Humfleet 2013.
Methods | Setting: HIV clinics, USA Health Care Recruitment: HIV clinic patients, volunteering for study |
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Participants | 209 smokers 82% M, av age 45, av cpd 20 Therapists: clinicians specialising in smoking cessation/social work/psychology |
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Interventions | Pharmacotherapy: NRT; patch or gum for 10 weeks, available to those who smoked ≥ 5 cpd, number not eligible, not specified 1. Self help: "How to Quit Smoking"; brief meeting with study staff who reviewed guide and recommended establishing a quit date 2. Individual counselling: 6 x 40 to 60‐min sessions of CBT targeted towards needs of HIV positive smokers, weeks 1, 2, 3, 4, 8 & 12 3. Computer‐based: each component structured into a “step” roughly corresponding to the first 5 sessions of the counselling intervention. Individuals were directed to complete self‐assessment exercises and homework assignments. |
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Outcomes | Abstinence at 52 weeks (7‐day PP) Validation: CO ≤ 10 ppm |
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Source of Funding/CoI | National Institute on Drug Abuse. California Tobacco‐Related Disease Research Program. Authors declared no conflicts of interest. | |
Notes | Individual counselling compared to self‐help in main MA, added computer‐based arm in sensitivity analysis | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Smokers stratified based on N cpd, gender, history of depression and then within each stratum randomised via computer algorithm to 1 of 3 conditions in 1:1:1 fashion into a parallel‐group design |
Allocation concealment (selection bias) | Low risk | Randomisation occurred after enrolment & stratification. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Biochemically validated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 19% overall loss to follow‐up |