NCT05162911Completed
Implementing Tobacco Use Treatment in HIV Clinics Vietnam
Implementing Tobacco Use Treatment in HIV Clinics in Vietnam
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
The primary objective of this study is to conduct a 3-arm randomized controlled trial (RCT) that compares the effectiveness of three multi-component interventions that are embedded in HIV outpatient clinics (OPCs): 1)3As+Referral to the national quitline: Ask about tobacco use, Advise to quit, Assist with brief counseling and Refer to Viet Nam's national Quitline; 2) AAA+ +Counsel (Counsel=6-session cessation counseling intervention adapted for patients living with HIV/AIDS (PLWH) and delivered by a trained, onsite nurse; and 3) AAA+Counsel+N (N=nicotine replacement therapy (NRT)). The main outcome is biochemically validated 6-months smoking abstinence. The investigators will recruit and randomize 672 patients across 13 outpatient clinics (OPCs) (48 per site, 16 per arm). The investigators will also recruit 75-nonsmokers to participate in a single survey to assess food safety. Therefore, the total sample = 747 patients.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 672 (actual)
- First submitted
- 10 Nov 2021
- Start date
- 23 Nov 2021
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- New York University
- Diseases
- HIV
- NCT number
- NCT05162911
What you commit to
- Study type: Interventional
- Participants enrolled: 672
- From 23 Nov 2021 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- patients with recent myocardial infarction (2 weeks)
- patients serious underlying arrhythmias
Other
- patients for whom there is a need for precaution in using NRT will be excluded
- patients who are pregnant or nursing
- patients are unable to demonstrate capacity for consent
- patients already enrolled in a tobacco use treatment program.
Who the study is looking for
- patients in the HIV OPCs
- current tobacco users
- patients who live in Hanoi
- patients reachable by phone
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nam Nguyen Coordinator of this site? Confirm its status | Hanoi | Vietnam | Unknown status |
Related publications
- 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.Lancet Glob Health · 2026 · PMID 41713442
- Multilevel barriers and facilitators to smoking cessation among men living with HIV in Vietnam: a qualitative study of male patients and healthcare providers.BMC Health Serv Res · 2026 · PMID 41612291
This page is information, not medical advice. Discuss any trial with your doctor.