Indian Journal of Public Health

ORIGINAL ARTICLE
Year
: 2010  |  Volume : 54  |  Issue : 4  |  Page : 179--183

A two-site hospital-based study on factors associated with nonadherence to highly active antiretroviral therapy


Vivek Lal1, Shashi Kant2, Richa Dewan3, Sanjay K Rai4, Ashutosh Biswas4,  
1 Assistant Professor, Institute of Health Management Research, Jaipur, India
2 Professor, All India Institute of Medical Sciences, New Delhi, India
3 Professor and Head of Medicine, Lok Nayak Jai Prakash Hospital, New Delhi, India
4 Associate Professor, All India Institute of Medical Sciences, New Delhi, India

Correspondence Address:
Vivek Lal
Assistant Professor, Institute of Health Management Research, 1, Prabhu Dayal Marg, Sanganer Airport, Jaipur-302011
India

Abstract

Objectives : To describe the pattern of adherence to Highly Active Antiretroviral therapy (HAART) and ascertain the factor(s) associated with nonadherence. Methods: This was a cross-sectional, two-site, hospital-based study. The study was undertaken in 2005; as a result of phased roll out of free HAART as part of National AIDS Control Program, patients at Lok Nayak Jai Prakash (LNJP) hospital were receiving free HAART, while patients at All India Institute of Medical Sciences (AIIMS) had to bear out-of-pocket expenses for HAART. Adherence was defined as not having missed even a single pill over the previous 4-day period on self-reporting. Results: Adherence at AIIMS was 47%, whereas it was 90% at LNJP. The difference was statistically significant. Multivariate analysis showed that nonadherence was associated with not having been told about the importance of HAART, having to pay out-of-pocket for HAART and reported continued risk behavior post HAART. Conclusion: With the provision of free HAART, adherence is likely to be high. Emphasis should be given on simultaneous recruitment of counselors, and physicians should be made aware about the need to inquire and counsel patients against continued risk behavior.



How to cite this article:
Lal V, Kant S, Dewan R, Rai SK, Biswas A. A two-site hospital-based study on factors associated with nonadherence to highly active antiretroviral therapy.Indian J Public Health 2010;54:179-183


How to cite this URL:
Lal V, Kant S, Dewan R, Rai SK, Biswas A. A two-site hospital-based study on factors associated with nonadherence to highly active antiretroviral therapy. Indian J Public Health [serial online] 2010 [cited 2019 Dec 6 ];54:179-183
Available from: http://www.ijph.in/text.asp?2010/54/4/179/77256


Full Text

 Introduction



At the United Nations General Assembly Special Session on HIV/AIDS in September 2003, the failure to deliver life-prolonging drugs to millions of people in need was declared a global health emergency. On World AIDS Day in 2003, World Health Organization (WHO) and UNAIDS launched "3 by 5" initiative - a global target to get 3 million people living with AIDS on Highly Active Antiretroviral therapy (HAART) by the end of 2005. This target is a vital step toward the ultimate goal of providing universal access to AIDS treatment for all those who need it.

Adherence to therapies is a primary determinant of treatment success. The consequences of nonadherence are serious for the individual as it is associated with the development of viral resistance, treatment failure, and increased risk of disease progression; from a public health perspective, the increase in prevalence of resistant virus is likely to result in an increase in transmission of resistant virus to newly infected individuals, and from a health economics perspective, it would require increased use of second-line and salvage regimens, which are in general more expensive than initial regimens. As of Jan 2009, the Government of India (GOI) is already providing treatment through 197 centers throughout the country. [1] While a major scale-up of HAART is on its way, there is still a window of opportunity to learn what works and what does not. India-specific data are scarce. Hence, there is a need to conduct adherence study in the light of expansion of free HAART in the country. Moreover, the knowledge of patient's adherence is important in differentiating between lack of treatment efficacy and inadequate adherence. Further, the factors that affect adherence could help to identify patients who may need support in maintaining adherence.

In this context, the study was conducted with the objectives to describe the pattern of adherence to HAART and ascertain the factor(s) associated with nonadherence in adults with HIV/AIDS in a typical hospital setting, so that appropriate interventions could be suggested to improve adherence and optimize treatment response.

 Materials and Methods



The study was a cross-sectional, hospital-based study. It was conducted at two study sites: Infectious Diseases clinic (I.D. clinic) and Medicine OPD of All India Institute of Medical Sciences (AIIMS) and ART clinic of Lok Nayak Jai Prakash (LNJP) Hospital at New Delhi. Both the hospitals offer tertiary level care in the public sector. At the time of the study, AIIMS did not dispense the drugs free; hence, patients had to procure the drugs at their own cost. The GOI re-designated this I.D. clinic as ART clinic, and since July 2005, patients started receiving free HAART. LNJP was identified by GOI as one of the first sites in India to offer free HAART. The clinic had been functional since April 2004. By the time the study was completed, number of patients enrolled in the clinic for HAART was 300 and the patients were regularly followed up. Both the sites adopted similar criteria for initiating HAART and had similar prescription.

According to WHO, adherence to HAART in developing countries is 60-80%. [2] For the present study, we opted for relative acceptable error as 10%. On applying 60% as the level of adherence, the total sample size was calculated to be 266. At the end of the study, we were able to enroll 200 patients at LNJP and another 100 at AIIMS. Thus, a total of 300 patients were enrolled.

HIV/AIDS patients attending outpatient clinics (OPD), on self-administered HAART for at least 1 week and aged 18 years or above, were included as study subjects. The patients who were unable to comprehend the study objectives and process or who suffered from any acute medical condition, which made them unable to participate in the interview or any psychiatric condition due to which the patient could not give valid consent, were excluded from the study.

Data were collected at LNJP from Jan 2005 to Dec 2005, whereas at AIIMS the collection was done from Jan 2005 to May 2005. Consecutive patients satisfying eligibility criteria were interviewed on the days of data collection on a first-come, first-served basis, till the OPD timing was over. OPD cards were marked to ensure that each patient was interviewed only once.

The study instrument consisted of a semi-structured anonymous interview schedule in the local language, Hindi. Data on duration of HIV diagnosis, duration of being on HAART and concurrent opportunistic infection were extracted from patient records. Adherence was assessed retrospectively over the previous 4-day period, as used in AIDS Clinical Trials Group (ACTG) follow-up questionnaire. [3] To achieve the highest likelihood of maximal viral suppression, adherence must be 95% or more over time. [4] Adherence was defined as not having missed even a single pill over the previous 4-day period on self-reporting. "Continued risk behavior post HAART" was defined as the behavior associated with increased risk for transmission of HIV by infected patients even after knowledge about their HIV status and having been started on HAART. Beck Depression Inventory (BDI), which is a 21-item scale, was used to measure depressive symptomatology. [5] Higher scores on the scale indicated a greater number of depressive symptoms or a greater probability of a major depressive disorder. The score ranged from 0 to 63. For the purpose of analysis, the score was dichotomized, with ≥10 being indicative of depression.

The questionnaire was pre-tested on patients from another hospital which was not part of the study, and then appropriately modified. Ethical clearance was obtained from the institutional review committee at both the study sites prior to the start of the study. After obtaining written informed consent, a semi-structured anonymous interview schedule was administered to the patients.

Data were entered in Microsoft Excel and analyzed using SPSS 10.0. The magnitude of association between different variables in relation to nonadherence to treatment was measured by Chi-square test and Fisher's exact test, where appropriate. P-values of ≤0.05 were considered statistically significant. Variables that were statistically significant on bivariate analysis were entered into multiple logistic regression analysis to find the best predictive model for nonadherence to HAART.

 Results



All the patients who fulfilled the eligibility criteria and were asked to enroll in the study gave consent. 100 patients at AIIMS and 200 patients at LNJP with mean age of 36.8 and 33.3 years, respectively, were interviewed.

Most of the patients seeking treatment from LNJP belonged to Delhi (84.5%); however, only 15.5% of patients seen at AIIMS were from Delhi. Patients at AIIMS had been on treatment for a longer duration than those at LNJP; with the mean duration being 68.4 and 33.1 weeks, respectively. The mean family income of patients at both the study sites was similar. Majority of the patients at both study sites were males, i.e., 78 and 65% at AIIMS and LNJP, respectively. Most of the patients interviewed at both the study sites belonged to the age group 31-40 years.

The pooled adherence for both the study sites was 75.7%. Adherence at AIIMS was 47%, whereas it was 90% at LNJP. This difference was statistically significant (P < 0.001). A total of 36% of the patients at AIIMS reported that they had never missed any dose, whereas 70.0% of the total patients at LNJP claimed to have always been adherent.

Adherence was found to be different significantly in bivariate analysis with respect to the variables like gender, place of residence, duration in weeks of being on HAART, concurrent opportunistic infection, continued risk behavior post HAART, whether told about the importance of HAART, adherence to timing of taking HAART and study site [Table 1]. These variables were entered into multiple logistic regression, with the dependent variable coded as 1 = nonadherence and 0 = adherence. It was found that those who reported not having been told about the importance of HAART (1 = no, 0 = yes) were 9.2 times more likely to be nonadherent compared to those who reported having been told about its importance [OR = 9.2 (95% CI = 3.2-25.8) P < 0.001]; those having to pay out-of-pocket for HAART at AIIMS (1 = out-of-pocket at AIIMS, 0 = free ART at LNJP) were 7.7 times more likely to report nonadherence than those getting free HAART at LNJP [OR = 7.7 (95% CI = 3.9-15.1) P < 0.001]; and those who reported continued risk behavior post HAART (1 = yes, 0 = no), were 6.3 times more likely to report nonadherence than those who did not report continued risk behavior after being started on HAART [OR = 6.3 (95% CI = 2.1-18.9) P = 0.001].{Table 1}

 Discussion



The study was designed to be an exploratory study on the factors associated with nonadherence to HAART. As free HAART began to be rolled out in a phased manner as part of the National AIDS Control Program (NACP), this study took advantage of the fact that one hospital (LNJP) had an established system for dispensing free HAART, while a decision on the same was pending for AIIMS and which finally rolled out free HAART. The data collection at AIIMS was completed before the roll out began.

The study showed high level of adherence (90%) among adult HIV patients receiving free HAART at LNJP, whereas adherence at AIIMS was lower than 50%. Our study found that affordability was the main issue due to which many of the patients were not adherent at AIIMS where they had to bear out-of-pocket expenses for HAART. Unlike at AIIMS, majority of patients at LNJP belonged to Delhi, thus making it convenient to access care regularly. Since AIIMS did not have a formal ART clinic in place, follow-up of the patients was not regular, with many of them returning after several months for prescription or only when they experienced side effects. This was unlike at LNJP where patients returned with empty blister packs every month. Further, as AIIMS did have ART counselors in place, patients would often leave the OPD after getting the prescription, without meeting the counselor. This was in contrast to the system at LNJP, where patients went through a formal session with ART counselor after meeting the doctor and getting their prescription. This difference in patient preparation prior to initiating HAART and adherence support while on treatment might have contributed to the differences in adherence measures between the two groups. This reasoning also corresponded well with the finding that more patients at LNJP reported having been told about the importance of HAART.

Our results were in contrast to a study conducted in Pune and Delhi, where the mean 4-day adherence was significantly lower among patients receiving free ART through insurance programs compared to patients paying out-of-pocket (81% vs. 96%, P < 0.001). [6] Our findings were similar to those reported from Chennai that the most common form of nonadherence was planned or unplanned breaks in treatment due to inability to pay for it. [7] Several other studies have also cited economic factor as the commonest reason among respondents for nonadherence. [8],[9],[10] In a study done in Senegal, it was found that adherence tended to be better among patients who were required to make little or no contribution toward the cost of their treatment. [11]

The percentage of patients who continued to have high-risk behavior even after starting on HAART was 10% at AIIMS and 5.5% at LNJP. These patients were more likely to be nonadherent. The variable could be indicative of the reckless attitude of patients toward medication and life, in general. In a study by Kalichman et al., it was found that people who had been nonadherent reported significantly more sex partners, greater rates of unprotected vaginal intercourse, and less protected sex behaviors. [12]

Only 3% of the patients at LNJP reported that they had not been told about the importance of HAART and how it helped, as against 24% at AIIMS who cited their ignorance about its importance. The association was found to be statistically significant. This variable could be indicative of the non-formal counseling at AIIMS with most of the patients missing out on them. A study was done on HIV-positive Latino men and women receiving treatment in community-based clinics. Results showed that informational support was significantly associated with the level of dose adherence. [13] Veinot et al. reported that many participants did not understand or believe in antiretroviral treatment. [14] It has been found that patients cite lack of trust in the medication's effectiveness and their perception that the medication only needed to be taken when they were feeling ill. These findings underscore the importance of appropriately communicating correct information to patients.

Both our study sites were tertiary referral centers, with no defined catchment area. Since the study was carried out in hospital setting, its generalizability is limited. But, it was difficult to conduct such a study in the community due to stigma attached to the disease. Therefore, studies on this topic have largely been carried out in the hospital setting. Our study did not examine adherence among HIV infected individuals who might have discontinued treatment or dropped out of the program.

Adherence was assessed using self-reported, retrospective recall method. Although there are concerns that self-report tends to overestimate adherence compared to other methods, [2] several studies have validated self-report as a method by which to measure adherence. It would be useful to keep in mind that higher adherence rates at LNJP may actually be lower than those reported. However, for lower levels of adherence as reported at AIIMS, self-reported data may be a more accurate measure. In studies based on retrospective data, there was a likelihood of recall bias. But this was unlikely considering the short recall period of 4 days used to define adherence.

Our study provided the much needed data on adherence among patients receiving free HAART through national program. This was found to be very high. This finding was further corroborated by the fact that we could compare this with patients who had to bear out-of-pocket expenses toward HAART. The adherence in the latter was low.

The data show that free HAART has been taken up well by the patients and lend support to the decision of scaling up of free HAART. At the same time, they point toward a greater responsibility on the system in terms of sustainability of free HAART program and support through formal counseling sessions, in order to help patients to continue to adhere to this lifelong therapy. We recommend that the GOI should continue to scale up free ART program, and should give emphasis on simultaneous recruitment of counselors, and also, physicians should be made aware about the need to inquire and counsel patients against continued risk behavior.

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