Nonadherence to HAART: A cross-sectional two-site hospital-based study Vivek Lal 1 ; Shashi Kant 2 ; Richa Dewan 3 ; Sanjay K. Rai 2 ; Ashutosh Biswas 2 1 Indian Institute of Health Management Research, Jaipur, India; 2 All India Institute of Medical Sciences, New Delhi; 3 Lok Nayak Hospital, New Delhi (Dr. Vivek Lal)

Background Commitment to “3 by 5” Initiative Expansion of free HAART in India million PLHA receiving free ART (2009) Adherence to therapies is a primary determinant of treatment success India-specific data on adherence is scarce

Objective To describe the pattern of adherence to HAART To ascertain the factor(s) associated with nonadherence in adults with HIV/AIDS in a typical hospital setting To suggest appropriate interventions to improve adherence & optimize treatment response

Methods Study design- Cross- sectional hospital- based study Study sites- Infectious Diseases Clinic of All India Institute of Medical Sciences (AIIMS) & ART Clinic of Lok Nayak Hospital (LNJP) at New Delhi, India ♦ Both hospitals offer tertiary level care in the public sector ♦ At the time of the study, AIIMS did not dispense drugs for free ♦ LNJP was identified as one of the first sites in India to offer free HAART (since April 2004) ♦ Both sites adopted similar criteria for initiating HAART & had similar prescription

Methods Operational definitions ♦ Adherence- Self-report by patient that they had not missed even a single pill over the previous four-day period ♦ Continued risk behavior- Behavior associated with increased risk for transmission of HIV by patients even after knowledge about their HIV status & having been started on HAART ♦ Told about importance of HAART- Self report by patient that they had been told about importance of HAART at the hospital from which they were receiving the prescription Study population- Total 300 patients enrolled (200 at LNJP & 100 at AIIMS)

Methods Inclusion criteria- HIV/AIDS patient ♦ Aged 18 years or above ♦ Attending outpatient clinic ♦ On self-administered HAART for at least one week Exclusion criteria- HIV/AIDS patient suffering from ♦ Any acute medical condition causing inability to participate ♦ Any psychiatric condition due to which the patient could not give valid consent Ethical considerations ♦ Study approved by Institutional Review Committee at both study sites ♦ Written informed consent obtained from participant 6

Table 1: Significant Socio-demographic & HAART-related Variables with Nonadherence (Bivariate Analysis) VariablesResponses Non-adherent n = 73 (%) Adherent n = 227 (%) p-value GenderMale Female 60 (82.2) 13 (17.8) 156 (68.7) 71 (31.3)0.026 Place of residenceDelhi Non Delhi 23 (31.5) 50 (68.5) 125 (55.1) 102 (44.9)<0.001 Time since initiation of HAART <= 24 wks 24 to 52 wks >52 wks 31 (42.5) 15 (20.5) 27 (37) 107 (47.1) 82 (36.1) 38 (16.8)0.001 Concurrent opportunistic infection Yes No 26 (35.6) 47 (64.4) 51 (22.5) 176 (77.5)0.025 Continued risk behavior post HAART Yes No 13 (17.8) 60 (82.2) 8 (3.5) 219 (96.5)<0.001 Told about importance of HAART Yes No 49 (67.1) 24 (32.9) 221 (97.4) 6 (2.6)<0.001 Adherence to timing of HAART Yes No 21 (28.8) 52 (71.2) 160 (70.5) 67 (29.5)<0.001 Study site AIIMS LNJP 53 (72.6) 20 (27.4) 47 (20.7) 180 (79.3)<

Multivariable Analysis Statistically significant variables entered into Multiple logistic regression Those who reported not having been told about the importance of HAART were 9.2 times more likely to be report nonadherence [OR- 9.2 ( ) p< 0.001] Those having to pay out-of-pocket for HAART at AIIMS were 7.7 times more likely to report nonadherence [OR- 7.7 ( ) p< 0.001] Those who reported continued risk behavior post HAART were 6.3 times more likely to report nonadherence [OR- 6.3 ( ) p= 0.001]

Policy Implications Study provided much needed data on adherence among patients receiving free HAART through national program (90% adherence at LNJP vis-à-vis 47% adherence at AIIMS) The Government of India continues to scale up free ART; the adherence is likely to be high While scaling up of free ART, government should give emphasis on simultaneous recruitment of counselors Physicians should be made aware about the need to inquire & counsel patients against continued risk behavior

Future Research Priorities Early identification of suboptimal adherence through simplified tools Explore the role of social supports in maintaining adherence