Implementing Tobacco Use Treatment in HIV Clinics Vietnam

NCT05162911 | Completed DMC

• 1 other identifier: i19-01783
• Study Type: interventional
• Target: 672
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Use

Keywords

Tobacco Use; Implementation Science

Outcome Measures

Primary Outcomes (1)

• Carbon test at 6-months of smoking abstinence

  biochemically validated 6-months smoking abstinence will be measured using expired-air carbon monoxide reading equal to or less than 8 ppm (CO \< 8 ppm). The scale is 0-50ppm, where the lowest values represent less CO levels, which indicate a patient is not smoking, and the highest values represent higher CO levels indicating a patient is actively smoking.

  6-months smoking abstinence

Secondary Outcomes (1)

• Factors that may influence tobacco cessation, and sustainability of the interventions tested

  18 months

Study Arms (3)

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 Quitline BEHAVIORAL

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

Ask, Advise, Assist (AAA) and Refer.

Ask, advise, Assist and referral to onsite counselor BEHAVIORAL

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

AAA plus referral to onsite counselor (Counsel).

Ask, advise, Assist and referral to onsite counselor and NRT BEHAVIORAL

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

AAA+Counsel+N (Nicotine gum).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients in the HIV OPCs
• current tobacco users
• patients who live in Hanoi
• patients reachable by phone

You may not qualify if:

• patients for whom there is a need for precaution in using NRT will be excluded
• patients with recent myocardial infarction (2 weeks)
• patients serious underlying arrhythmias
• patients who are pregnant or nursing
• patients are unable to demonstrate capacity for consent
• patients already enrolled in a tobacco use treatment program.

Sponsors & Collaborators

• New York University: lead

Study Sites (1)

Nam Nguyen

Hanoi, Nam Tu Liem, 2QJG+94, Vietnam

Location

Related Publications (2)

• Shelley D, Armstrong-Hough M, Nguyen T, Alvarez GG, Kapur R, Shuter J, Goldsamt L, Tozan Y, Van Minh H, Van Vu G, Phan PT, Cleland CM, Nguyen N. 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 Mar;14(3):e407-e416. doi: 10.1016/S2214-109X(25)00451-6.

  PMID: 41713442 DERIVED

• Shelley D, Alvarez GG, Nguyen T, Nguyen N, Goldsamt L, Cleland C, Tozan Y, Shuter J, Armstrong-Hough M. Adapting a tobacco cessation treatment intervention and implementation strategies to enhance implementation effectiveness and clinical outcomes in the context of HIV care in Vietnam: a case study. Implement Sci Commun. 2022 Oct 17;3(1):112. doi: 10.1186/s43058-022-00361-8.

  PMID: 36253834 DERIVED

MeSH Terms

Conditions

Tobacco Use

Interventions

corticosteroid hormone-induced factor; Insemination, Artificial, Heterologous; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Drug Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized control trial

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 17, 2021
• Study Start: November 23, 2021
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)