We show that in this ART programme 14% of individuals who would potentially have benefited from treatment did not start ART. This is similar to the estimate (16.4%) from a retrospective cohort study in South Africa but lower than the 25.5% reported by a retrospective cohort study in southern Malawi. Similar to the experience of TB programmes, exclusion from analysis of patients who die or are lost between presentation and starting treatment may potentially bias programme estimates of treatment outcomes, making them difficult to interpret and potentially misleading[10, 11].
In a context where CD4 counts are not available, MUAC and reported difficulties in dressing may provide useful screening indicators to identify sicker ART-eligible individuals at high risk of dropping out of the programme who might benefit from being brought back quickly or admitted to hospital for observation. The finding that WHO stage IV was not associated with a higher odds of dropout before ART initiation compared to those in WHO stage III was unexpected. This may reflect the specific policy of keeping some appointments each week available for sicker patients, or represent an increased effort by individuals to seek treatment because they were sicker. Higher odds of defaulting among lower educated individuals has been shown elsewhere in Africa and may suggest that the content, amount and complexity of information given to patients during the screening visit may need to be adapted .
The significant positive association between dropout and length of delay from screening to the initiation appointment is consistent with a Cambodian study . Now that the service at Karonga is well established, delays between screening and starting treatment are no longer a prominent feature. This is likely to change if criteria are altered to enable people to start treatment at an earlier stage, and may require a two stream service to ensure that those in more clinical need are not affected by waiting lists. The finding that participants enrolled in the later calendar periods of the study had a significantly higher odds of dropout compared to those recruited in the earliest period of the study may be due to particularly motivated patients coming for screening as soon as the clinic opened.
Previous work by our group has suggested that ART eligibility based on clinical staging criteria alone may miss up to two-thirds of those considered eligible using criteria based on clinical staging and CD4 cell count, and has highlighted a need for simpler CD4 testing methods. However, in countries with constrained resources, and increasing decentralisation of services, the current available technologies make it unlikely that CD4 testing will be available in small health centres that are now integral to ART programmes. Where equipment is available and CD4 testing is a policy, challenges remain in ensuring no interruptions in the supply of reagents, power supply and trained technicians. In many aspects the ART Clinic in Karonga operated like any other district ART clinic in Malawi, characteristic of the simplified public health approach established by the Malawi Ministry of Health, furthermore outcomes of those who started ART at Karonga were not significantly different to those reported from other clinics[17–19]. The results of this study are therefore generalisable to other clinics in similar contexts.
We found that 58% of defaulters followed up in the community had died; 60% of whom died before their initiation appointment. This high level of pre-treatment mortality is consistent with findings from a South African study, and emphasize the need for priority initiation and improved availability of key drugs and clinical management. However, the proportion of individuals in WHO stage 4 at screening (55%), is higher than reported in established ART clinics in rural Malawi for the same period and more recently. Our study population included HIV positive people who may have been eligible for some time but had no local access to ART previously.
Among those found to be alive at the tracking visit, the most frequently reported barrier to returning to the clinic was cost of transport, a barrier that has also been documented in centralised prevention of mother-to-child transmission and ART programmes elsewhere in rural Malawi[23, 24]. These reports suggest that targeted support may be beneficial at screening visits but poverty-related barriers are likely to be persistent and also affect long-term retention on ART. More recent devolvement of ART initiation from the district hospital alone to additional rural hospitals within the district, resulting in shorter distances for individuals to attend an ART clinic is likely to have eased this barrier.
Several other ART-eligible patients alive at the tracking visit cited lack of a suitable guardian/buddy as a barrier to ART. The policy of requiring a guardian to accompany individuals until they are established on ART remains part of the national programme in Malawi. This policy is based on experience of the national TB treatment programme and its impact has not been formally evaluated in the ART programme. In a society where literacy and education levels are low, a guardian also receives the treatment-related education and can support the individual, remind them to take drugs, help with drug taking, attend clinic on their behalf etc. In Malawi, hospital patients are expected to come with a guardian to provide basic nursing care - washing, feeding, toileting etc. In the ART programme context, guardians can also provide physical help to get to clinic, and care whilst at the clinic.
ART programme success is currently measured as the proportion continuing to receive ART among those who started treatment and survived. However we have shown that there are many patients who are considered eligible for ART, but do not start treatment. For many of these patients the reason for not receiving ART was that they had died. These early deaths are not included in routine programme statistics. Considering all those who are eligible for ART as a denominator for programme indicators would help to highlight this vulnerable group, in order to identify new opportunities for further improving ART programmes.