Lloyd‐Richardson 2009.

Methods	Study design: RCT Location: USA Setting: immunology clinics (6 outpatient HIV clinics and 2 primary care medical offices) Recruitment: patients who smoked, were deemed eligible to participate by their physician, and were willing to speak with a health educator (HE) were referred to the study.
Participants	Defining eligibility criteria?: HIV‐positive Participant characteristics: 444 HIV‐positive, adult smokers, randomised to intervention (232) and control (212); 56.7% female; mean age 42.0; cpd 18.3 Motivation to quit?: not selected on motivation
Interventions	1. Control: NRT + brief standard care intervention (SC). 2 brief sessions, including brief assessment of quitting plans. Participants returned to the clinic biweekly for distribution of additional patches, allowing the counsellors to briefly (5 mins) reinforce quit efforts, check on patch side effects and answer questions. HEs were instructed to provide praise of participant’s efforts and answer any questions asked, but not to initiate additional discussion of the quit effort. Participants unwilling to set a quit date were instructed to contact the counsellor when ready. This reflects the minimum standard of care recommended by the Agency for Health Research and Quality (AHRQ). 2. Intervention: NRT + intensive motivationally enhanced counselling intervention (ME). Participants received 4 30‐min intervention sessions, as well as a quit‐day counselling call. Quit dates determined by individual participants in consultation with counsellors. MI elements delivered throughout all contacts. Participants not willing to set a quit date were engaged in discussion of ‘quitting as a process’ and barriers to quitting. Provider: counsellors Intensity: 4 biweekly medication contacts plus 5 counselling contacts Was MI fidelity monitored?: "We monitored the delivery of both intervention conditions by: (i) audio‐taped supervision on a random subsample of counseling sessions; (ii) patient exit interviews (conducted by the intervention‐blinded research assistant); and (iii) documentation of time spent in each intervention. To examine fidelity to each intervention protocol, two independent raters reviewed audio tapes of 20% of all sessions and rated (i) the degree to which intervention providers of the ME intervention adhered faithfully to the spirit of motivational interviewing (i.e. establish rapport, express empathy, reflective listening, explore ambivalence); and (ii) the degree to which there was contamination across conditions."
Outcomes	Definition of cessation used: 7‐day point prevalence Length of longest follow‐up: 6 months Validation: exhaled CO (< 10 ppm) Was mental health and/or well‐being measured at follow‐up?: no Was quality of life measured at follow‐up?: no
Funding source	Grants from the National Institute of Drug Abuse (R01‐DA12344‐06), the National Heart, Lung and Blood Institute (K23‐HL069987), the National Cancer Institute (K07‐CA95623), the NIH‐funded Transdisciplinary Tobacco Use Research Center (P50 CA084719), NIH‐funded Lifespan/Tufts/Brown Center for AIDS Research (P30 AI42853), and by the Robert Wood Johnson Foundation
Author conflicts of interest	Paper stated that authors had no declarations of conflicts of interests.
Notes	Different Ns and different loss to follow‐up allocated to intervention and control arms in the results section in comparison to the participant flow chart. Table 1 seemed consistent with text. Data inferred based on this assumption as there was no response to a data request from authors
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	QUOTE: "Patients were then randomized (using block randomization) to ensure stratification by gender and level of motivation to quit smoking". No further information provided
Allocation concealment (selection bias)	Unclear risk	QUOTE: "Patients were then randomized (using block randomization) to ensure stratification by gender and level of motivation to quit smoking". No further information provided
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Cessation validated using exhaled carbon monoxide measures
Incomplete outcome data (attrition bias) All outcomes	Low risk	60/212 (28%) in the intervention (ME) group, and 66/232 (28%) in the control (SC) group were lost to follow‐up at 6 months. Therefore, rates were similar between groups.