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Implementing Tobacco Use Treatment in HIV Clinics Vietnam

NCT05162911 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 672

Last updated 2025-07-25

No results posted yet for this study

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

Interventions

BEHAVIORAL

Ask, advise, Assist and refer to the Quitline

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

BEHAVIORAL

Ask, advise, Assist and referral to onsite counselor

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

BEHAVIORAL

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

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

Sponsors & Collaborators

  • New York University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-23
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05162911 on ClinicalTrials.gov