Low risk express care: A nurse-centered model for the management of stable

patients on combination antiretroviral therapy (cART)

K. Wools-Kaloustian, R. Kosgei, S. Kimaiyo, P. Braitstein, E. Sang, B. Musick, C. Yiannoutsos, A. Siika

Low Risk Express Care

Background• ART rollout in resource-constrained settings has been

slow. • More than 5 million of the 9.5 million people living in low- and

middle-income countries in need of ART are still without access to treatment.

• Delays in rollout are in part due to the substantial financial and human resources necessary to establish and maintain an HIV care delivery infrastructure.

• Sub-Saharan Africa is the home of two thirds of persons living with HIV/AIDS but only 3% of the world’s health care workers and commands less than 1% of the world’s health expenditures.

Low Risk Express Care

Background• To maximize access to ART in resource-constrained

settings, leaders in international health have advocated:• The decentralization of HIV care

• Use of existing infrastructure

• A shift from physician-centered care models to those utilizing non-physician health workers trained in simplified and standardized approaches to care

• Experience with feasible models of task shifting in HIV care programs in resource poor areas is limited

Low Risk Express Care

Methods: Objective

• To evaluated the impact of “Low Risk Express Care” (LREC), a program in line with WHO's recommendation to shift much of the responsibility of HIV-care from physicians and mid-level practitioners (clinicians) to nurses.

Methods: SettingLow Risk Express Care

USAID-AMPATH Partnership Clinics

Low Risk Express Care

Methods: Eligibility

LREC eligibility criteria:

•>18 years

•Stable on cART > 6 mo

•CD4 count > 200 cells/µl

• No active opportunistic infection

• No history of adherence issues

Low Risk Express Care

Methods: Model

Task Shifting with the LREC Model (derived from WHO Task shifting: Global Recommendations and guidelines)

Standard of Care LREC Model

P CO N P CO N

Clinical Monitoring

Monitor and support ART adherence ▪▪▪ ▪▪▪ ▪▪▪ ▪ ▪ ▪▪▪Take weight ▪▪▪ ▪Take vitals ▪▪▪ ▪Determine Functional Status ▪▪▪ ▪▪▪ ▪ ▪ ▪▪Request CD4 Count and Viral Load ▪▪▪ ▪▪▪ ▪▪▪ ▪▪▪Identify ART Side Effects ▪▪▪ ▪▪▪ ▪ ▪ ▪▪Manage ART Side Effects ▪▪▪ ▪▪▪ ▪▪▪ ▪▪▪Identify OI Symptoms ▪▪▪ ▪▪▪ ▪ ▪ ▪▪Manage OIs ▪▪▪ ▪▪▪ ▪▪▪ ▪▪▪

▪▪▪ Responsible during all visits▪▪ Responsible during two thirds of visits▪ Responsible during one third of visits

P= Physician; CO= Clinical Officer; N = Nurse

Low Risk Express Care

Methods: Analysis

• A retrospective analysis including data from the 12-month period both pre and post introduction of LREC

Introduction ofLREC – 12 mo.

Introduction ofLREC

Introduction ofLREC + 12 mo

Patient 1

Patient 2

Patient 3

Patient 4

Low Risk Express Care

Methods: Analysis

• Outcomes of interest between groups and time dependent

– Adherence– CD4 Response ( square root of CD4)– Death/LTFU (LTFU define as no visit for 6 months)

• Data were analyzed using:• Descriptive statistics• Longitudinal analyses • Proportional hazards regression models addressing time

until loss-to-follow-up or death • Analyses were weighted by propensity scores to adjust for

differential LREC enrollment

Low Risk Express Care

Results: Univariate Analysis• 17,922 patients were eligible for LREC with 38.2% enrolling • Enrolled and non-enrolled groups were equivalent with regard to:

• Gender : 70% female • Median age: 36 years

• The LREC-enrolled group had a significantly:• Higher median CD4 count at:

– cART initiation: 143 versus 135 cells/µl (p = 0.015)

– LREC eligibility: 326 versus 301 cells/µl (p< 0.0001)

• Lower WHO stage at:– cART initiation: Stage I/II 49.7 versus 46.6% (p = 0.0002)

– LREC eligibility: Stage I/II 52.0% versus 47.4% (p< 0.0001)

• Less likely to be cared for at the Referral Hospital – 20.6% versus 34.1% (p< 0.0001)

Low Risk Express Care

Results: Logistic-Regression Model for Enrollment

Factor Odds Ratio 95% WaldConfidence Limits

p-value

Referral Hospital (yes versus no) 0.298 0.265 0.336 <.0001

Gender (male versus female) 1.321 1.175 1.485 <.0001

Age at EC eligibility (per year) 0.985 0.979 0.991 <.0001

WHO stage closest to EC eligibility (3,4 versus 1,2)

0.787 0.709 0.874 <.0001

CD4 count within 9 months of EC eligibility (per cell increase)

1.001 1.001 1.001 <.0001

First 12 visits from AMPATH enrollment to EC eligibility (per visit)

1.537 1.454 1.624 <.0001

13 visits or more from AMPATH enrollment to EC eligibility (per visit)

1.058 1.052 1.064 <.0001

Low Risk Express Care

Results: Adherence Longitudinal Model

FactorOdds ratio

estimate95% Confidence

Limitsp-value

Referral Hospital (yes versus no) 1.053 0.802 1.383 0.711

Gender (male versus female) 1.018 0.733 1.414 0.915

Age at eligibility (per year) 1.016 0.997 1.034 0.103

EC (available versus not available) 1.248 0.950 1.639 0.112

EC (enrolled versus not enrolled) 0.384 0.083 1.783 0.222

Log of week after EC eligibility 0.615 0.553 0.682 <0.001

EC availability-by-log-week interaction 1.377 0.965 1.965 0.078

CD4 (<200 cells/μl versus >200 cells/μl) 3.827 2.780 5.268 <0.001

WHO stage (3,4 versus 1,2) 0.719 0.543 0.952 0.021

Low Risk Express Care

Results: Adherence

Average probability of being perfectly adherent by weeks from eligibility for EC

Low Risk Express Care

Results: Factors associated with square root CD4 counts after EC eligibility

Factor Regression Co-efficient

95% Confidence Limits

p-value

Week after EC eligibility 0.0188 0.0169 0.0207 <.0001

Enrolled in EC -0.1824 -0.3288 -0.0359 0.0147

EC availability 0.5023 0.3898 0.6148 <.0001

Gender (male versus female) -1.2218 -1.4088 -1.0349 <.0001

Referral Hospital (yes versus no) -0.4488 -0.6247 -0.2729 <.0001

WHO stage at last observation (3,4 versus 1,2)

-0.2322 -0.4016 -0.0628 0.0072

Low Risk Express Care

Results: CD4 Trajectory

Adjusted analysis of CD4 trajectory for enrollees in EC and those patients not enrolled

CD

4 c

ount (c

ells

/ml)

350

360

370

380

390

400

410

420

430

440

450

460

Weeks since EC availability at clinic

0 20 40 60 80 100

Adjusted analysis

Not enrolled in EC Enrolled in EC

Low Risk Express Care

Results: Risk of LTFU/Death

EFFECT HazardRatio

95% Hazard Ratio Confidence

Limits

p-value

Referral Hospital (yes versus no) 0.714 0.653 0.781 <0.0001

Gender (male versus female) 1.096 1.020 1.178 0.0126

Age at eligibility (years) 0.984 0.980 0.988 <0.0001

EC available at the site 0.629 0.575 0.688 <0.0001

Enrollment in EC 0.630 0.569 0.696 <0.0001

Enrollment in EC-by-Referral Hospital interaction

0.897 0.732 1.098 0.2916

CD4 count (<200 cells/μl versus >200 cells/μl) 0.920 0.808 1.046 0.2040

WHO stage (3,4 versus 1,2) 1.274 1.193 1.360 <0.0001

Low Risk Express Care

Limitations

• Biases Related to:• Referral versus non-referral clinic site• Make-up of cohort and duration of cohort involved in each of

these sites • Frequency of CD4 count testing (variability between Referral

Hospital and other sites)• Frequency of Adherence assessment

Low Risk Express Care

Conclusions• Patients with higher CD4 counts and less advanced HIV disease,

treated at rural health centers, were preferentially enrolled into LREC.

• After adjusting for this finding, LREC appears to have no adverse impact on patient outcomes and may decrease the rate of loss to program (LTFU or Death).

• More rigorous assessments of task shifting are necessary in order to unequivocally conclude that these models are equivalent or better than the current standard of care.

• Randomized Controlled Trials

Acknowledgements• Indiana University School of Medicine

• Moi University School of Medicine

• Moi Teaching and Referral Hospital

• This research was supported in part by a grant to the USAID-AMPATH Partnership from the United States Agency for International Development as part of the President’s Emergency Plan for AIDS Relief (PEPFAR).

Moi Teaching and Referral Hospital