The main finding from the study was the evidence of sustained improvements in ART treatment delay from most recent positive HIV test to initiation of ART over eight years of rapid programmatic scale-up, a period during which nearly 16,000 individuals initiated treatment. The most recent year that was analysed (2011) had the shortest mean treatment delay, suggesting that the public health approach to ART delivery  that is recommended in the Malawian National Programme and implemented at QECH, continues to meet its objective of providing rapid access to ART despite extremely limited resources.
In September 2011, new Malawian National ART guidelines were introduced promoting initiation of ART for HIV-infected individuals with a CD4 count of <350 cells/μl, or in WHO stage 3 or 4, or who are pregnant or breastfeeding . Given the long experience of providing ART with no appreciable increase in delay seen in this study, we anticipate that time to initiation will continue to shorten – although with a greater number of potential patients meeting eligibility criteria, current levels of resourcing will need to be sustained or increased. This study found an overall median treatment delay of 35 days, although this varied cover time and was considerably shorter in more recent years. This compares similarly with other national programmes in the region: a recent systematic review found that the majority of ART initiators started treatment within one month , although two studies reported higher median delays of 2.4 months  and 6.6 months .
A key success to the sustainability of the Malawian national programme has been decentralisation of ART services from tertiary facilities to primary health care centres . However, we found that patients who were diagnosed with HIV at a site outside of QECH and subsequently attended QECH for ART initiation were significantly more likely to experience delay. This may have been because, unlike patients who were diagnosed within QECH, they would have had to make repeated journeys to the hospital for ART eligibility assessments and treatment education classes . Further, patients who were diagnosed at a primary care facility and opted to initiate ART at QECH may have had more complex clinical problems requiring specialist care that delayed ART initiation. Alternatively, they may have been reluctant to return to the primary health care centre for treatment because of anticipated stigma or previous bad experiences with providers . Finally, individuals diagnosed with HIV at the tertiary hospital may have had more advanced immunosuppression, which mean that CD4 eligibility thresholds would be met earlier.
Women had longer delay to ART initiation than men, possibly reflecting their propensity to be diagnosed earlier in the course of their infection through routine HTC during antenatal care [8, 18]. Men are known to initiate ART at a more advanced stage of illness and with lower CD4 counts than women  and have a higher risk of immediate post-ART initiation mortality [20, 21]. In this study, we were not able to adjust for the effect of pregnancy (which is associated with diagnosis at an earlier stage of HIV infection ) at ART initiation to determine whether this could have explained women’s longer delay. Nevertheless, given that more women currently access ART in sub-Saharan Africa , further studies, including qualitative research, are required to understand the gendered factors contributing to delay between HIV diagnosis and initiation of ART.
Factors resulting in delay between HIV diagnosis and initiation of ART can include the complexity and time-consuming nature of eligibility assessments (CD4 count measurement and WHO clinical staging) [8, 14, 22], especially when these require substantial patient expenditure and repeat facility visits . Moves towards introducing point-of-care CD4 count measurement  within HIV testing sites should allow same-day, same-clinic eligibility assessments reducing delays for men and women, while the universal ART eligibility of pregnant women infected with HIV in Malawi (“Option B+”)  should result in more rapid initiation of treatment for pregnant women. We noted peaks in ART initiations in 2004 and 2005, after ART became freely available at the clinic through the national treatment programmes. There are two possible related reasons for this. Firstly, the large number of individuals who were awaiting treatment could have overwhelmed clinic capacity. However, we found that the number of clients initiating ART per year was not significantly associated with delay. Alternatively with treatment guidelines stipulating that only individuals with advanced immunosuppression (CD4 count <200 cells/ μl were eligible for ART during this time, overall HIV diagnosed individuals may have had to wait longer before they met ART eligibility criteria.
The majority of ART initiators in this study were adolescents and young adults. Adolescents were significantly more likely to initiate ART with advanced HIV infection than individuals in other age groups. This supports data from Zimbabwe showing that HIV-infected adolescents are a neglected group, with high rates of undiagnosed HIV , late presentation for care with high a prevalence of chronic complications [27, 28] and numerous socio-economic complications, including an extremely high rate of orphanhood of 73%  and emotional and psychological difficulties. We were reassured to find that, on adjusted analysis, adolescents and young adults did not have a higher risk of ART treatment delay, and this may be due to the availability of teen groups and integrated family clinics at QECH supporting access to care. However, the advanced stage of HIV at which the majority of children and adolescents are diagnosed requires urgent intervention, perhaps by including HIV screening as part of regular infant health screening clinics.
There were limitations to this study. We only examined delay from most recent positive HIV test to initiation of ART and some individuals may have tested positive on a prior occasion. Nearly 40% of ART initiators did not have complete data recorded for either date of most recent HIV-positive test or ART initiation, meaning that treatment delay may have been under- or over-estimated. As this was a retrospective cohort study (although using prospectively collected data), we were unable to assess several unrecorded variables which may have potentially impacted upon delay. Finally, we did not give a time-delineated definition of “delay” and instead used a continuous dependent variable within our regression models. This avoids over-simplification of a complex construct and recognises that criteria for ART initiation have evolved over time. However, it means that we cannot give a definite proportion of patients who were “delayed”. New Malawian National guidelines  introduced in September 2011 recommend that ART is initiated within seven days of confirmed infection (for those meeting eligibility criteria). Even in the year with the shortest mean delay to treatment initiation (2011), only 18% of ART initiators initiated treatment within 7 days of their most recent positive HIV test. It will be important to continue to measure ART delays with regards to this target.