Michael J. Mugavero, MD, MHSc University of Alabama at Birmingham January 8, 2013

HPTN 052 Press release, May 12, % reduction in new HIV infections

Moore RD & Bartlett JG. Clin Infect Dis 2011;53:600 Johns Hopkins HIV Clinical Cohort

Adapted from: Gardner et al. Clin Infect Dis 2011;52:793, Cohen et al. MMWR 2011;60:1618 HIV Treatment Cascade 49%

Ulett et al. AIDS Pt Care STDS 2009;23:41-49, Mugavero et al. Clin Infect Dis 2011;52(S2)

Adapted from: Mugavero et al. Clin Infect Dis 2011;52(S2)

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% Ulett et al. AIDS Pt Care STDS 2009;23:41-49, Mugavero et al. Clin Infect Dis 2011;52(S2).

Factors Linked to Poor Engagement Younger age Female sex Racial / ethnic minority Lack of health insurance Mental illness Substance abuse Unstable housing Unmet needs for supportive services Passive referral to care HIV testing in community setting Keruly et al. AJPH 2002;92, Robbins et. al. JAIDS 2007;44Giordano et al. Clin Infect Dis 2007;44, Mugavero et al. JAIDS 2009;50, Metsch et al. Clin Infect Dis 2008;47, Hall et al. JAIDS 2012;60

Implications of Poor Engagement Individual Level  Delayed ART receipt & ART non-adherence  Inferior CD4 count & viral load outcomes  Emergence of HIV resistance mutations  Increased risk for clinical events & mortality Population Level  Mediator of health care disparities  Role in transmission  PwP Change in risk transmission behaviors Impact of ART in reducing transmission Keruly et al. AJPH 2002;92, Robbins et. al. JAIDS 2007;44, Park et al. J Intern Med 2007;261, Giordano et al. Clin Infect Dis 2007;44, Mugavero et al. JAIDS 2009;50, Marks et al. AIDS 2006;20, Metsch et al. Clin Infect Dis 2008;47, Cohen et al. N Engl J Med 2011;365

Adapted from: Gardner et al. Clin Infect Dis 2011;52:793, Cohen et al. MMWR 2011;60:1618 COMMUNITY CLINIC

Thompson MA et al. Ann Intern Med 2012;156: Evidence-based recommendations  5 Recommendations for linkage and retention  Emphasis on special populations  Recommendations for future research

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.

Evidence-Based Recommendations: Entry into and Retention in Care Systematic monitoring of successful entry into HIV care recommended for all individuals diagnosed w/ 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) Thompson MA et al. Ann Intern Med 2012;156:817-33

Brief, strengths-based case management for individuals with a new HIV diagnosis (IIB) 1 Gardner LI et al. AIDS 2005;19 CDC ARTAS 1 : Multi-site RCT to test linkage case management (CM) 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

Gilman. AIDS Pt Care STDS 2012;26  Case study of 7 LTC programs in 5 jurisdictions  Barriers: System/Community, Organizational, Clinician/Staff, Individual/Client “One of the key findings of this study is that LTC programs vary widely based on the needs, resources, partnerships, organizational structures, leadership, target populations, and policies of each setting”

Key characteristics: Low cost Paraprofessional staff Intensive Significant time investment Time- limited LTC services of short duration Unique Distinct from medical case management Flexible Tailored to community needs/resources LTC: testing in non-primary care settings Gilman. AIDS Pt Care STDS 2012;26

Core components: Dedicated linkage staff Training in MI counseling, HIV, & local healthcare and HIV resources Active referral Client education and skill building, assistance scheduling / attending visits Person- centered Focus on client “assets” Cultural concordance Cultural and linguistic concordance of linkage workers with population served LTC: testing in non-primary care settings Gilman. AIDS Pt Care STDS 2012;26

Operational factors: Protocol adherence Developing and adhering to LTC protocol Selection of LTC staff Personality, cultural background, experience and interpersonal skills Execution of LTC program Coordination & integration of services across and w/in organizations Program sustainability Coordination of federal, state, local resources from multiple funders LTC: testing in non-primary care settings Gilman. AIDS Pt Care STDS 2012;26

Case Management Standard of Care P-value 6 months 78%60%<0.01 Gardner et al. AIDS 2005;19  Linkage case management efficacious, but early retention in care a formidable challenge… 12 months 64%49%<0.01 ARTAS: Early retention in care

Intensive outreach for individuals not engaged in medical care w/in 6 mos of a new diagnosis (IIIC) Recommendation based upon HRSA SPNS 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 pts underserved by health system  Youth, women, mental health, substance abuse Medium (III): RCT evidence w/ critical limitations Observational evidence w/o limitations Optional (C): Consideration based on individual circumstances Not recommended routinely 1 Naar-King S et al. AIDS Patient Care STD. 2007;21 Suppl 1

 10 Demonstration projects  Non-randomized design without comparison or control groups in most studies  Focus on linkage to care, retention of sporadic users & re-engagement of pts LTFU  Conceptual framework: IOM barriers to care:  Structural barriers  Financial barriers  Personal / Cultural barriers  Individual site & multi-site mixed methods evaluation Tobias et al. AIDS Pt Care STDS 2007;21:S3, Rajabuin et al. AIDS Pt Care STDS 2007;21:S9 HRSA SPNS Outreach Initiative

 Study sites:  Community based organizations = 7  Community based health centers = 2  Hospital based clinic = 1  Heterogeneous approaches & samples:  Behavioral interventions  Intensive case management  Health literacy and life skills  Outreach in provision of medical services  Supportive services included in 8 of 10 programs Tobias et al. AIDS Pt Care STDS 2007;21:S3, Rajabuin et al. AIDS Pt Care STDS 2007;21:S9 HRSA SPNS Outreach Initiative

 On balance, interventions were effective  Structural, financial & personal barriers common, and highly correlated with retention  Reduction in barriers  improved retention  Factors associated with loss to follow-up (29%)  Illicit drug use  Unstable housing  Unmet supportive service needs HRSA SPNS Outreach Initiative Bradford. AIDS Pt Care STDS 2007;21:S85

 Barriers to HIV care can be reduced or removed with sufficient resources  Coaching, skill-building, knowledge gains, respectful trusting relationships b/t client and outreach worker facilitate HIV care utilization  Additional resources and system changes needed for most disadvantaged persons  Outreach interventions can be implemented to comply with research standards Bradford. AIDS Pt Care STDS 2007;21:S85 HRSA SPNS Outreach Initiative

1 Bradford JB et al. AIDS Patient Care STDS. 2007;21 Suppl 1 Recommendation based upon HRSA SPNS initiative 1  A series of observational studies with comparators that measured behavioral and biological outcomes  PN rec 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

 Patient navigation shares features w/ advocacy, health education, case management  Distinctive features:  Concerned with individuals vs. system  Less proactive in addressing knowledge gaps  Principles of CM, but no “ home agency ”  Apply strengths-based principles w/o BSN or SW  Peers or near-peers with shared cultural background Bradford. AIDS Pt Care STDS 2007;21:S49 HIV system navigation

Comparative evaluation of monitoring strategies in conjunction with intervention studies Comparison of retention measures with one another Operational research to optimize and 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 Future Research Recommendations Thompson MA et al. Ann Intern Med 2012;156:817-33

Mugavero et al. Clin Infect Dis 2011;52(S2). Feedback loop: An approach to monitor & implement engagement interventions Systematic monitoring

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