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. |