2006 Webel, 2010 Wilson et al, 2010 Garcia et al, 2005 Javanbakht et al, 2006 Remien et al, 2005 Koenig et al, 2008 27 studies 22/25 had some positive effect on adherence 5/12 positive effects on biological measures

8. PROVIDING ONE-ON-ONE ADHERENCE SUPPORT TO PATIENTS THROUGH 1 OR MORE ADHERENCE COUNSELLING APPROACHES IS RECOMMENDED (II A) Type of counseling discussions varies Cognitive behavioral Patient-centered Motivation-based (e.g., motivational interviewing)] Included a focus on motivation, social support, and skills building Client-centered delivery formats. From this evidence base… Diversity in: Length; Deliverer; Location; Targeting

9. PROVIDING ONE-ON-ONE ADHERENCE SUPPORT TO PATIENTS THROUGH 1 OR MORE ADHERENCE COUNSELLING APPROACHES IS RECOMMENDED (II A) From this evidence base… “Counseling” Use of communication skills, basic principles of therapy or problem solving approaches in interactive discussion Training in approach provided (varying requirements for a counseling background) NOT “Counseling” Reminding and persuading Delivering preset messages

10. Implementation challenges? Sufficient resources to provide individualized counseling Time (15 to over 60 minutes) Personnel (implement and supervise) Space Need to figure out approach for given population… Requires additional work! Review literature/models Make use of available resources Work with communities and patients PROVIDING ONE-ON-ONE ADHERENCE SUPPORT TO PATIENTS THROUGH 1 OR MORE ADHERENCE COUNSELLING APPROACHES IS RECOMMENDED (II A) Most providers/agencies surveyed in IAPAC web survey report providing some kind of 1:1 counseling (70%*)

11. GROUP EDUCATION AND GROUP COUNSELLING ARE RECOMMENDED; HOWEVER, THE TYPE OF GROUP FORMAT, CONTENT, AND IMPLEMENTATION CANNOT BE SPECIFIED ON THE BASIS OF THE CURRENTLY AVAILABLE EVIDENCE (II C) High (II)Strong evidence with important limitations; Strong evidence from observational studies Optional (C)There may be consideration for this recommendation on the basis of individual circumstances. Not recommended routinely Antoni et al., 2006 Berger et al., 2008 Chiou et al., 2006 Chung et al., 2009 Kalichman et al., 2011 Sampaio-Sa et al., 2008 Van Servellen et al., 2005 7 intervention studies 4 generally + effects on adherence 4 generally + effects on biomarkers

12. GROUP EDUCATION AND GROUP COUNSELLING ARE RECOMMENDED; HOWEVER, THE TYPE OF GROUP FORMAT, CONTENT, AND IMPLEMENTATION CANNOT BE SPECIFIED ON THE BASIS OF THE CURRENTLY AVAILABLE EVIDENCE (II C) Variability in participant groups, geography and methods/targets of group intervention From this evidence base… Heterogeneous in Length Timing Orientation; Target

13. GROUP EDUCATION AND GROUP COUNSELLING ARE RECOMMENDED; HOWEVER, THE TYPE OF GROUP FORMAT, CONTENT, AND IMPLEMENTATION CANNOT BE SPECIFIED ON THE BASIS OF THE CURRENTLY AVAILABLE EVIDENCE (II C) Implementation challenges? Sufficient resources to Schedule and populate groups Time commitment (60 to over 120 minutes) Personnel (implement and supervise) Space Like 1:1 counseling…additional work is needed Review literature/models Work with communities and patients 36% provide group education; 35% provide group counseling from IAPAC

14. MULTIDISCIPLINARY EDUCATION AND COUNSELLING INTERVENTION APPROACHES ARE RECOMMENDED (III B). Frick et al. 2006 Levy et al. 2004 Medium (III)RCT evidence with critical limitations Observational study evidence without important limitations Moderate (B)Most patients should receive the recommended course of action. However, other choices may be appropriate for some patients 2 intervention studies specifically evaluated Frick et al 2006 No difference in pharm-refill adherence Sig difference in VL and change in VL at 12 months [adj] Levy et al 2004 Sig difference in adherence (phone based self-report) No difference in VL or CD4 at ~20 weeks

15. MULTIDISCIPLINARY EDUCATION AND COUNSELLING INTERVENTION APPROACHES ARE RECOMMENDED (III B) Use of multidisciplinary teams NOT the same as having multiple team members duplicate efforts or content concerning adherence. Each team member had clearly delineated roles and covered content specific to their particular areas of expertise. From this evidence base…

16. MULTIDISCIPLINARY EDUCATION AND COUNSELLING INTERVENTION APPROACHES ARE RECOMMENDED (III B) Implementation challenges? Need to have a team Can teams be created? Time (coordination of care team meetings) Need to clearly identify who does what How to coordinate the systems What unmet needs will be addressed How to conduct process and outcome monitory Over half of respondents of IAPAC web survey (64%) reported coordination of care across disciplines

17. OFFERING PEER SUPPORT MAY BE CONSIDERED (III C). Medium (III)RCT evidence with critical limitations Observational study evidence without important limitations Optional (C)There may be consideration for this recommendation on the basis of individual circumstances. Not recommended routinely Chang et al. 2010 Munoz et al. 2010 Mugusi et al. 2009 Nachega et al. 2010 Pearson et al. 2007 Ruiz et al. 2010 Simoni et al. 2007 Simoni et al. 2009 Taiwo et al. 2009 9 intervention studies 5 generally + effects on adherence 3 generally + effects on biomarkers

18. OFFERING PEER SUPPORT MAY BE CONSIDERED (III C) Diversity in type of peer-based approach 4 studies monitored administration of ART 4 targeted peer support 1 Peer included psycho-education Similar to other intervention approaches there was diversity in…. Type, length, location or content of peer delivered intervention From this evidence base…

19. Implementation challenges? Who serves as peers Training and supervision requirements Resources to compensate peers Who will coordinate peer services What approach will be adopted or developed How to ensure confidentiality/privacy How to conduct process and outcome monitory OFFERING PEER SUPPORT MAY BE CONSIDERED (III C) 27% overall reported use of peers; 67% of respondents located in Africa reported use of peers in IAPAC’s web survey

20. APPROACHES REPRESENTED IN EVIDENCE BASE …BUT NOT EMERGING INTO A GUIDELINE (YET) Dyad/couples counseling Contingency management Technology

21. GUIDELINES ARE FIRST OF SEVERAL STEPS General Guideline Evidence Base  One on One  Education  Counselling  Multidisciplinary support  Peer support  Group  Education  Counselling  Peer support  One on One  Education  Counselling  Multidisciplinary support  Peer support  Group  Education  Counselling  Peer support

22. General Guideline Evidence Base IMPLEMENTATION OF Evidence Based Approaches  Not specified  When to provide  Who to involve  What to target/include  How long  Over what period of time  How to support  How to sustain  How to monitor  How to adapt  One on One  Education  Counselling  Multidisciplinary support  Peer support  Group  Education  Counselling  Peer support  One on One  Education  Counselling  Multidisciplinary support  Peer support  Group  Education  Counselling  Peer support GUIDELINES ARE FIRST OF SEVERAL STEPS

23. Opportunities to incorporate and reflect – Local/community/cultural needs – Identify and address unmet needs – Local (clinic, organizational) resources – Building/leveraging capacities for implementation and monitoring of outcomes THE GREY AREAS ARE NEEDED IN BEHAVIORAL GUIDELINES… Targeting and tailoring increases chances of implementing something effective for a given person, at a given time, in a given context

24. PROCESS APPROACH TO INTERVENTION DEVELOPMENT

25. Suggestions for implementation of education and counseling guidelines: 1.Needs assessment (drivers of adherence) 2.Identification of needs not presently met (intervention targets) and resources available 3.Identification/development of intervention approach(theory, models) to use (packaged, general strategies) 4.Identification of how to disseminate approach to interveners (manuals, workshop) 5.Identification of how to support approach (sustainability) (opinion leaders, champions) 6.A monitoring and evaluation plan 7.Plan for modifications and adaptation

26. Suggestions for existing education and counseling practices: 1.What does the intervention in place target? What pathways to adherence are promoted? Does that match with community work, theories, or evidence base? 2.How does the intervention try to change, promote, reduce or influence adherence or behaviors on the pathway to adherence? Does each strategy have support from community work, theories, or evidence base? 3.Is there good uptake/acceptability of intervention? 4.Are implementers satisfied? 5.What are the costs of implementation presently? 6.Process and outcomes monitoring!

27. THE SCIENCE OF DISSEMINATION AND IMPLEMENTATION EXTENSIVE AREA OF SCIENTIFIC INQUIRY

28. THE SCIENCE OF DISSEMINATION AND IMPLEMENTATION

29. CDC Manuals and resources for specific packaged approach available

30. RESOURCES ALREADY AVAILABLE

31. “Making a difference in practice means listening to what those doing the work and those affected by the work have to say." Jim Dearing

32. THANK YOU! The IAPAC guidelines reviewed were the result of sustained efforts from numerous individuals including: Panel Members Frederick L. Altice K. Rivet Amico MA. de Ávila Vitória David R. Bangsberg Magda Barini-García Victoria A. Cargill Larry W. Chang John G. Bartlett Curt G. Beckwith Nadia Dowshen Vanessa Elharrar Christopher M. Gordon Robert Gross Charles Holmes Tim Horn Shoshana Kahana Peter Kilmarx Princy Kumar Cynthia Lyles Henry Masur Tia Morton Michael J. Mugavero Jean B. Nachega Catherine Orrell Celso Ramos Robert H. Remien James D. Scott Jane M. Simoni Michael J. Stirratt Melanie A. Thompson Evelyn Tomaszewski The authors, research teams, supporting agencies and participants directly responsible for the evidence available to date.

33. ACKNOWLEDGEMENTS Funding was provided by the US National Institutes of Health, Office of AIDS Research and IAPAC Cindy Lyles, PhD: CDC Prevention Research Synthesis database IAPAC: Jose Zuniga, PhD, MPH; Angela Knudson Systematic reviews: Laura Bernard, MPH, Kathryn Muessig MPH, Jennifer Johnsen, MD Editorial assistance: Anne McDonough