Bell 2017.
Study characteristics | ||
Methods | Design: Pragmatic, uncontrolled, mixed‐methods trial Recruitment: Targeted settings for people with HIV Setting: Community, Brisbane, Australia Study start date: 21 February 2017; Study end date: 26 October 2017 |
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Participants | Total N: 30 Inclusion criteria:
Exclusion criteria:
Inclusion based on specific population characteristic: People living with HIV 29 participants identified as male, and 1 participant did not identify as male or female; Mean age: 42; Mean cpd: 18 EC use at baseline: 46.7% (n = 14) Never tried; 50% (n = 15) Tried, never used for an extended period; 3.3% (n = 1) Used on a regularly (weekly) basis Willing to attempt to quit |
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Interventions |
EC: Refillable Single‐arm study. Print materials to help quit smoking. Provided booklet with instructions on how to use, store and handle EC; copies of device user manuals. Given Innokin Endura T18® vaporiser kit, Innokin Endura T22® vaporiser kit, 4 spare coils, 1 wall charger, 10 x 10‐mL bottles of Nicophar® 12 mg nicotine e‐liquid. Supplies to last 12 weeks |
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Outcomes | Weeks 1, 4, 8, 12, 24; Self‐report and semistructured interviews Cessation: 7 days point prevalence at weeks 4, 8, 12 and 24. Continuous abstinence at weeks 12 and 24. No biochemical validation Adverse events Other outcomes: Acceptability and use of trial products; Number of quit attempts |
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Study funding | "This work was supported by the HIV Foundation Queensland. The funder will play no role in the analysis and interpretation of results. All trial products were purchased and the suppliers have no involvement in the conduct of the trial or the interpretation or reporting of the results." | |
Author declarations | "No other authors declare conflicts of interest. Mark Boyd has received research grant funding (paid to the institution) from AbbVie, Gilead and Merck and received honoraria for participation in HIV Advisory Boards and for the preparation and delivery of educational materials from AbbVie, Boehringer‐Ingelheim, Bristol Myers Squibb, Gilead, Janssen‐Cilag, Merck and ViiV Healthcare." | |
Notes | Additional data provided from authors. New for 2020 update | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Uncontrolled study |
Allocation concealment (selection bias) | High risk | Uncontrolled study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: “At Week 24, 26 of the 30 participants who enrolled in the study were followed up.” (confirmed by authors) |
Selective reporting (reporting bias) | Low risk | Study not published at time of data extraction, but study protocol published |