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Supported by the National Institute of Mental Health and National Institute of Nursing Research R01 MH/NR62287 HIV Treatment Adherence Counseling Intervention for People Living with HIV and Limited Health Literacy Seth C. Kalichman University of Connecticut

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Page 1: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Supported by the National Institute of Mental Health and

National Institute of Nursing Research R01 MH/NR62287

HIV Treatment Adherence Counseling

Intervention for People Living with HIV

and Limited Health Literacy

Seth C. Kalichman

University of Connecticut

Page 2: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

HEALTH LITERACY

Institute of Medicine:

"the degree to which individuals have the

capacity to obtain, process, and understand

basic health information and services needed

to make appropriate health decisions."

Page 3: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Limited health literacy is associated

with…

Poorer Type 2 diabetes glycemic control and

higher rates of retinopathy. (Schillinger, 2002)

Higher mortality rates within a managed care

setting. (Baker et al 2007)

Poorer understanding of medical

labels/instructions, and greater likelihood of taking

medicines incorrectly. (Bennett et al., 2009;

Soroui et al., 2008)

Page 4: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Health Literacy and

Adherence to

Antiretroviral Therapies

Page 5: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Literacy and HIV Health Status

Lower Literacy Higher Literacy

CD4 < 300 74% 55% *

Prescribed ART 59% 73% *

Undetectable Viral Load 8% 36% *

*p<.05

Kalichman et al., 2000

Page 6: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Literacy and ART Adherence

Lower Literacy Higher Literacy

> 75% Adherent 69% 82%*

> 90% Adherent 55% 70%*

*p<.05

Kalichman et al., 2002

Page 7: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Stick-To-It

Individualized

ART Adherence Counseling

for Low-Literacy Adults Living with HIV

Page 8: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Stick-To-It

2-60 min. Sessions +

1 30-min booster

Pictographic Flip-Chart

Personalized Feedback

Custom Adherence Plan

Page 9: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Doak et al.’s (1996) Principles ____________________________________________________

Set Realistic Objectives Limit to the targeted goals

Use a planning sheet

Focus on Behaviors/ Skills Emphasize skills

Enhance motivation

Present Context Before State the purpose

new Information Relate to the person’s life

Partition Complex Break information up

Instructions Create opportunities for

success

Use Interactive Instructions Demonstrate, practice,

problem solve

Page 10: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120
Page 11: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120
Page 12: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120
Page 13: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120
Page 14: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120
Page 15: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120
Page 16: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Comparison Interventions

Standard (Untailored)

Adherence Counseling

General Health Improvement Skills

(Not ART Adherence)

Nutrition and Stress Reduction

Page 17: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Contacted Research Site

N = 1385

>90% Correct TOFHLA N = 417

Not Taking ART N = 374

Not HIV+ = 120

< 90% Correct on TOFHLA & Taking ART

Attended Intake Session N = 474

Pictograph Guided

N = 148

Standard Adherence

N = 157

Health Improvement

N = 141

Baseline ACASI, Viral Load

Randomized N= 446

Did not return

for baseline

assessment

N=28

** Entry Criteria: HIV+ treated with ART, 18 or older, TOFHLA

Score < 90% correct

Page 18: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Contacted Research Site

N = 1385

>90% Correct TOFHLA N = 417

Not Taking ART N = 374

Not HIV+ = 120

< 90% Correct on TOFHLA & Taking ART

Attended Intake Session N = 474

Pictograph Guided

N = 148

Standard Adherence

N = 157

Health Improvement

N = 141

Baseline ACASI, Viral Load

Randomized N= 446

Did not return

for baseline

assessment

N=28

Completed Counseling

Session 1 97%

Session 2 91%

Session 3 84%

Completed Counseling

Session 1 97%

Session 2 95%

Session 3 90%

Completed Counseling

Session 1 95%

Session 2 91%

Session 3 86%

Page 19: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Follow-up for

9-months post-

counseling was

> 85% for all

conditions & all

assessments

Page 20: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Characteristics of clinical trial participants.

Page 21: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Literacy Groups X Condition

TOFHLA

Score

(Correct)

Pictographic

Adherence

Standard

Adherence

General

Health

85-90% 62 73 84

< 85% 86 84 57

Page 22: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Primary Outcomes

ART Adherence

via unannounced

pill counts & HIV

RNA (Viral Load)

Page 23: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Adherence 3 (Condition) X 2 (Literacy Groups) X 9

(Unannounced Pill Counts)

Outcome Analyses

Viral load 3 (Condition) X 2 (Literacy Groups)

GEE Models controlling for baseline

Page 24: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Adherence Outcomes

Intervention condition

X literacy group interaction

Pictographic and Standard

counseling improved ART

adherence for people with moderate

literacy, but not lower-literacy

Page 25: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Perc

ent

> 9

5%

Adhe

rent

GEE Model Condition X Literacy Group Interaction, Wald X2 =5.93, p < .05

Moderate Health Literacy

(85% to 90% on TOFHLA)

Page 26: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Perc

ent

> 9

5%

Adhe

rent

Lower Health Literacy

(< 85% on TOFHLA)

Page 27: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

% U

ndete

cta

ble

Vir

al Load a

t 9

-month

follo

w-u

p

GEE Model Condition X Literacy Group Interaction, Wald X2 =2.05, p < .01

Percent Undetectable

Viral Load at Follow-up

Page 28: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

% U

ndete

cta

ble

Vir

al Load a

t 9

-month

follo

w-u

p

GEE Model Condition X Literacy Group Interaction, Wald X2 =2.05, p < .01

Percent Undetectable

Viral Load at Follow-up

Page 29: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Participants who

entered the trial with

detectable viral loads

and achieved

undetectable viral

loads.

Optimal Outcomes

Pellowski et al., in process

Page 30: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

% C

han

ge

to U

nde

tecta

ble

Vir

al Lo

ad

Optimal Viral Load

Outcomes

Page 31: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Optimal Outcomes

Pellowski et al., in process

Page 32: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Multivariate Logistic Regression

Predicting Optimal Outcomes

Pellowski et al., in process

Predictor Adjusted OR 95%CI

Gender 1.82 0.92-3.60

Alcohol use 0.85* 0.74-0.99

Stress 0.91 0.83-1.01

Health Literacy 2.15* 1.15-4.01

Note all predictors significant in bivariate analyses,

* p < .05

Page 33: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

Brief counseling improves ART adherence for people

with moderate literacy.

Tailoring counseling for moderately literate patients

seems unnecessary.

Lower literacy participants demonstrated little if any

benefit from adherence counseling.

Dose-proximal interventions may be needed for

people with low literacy skills: Modified DOT, Wisepill,

cell-phone and SMS assisted counseling.

Conclusions

Page 34: HIV Treatment Adherence Counseling Intervention for People ... Treatment... · Contacted Research Site N = 1385 >90% Correct TOFHLA N = 417 Not Taking ART N = 374 Not HIV+ = 120

The SHARE Project

Lisa Eaton Chauncey Cherry

Demetria Cain Moira Kalichman

Christina Amaral Denise White

Tamar Grebler Chris Washington

Megan McKerey Ginger Hoyt

Cyndi Merely Brandi Welles

Daniel Driffin Harlan Smith

Jennie Pellowski Star Chen

Marcus Henderson

Supported by Grant R01 MH/NR62287