Geoffrey Fatti, Ashraf Grimwood , Eula Mothibi, Mokgadi Malahlela, Alfeous Rundare

Community-Based Adherence Support Associated with Improved Virological Suppression in Adults

Receiving ART: Five-Year Outcomes from a South African Multicentre Cohort Study

Geoffrey Fatti, Ashraf Grimwood, Eula Mothibi, Mokgadi Malahlela, Alfeous Rundare

Kheth’Impilo, Cape Town, South Africa

Kheth’Impilo

• SA NGO supports district scale up quality services for the management of HIV/AIDS at PHC level, focusing on providing a family centered comprehensive & integrated service

• KI operates in: 142 sites in the Eastern Cape, KwaZulu Natal, Mpumalanga & the Western Cape with >145000 patients RIC

• Programmes: Health Services Cluster (HSC) – ART (Adults & children), TB, HCT & PMTCT linked to Community Support Cluster (CSC) – for Adherence & Psychosocial support

Community Adherence• Clinic based Community outreach adherence support (CBAS)

health care workers called Patient Advocates (PAs) were introduced in 2004;

• Link clinical services & community; trained in the basics of HIV, patient rights, confidentiality, ethics, etc.

• Ensure ongoing adherence, counselling and psycho-social support at the community level and support community services to ensure the continuum of care;

• Special attention paid to very important patients (VIPs); the ill, pregnant, TB, children & adolescents, those who have not disclosed & those showing early signs of defaulting;

• VIPs make up 40% of PA’s workload;• Patients encouraged to contract with themselves & get a

treatment buddy to facilitate adherence to positive lifestyle choices that include the taking of treatment & keeping appointments

PA Support Structure

AREA COORDINATOR

PA PA PA PA PA PA

PA

PA

PAPRIMARY HEALTH CARE

CENTRE (Clinics)PRIMARY HEALTH CARE

CENTRE (Clinics)

DISTRICT OFFICE

NATIONAL OFFICE

COMMUNITY HEALTH CENTRE · Site Facilitator

· CSC District Coordinator· CSC Trainer· Doctor

· Nurse· Pharmacist

· PMTC Quality Mentor· Social Worker

· Data Quality Manager

Roving SWAT TEAM

· Site Facilitator· Site Facilitator

MethodsObjectives: • Estimate effect of CBAS on mortality, loss to follow up, &

virological suppression in adults receiving ART.• Multicentre cohort analysis using routinely collected data.• ART naïve adults starting ART between Jan 2004 and Sep

2010 at 57 government ART sites in 4 provinces.• Patients categorised as receiving or not receiving CBAS

from the start of ART.• Allocation was performed by clinic-based patient

facilitators & area coordinators, based on patient consent, programmatic , clinical or psychosocial considerations.

• Virological suppression (< 400 copies/ml) at six-monthly intervals until 5 years of ART, by intention to treat analysis.

XIX International AIDS Conference www.aids2012.org

Analyses

• Analyses were primarily by intention-to-treat (including all patients in each group as at allocation).

• Extreme case sensitivity analyses performed to estimate potential bias due to missing viral load results.

• Multivariable generalised estimating equations and logistic regression with multiple imputation of missing covariate values.


Results: Patients included and baseline characteristics


Patients received CBAS (n= 19,668; 29.4%)

Patients without CBAS (n= 47,285; 70.6%)

Relative Risk (95% CI)

Median age, y (IQR) 35.1 (29.4-42.3) 34.6 (29.3-41.4)

Male gender, n (%) 5955 (30.3%) 15,154 (32.1%) 0.94 (0.92-0.97)

WHO clinical stage, n (%)

I/II 3268 (26.0%) 9810 (29.5%) 0.89 (0.86-0.92)

III 7874 (62.7%) 20,250 (60.9%) Reference

IV 1412 (11.3%) 3173 (9.6%) 1.10 (1.05-1.15)

CD4 cell count; median (IQR), (cells/µl)

132 (73-181) 122 (63-173)

Tuberculosis, n (%) 2762 (14.3%) 5170 (12.6%) 1.10 (1.07-1.14)

Pregnancy, n (%) 928 (4.8%) 1713 (4.0) 1.14 (1.08-1.20)

PHC based care, n (%) 17,198 (87.4%) 30,796 (65.1%) 2.75 (2.64-2.86)

Year of starting ART, median (IQR)

2009 (2008-2010) 2008 (2007-2010)

Results (cont)

• Total observation time was 100,295 person-years • Deaths: 970 (4.9%) CBAS patients; 2,968 (6.3%) non-

CBAS patients. (P < 0.0001)• LTFU: 1,185 (6.0%) CBAS patients and 4,498 (9.5%)

non-CBAS patients. (P < 0.0001)• Virological suppression (at six months):

-CBAS patients: 76.6% (95% CI: 75.8%-77.5%)-Non CBAS patients: 72.0% (95% CI: 71.3%-72.5%)(P < 0.0001)


Virological suppression by intention-to-treat on ART


Pro

porti

ons

with

viro

logi

cal s

uppr

essi

on

Months on ART

Multivariable analysis of virological suppression


Patients received

CBAS

Patients without

CBAS

Months of

ART

n suppressed/N n suppressed/N Crude RR (95% CI) Adjusted OR

(95% CI)

6 7266/9481 15,458/21,478 1.06 (1.05-1.08) 1.22 (1.14-1.30)

12 4004/6087 8,271/14,813 1.18 (1.15-1.21) 1.33 (1.24-1.43)

24 1724/3248 3143/8954 1.51 (1.45-1.58) 1.57 (1.42-1.72)

36 714/1681 1088/4709 1.84 (1.70-1.98) 2.20 (1.87-2.59)

48 216/649 317/2157 2.26 (1.95-2.62) 2.50(1.79-3.49)

60 75/192 110/791 2.80 (2.19-3.60) 2.66 (1.61-4.40)

Sensitivity analysis: Considering all missing test results as suppressed.


Pro

porti

ons

with

viro

logi

cal

supp

ress

ion

Months on ART

aOR 1.44 (95% CI: 1.37-1.52)

Sensitivity analysis: Considering all missing test results as unsuppressed.


Pro

porti

ons

with

viro

logi

cal s

uppr

essi

on

aOR 1.15 (95% CI: 1.11-1.19)

On-treatment analysis


Prop

ortio

ns w

ith v

irolo

gica

l sup

pres

sion

RR 0.97 (95% CI: 0.96-0.97)

Results: Mortality after starting ART

0.00

0.02

0.04

0.06

0.08

0.10

Cum

ulat

ive

inci

denc

e of

mor

talit

y

0 12 24 36 48 60

without CBAS

with CBAS

P < 0.0001

Months on ARTMultivariable analyses adjusted for confounding:Mortality in patients with CBAS independently reduced: aHR 0.65 (95% CI: 0.59-0.72)

Results: LTF after starting ART

0.00

0.05

0.10

0.15

0.20

Cum

ulat

ive

inci

denc

e of

loss

to fo

llow

-up

0 12 24 36 48 60Months since starting ART

without CBAS

with CBAS

P < 0.0001

Multivariable analyses adjusted for confounding:LTF in patients with CBAS independently reduced: aHR 0.63 (95% CI: 0.59-0.68)

Conclusions• Adults receiving community based adherence

support had reduced mortality, LTFU and improved virological suppression (ITT analyses) after starting ART.

• Further scale-up of these programs should be considered in low-income settings.

Limitations: • Non randomised allocation to groups• Observational, use of routine data• Lack of effect seen in on-treatment VS analyses:

May be due to averted mortality and LTF amongst higher-risk patients who received CBAS, who would thus remain in care and at increased risk of viraemia.

This research was made possible by the President's Emergency Plan for AIDS Relief (PEPFAR) through the United States Agency for International Development (USAID) under the terms of grant no. P3121A0051. The contents of the presentation are the sole responsibility of “Kheth’Impilo” and do not necessarily reflect the views of USAID, The United States Government or The Global Fund.

Acknowledgements

Acknowledgements:

Geoffrey Fatti, Ashraf Grimwood , Eula Mothibi, Mokgadi Malahlela, Alfeous Rundare

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