We did this study at Arba Minch Hospital in southern Ethiopia. Arba Minch Hospital is a district hospital located 500 km south of Addis Ababa. The hospital serves about 1.5 million people with capacity of 158 beds. Since the early 1990s, the hospital has been delivering HIV counselling and testing services. In 2002, in preparation to start ART, we trained staff, renovated rooms, designed patient record forms and installed basic laboratory equipment. In January 2003, we started adult HIV clinic. A medical doctor, assisted by two others, headed the clinic. Other members of the team included five nurse counsellors, two laboratory technicians, two community agents, and a data clerk. The health workers were permanent employees of the hospital. The community agents and the data clerk were recruited through a public notice. These were secondary school leavers with previous record of anti-HIV activities in the community. Familiarity with data management and computer literacy were additional criteria for the data clerk. All members of the team completed the necessary national courses.
We started ART in August 2003 as one of the first public hospitals to start ART in Ethiopia. Prior to that, patients were treated only for opportunistic infections. We previously reported the pattern of disease progression among untreated patients , and the results comparing the clinical outcome before and after treatment with HAART . Here, we report the outcome of the first consecutive patients who were treated with HAART at our clinic between August 2003 and January 2005 and followed through 9 August, 2005.
Patient flow, treatment and follow-up
A nurse referred all HIV infected adult patients (age >= 15 years) to a medical doctor following a standard counselling and testing procedure  and after recording socio-demographic information, body weight, height and test results in a standardized patient record form. The doctor did standard clinical examination and staged patients according to the WHO clinical staging system .
Following clinical staging, complete blood cell count (CBC) was measured in all patients using automated haematology analyser (Sysmex Kx-21, Sysmex Corporation, Kobe, Japan). CD4 machines were not available. In those with indication for HAART, we did liver and renal function tests using a semi-automatic photometer (Photometer 5010, Riele, version 3.0) at baseline and then regularly according to the national treatment guideline .
According to the guideline, only symptomatic patients (WHO stage II-IV) were eligible for treatment. In stage II, the TLC<= 1200/mcL was used as an additional criterion. Patients were treated on a first-come first-served basis. Triple combinations of stavudine (d4T), lamivudine (3TC), nevirapine (NVP), zidovudine (ZDV), and efavirenz (EFV) were available. d4T/3TC/NVP was the first-line combination of choice. EFV was reserved for patients in their intensive phase of antituberculosis therapy. Drugs were refilled every 4 weeks. At each visit, we measured body weight. CBC was repeated 4 weeks later and then every 12 weeks.
We assigned unique identification numbers to each newly started patient. The data clerk then recorded the information and notified the community agents. Every month, the community agents visited the patients in their homes and reported the status of each patient to the data clerk and to the doctor. Death was the main outcome variable, and all non-accidental deaths were considered HIV-related. Specific causes of death were not determined. Also, the community agents reported if the patients were lost, transferred or stopped treatment.
Patients were censored on the date of any one of the following events, whichever occurred first: (i) if the patient was lost to follow-up, the date of the last contact the patient had with the community agent (ii) if the patient was transferred to another health institution, the date of transfer, (iii) if the patient stopped treatment, the last date of drug re-supply plus two months, and (iv) if the patient was alive and on treatment at the end of the follow-up, August 9 2005.
We used the Kaplan-Meier and the Cox-regression survival analysis techniques to identify predictors of death. We included the baseline WHO clinical stage, TLC, BMI, and HGB as potential predictors. TLC, BMI, and HGB were treated as dichotomous variables at clinically useful cut-off points as described elsewhere [13, 14]. Also, we calculated the magnitude and direction of change in HGB, body weight, BMI, and TLC values at the first and second follow-up visits. Then we dichotomized the resulting change in the laboratory and clinical values at two cut-off points: (i) [no change or decrease] versus [increase]; (ii) [decrease] versus [no change or increase]. Thus we evaluated changes in HGB, body weight, BMI and TLC from baseline to the first and second visits as potential predictors of death.
In the multivariate Cox regression model, we included only those variables significantly associated with death in univariate analysis. We included interaction terms in multivariate models to check for multicolinearity. Results were presented as hazard rations (HR) with 95% confidence intervals (95% CI). We used the Kaplan-Meier curves to highlight important features and the Log-rank test was used to test for statistical significance.
We calculated mortality rates for each phase of the follow-up: (i) from baseline to the first follow-up visit, (ii) from baseline to the 2nd follow-up visit, (iii) from the first follow-up to the second follow-up visit, (iv) from the first follow-up visit to the end of the study, (v) from the second follow-up visit to the end of the study, and (vi) from baseline to the end of the study. Mortality rates were described as number of deaths per 100 person-years of observation (PYO). Then we calculated mortality rate ratios for each phase of the follow-up. We used SPSS version 14.0 (SPSS Inc., Chicago, IL, USA) for data analysis. All statistical tests were two-sided and P <0.05 was considered statistically significant.
The National Ethics Review Committee in Ethiopia and the Regional Committee for Medical Research Ethics in Western Norway approved the study protocol. All patients gave informed consent before HIV testing and for taking part in the study.