Pearson 2007.

Methods	Randomized controlled trial
Participants	The study location was HIV care clinic in the Beira Central Hospital, Mozambique 175 participants were randomized to the intervention group and 175 participants were randomized to the control group The inclusion criteria were at least 18 years of age, living near the HIV clinic in the Beira Central Hospital, and free of severe mental illness or dementia
Interventions	Intervention: PEER DELIVERED MODIFIED DIRECTLY OBSERVED THERAPY (MDOT) The participants in the MDOT intervention group received both the standard of care and a 6‐week peer intervention to monitor their morning weekday dose. Peers also provided daily social support, information about the benefits and side effects of HAART, and help to address barriers to adherence. Peers were also a link between participants and other members of the HIV clinic team and the community Control: STANDARD CARE It includes no‐cost medications, clinical and laboratory follow‐up, psychosocial adherence support by a trained social worker, and referral to community‐based peer support groups. Mandatory pre‐HAART counseling involves education about dosing, side effects, nutritional requirements, and the importance of adherence. Patients were encouraged to identify a treatment partner to help with adherence, provided with information on community‐based support groups and nutritional resources, and instructed to contact their medical provider, nurse, pharmacist, or peer if they have any difficulties or concerns about their medication regimen. Peers were HIV‐positive, chosen from among patients at the clinic and participants in community‐based groups through self nomination or nominations by clinic staff, and were paid a small stipend for their work. Patients met with the pharmacist and peer for pharmacy refills at week 2, 4, and 6 for the first 2 months and monthly thereafter
Outcomes	The measures of adherence were self reported and assessed at 6‐ and 12‐month interviews where 2 adherence questions were asked The patient outcomes were CD4 cell count at 6 and 12 months. Participants provided a 4 to 5 ml blood sample for a CD4 cell count as part of standard care immediately before and 4 and 10 months after initiating HAART. The absolute CD4 cell count was determined through flow cytometry. A chart review was conducted to record the CD4 test result closest to the assessment point but within 2 months. If a CD4 result was not available during this time frame, the participant was excluded from the intent‐to‐treat (ITT) and change‐score analyses of CD4 outcome. Mortality was verified by either medical records or by a family member who witnessed the death. If death was not verified by either of these 2 methods, then participants were assumed alive. Both measures were conducted as close to the 2 assessment points of 6 months and 12 months
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random assignment to condition was based on a computer‐generated allocation sequence prepared by an external statistician (pg 239)
Allocation concealment (selection bias)	Low risk	Allocation concealment involved the use of sequentially numbered, opaque, sealed envelopes containing the group assignment, which the research manager opened at the moment of randomization after enrolling participants (pg 239)
Selective reporting (reporting bias)	Unclear risk	No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol
Other bias	Low risk	The study seems to be free of other types of bias
Blinding of outcome assessment (detection bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ No blinding of staff. "Due to the nature of the intervention, participants and the study team could not be blinded to intervention." (pg 239)
Blinding of outcome assessment (detection bias) Patient outcome	High risk	(PRIMARY) CD4 CELL COUNT ‐ A chart review was conducted to record the CD4 test result closest to the assessment point but within 2 months. Study personnel not blinded
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ This is a subjective measure; there is no information on blinding
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) CD4 CELL COUNT ‐ Patient unblinding unlikely to affect the outcome
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ No information on blinding given. There is insufficient information to permit judgment of 'Low risk' or 'High risk'
Blinding of personnel (performance bias) Patient outcome	High risk	(PRIMARY) CD4 CELL COUNT ‐ Not blinded
Incomplete outcome data (attrition bias) Adherence measure	Unclear risk	(PRIMARY) SELF REPORT ‐ INTERVIEW ‐ There were fewer participants in the control group than in intervention group at both 6 and 12 months
Incomplete outcome data (attrition bias) Patient outcome	Unclear risk	(PRIMARY) CD4 CELL COUNT ‐ The author notes that they reported that MDOT participants were more likely than those in the standard care arm to get a CD4 cell count (at 6 months post HAART: 90% versus 79%, OR = 2.5, 95% CI 1.3 to 5.3; at 12 months post HAART: 96% versus 83%, OR = 5.3, 95% CI 2.0 to 16.2). However, mean CD4 count among those with CD4 data did not differ between arms at baseline (Table 1) or at 6 and 12 months (Table 2)