Effectiveness of behavioural tobacco cessation interventions with and without pharmacotherapy among people living with HIV in Viet Nam: a three-arm pragmatic randomised controlled trial

BACKGROUND: People living with HIV are two to three times more likely to smoke than the general population, resulting in higher risk for tobacco-related morbidity and mortality. Despite this growing burden of disease, there is little evidence for the long-term effectiveness of tobacco cessation interventions among people living with HIV, particularly in low-income and middle-income countries. We aimed to compare the effectiveness of three tobacco cessation interventions among people living with HIV. METHODS: We conducted an open-label, three-arm pragmatic randomised controlled trial in 13 outpatient HIV clinics (OPCs) in Hanoi, Viet Nam. Adults who smoked at least one cigarette a day, lived in Hanoi, had a clinic visit in the past 12 months, and had daily access to a mobile telephone that could receive text messages were allocated (1:1:1) to either: proactive referral to Viet Nam's national smokers' Quitline counselling programme (Quitline group); six-session tailored counselling delivered by trained OPC nurses plus text messages (Counselling + SMS group); or Counselling + SMS plus 6 weeks of nicotine replacement therapy (ie, 2 mg nicotine gum; Counselling + SMS+ gum group). Randomisation was by stratified permuted block randomisation with block sizes of three and six. Neither study participants, OPC health-care workers, nor study staff were masked to group assignment. All patients received advice to quit and brief cessation counselling during their physician visit. The primary outcome was 7-day point-prevalence smoking abstinence confirmed at 6 months by exhaled carbon monoxide concentration of less than 8 ppm, assessed with an intention-to-treat analysis. The trial was registered on Dec 17, 2021, at ClinicalTrials.gov (NCT05162911). FINDINGS: Between Nov 30, 2021 and Sept 27, 2023, 672 patients were randomly allocated to the three test groups (221 to the Quitline group, 225 to the Counselling + SMS group, and 226 to the Counselling + SMS + gum group). 338 (50%) patients reported dual waterpipe and cigarette use. At 6 months, 109 (16%) patients had confirmed abstinence (28 13% for Quitline, 40 18% for Counselling + SMS, and 41 18% for Counselling + SMS + gum). There were no significant differences between intervention groups: Counselling + SMS versus Quitline (odds ratio 1·48, 95% CI 0·78-2·81; p=0·33), Counselling + SMS+ gum versus Quitline (1·64, 0·86-3·11; p=0·17), and Counselling + SMS + gum versus Counselling +SMS (1·11, 0·61-2·00; p=0·91). There were no serious adverse events linked to the study interventions throughout the trial duration. INTERPRETATION: Integrating nurse-delivered cessation treatment and proactive referral to a national Quitline was feasible within the context of HIV care. In the absence of evidence that tailored interventions provide additional benefit, our findings suggest that national Quitlines, available in 42 low-income and middle-income countries, might serve as a resource for integrating tobacco treatment into HIV care systems. FUNDING: US National Cancer Institute.