Implementing Tobacco Use Treatment in HIV Clinics Vietnam

NCT ID: NCT05162911

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 672 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-23
• Study Completion Date: 2026-04-30

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.

Detailed Description

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.

Conditions

Tobacco Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ask, Advise, Assist (AAA) and Refer.

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

Group Type: ACTIVE_COMPARATOR

Ask, advise, Assist and refer to the Quitline

Intervention Type: BEHAVIORAL

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

AAA plus referral to onsite counselor (Counsel).

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

Group Type: ACTIVE_COMPARATOR

Ask, advise, Assist and referral to onsite counselor

Intervention Type: BEHAVIORAL

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

AAA+Counsel+N (Nicotine gum).

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

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

Interventions

Ask, advise, Assist and refer to the Quitline

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

Intervention Type: BEHAVIORAL

Ask, advise, Assist and referral to onsite counselor

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nam Nguyen

Hanoi, Nam Tu Liem, Vietnam

Countries

Vietnam

References

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.

Reference Type: DERIVED

PMID: 36253834 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

i19-01783

Identifier Type: -

Identifier Source: org_study_id