1. Getting to Virologic Suppression Tess Barton, MD Medical Director, ARMS Clinic Children’s Medical Center Dallas

2. Diagnosis & Linkage to Care Routine Medical Care & Monitoring HIV Treatment Virologic Suppression Improve healthy survival Reduce HIV transmission

3. Diagnosis & Linkage to Care Routine Medical Care & Monitoring HIV Treatment Virologic Suppression Improve healthy survival Reduce HIV transmission Timely appointments available Patient keeps appointments Monitoring/screening is done Results/problems are addressed Timely appointments available Patient keeps appointments Monitoring/screening is done Results/problems are addressed

4. Diagnosis & Linkage to Care Routine Medical Care & Monitoring HIV Treatment Virologic Suppression Improve healthy survival Reduce HIV transmission Medical Assessment for Treatment Patient Readiness Assessed Funding for Medication Secured Barriers to Adherence Recognized Medical Assessment for Treatment Patient Readiness Assessed Funding for Medication Secured Barriers to Adherence Recognized

5. Diagnosis & Linkage to Care Routine Medical Care & Monitoring HIV Treatment Virologic Suppression Improve healthy survival Reduce HIV transmission Resistance Testing to Determine Best Regimen Monitoring of Treatment Labs Definition of Suppression Adherence Assessment Ongoing Funding Resistance Testing to Determine Best Regimen Monitoring of Treatment Labs Definition of Suppression Adherence Assessment Ongoing Funding

6. CMC Performance Measures 3 patients with <2 visits in 12 months 2 in process of moving during reporting period (both virologically suppressed!) 1 truly not seen >6 months 38%??? How is this possible?

7. Retention in Care Appointment Processes – New patients Sources of most referrals: Health Dept, outside MDs, CMC inpatient Direct phone contact between family + program coordinator Same day appointment available with MD (can see MD same day of dx, if needed) Financial counseling done on arrival – Existing patients Follow-up appointment made at time of checkout, provided on written visit summary (most @ 3 month intervals) Pre-registration 3-7 days before appointment Phone call from program coordinator day before Program coordinator cell # available for teens – text reminders PRN

8. Retention in Care Minimizing lost-to-care – Missed appointments Same-day call from front desk or program coordinator Multiple team members with access to electronic scheduling (minimal phone transfers) Telephone, email, Facebook, text msg, UTSW peers If unable to make contact in 2 weeks, certified letter sent – Overdue appointments CareWare used to generate custom report of patients not seen in >4 months Program coordinator + social worker contact these families to make appointment

9. Retention to Care Unmeasurable Factors – Personal touch Use of minimal personnel – family knows the person who is calling Friendly atmosphere – Hugs from MD, birthday treats, personal conversations – Creating closer patient + team relationship Camps, teen group, parent support group, Facebook – Availability Same-day appointments, sick visits, 24-hour on-call provider Personal contact

10. Retention to Care Challenges – 20% no-show rate for each clinic session despite efforts 3-month visits + vigilant chasing of no-shows leads to good performance on HAB measure – Staff effort/phone calls difficult to track and fund 10 phone calls/messages to get a patient to keep 1 appointment is not a billable or reimbursable service How much additional time is spent documenting – Additional activities to create relationships requires time + money

11. CMC Performance Measures Only 1 patient not seen in >6 months 14/108 (13%) not on treatment 42/108 = 38%

12. Viral Suppression In+Care Campaign Measure: Retention Measure 4: Viral Load Suppression – Percentage of patients, regardless of age, with a diagnosis of HIV/AIDS with a viral load less than 200 copies/mL at last viral load test during the measurement year Why? – Critical link between efforts at medical care and healthy patient survival – Recent indication of viral suppression as means of preventing transmission

13. VL Not Suppressed Not on treatment = 13% (n=14) – CD4 >500 = 7 – CD4 350-500 = 4 2 started on medications after reporting period 1 transitioned to adult care 1 disclosed in preparation – CD4 <350 = 3 all started on medications after reporting period

14. VL Not Suppressed 27 had VL<200 within 6 months before/after – Blips – Assay variation – Re-suppression – Regimen change 25/94 (26%) treated patients had VL <1000 – VL 200-500 = 16 – VL 500-1000 = 9

15. Low Level Viremia – E.R. Case 18 year-old male Tested HIV+ with blood donation 11/2010 - 12/2010 – received notification from Carter BloodCare 12/16 – CMC ER visit to get evaluated – PCR sent 12/21 – ARMS Clinic MD appointment to discuss results

16. Date Viral LoadCD4 History December 2010 14,000256 February 2011 12,000329 Started Atripla March 2011 590440 April 2011 950501 July 2011 340576 Genotype – all drugs susceptible October 2011 410626 Loses Medicaid; Transfer to Parkland Young Adult Clinic (Barton) January 2012<20650 April 2012<20585 August 2012<20691 Virologic History Always reporting 100% adherence Is the lab assay used at PHHS different than the one used by CMC (sent to ARUP)? If purpose of treatment is improved healthy survival and reduced transmission, am I concerned about this viral load?

17. VL Not Suppressed 38% virologically suppressed 13% not requiring treatment 23% low level viremia, or having blips 26% truly not virologically suppressed Chart Review of 62 non- suppressed patients revealed that 30 had adherence problems

18. Adherence Problems Randomly chosen cases to present today: D.H. – 17 y/o perinatal HIV – VL 23,000; CD4 442 – Conflicts with dad over authority, sexual orientation – Asserting independence, exploring autonomy – medications not a priority for him – Probable bipolar d/o, refusing treatment – Solution: JobCorps, needs to mature, keep engaged in care during uncertain living situation, reinforce safe sex, wait

19. Adherence Problems A.J. – 11 year-old perinatal HIV VL 1100, CD4 1209 Recently moved to Dallas area (labs were 2nd visit) Recently disclosed, does admit to missed doses (mostly forgotten) Mom with long hx non-adherence Solutions: CPS involved at time of transfer to Dallas, reminders, enlisted help of nearby aunt to assist mom, gave child task of reminding mom to take her own medicines, enroll in summer camp for HIV+ kids

20. Adherence Problems J.T. – 10 y/o perinatal HIV/AIDS, lowest CD4 190s, no AIDS illnesses Not disclosed, mom not ready Mom never adherent - recently hospitalized with PCP, very ill; mom’s partner not aware of her HIV status Older HIV-negative brother recently learned mom, brother HIV status VL 1100, CD4 914 (up from 200s 9 months ago) Solutions: CPS involved numerous times; mom and patient clearly trying now; regimen recently optimized for once-daily and reduced side effects; enlist help of older brother; pressuring mom to allow disclosure

21. Adherence Problems B.E. – 12 month perinatal HIV, asymptomatic VL 49,000; CD4 24.1% Mom in denial about HIV during pregnancy, still not in care for herself; struggling emotionally with infant infection After extended visit, she admitted to not giving infant medications due to emotional distress – expressed relief after confessing, and commitment to improving Next VL 870, CD4 43% Solutions: Continue to support mom, encourage her to stay in care, frequent appointments (transportation assistance needed)

22. CMC Performance Review How can CMC have 98% retention in care, but only 38% virologically suppressed? – Patients being brought into care, tracked closely, monitored and assessed – Partly related to inherent reporting flaws Single time point of dynamic value Denominator including untreated patients – Nuances of viral load vs. clinical status – the art of medicine Our barrier to VL suppression is not lack of retention

23. CMC Performance Review Areas for improvement – Evaluation of VL assay – ADHERENCE How often are adherence assessments done? How are adherence assessments done? Multifactorial solution – Mental health issues – Adolescent emotional development – Caregiver role – Treatment readiness – Bribery? Can make #s look prettier for reporting purposes with no real change in patient care Confounding issues of blood volume, cost May investigate further to minimize provider frustration and patient anxiety Can make #s look prettier for reporting purposes with no real change in patient care Confounding issues of blood volume, cost May investigate further to minimize provider frustration and patient anxiety Adherence barriers are highly individualized Single solution approach will not impact overall suppression rate Standardized adherence assessments are NOT the solution in a setting where adherence barriers are already being recognized Adherence barriers are highly individualized Single solution approach will not impact overall suppression rate Standardized adherence assessments are NOT the solution in a setting where adherence barriers are already being recognized

24. Diagnosis & Linkage to Care Routine Medical Care & Monitoring HIV Treatment Virologic Suppression Improve healthy survival Reduce HIV transmission Timely appointments available Patient keeps appointments Monitoring/screening is done Results/problems are addressed Timely appointments available Patient keeps appointments Monitoring/screening is done Results/problems are addressed ✓

25. Diagnosis & Linkage to Care Routine Medical Care & Monitoring HIV Treatment Virologic Suppression Improve healthy survival Reduce HIV transmission Medical Assessment for Treatment Patient Readiness Assessed Funding for Medication Secured Barriers to Adherence Recognized Medical Assessment for Treatment Patient Readiness Assessed Funding for Medication Secured Barriers to Adherence Recognized ✓ ✓

26. Diagnosis & Linkage to Care Routine Medical Care & Monitoring HIV Treatment Virologic Suppression Improve healthy survival Reduce HIV transmission Resistance Testing to Determine Best Regimen Monitoring of Treatment Labs Definition of Suppression Adherence Assessment Ongoing Funding Resistance Testing to Determine Best Regimen Monitoring of Treatment Labs Definition of Suppression Adherence Assessment Ongoing Funding ✓ ✓

27. Questions?

28. Follow-up Project Attempted to arrange duplicate viral load testing – ARUP vs. Mayo – Blood sent on 3, only able to obtain results for 1 – VL 230 vs 270 County hospital tests remain <20 for those transitioned patients Next step: Switch to county lab for 2-3 month trial period

29. Follow-Up Data From 4/1/2011-3/31/2012 – InCare Viral Load Suppression Measure 50/108=46.3% (this is the measure we currently use in the Regional Group) – Viral Load Suppression for those clients who are on ARVs (all ages): 47/88=53.41% – Viral Load Suppression for those clients who are on ARVs and below 13 yrs: 24/35= 68.6% – Viral Load Suppression for those clients who are on ARVs and 13 yrs and older: 23/53=43.4% – Viral Load Suppression for all ages using the new HAB measure indicator definition: 46/84=54.8%