| Methods |
Design: cluster randomised trial, 22 clusters for each arm, median size 25 ‐ 36, inter‐cluster co‐efficient 0.2
Duration: February 2005 ‐ December 2006, follow‐up until 31 January 2009, median follow‐up 27 ‐ 28 months |
| Participants |
Country: Uganda.
Setting: urban, peri‐urban and rural, varying distance from the hospital.
Inclusion criteria: adults >18 years old, CD4 count <200cells/mm3, WHO clinical stage 3 or 4.
Exclusion criteria: living >100 km from facility.
Comparable CD4 count or clinical stage at baseline: similar, slightly lower CD4 count for intervention arm. |
| Interventions |
Intervention: initiated at hospital by doctors, maintained in community by field officers who delivered treatments every month on motorcycles, monitored adherence, drug toxicity and disease, they referred patients; had access to mobile phones for on‐site call to doctor. If patients was absent, followed up. Reviewed at hospital 6 monthly.
Control: initiated and maintained at hospital. Monthly clinic visits to collect medicine, reviewed by medical officer 3 monthly, drop in clinic; if defaulted, followed up at home; household vouchers for counselling. |
| Outcomes |
Rate of virological failure, time to detectable viral load >500 copies/mL, time to detectable viral load >500 copies/mL at any visit from 12 months if it was <500 copies/mL at 6 months or increase in 1000 copies/mL between two consecutive tests in those who did not have viral load <500 copies/ mL at 6 months, all cause mortality, admission, change to second line antiretrovirals, outpatient attendance, adherence in previous 28 days, cost incurred by health services and patients, patient diagnosed with TB at first admission, proportion of those with CD4 count > 200cells/mm3.
Timepoints of outcome assessment not clear. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Baseline CD4 count (All studies) |
Low risk |
Similar, slightly lower CD4 count for intervention arm. |
| Other baseline variables (All studies) |
Low risk |
Similar baseline characteristics for both groups. |
| Co‐ interventions (All studies) |
Low risk |
model of care in both groups differed by facility. |
| Random sequence generation (Trials) |
Unclear risk |
Not described. |
| Allocation concealment (Trials) |
Low risk |
Allocation cards labelled with stratum number and sealed in advance was drawn from a concealed box in the presence of all stakeholders. |
| Contamination Protection (Trials) |
Low risk |
No evidence of contamination. |
