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Transcript of Www.ias2013.org Kuala Lumpur, Malaysia, 30 June - 3 July 2013 Factors related to non-adherence to...
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Factors related to non-adherence to antiretroviral (ART) drugs among adult ART clients attending 18 facilities in Tanzania, Uganda and Zambia
Julie Denison, FHI360Olivier Koole, Institute of Tropical Medicine
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Study Team
• FHI 360, USA• Muhimbili University of Health and Allied
Sciences, Tanzania• Infectious Diseases Institute, Makerere University
Medical School, Uganda• Tropical Diseases Research Centre, Zambia• Institute of Tropical Medicine, Belgium • Massachusetts General Hospital, USA • Centers for Disease Control and Prevention, USA
• Gideon Kwesigabo• Fred Wabwire-Mangen• Modest Mulenga• Julie Denison• Sharon Tsui• Cindy Geary• Meng Wang• Ya Diul Mukadi• Leine Stuart• Eric Van Praag• Kwasi Torpey• Joris Menten• Robert Colebunders• Olivier Koole• David Bangsberg• Andrew Auld• Simon Agolory• Seymour Williams• Jonathan Kaplan• Aaron Zee
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Context
• Massive ART scale-up: 8 million people on ART
• High levels of ART adherence required for viral suppression and good clinical outcomes
• Adherence levels higher in sub-Saharan Africa– Mills et al pooled estimate: 55% N. America; 77%
SSA (JAMA 2006)– Nachega et al (Curr Opin HIV/AIDS 2010)
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Objectives
Primary To characterize the current level of adherence
among ART clinic patients across multiple program settings
SecondaryTo identify important factors associated with
ART adherence, including both individual risk factors and program characteristics
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Study Population and Sites
• Study Population– 18+ years at ART
initiation at study site– Initiated 3 ARVs at least
6 months prior to data collection
• Study sites– 3 countries – 6 sites per country,
purposively selected
UGANDA
TANZANIA
ZAMBIA
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Methods
Adherence
Self-reports: 3-day, 30-day, 30-day VAS, Case Index
Provider estimates: 30-day
Pharmacy data: medication possession ratio (mpr)
Known risk factors
Stigma, depression, alcohol use, social support, disclosure, wealth index
Pre ART CD4 count, WHO Stage, ART regimen, pill burden, number of years on ART
Cross-sectional design: 250 patients per site systematically selected April-August 2011
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Methods
• Viral load testing conducted at six sites
• June to July 2011, Health Care Manager questionnaire conducted at 18 sites – Rural/Urban– Level and type of health facility– Community ART dispensing– ART initiation requirements– Stockouts– Type of clinic staff (i.e. Lay counselors)
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Analysis
1. Adherence levels described with cutoff points determined by ROC curve analysis using HIV viral load (VL) < />=1,000 copies/ml
2. Optimal adherence measures selected based on degree of association with viral load failure
3. Multivariate regression analysis, adjusted for site-level clustering, assessed associations between non-adherence and individual and program factors
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Patient AccountingNumber of ART clients screened 6,825Number of ineligible ART clients 1,854 Initiated ART <6 months before study 1,529 Less than age 18 729 Did not speak a study language 783Number of eligible ART clients 4,971 Number who did not consent 482 Number who consented and are in the analysis 4,489
Country Number of sites Number of participants
Tanzania 7 1498
Uganda 6 1495
Zambia 6 1496
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Selected Participant CharacteristicsCharacteristic 4,489
n (%)
Age (year), mean (SD)
40.9 (9.4)
Sex, Female 3,045 (67.8)Years on ART < 2 1,102 (24.6) 2-5 2,249 (50.1) >5 1,138 (25.4)Pre-ART CD4 <=250 3,020 (67.3) >250 567 (12.6) Missing 902 (20.1)
Characteristic 4,489n (%)
Current ART regimend4T(30),3TC,NVP 731 (16.3)TDF,3TC/FTC, EFV 699 (15.6)AZT,3TC,EFV 773 (17.2)AZT,3TC,NVP 1,427 (31.8)Other 684 (15.2)Missing 175 (3.4)
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Selected Program Characteristics
Characteristic nTotal number of clinics
19
Setting Rural/peri-urban 6 Urban 13Number of adults on ART < 2000 8 2000-4000 7 > 4000 4
Characteristic nLevel of health facility National referral 4 Provincial/Regional 4 District 6 Primary/ community based
5
Type of health facility Government 10 Mission 5 Non-religious NGO 4
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
1. Levels of Incomplete Adherence
• 9.9% (148/1,496) had VL >1000 copies/ml
• VL failure ranged from 7.2%- 17.2% by study site
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
1. Levels of Incomplete Adherence
Adherence measure
ROC Cutoff
n/N % IncompleteAdherence
3-day 93% 340/4397 7.7
30-day 99% 611/4387 13.9 30-day VAS
99% 2401/4450 54.0
Case Index 11 751/4473 16.8Health provider 98% 2617/4415 59.3Pharmacy MPR 90% 1634/4070 40.1
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
2. Selection of Adherence Measures: Associations with Viral Load Failure
Adherence measure
Category VL Failure >1,000 copies/ml
OR (95% CI)
Self-Report
3-day <93% 1.40 (0.80,2.46)
> 93% 30-day <99% 1.13 (0.71,1.78) >99%
30-day VAS <99% 0.86 (0.57,1.30)>99%
Case Index <11 1.30 (0.84, 2.01)>11
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
2. Selection of Adherence Measures: Associations with Viral Load Failure
Adherence measure Category VL Failure >1,000
copies/mlOR (95% CI)
Provider Report <98% 1.57(1.02,2.41)
>98%
Pharmacy MPR <90% 1.48 (1.02,2.15)
>90%
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
3. Model Building: BivariateIncomplete Adherence Pharmacy MPRIndividual characteristicsSignificant and selected (p<0.1) Non –significant and not
selected (p>0.1)- Female sex- Younger than 35 years- On ART between 2-5 years- Greater internalized stigma- Positive screen for depression- Taking four or more pills daily- Missing pre-ART CD4 count
- Marital Status- Social support- CAGE alcohol abuse- DHS Wealth Index- Cost to clinic- Time to clinic- Disclosure- Pre-ART WHO-stage
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
3. Model Building: BivariateIncomplete Adherence Pharmacy MPR
None of the Program characteristics were significant at p<0.2
- Level of health facility- Type of health facility- Dispensing of ARVs at community level- Buddy needed for ART initiation- Lay counselor provides adherence counseling- ART stock out (past six months)- Location (urban/rural)
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
3. Model Building: MultivariableIncomplete Adherence Pharmacy MPR
Adjusted Odds Ratios (95% CI)
Age >35 0.85 (0.73-0.99)
Years on ART <2 1
2-5 1.21 (1.02-1.43)
5+ 0.88 (0.72-1.10)
Stigma High 1.26 (1.06-1.50)
Pill Burden 4+ daily 1.35 (1.12-1.62)
Pre-ART CD4 Missing 1.37 (1.15-1.63)
www.ias2013.org Kuala Lumpur, Malaysia , 30 June - 3 July 2013
Conclusions
• Wide variability in adherence levels
• Pharmacy MPR and provider estimates associated with VL failure
• Interventions needed to– Reach younger ART clients– Support long-term adherence– Address internalized stigma