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Completed

NCT Number: NCT05162911

Implementing Tobacco Use Treatment in HIV Clinics Vietnam

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nam Nguyen

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

About this study

This research has three phases. For Aim 1 the investigators will conduct a formative assessment to inform further modifications to the intervention components. Participants in Aim 1 will be patients of the outpatient clinics (OPC) or health care providers who work there. Patients who use tobacco will be asked to participate in individual interviews (n=24 ). The investigators will conduct key informant interviews with health care providers from 3 OPCs (n=28) to adapt the intervention to the OPC clinical context. The investigators will then conduct a pilot test of ARM 1 and 3 in one OPC with 16 patients. The recruitment and enrollment process will be the same as described for Aim 2. For Aim 2 the investigators will conduct a three-arm randomized controlled trial (RCT) to compare the effectiveness of three interventions aimed at increasing tobacco cessation rates among people living with HIV/AIDS (PLWH). Patients (n=672) will be recruited and enrolled from the 13 OPCs. All enrolled patients will complete a baseline survey in person. This survey will be administered once eligibility is established and consent is obtained. The consent and survey will last 30 minutes. Follow up surveys will occur at 3-, -6 and 12-months after enrollment. Follow up surveys will be conducted by telephone. At 6-months follow up, patients who report smoking abstinence will be asked to come in person to the OPC and will complete a carbon monoxide test to validate self-report. The investigators will conduct baseline, 12 and 18 month surveys with all health care providers in the study sites in person (n=98). For Aim 3 the investigators will conduct a post intervention (12-month) assessment of factors associated with implementation effectiveness and potential for sustainability. This includes repeating the health care provider surveys and Key informant interviews. The investigators will conduct baseline, 12 and 18 month surveys with all health care providers in the study sites in person (n=98). For Aim 4 the investigators will enroll 75 more patients who are non-smokers for a total of (n=747) patients and assess the relationship between food insecurity and tobacco use among PLWH (75 smokers and 75 non-smokers), which includes administering the Household Food Insecurity Access Scale (HFIAS) survey to patients at baseline and 6-months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Ask, advise, Assist and refer to the Quitline

Behavioral

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

Ask, advise, Assist and referral to onsite counselor

Behavioral

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

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

Primary outcomes

  1. Carbon test at 6-months of smoking abstinence

    Time frame: 6-months 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.

Secondary outcomes

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

    Time frame: 18 months

    Using questionnaires measure health care setting, provider, and patient level factors that may influence tobacco cessation, and sustainability of the interventions tested.

Sponsors and collaborators

Lead sponsor

New York University

Other

Registry information

Official study title

Implementing Tobacco Use Treatment in HIV Clinics in Vietnam

Acronym: Vquit

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2021
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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