The present study was conducted from January 2012 to June 2014 at the Department of Microbiology of a tertiary care health centre in New Delhi. Of the 1263 HIV seropositive clients diagnosed during this study period, only those 470 HIV seropositive clients were included who were ART-naive, registered at the linked ART centre and whose baseline CD4+ counts were available. All ART-experienced patients; registered patients referred from other centers and patients below the age of 18 years were excluded from the analysis. Information regarding the socio-demographic and risk behaviour profile of HIV seropositive attendees was retrieved retrospectively from records of the Integrated Counselling and Testing Centre (ICTC).

Diagnosis of HIV infection was done as per the standard protocol that included a pre-test as well as post-test counselling and the practice of obtaining written informed consent from the client before HIV testing. Serodiagnosis of HIV was done as per strategy III of NACO guidelines [8]. All HIV seropositive subjects were referred to the ART clinic of the linked hospital. The registered clients were then referred back to our laboratory for evaluation of CD4+ counts. CD4+ counts were determined by employing the BD FACS CountTM system (Becton, Dickinson and Company, San Jose, CA, USA).

All the data was entered in Microsoft excel sheet and statistical analysis performed using the SPSS software, version 20. Qualitative data was analysed by Chi-square test and Fisher’s exact test, while quantitative variables were analysed using the One-Way ANOVA followed by post-hoc test. The differences were considered to be statistically significant when the obtained p-value was less than 0.05.

Of the total 470 HIV seropositive patients analysed during the study period, 256(54.47%) were between 30-45 years of age. The mean age of the study population was 35.35±10.18 years with the mean age of HIV seropositive males and females being 35.48±9.93 years and 35.06±10.91 years respectively. The study population comprised of 334(71.06%) males, 130(27.66%) females and 6 (1.28%) transgenders. With regard to level of education, most of the patients (172; 36.60%) were educated up to primary school level. Majority of study subjects were daily wagers (47.87%). Heterosexual route (448; 95.32%) was the most common route of HIV transmission, followed by intravenous drug abuse (9; 1.91%). The socio-demographic profile of the study population is summarized in [Table/Fig-1].

Most of the HIV seropositive individuals (287; 61.06%) were referred clients, of which 246 (52.34%) were referred from government health facilities. One hundred and eighty three (38.94%) seropositive clients were direct walk-in ICTC attendees [Table/Fig-2].

The baseline CD4+ count distribution of HIV seropositive individuals is summarized in [Table/Fig-3]. As per the 2010 WHO guidelines for initiation of ART in asymptomatic HIV reactive patients (considering a CD4+ count of 350cells/mm³ as cut-off) [9], 348 (74.04%) of the 470 registered patients required ART on enrolment.

The correlation of CD4+ counts with socio-demographic profile and the type of client is depicted in [Table/Fig-2,4] respectively. Ninety one (62.76%) of 145 HIV seropositive clients between 18-29 years of age presented with CD4+ count < 350cells/mm³ and required ART, versus 14 (77.78%) of 18 clients ≥60 years of age (p=0.001). Two hundred and fifty nine (77.54%) males, 83(63.85%) females and all transgenders presented with CD4+ count < 350cells/mm³ [Table/Fig-2].

The mean CD4+ count of the study group was 249.77± 216.0cells/mm³. HIV seropositive clients between 18-29 years of age had significantly higher mean CD4+ counts as compared to clients more than 60 years of age (p=0.013) Females had higher mean CD4+ counts as compared to males and the difference was statistically significant (300.31±240.47cells/mm³ versus 232.38±204.25cells/mm³; p =0.002). Married and widowed clients had mean CD4+ counts of 246.96±213.41cells/mm³ and 148.80±146.31cells/mm³ respectively (p =0.08) [Table/Fig-4].

The mean CD4+ count of direct walk-in clients was higher (317.40±220.30cells/mm³) as compared to referred ones (206.66±202.24cells/mm³) and the difference was statistically significant (p< 0.001). Two hundred and thirty nine (83.30%) of 287 referred clients had CD4 count < 350cells/mm³ and required ART versus 113 (61.74%) of 183 direct walk-in clients and the difference was statistically significant (p<0.001). Among the referred clients CD4+ count of ward patient was lowest i.e. 135.55±157.65cells/mm³ followed by DOTS clinic patients [Table/Fig-2].

The mean CD4+ counts were higher among young individuals compared to older age groups. Similar findings have been reported in another Indian study conducted by Shastri S et al., [10]. A possible explanation is that older individuals though get infected at younger ages, have a delayed diagnosis [11]. We report mean CD4+ counts of 232.38±204.25 and 300.31±240.47cells/mm³ in Highly Active Anti-Retroviral Therapy (HAART)-naive, HIV positive males and females respectively and an overall mean CD4+ count of 249.77 ± 216.09cells/mm³ which is in concordance with the study conducted by Akinbami A et al., [12]. On the other hand in the another study conducted in eastern India the mean CD4+ counts of male and female were 142.19 ± 139.33cells/mm³ and 235.92± 185.11cells/mm³ respectively and an overall mean CD4+ count of 176.04±163.49cells/mm³ [13]. A plausible hypothesis for the higher mean CD4+ counts reported among females is that, females present to care and get tested for HIV earlier through expanded HIV testing programs in pregnancy and through expanded partner testing programs after their spouse tests positive [10]. With regard to marital status, widows presented with lower CD4+ counts, indicating the difficulties in accessing the health care system in Indian setting, a finding in concordance with study conducted by Alvarez Uria G et al., [14]. Furthermore, similar to findings of Thompson LH et al., HIV reactive patients from in-patient settings had lower CD4+ counts compared to those from out-patient departments [15]. In our study, 38.94% seropositive clients were direct walk-in ICTC attendees while in another study conducted in West Bengal only 6% visited the ICTC voluntarily [16]. This discrepancy may be due to difference in education level and awareness among the general population.

Using a CD4+ count of 350cells/mm³ as cut-off criterion for initiation of ART, 74.03% of our registered patients required ART on enrolment. Another Indian study [13], documented that 86.67% of the HIV reactive patients required treatment, while according to Singh K et al., 58.91% of HIV positive clients required treatment on enrolment [17]. In another study conducted by Shastri S et al., 65% of HIV positive patients presented with a CD4+ count below 350cells/mm³ [10]. This shows that, majority of HIV positive patients in Indian setting do not present for care and treatment until the disease is advanced [18]. Late initiation of ART results in less favourable outcomes [14,15,17] and is associated with increased medical costs [18,19]. Furthermore, untreated people may contribute to the spread of HIV for several years.

The 2010 WHO guideline implementation in India, requires immediate implementation of ART to more than two third of newly diagnosed HIV infected patients in the country. As the side effects of ART are common and many of the patients are asymptomatic, this has become challenging. Intensive counselling of the various side effects of the drugs and long term benefits of the regime is essential so that patients are not lost during follow-up.

Being a retrospective analysis, data on clinical manifestations of the patients was not available. Thus, some of the patients with CD4+ counts more than 350cells/mm³, who may have required initiation of ART because of their HIV-related symptoms were missed out.

Our study provides, an insight into the demographics of newly diagnosed HIV seropositive individuals in this part of India. In addition, our finding that nearly three-fourths of newly diagnosed HIV positive Indian patients require initiation of ART at registration reinforces the need for timely baseline CD4+ cell count testing of HIV positive patients, as well as the urgency of initiating treatment in HIV reactive individuals in Indian health care settings.