1 in+care Campaign Meet the Author September 19, 2012

2 Ground Rules for Webinar Participation Actively participate and write your questions into the chat area during the presentation(s) Do not put us on hold Mute your line if you are not speaking (press *6, to unmute your line press #6) Slides and other resources are available on our website at incareCampaign.org All webinars are being recorded

3 Agenda Welcome & Introductions, 5min IAPAC Guidelines, 30min Introduction to the Guidelines - Melanie Thompson, MD Monitoring - Robert Gross, MD Interventions for Entry/Retention - Michael Mugavero, MD Recommendations for Special Populations - Victoria Cargill, MD Q & A Session, 20min Updates & Reminders, 5min

June 5,

Quality of Body of Evidence Interpretation Excellent (I) RCT evidence without important limitations Overwhelming evidence from observational studies High (II) RCT evidence with important limitations Strong evidence from observational studies Medium (III) RCT evidence with critical limitations Observational study evidence without important limitations Low (IV) Observational study evidence with important or critical limitations Strength of Recommendation Strong (A) Almost all patients should receive the recommended course of action. Moderate (B)Most patients should receive the recommended course of action. However, other choices may be appropriate for some patients. Optional (C)There may be consideration for this recommendation on the basis of individual patient circumstances. Not recommended routinely.

Monitoring Entry, Retention, and ART Adherence Robert Gross, MD MSCE Associate Professor of Medicine (ID) and Epidemiology University of Pennsylvania Perelman School of Medicine Penn Infectious Diseases CCEB

Monitoring Overview Most research on adherenceMost research on adherence Entry and retention have emerged as highly importantEntry and retention have emerged as highly important –Less data available on “how to” –More local logistics come into play Overarching messageOverarching message –“Monitoring provides key data on which patients need interventions”

Entry Monitoring Entry into care shortly after dx associated with survivalEntry into care shortly after dx associated with survival Monitoring challengeMonitoring challenge –Multiple sources of data (e.g., dedicated testing sites, clinics) –Responsible parties need to be identified and logistics arranged

Retention Monitoring Retention has multiple benefitsRetention has multiple benefits –Decreased morbidity/mortality –Decreased community viral load Various metrics usedVarious metrics used –Visit adherence, gaps in care, visits per time frame Logistics easier than for entryLogistics easier than for entry –Use medical records and admin data –May require integration of sources

Need for Continued Monitoring Can detect impending failureCan detect impending failure –Irrespective of viral load monitoring (e.g., Bisson G, Gross R et al. PLoS Med 2008) Intervention before failureIntervention before failure Same principles likely for entry and retention in careSame principles likely for entry and retention in care

Monitoring Recommendations Assess adherence each visitAssess adherence each visit –Self-report (II A) –Pharmacy refill data (MPR) (II B) –Do not recommend microelectronic monitors at this time (I C) –Do not recommend drug concentrations at this time (III C) –Do not recommend routine pill counts (III C)

RECOMMENDATIONS: ENTRY INTO AND RETENTION IN CARE Michael J. Mugavero, MD, MHSc University of Alabama at Birmingham

National HIV/AIDS Strategy Increase linkage to care w/in 3 months of Dx from 65% to 85% Increase HIV serostatus awareness from 79% to 90% Increase RW clients in continuous care from 73% to 80% Increase proportion of HIV Dx’d persons with undetectable VL by 20%

RECOMMENDATIONS: ENTRY INTO/RETENTION IN CARE  Systematic monitoring of successful entry into HIV care is recommended for all individuals diagnosed with HIV (IIA)  Systematic monitoring of retention in HIV care is recommended for all patients (IIA)  Brief, strengths-based case management for individuals with a new HIV diagnosis is recommended (IIB)  Intensive outreach for individuals not engaged in medical care within 6 months of a new HIV diagnosis may be considered (IIIC)  Use of peer or paraprofessional patient navigators may be considered (IIIC)

Brief, strengths-based case management for individuals with a new HIV diagnosis is recommended (IIB) 1 Gardner LI et al. AIDS 2005;19  CDC ARTAS 1 : Multi-site RCT to test a case management (CM) intervention vs. SOC to improve linkage to care  Empowerment & self efficacy  Asks clients to identify internal strengths & assets  Up to 5 CM contacts allowed in 90 days  78% linkage to care w/in 6 months in CM group vs. 60% in SOC group (P<0.01) High (II): RCT evidence w/ limitations Strong evidence from observational studies Moderate (B): Most patients should receive Other choices may be appropriate for some

Brief, strengths-based case management for individuals with a new HIV diagnosis is recommended (IIB) 1 Craw JA et al. J Acquir Immune Defic Syndr. 2008;47, 2 Craw JA et al. BMC Health Serv Res. 2010;10, 3 Gilman B et al. AIDS Patient Care STDS. 2012;26  CDC ARTAS II 1 : 79% effect size for LTC w/in 6 months  Health departments and CBOs  Structural factors & best practices for implementation 2  LTC implementation w/ HIV testing in non-clinical settings 3  Key characteristics, Core components, Operational factors  Barriers: System/Community, Organizational, Clinician/Staff, Individual/Client

Intensive outreach for individuals not engaged in medical care within 6 months of a new diagnosis may be considered (IIIC) 1 Naar-King S et al. AIDS Patient Care STDS. 2007;21 Suppl 1  Recommendations based upon HRSA SPNS outreach initiative 1  A series of observational studies with comparators that measured behavioral and biological outcomes  Outreach recommendation based on 1 study (n=104)  Intensive outreach improved retention in care and HIV-1 RNA suppression in patients underserved by health care system  Youth, women, mental health, substance abuse disorders Medium (III): RCT evidence w/ critical limitations Observational evidence w/o limitations Optional (C): Consideration based on individual circumstances Not recommended routinely

1 Bradford JB et al. AIDS Patient Care STDS. 2007;21 Suppl 1  Recommendations based upon HRSA SPNS outreach initiative 1  A series of observational studies with comparators that measured behavioral and biological outcomes  PN recommendation based upon 4 studies (n>1100 pts)  PN associated w/ increased retention in care from 64% to 79% and 50% increase in HIV-1 RNA 12 months Use of peer or paraprofessional patient navigators may be considered (IIIC) Medium (III): RCT evidence w/ critical limitations Observational evidence w/o limitations Optional (C): Consideration based on individual circumstances Not recommended routinely

1 Bradford JB et al. AIDS Patient Care STDS. 2007;21 Suppl 1  Patient navigation shares features w/ advocacy, health education & case management 1  Distinctive features of patient navigation:  Concerned with individuals vs. system as a whole  Less pro-active in addressing knowledge gaps  Use principles of CM but don’t have a “home agency”  Usually do not have nursing or SW degrees, although apply strengths-based principles  PN often peers or near-peers w/ shared cultural background Use of peer or paraprofessional patient navigators may be considered (IIIC)

FUTURE RESEARCH RECOMMENDATIONS : ENTRY INTO/RETENTION IN CARE  Comparative evaluation of monitoring strategies in conjunction with intervention studies  Comparison of retention measures with one another  Operational research to optimize / standardize measurement  Comparative evaluation of CM in community settings  Comparative evaluation and cost effectiveness for best practices for implementation of CM interventions  Comparative evaluation of other intervention approaches: peer support, patient navigation, health literacy, life skills  Prospective evaluation of pay for performance interventions

Improving Retention and Treatment Adherence in Vulnerable Populations Victoria A Cargill, MD, MSCE Director of Minority Research and Clinical Studies Office of AIDS Research

Focus on Special Populations Who: Homeless, incarcerated, mentally ill, substance using, pregnant women, adolescents and children Why: Disparities in care retention, medication adherence and poor outcomes have been well documented All share unique challenges superimposed upon their HIV infection Given the challenges, effective evidence based interventions are needed

Substance Use Disorders Individuals with substance use and/or alcohol disorders are at higher risk for poor retention, adherence and virologic failure with worse outcomes Offer buprenorphine or methadone to opioid dependent patients. (Level II A) Directly administered ART is recommended for individuals with substance use disorders. (Level I B) Integration of directly administered ART into methadone maintenance programs (Level II B)

Related Vulnerabilities Mental Health Disorders Homeless and Marginally housed Mental health disorders are common among individuals living with HIV – with a strong relationship between depression and nonadherence Screening, management and treatment for depression and other mental illness in combination with adherence counseling. (II A) Homelessness disrupts daily routines including medication taking and make medication storage challenging. Case management to address the many adherence barriers in the homeless. (III B) Pill box organizers (II A)

Incarcerated Populations Globally HIV prevalence is higher among incarcerated populations. Incarceration provides an opportunity to provide ART yet stigma and other barriers confound this opportunity. DAART is recommended during incarceration. (III B) It may also be considered upon release to the community. (II C) Note: DAART in prison is associated with higher rates of viral suppression. DAART through community workers was superior in achieving viral suppression.

Both Ends of the Spectrum Pregnant Women Children and Adolescents Globally optimum ART adherence during pregnancy remains a challenge, further confounded by limited data on effective adherence interventions. Targeted PMTCT treatment improves adherence to ART for PMTCT. (III B) Labor ward based MPTCT adherence services for women who are not receiving ART before labor. (II B) HIV infected children and adolescents have a wide range of needs depending upon their developmental stage, and care giving situations. Intensive youth focused case management for adolescents and young adults to improve entry into care and retention. (IV B)

Pediatric and Adolescent Populations Additional recommendations: Pediatric and adolescent focused therapeutic support interventions using problem solving approaches. (IIIB) Pediatric and adolescent focused support using problem solving to address psychosocial context and issues. (IIIB) Pill swallowing training my be helpful for younger patients. (IV B) DAART for pediatric and adolescent patients based upon short term treatment outcomes data. (IV C)

Lessons Learned Paucity of data to guide evidence based recommendations for many of these vulnerable populations. Even when evidence exists it may be skewed The diversity of the population of interest – e.g. children and adolescents – may further limit the data, as the developmental stages make comparison across age groups difficult. Long term studies of the success of adherence interventions that can be linked to HIV biomarkers are sorely needed. Limited data on the impact of important transitions on ART adherence for many of these populations. Rigorous implementation and effectiveness studies on ART adherence interventions in pregnancy are virtually nonexistent.

Future Directions For special populations, the groups with the greatest number of gaps included: c hildren and adolescents, the incarcerated, substance using individuals and those with mental illness. Specific and targeted gaps were identified for pregnant women and homeless/marginally housed individuals ▫Investigation of specific ART adherence barriers related to pregnancy. ▫Controlled studies to understand adherence barriers in the antenatal and post partum period. ▫Identifying better strategies to assess adherence and detect lapses in homeless and marginally housed individuals. ▫More studies on DAART effectiveness, useful adherence tools, and effective case management for homeless/marginally housed individuals.

35 Time for Questions and Answers

36 Campaign Office Hours: Mondays & Wednesdays 4-5pm ET Data Collection Submission Deadline: October 1, 2012 Improvement Update Submission Deadline: October 15, 2012 Next Campaign Webinar: Identifying Patients at Risk of Falling Out of Care Tuesday, September 25, pm ET Upcoming Events and Deadlines

37 Campaign Headquarters: National Quality Center (NQC) 90 Church Street, 13 th floor New York, NY Phone incareCampaign.org youtube.com/incareCampaign