Effectiveness of Different Adherence Support Program Models in Helping Clients Adhere to HAART

Effectiveness of Different Adherence Effectiveness of Different Adherence Support Program Models in Helping Support Program Models in Helping

Clients Adhere to HAARTClients Adhere to HAART

Ruth Finkelstein, ScD Ruth Finkelstein, ScD andand

HRSA SPNS Adherence Support Evaluation HRSA SPNS Adherence Support Evaluation CollaborationCollaboration

The New York Academy of MedicineThe New York Academy of MedicineNew York, New YorkNew York, New York

Funding for this study provided by:Funding for this study provided by:Health Resources and Services Administration Grant # 1H97HA 00128 – 01Health Resources and Services Administration Grant # 1H97HA 00128 – 01

HRSA SPNS ADHERENCE SUPPORT HRSA SPNS ADHERENCE SUPPORT EVALUATION COLLABORATION EVALUATION COLLABORATION

CO-AUTHORSCO-AUTHORS

Ruth Finkelstein, ScD, The New York Academy of Medicine Ruth Finkelstein, ScD, The New York Academy of Medicine

Lois Eldred, DrPH, HIV/AIDS Bureau, HRSALois Eldred, DrPH, HIV/AIDS Bureau, HRSA

Ricardo Alvarez, MD, Mission Neighborhood Health Center Ricardo Alvarez, MD, Mission Neighborhood Health Center

G. Stephen Bowen, MD, North Broward Hospital DistrictG. Stephen Bowen, MD, North Broward Hospital District

Adan Cajina, MS, HRSAAdan Cajina, MS, HRSA

Daniel D. Ciccarone, MD, Urban Health Study, University of California, San FransiscoDaniel D. Ciccarone, MD, Urban Health Study, University of California, San Fransisco

John Dougherty, PhD, Multnomah County Health Department John Dougherty, PhD, Multnomah County Health Department

Barbara Hanna, MD, AIDS Services CenterBarbara Hanna, MD, AIDS Services Center

Lisa R. Hirschhorn, MD, MPH, Dimock Community Health CenterLisa R. Hirschhorn, MD, MPH, Dimock Community Health Center

Mary K. Irvine, MPH, Mailman School of Public Health, Columbia UniversityMary K. Irvine, MPH, Mailman School of Public Health, Columbia University

Sharon B. Mannheimer, MD, Harlem Hospital CenterSharon B. Mannheimer, MD, Harlem Hospital Center

Joanne E. Mantell, PhD, MSPH, The New York Academy of MedicineJoanne E. Mantell, PhD, MSPH, The New York Academy of Medicine

Richard Moore, MD, Johns Hopkins University School of MedicineRichard Moore, MD, Johns Hopkins University School of Medicine

Rajat Mukherjee, MS, The New York Academy of MedicineRajat Mukherjee, MS, The New York Academy of Medicine

Linda M. Mundy, MD, Washington University School of MedicineLinda M. Mundy, MD, Washington University School of Medicine

Emily Richie, MD, Chase Brexton Health Services, Inc.Emily Richie, MD, Chase Brexton Health Services, Inc.

Mark Waters, RN, MPH, New York State Department of Health AIDS InstituteMark Waters, RN, MPH, New York State Department of Health AIDS Institute

Tracey E. Wilson, PhD, SUNY Downstate Medical CenterTracey E. Wilson, PhD, SUNY Downstate Medical Center

BACKGROUNDBACKGROUND• Adherence to HAART is critical for successful HIV outcomes Adherence to HAART is critical for successful HIV outcomes

defined as HIV suppression, immune restoration and survival.defined as HIV suppression, immune restoration and survival.

• HIV practice sites across the United States have struggled to HIV practice sites across the United States have struggled to implement adherence programs that meet the multifaceted needs of implement adherence programs that meet the multifaceted needs of the clients they serve.the clients they serve.

• Some successful strategies to promote and support adherence have Some successful strategies to promote and support adherence have been described, including directly observed therapy (DOT), been described, including directly observed therapy (DOT), pharmacist interventions, psycho-educational interventions and pharmacist interventions, psycho-educational interventions and electronic reminders.electronic reminders.

• However, most studies of the effectiveness of adherence support However, most studies of the effectiveness of adherence support have had small sample sizes, short follow-up, often in specific sub-have had small sample sizes, short follow-up, often in specific sub-populations.populations.

OBJECTIVEOBJECTIVE

To assess the effectiveness of different adherence To assess the effectiveness of different adherence support programs using 12 months of longitudinal support programs using 12 months of longitudinal data from participants in 11 adherence support data from participants in 11 adherence support evaluation programs funded by the DHHS - Health evaluation programs funded by the DHHS - Health Resources Services Administration (HRSA) Special Resources Services Administration (HRSA) Special Projects of National Significance (SPNS) program.Projects of National Significance (SPNS) program.

METHODSMETHODSStudy Design: Cross-Site EvaluationStudy Design: Cross-Site Evaluation

• Mixed methods approach incorporating longitudinal Mixed methods approach incorporating longitudinal assessment; uniform measures of client characteristics assessment; uniform measures of client characteristics and outcomes; intervention characteristics; and process and outcomes; intervention characteristics; and process documentation of services used. documentation of services used.

• Recruitment and enrollment conducted locally at each Recruitment and enrollment conducted locally at each SPNS site from July 2000 through April 2002. SPNS site from July 2000 through April 2002.

• Prospective enrollment of clients to the adherence Prospective enrollment of clients to the adherence support program, but not necessarily to other services support program, but not necessarily to other services

at the site or to HAART.at the site or to HAART.

METHODSMETHODSStudy Design: This AnalysisStudy Design: This Analysis

• Longitudinal analysis of adherence and viral Longitudinal analysis of adherence and viral load for cross-site evaluation participants with load for cross-site evaluation participants with baseline assessments, and at least 3 of 4 possible baseline assessments, and at least 3 of 4 possible quarterly assessments through 12 months. quarterly assessments through 12 months.

• Adherence support model identified by Adherence support model identified by structured qualitative site assessment coded structured qualitative site assessment coded into discrete “program variables” to describe into discrete “program variables” to describe the intervention frameworks, services, settings, the intervention frameworks, services, settings,

and staffingand staffing..

METHODSMETHODSSampleSample

Clients with baseline assessments and at least 3 quarterly follow-ups. Clients with baseline assessments and at least 3 quarterly follow-ups. N = 670N = 670Sites:Sites: Health Services Center, Inc., Hobson City, ALHealth Services Center, Inc., Hobson City, AL

Chase Brexton Health Services, Inc., Baltimore, MDChase Brexton Health Services, Inc., Baltimore, MD

Dimock Community Health Center, Roxbury, MADimock Community Health Center, Roxbury, MA

Harlem Hospital Center, New York, NYHarlem Hospital Center, New York, NY

Helena Hatch Special Care Center, Washington University, St. Louis, MOHelena Hatch Special Care Center, Washington University, St. Louis, MO

Johns Hopkins University School of Medicine, Baltimore, MDJohns Hopkins University School of Medicine, Baltimore, MD

Mission Neighborhood Health Center, San Francisco, CAMission Neighborhood Health Center, San Francisco, CA

Multnomah County Health Department, Portland, ORMultnomah County Health Department, Portland, OR

SUNY Downstate Medical Center, Brooklyn, NYSUNY Downstate Medical Center, Brooklyn, NY

North Broward Hospital District, Ft. Lauderdale, FLNorth Broward Hospital District, Ft. Lauderdale, FL

Urban Health Study, San Francisco, CAUrban Health Study, San Francisco, CA

METHODSMETHODSData CollectionData Collection

Quarterly Client AssessmentQuarterly Client Assessment

– A common interviewer-administered questionnaire developed by A common interviewer-administered questionnaire developed by CASE and program investigators to collect participant self-CASE and program investigators to collect participant self-report data at baseline, 3,6,9 and 12 months of follow-up. report data at baseline, 3,6,9 and 12 months of follow-up.

– Data included demographics: behavioral variables including Data included demographics: behavioral variables including

substance use, self efficacy, HIV disclosure and support, and substance use, self efficacy, HIV disclosure and support, and

HAART adherence; clinical data including recent HAART adherence; clinical data including recent

hospitalizations, mental health diagnosis, depression assessment, hospitalizations, mental health diagnosis, depression assessment,

and health status.and health status.

– Interviewers at each site were trained by CASE to ensure Interviewers at each site were trained by CASE to ensure standardizationstandardization

METHODSMETHODSData Collection (continued)Data Collection (continued)

Encounter DataEncounter Data

– Recorded services, provider characteristics, and visit lengthRecorded services, provider characteristics, and visit length

Qualitative Site InterviewQualitative Site Interview

– Used by CASE evaluation staff to conduct on-site interviews to collect individual program Used by CASE evaluation staff to conduct on-site interviews to collect individual program variable data to be used for classification of adherence support programs by type of services variable data to be used for classification of adherence support programs by type of services providedprovided

Quarterly Chart AbstractionQuarterly Chart Abstraction

– Chart abstractions conducted at sites within 30 days of Chart abstractions conducted at sites within 30 days of each interview to collect laboratory data(CD4 count, each interview to collect laboratory data(CD4 count, HIV RNA level) and prescribed ART medication dataHIV RNA level) and prescribed ART medication data

METHODSMETHODSAdherence Support Program ModelsAdherence Support Program Models

Coded from site self-assessment and interviewCoded from site self-assessment and interview

• Peer Support: a main program component is one on one Peer Support: a main program component is one on one peer support from trained HIV-infected peer workerspeer support from trained HIV-infected peer workers

• Readiness Training: a main program component is focused Readiness Training: a main program component is focused on preparing participants on preparing participants beforebefore starting a new regimen starting a new regimen

• Medication Pickup: a main component is on-site pick up of Medication Pickup: a main component is on-site pick up of medications (usually including pill box packing, medications (usually including pill box packing,

counseling, review)counseling, review) Note: other program models include case management and DOT. However, Note: other program models include case management and DOT. However,

neither can be included in this analysis due to lack of variability in the sample.neither can be included in this analysis due to lack of variability in the sample.

METHODSMETHODSMeasuresMeasures

AdherenceAdherence

• Missed dose in last 3 Missed dose in last 3 days (self report)days (self report)

• >1 missed dose in last 3 >1 missed dose in last 3 days is non-adherencedays is non-adherence

• % adherence calculated % adherence calculated by number of doses by number of doses taken divided by number taken divided by number prescribed (self-report)prescribed (self-report)

Viral LoadViral Load

• HIV RNA copies/ml HIV RNA copies/ml from medical record from medical record within 30 days of within 30 days of interviewinterview

• HIV RNA <400 HIV RNA <400 copies/ml defined as copies/ml defined as undetectableundetectable

METHODSMETHODSData AnalysisData Analysis

• Generalized Estimating equation (GEE) methodology was Generalized Estimating equation (GEE) methodology was used to model the logit of missed doses and undetectable viral used to model the logit of missed doses and undetectable viral load for different program models. load for different program models.

• Odds ratios ( with 95% confidence intervals) were estimated Odds ratios ( with 95% confidence intervals) were estimated to compare different client groups in different program to compare different client groups in different program models.models.

• In each case, all clients in a particular program model were In each case, all clients in a particular program model were compared to all clients not in that program model. compared to all clients not in that program model.

• All statistical analyses were carried out on SAS V.8, using All statistical analyses were carried out on SAS V.8, using PROC GENMOD for fitting GEE models.PROC GENMOD for fitting GEE models.

• Association with missing data patterns were tested in the Association with missing data patterns were tested in the GEE models.GEE models.

RESULTSRESULTSSample DescriptionSample Description

Demographic N = 670

Age: median years (range) 40 (18 – 66)Gender: male % 57%Race/ethnicity, % African American Latino White Other

67%5%24%4%

BehavioralHIV Risk Category, % Heterosexual MSM IDU/Heterosexual & IDU /MSM & IDU Blood transfusion

37%31%24%3%

Unstable housing 30%Current substance use, % 12%Current alcohol use 38%Prior psychiatric diagnosis, % 38%Current Depressive Symptoms (CES-D Scale) 23%

ClinicalBaseline:HAART Naïve at BaselineHAART Experienced (Stable Regimen)HAART Experienced (Salvage)

CD4 counts: median cells/mm3

HIV RNA log10RNAMean Self-reported adherence% with >1 missed dose

14%62%24%

2173.85 89% 17%

12-month follow-up:CD4 counts: median cells/mm3

12 mo. HIV RNA log10RNAMean Self-reported adherence% with >1 missed dose

2793.2691%16%

Different Trajectories for Log Viral Load Based On HAART Experience at

Baseline

Salvage

Naive vs.Naive vs.

Experienced 1.2 ( 1.2047, 1.2378 ) 0.3542 Experienced 1.2 ( 1.2047, 1.2378 ) 0.3542

Salvage vs.Salvage vs.

Experienced 0.5 ( 0.4941, 0.5062 ) 0.0003 Experienced 0.5 ( 0.4941, 0.5062 ) 0.0003

Naive vs. Naive vs.

Salvage 2.4 ( 2.4018, 2.4821 ) 0.0007Salvage 2.4 ( 2.4018, 2.4821 ) 0.0007

Odds Ratio EstimatesOdds Ratio Estimates

Group Odds Confidence P ValueGroup Odds Confidence P Value

Ratios LimitsRatios Limits

Odds Ratio of Achieving Undetectable Odds Ratio of Achieving Undetectable Viral Load Over Time for Three GroupsViral Load Over Time for Three Groups

3 Month vs. Base 1.6 ( 1.5698, 1.5979 ) 0.0012 3 Month vs. Base 1.6 ( 1.5698, 1.5979 ) 0.0012

6 Month vs. Base 1.7 ( 1.6591, 1.6875 ) 0.0001 6 Month vs. Base 1.7 ( 1.6591, 1.6875 ) 0.0001

9 Month vs. Base 1.7 ( 1.6402, 1.6694 ) 0.00039 Month vs. Base 1.7 ( 1.6402, 1.6694 ) 0.0003

12 Month vs. Base 1.8 ( 1.8150, 1.8493 ) <0.0001 12 Month vs. Base 1.8 ( 1.8150, 1.8493 ) <0.0001


Time Odds Confidence P ValueTime Odds Confidence P Value


Odds Ratio of Achieving Undetectable Odds Ratio of Achieving Undetectable Viral Load Over TimeViral Load Over Time

Not Missed Not Missed

vs. 1.5 ( 1.4961, 1.5185 ) 0.0005vs. 1.5 ( 1.4961, 1.5185 ) 0.0005

MissedMissed


Adherence Odds Confidence P ValueAdherence Odds Confidence P Value

Group Ratios LimitsGroup Ratios Limits

Odds Ratio of Achieving Undetectable Odds Ratio of Achieving Undetectable Viral Load Over TimeViral Load Over Time

Mean Adherence by HAART Mean Adherence by HAART Experience at BaselineExperience at Baseline

Salvage

Adherence Support Program ModelsAdherence Support Program Models

32232277Core Med PickupCore Med Pickup

38238266ReadinessReadiness

21521544PeerPeer

Total Total

ClientsClients

Number of Number of

Sites* Sites*

Adherence Adherence Support ModelsSupport Models

* Models are not mutually exclusive, so neither * Models are not mutually exclusive, so neither number of sites nor number of clients is additive.number of sites nor number of clients is additive.

Evidence Regarding Effectiveness Evidence Regarding Effectiveness of Peer Program: Log VLof Peer Program: Log VL

Peer vs. NotPeer vs. Not

Overall 2.3 ( 1.5044, 3.4473 ) < 0.0001Overall 2.3 ( 1.5044, 3.4473 ) < 0.0001

Baseline 1.6 ( 1.5867, 1.6491 ) 0.1184 Baseline 1.6 ( 1.5867, 1.6491 ) 0.1184

3 Months 3.9 ( 3.8556, 3.9855 ) < 0.00013 Months 3.9 ( 3.8556, 3.9855 ) < 0.0001

6 Months 2.4 ( 2.4073, 2.4876 ) 0.00066 Months 2.4 ( 2.4073, 2.4876 ) 0.0006

9 Months 2.3 ( 2.2355, 2.3155 ) 0.00339 Months 2.3 ( 2.2355, 2.3155 ) 0.0033

12 Months 1.7 ( 1.7062, 1.7642 ) 0.038512 Months 1.7 ( 1.7062, 1.7642 ) 0.0385


Program Odds Confidence P ValueProgram Odds Confidence P Value

Model Ratios LimitsModel Ratios Limits

Odds Ratio of Achieving Undetectable Odds Ratio of Achieving Undetectable Viral Load Over Time: Peer ProgramViral Load Over Time: Peer Program

Mean Adherence Change Over Mean Adherence Change Over Time: Peer ProgramTime: Peer Program

Peer vs. NotPeer vs. Not

Overall 1.0 ( 0.6570, 1.6493 ) 0.8643 Overall 1.0 ( 0.6570, 1.6493 ) 0.8643

3 Months 1.6 ( 1.5332, 1.5929 ) 0.1428 3 Months 1.6 ( 1.5332, 1.5929 ) 0.1428

6 Months 0.9 ( 0.9132, 0.9509 ) 0.8625 6 Months 0.9 ( 0.9132, 0.9509 ) 0.8625

9 Months 0.9 ( 0.9214, 0.9576 ) 0.8383 9 Months 0.9 ( 0.9214, 0.9576 ) 0.8383

12 Months 0.9 ( 0.8424, 0.8745 ) 0.608212 Months 0.9 ( 0.8424, 0.8745 ) 0.6082




Odds Ratio of Missed Dose: Odds Ratio of Missed Dose: Peer ProgramPeer Program

Evidence Regarding Effectiveness of Evidence Regarding Effectiveness of Readiness Program: Log VLReadiness Program: Log VL

Readiness vs. NotReadiness vs. Not

Overall 1.0 ( 0.6696, 1.4780 ) 0.9676 Overall 1.0 ( 0.6696, 1.4780 ) 0.9676

Baseline 0.5 ( 0.5186, 0.5383 ) 0.0318Baseline 0.5 ( 0.5186, 0.5383 ) 0.0318

3 Months 1.5 ( 1.4434, 1.4893 ) 0.12523 Months 1.5 ( 1.4434, 1.4893 ) 0.1252

6 Months 1.2 ( 1.1897, 1.2277 ) 0.45016 Months 1.2 ( 1.1897, 1.2277 ) 0.4501

9 Months 1.1 ( 1.0978, 1.1342 ) 0.67359 Months 1.1 ( 1.0978, 1.1342 ) 0.6735

12 Months 0.9 ( 0.9040, 0.9332 ) 0.737912 Months 0.9 ( 0.9040, 0.9332 ) 0.7379




Odds Ratio of Achieving Undetectable Viral Odds Ratio of Achieving Undetectable Viral Load Over Time: Readiness ProgramLoad Over Time: Readiness Program

Mean Adherence Change Over Mean Adherence Change Over Time: Readiness ProgramTime: Readiness Program

Readiness Readiness

vs. 1.1 ( 0.6787, 1.7033 ) 0.7574 vs. 1.1 ( 0.6787, 1.7033 ) 0.7574

Not ReadinessNot Readiness




Odds Ratio of Missed Dose: Odds Ratio of Missed Dose: Readiness ProgramReadiness Program

Evidence Regarding Effectiveness of Evidence Regarding Effectiveness of Core Medication Pickup: Log VLCore Medication Pickup: Log VL

Core Medication Pickup vs. NotCore Medication Pickup vs. Not

Overall 1.5 ( 0.9824, 2.2441 ) 0.0607Overall 1.5 ( 0.9824, 2.2441 ) 0.0607

Baseline 3.0 ( 2.9766, 3.0972 ) 0.0005Baseline 3.0 ( 2.9766, 3.0972 ) 0.0005

3 Months 1.0 ( 0.9867, 1.0200 ) 0.99033 Months 1.0 ( 0.9867, 1.0200 ) 0.9903

6 Months 1.5 ( 1.4698, 1.5176 ) 0.11556 Months 1.5 ( 1.4698, 1.5176 ) 0.1155

9 Months 1.5 ( 1.4524, 1.5014 ) 0.14039 Months 1.5 ( 1.4524, 1.5014 ) 0.1403

12 Months 1.1 ( 1.0565, 1.0922 ) 0.787212 Months 1.1 ( 1.0565, 1.0922 ) 0.7872




Odds Ratio of Achieving Undetectable Odds Ratio of Achieving Undetectable Viral Load Over Time: Medication PickupViral Load Over Time: Medication Pickup

Mean Adherence Change Over Time: Mean Adherence Change Over Time: Medication PickupMedication Pickup

Core Medication Pickup vs. Not

Overall 0.7 ( 0.4592, 1.0843 ) 0.1117

3 Months 0.4 ( 0.2111, 0.7097 ) 0.0022

6 Months 0.8 ( 0.4596, 1.3996 ) 0.4374

9 Months 0.9 ( 0.4753, 1.5224 ) 0.5859

12 Months 0.9 ( 0.5673, 1.5539 ) 0.8061




Odds Ratio of Missed Dose: Odds Ratio of Missed Dose: Medication PickupMedication Pickup

LIMITATIONSLIMITATIONS

• This analysis is based on program models as designed, This analysis is based on program models as designed, not as delivered. not as delivered.

• Future analyses will incorporate services received. Future analyses will incorporate services received.

• Program models are not mutually exclusive, so true Program models are not mutually exclusive, so true comparisons between models are not possible in this comparisons between models are not possible in this analysis.analysis.

• High rates of loss to follow up and sporadic participation High rates of loss to follow up and sporadic participation (baseline enrollment is 1700; 12 month completion with 4 (baseline enrollment is 1700; 12 month completion with 4 of 5 observations is 670). of 5 observations is 670).

• Lack of randomization or control group (comparisons Lack of randomization or control group (comparisons are between interventions). are between interventions).

CONCLUSIONSCONCLUSIONS

• This disadvantaged study population overall This disadvantaged study population overall achieved some improvement in adherence and achieved some improvement in adherence and virologic suppression over the study period.virologic suppression over the study period.

• Some specific models appear to promote such Some specific models appear to promote such improvement more quickly: peer support, improvement more quickly: peer support, medication pick up, and readiness training.medication pick up, and readiness training.

• HAART experience and baseline adherence HAART experience and baseline adherence remain important predictors of adherence and remain important predictors of adherence and viral suppression across all models of adherence viral suppression across all models of adherence support.support.

IMPLICATIONSIMPLICATIONS

• Next steps for data analysis include integration of Next steps for data analysis include integration of services received.services received.

• Cross site evaluation allows us to assess the Cross site evaluation allows us to assess the effectiveness of multiple interventions effectiveness of multiple interventions simultaneously.simultaneously.

• It is helpful to begin adherence support in advance It is helpful to begin adherence support in advance of medication prescription.of medication prescription.

• While adherence support is labor intensive, effective While adherence support is labor intensive, effective models are delivered by relatively inexpensive staff models are delivered by relatively inexpensive staff (peers, counselors, nurses).(peers, counselors, nurses).

Documents

Effectiveness of Different Adherence Support Program Models in Helping Clients Adhere to HAART