The study was conducted at The AIDS Support Organisation (TASO) clinic in Jinja, SE Uganda. TASO is a large non-governmental organisation with 11 centres in the country offering counselling, social and clinical services to HIV-infected subjects.
The clinic in Jinja serves a predominantly rural/semi-urban population up to a radius of about 100 kilometres. Treatment and care are provided free and patients are managed according to national health service guidelines.
TASO began providing information about ART to its clients around the end 2003, mostly through group meetings and drama shows. Patients were screened for eligibility from August 2004 and the first patients began treatment about 4 weeks later. Recruitment into the programme ended in December 2006 when the funds available at that time had been used up. TASO was by far the largest provider of ART in the region. Patients who had been with the organisation the longest were given priority during the first year of the programme and thereafter ART was made available to all on a first come first served basis.
Assessment for ART was done over 3 visits to clinic which were usually spread over 4–8 weeks. At the first visit, patients were examined clinically and blood was taken and sent for CD4 count testing. Information and counselling were provided on ART focussing on adherence, side-effects, drug sharing, safer sexual behaviour, and was done both one-to-one and in groups. The second appointment was usually 2 weeks later. Those at WHO stage III (chronic fever of unknown origin, chronic diarrhoea of unknown origin, oral hairy leukoplakia and pyomyositis), stage IV, or with CD4 count less 200 × 106/l were considered eligible for ART. Counselling was repeated and patients were asked to return for a 3rd visit approximately 2 weeks later. They were also asked to identify a medicine companion who could provide support and reminders about drug taking. Between the 2nd and 3rd visit, case-conferences were held by TASO clinical and counselling staff. Patients' readiness for ART as well as their clinical eligibility was re-assessed and a decision was taken whether or not to provide ART. It was then at the 3rd visit that ART was offered (following further information and patient counselling). The first line regimen comprised either zidovudine or stavudine, lamivudine, and either nevirapine or efavirenz. Those who were not eligible for ART (at the second visit) were provided counselling and asked to return to clinic every 3–6 months for monitoring.
Patients who completed the screening and started on ART after February 2005 were invited to join a cluster randomised trial comparing different ART delivery strategies, which was co-ordinated from the study site [12
]. The trial was done under normal programme conditions with TASO staff responsible for patient screening before and patient management during the trial whilst a team of independent research staff documented trial outcomes. Trial and non-trial subjects were managed identically and for example no incentives were given either to staff or patients.
The data presented here refer to the screening period before ART initiation and were collected to inform TASO services. Follow-up of subjects who were eligible for ART but dropped out of the programme and did not initiate on ART at TASO Jinja was done between June 2007 and December 2007. We ascertained survival status and if alive, whether or not the subject was on ART from a different provider. Visits were done by trained field officers. Deaths were verified by close family members. Subjects not found at home were visited again at least once.
Distributions of sex, age and CD4 count categories were compared between groups using a chi-squared test. Comparions of CD4 count continuous data were compared using the Kruskall-Wallis test. Factors associated with completing three screening visits and starting ART were investigated by fitting logistic regression models. The analysis of survival time (time to death or date last seen alive) was investigated using survival analysis methods, with the survival time being described using a Kaplan Meier plot and summarized using mortality rates and incidence rates for a composite endpoint of mortality or loss-to-follow-up. The effect of CD4 count on mortality was investigated by fitting Poisson regression models. All analyses were done using Stata release 10.0.