Watakasol 2010

Methods	A pilot randomised controlled trial conducted between December 2009 and May 2010.
Participants	Rural persons (n=42) living with HIV in the United States of America. The majority (81%) were white, 7.1% were black and 4.9% were 'other' ethnicity. 40% of participants were female.
Interventions	Participants were randomised to a telephone‐administered motivational interviewing adherence improvement intervention (n=21) and a self‐monitoring comparison condition control group (n=21). Those in the intervention group received a one‐session telephone‐administered 60 minute structured scripted adherence improvement intervention. Those in the control group received no active intervention, but were asked to complete medication diaries over a five‐week period, which was equal to the number of weeks that intervention participants completed medication diaries.
Outcomes	Outcomes were: dose adherence; schedule adherence; readiness to change; intrinsic motivation; self‐efficacy; depression; and reasons for non‐adherence.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Study quote: 'Block randomization with a 1:1 allocation using a random block size of two was used to ensure equal numbers within both conditions. Specifically, every time two participants returned their pre‐intervention questionnaires; a researcher drew a card from an envelope. The envelope contained two cards; one was labelled 'Intervention group' and the other one was labelled 'Control group'.
Allocation concealment (selection bias)	Unclear risk	It does not mention whether the envelopes used were sealed and opaque. Assignment envelopes may have been used without appropriate safeguards.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinding of participants and personnel was unlikely to be feasible in this study, but we do not think this will have affected the results.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No mention of blinding of outcome assessment in the study.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Study quote: 'All participants completed the pre‐intervention questionnaire and the 2‐week medication diary. However, two intervention (9.5%) and two control group participants (9.5%) did not return 3‐week medication diaries. One intervention group (4.7%) and one control group participant (4.7%) did not return the post‐intervention questionnaires. Contact was lost with these participants and the reasons for their termination in the study remain unknown.'
Selective reporting (reporting bias)	Unclear risk	Protocol was unavailable to us.
Other bias	Unclear risk	There may be risk of bias due to significant baseline differences between the intervention and the control group. Study quote: 'There were significant differences between conditions at baseline on number of years on ART medications, number of different ART medications, and number of total ART pills prescribed. On average, intervention participants (15.3 years) were on ART medications for a longer period of time compared to controls (11.1 years). Compared to control group participants (2.1), intervention group participants (3.1) were prescribed a greater number of different ART medications and a greater number of total ART pills (intervention group= 5.4, control group=3.2).' However, we feel that this may have been inevitable given the small sample size.