Clinical trial NCT06818786: Effects of New Pictorial Cigarette Pack Warnings on Vietnamese Smokers' Perceptions and Smoking Behaviors
Official title: Effects of New Pictorial Cigarette Pack Warnings on Vietnamese Smokers' Perceptions and Smoking Behaviors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pictorial Health Warnings
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: Hanoi University of Public Health
First posted: 2025-02-10
Enrollment: 1010
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This proposed study will assess the effects of different scenarios of PHW policies on smokers' reactions to warnings, attitudes and beliefs, behavioral intentions, and quitting behaviors, with specific aims: 1) to assess the impact of new PHWs covering 50% of cigarette packs, 2) to assess the impact of new larger PHWs covering 85% of cigarette packs, 3) to assess the impact of incorporating quitline information on cigarette packs, and 4) to assess the impact of plain packaging. These aims will be achieved by conducting a five-arm RCT among 1000 adult smokers (n=200 per arm). It includes four intervention groups: 1) branded pack with a new set of 6 PHWs covering 50% of cigarette packs without quitline information, 2) branded pack with a new set of 6 PHWs covering 85% of cigarette packs without quitline information, 3) branded pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information, and 4) plain pack with a new set of 6 PHWs covering 85% of cigarette packs with quitline information. A control group will use branded packs with the current set of 6 PHWs, covering 50% of cigarette packs without quitline information.

Given that the pictorial health warnings (PHW) on cigarette packs need to be renewed, this project will provide highly policy-relevant and timely scientific evidence on the effect of new PHW policies in Vietnam. Additionally, this project would be the first to address the research gap in understanding the effect of adding quitline information to PHWs-a gap not explored in previous studies. With the potential for significant outcomes, the findings will help Vietnamese policymakers enact stronger PHW policies in upcoming years, aiming to increase perceived harms of smoking and foster smoking cessation, ultimately saving millions of lives in Vietnam


Eligibility criteria: Inclusion Criteria:

* having smoked at least 100 cigarettes in their lifetime and currently smoking
* aged 18 or older
* fluent in Vietnamese
* smartphone users

Exclusion Criteria:

-

Primary outcomes:
measure: Emotional and cognitive responses
timeFrame: At the enrollment
Secondary outcomes:
measure: Attitudes and beliefs
timeFrame: At the enrollment
measure: Behavioral intentions
timeFrame: At the enrollment
measure: Recall and behavioral outcomes at 2-week follow-up
timeFrame: at 2 weeks
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi University of Public Health
Study officials:
References: