Table 3

Risk of bias in included studies
Study Adequate sequence generated? Allocation concealment? Blinding of participants and personnel? Blinding of viral load assessment? Incomplete outcome data addressed? (Missing at follow up = treatment failure) Free of other bias?
Jaffar et al. [37] Yes. Yes. No. Yes. No. Yes.
Cards were sealed in advance and labelled with stratum numbers and placed into a box Sealed cards were drawn from a concealed box. The study was cluster randomized trial; researchers and participants knew which clusters were receiving the interventions. Probably done, because Blood taken for viral load testing was for research purposes; the testing was done in batches rather than in real-time. “Those who withdrew or were lost to follow-up before 12 months were excluded from the primary endpoint analysis…” The two groups were well balanced according to baseline characteristics apart from CD4-cell count, which was lower in the home-based than in the facility-based group [39]. There were no losses of clusters. The analysis adjusted for the effect clustering
Nachega et al. [35] Yes. Yes. No. Unclear. Yes. No.
Probably done, because there was sequential allocation concealment “[T]reatment assignments were placed in opaque envelopes, which were sequentially opened by the study coordinator at enrolment.” The study was an open-label, randomized controlled trial; both the researchers and the participants knew which intervention was being administered. Measurement of viral loads performed was every 6 months as part of routine monitoring Missing viral load values were considered detectable. Trial terminated early for futility by an independent Data and Safety Monitoring Board
Chang et al. [38] Yes. Yes. No. Unclear. No. No.
An allocation sequence was generated Random allocation was by drawing of lots. The study was cluster randomized trial; researchers and participants knew which clusters were receiving the interventions. "Viral loads … were performed every 24 weeks on all patients as part of routine patient monitoring procedures." Those who died or were lost to follow-up were excluded from the analysis of shorter-term virologic outcomes Contamination in the control arm was reported in subsequent evaluation study [40].
Taiwo et al. [36] Yes. Yes. Yes. No. Yes. Yes.
“Using a computer-generated allocation sequence, randomization was performed …” Probably done, because there was computer-generated allocation sequence. “The study pharmacist, who was blinded to treatment arm, provided one-on-one reinforcement of the education provided by the adherence counsellor plus information specific to each participant’s regimen.” Probably not done because patients who had detectable viral loads at week 24 underwent intensive adherence retraining with the adherence counsellor. “[P]articipants who were missing virologic indicators and were reported to have died were counted as failures.” There were no significant differences between treatment groups at baseline.
Matovu et al. [17] Yes. Unclear. No. Unclear. No. No.
Probably done, because patients were randomly allocated. Insufficient information to permit judgement of “Yes” or “No”. The study was an open randomized non-inferiority intervention trial. Insufficient information to permit judgement of “Yes” or “No”. Patients lost to follow-up were excluded from the analysis. Baseline viral load was adjusted for. This means there were significant differences in viral loads between intervention groups at baseline.

Chishinga et al.

Chishinga et al. BMC Public Health 2014 14:239   doi:10.1186/1471-2458-14-239

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