CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 672 enrolled / 672 target
Drug / intervention
Ask, advise, Assist and refer to the Quitline +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05162911
NCT05162911N/ACompletedHigh Momentum (12.2/mo)Completion was 2mo ago

Implementing Tobacco Use Treatment in HIV Clinics in Vietnam

New York University·interventional·Posted Dec 17, 2021·Updated Jun 1, 2026

In Brief

A clinical study evaluating Ask, advise, Assist and refer to the Quitline, Ask, advise, Assist and referral to onsite counselor, and 1 other intervention for Tobacco Use. Completed, enrolled 672 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTobacco Use
CountriesVietnam
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedDec 17, 2021
Enrollment StartNov 23, 2021
Primary CompletionApr 30, 2026
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 4.5 years ago

Arms & Interventions

Ask, Advise, Assist (AAA) and Refer.active_comparator

Patients will receive Ask, Advise, Assist (AAA) and refer to the quitline as the intervention.

Behavioral: Ask, advise, Assist and refer to the Quitline
AAA plus referral to onsite counselor (Counsel).active_comparator

Patients will receive Ask, Advise, Assist plus referral to onsite counselor.

Behavioral: Ask, advise, Assist and referral to onsite counselor
AAA+Counsel+N (Nicotine gum).active_comparator

Patients will receive Ask, Advise, Assist, plus referral to onsite counselor and nicotine gum.

Behavioral: Ask, advise, Assist and referral to onsite counselor and NRT

Interventions

Ask, advise, Assist and refer to the Quitlinebehavioral

A nurse will ask, advise, assist and refer patient to the Quitline

Ask, advise, Assist and referral to onsite counselorbehavioral

A nurse will ask, advise, assist and refer patient to a counselor

Ask, advise, Assist and referral to onsite counselor and NRTbehavioral

A nurse will ask, advise, assist and refer patient to a counselor and provide nicotine replacement therapy in the form of gum