Taiwo 2010.

Methods	Randomized controlled trial
Participants	The study location was JUTH, Jos, Nigeria 248 participants were randomized to the intervention group and 251 participants were randomized to the control group The inclusion criteria were HIV‐1–infected, treatment‐naive adults (> 15 years of age) at the JUTH ART clinic who were eligible for treatment based on a clinical diagnosis of AIDS, CD4 cell count < 350 cells per cubic millimeter with HIV‐related symptoms, or CD4 cell count < 200 cells per cubic millimeter regardless of symptoms were invited to participate. Willingness and ability to select a treatment partner were required The exclusion criteria were individuals with severe illness such as advanced malignancy or active opportunistic infection, including tuberculosis
Interventions	Intervention: TREATMENT PARTNER INTERVENTION In addition to standard care, patients randomized to the treatment partner intervention (TPA) arm chose a treatment partner who was aware of the patient's HIV infection and resided in the same house or in close proximity. Treatment partners attended 1 adherence education session similar to that for study participants. They were asked to observe the ingestion of HIV drugs at least once daily, assist with the reporting and management of adverse effects, and remind participants of drug pickup. No compensation was provided for participation, but treatment partners with financial constraints received travel stipends of USD 2 to 14 (total) Control: STANDARD CARE All participants were given a 2‐hour interactive adherence session in English and local language conducted by a nurse who was openly HIV‐positive, trained as an adherence counselor. Content included information on ART, HIV drug resistance, symptom management, and emphasis on the importance of adherence and benefits of disclosure. Each patient was given a pillbox and educated on proper use. The study pharmacist, who was blinded to treatment arm, provided one‐on‐one reinforcement of the education provided by the adherence counselor plus information specific to each participant's regimen. The pharmacist had formal training in adherence counseling and more than 3 years experience at study clinic. At each drug pickup visit, the pharmacist provided targeted counseling based on the participant's self report of adherence and adverse effects. Patients who had detectable viremia at week 24 underwent intensive adherence retraining with the adherence counselor. This retraining was aimed at identifying individualized obstacles to adherence and practical tips for overcoming them. Follow‐ups were conducted at 12, 24, and 48 weeks after baseline
Outcomes	The measures of adherence were drug pickup adherence to the regime, calculated from pharmacy records at 24 and 48 weeks and dichotomized as >= 95% and < 95% adherent. Per cent adherence = total number of days ‐ % of days alive without medication (e.g. if 6 days late picking up prescriptions through week 24 was 100% ‐ [((168‐6)/168)x100] = 96.4% adherent). For participants who died during the course of the study, adherence was computed through the day of death. For patients who were lost to follow‐up, we assigned the maximum number of possible days without medication The patient outcomes were plasma viral load and CD4 cell count measured at baseline and weeks 12, 24, and 48 and mortality determined from hospital records, clinic charts, social contacts, treatment partners, study staff, and social workers
Notes	―
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random numbers were used for randomization. "Using a computer‐generated allocation sequence, randomization was performed in a 1:1 ratio to treatment partner–assisted (TPA) ART (treatment arm) or patient‐administered standard of care (SOC) ART (control arm)." (pg 86)
Allocation concealment (selection bias)	Unclear risk	No information was provided about how allocation was handled
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	Low risk	(PRIMARY) PHARMACY FILL RECORD ‐ The study pharmacist, who was blinded to treatment arm, provided one‐on‐one reinforcement of the education provided by the adherence counselor plus information specific to each participant's regimen
Blinding of outcome assessment (detection bias) Patient outcome	Low risk	(PRIMARY) PLASMA VIRAL LOAD ‐ Objective outcome measurement not likely to be influenced by lack of blinding
Blinding of participants (performance bias) Adherence measure	High risk	(PRIMARY) PHARMACY FILL RECORD ‐ Patients likely to be aware of both the intervention and measure
Blinding of participants (performance bias) Patient outcome	Low risk	(PRIMARY) PLASMA VIRAL LOAD ‐ Objective outcome measurement not likely to be influenced by lack of blinding
Blinding of personnel (performance bias) Adherence measure	Unclear risk	(PRIMARY) PHARMACY FILL RECORD ‐ 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	Low risk	(PRIMARY) PLASMA VIRAL LOAD ‐ Objective outcome measurement not likely to be influenced by lack of blinding
Incomplete outcome data (attrition bias) Adherence measure	Low risk	(PRIMARY) PHARMACY FILL RECORD ‐ Missing data fairly balanced
Incomplete outcome data (attrition bias) Patient outcome	Low risk	(PRIMARY) PLASMA VIRAL LOAD ‐ Missing data fairly balanced