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ACTIVE NOT RECRUITING
NCT05162911
NA

Implementing Tobacco Use Treatment in HIV Clinics Vietnam

Sponsor: New York University

View on ClinicalTrials.gov

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.

Official title: Implementing Tobacco Use Treatment in HIV Clinics in Vietnam

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

672

Start Date

2021-11-23

Completion Date

2026-04-30

Last Updated

2025-07-25

Healthy Volunteers

No

Conditions

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

Locations (1)

Nam Nguyen

Hanoi, Nam Tu Liem, Vietnam