Implementing Tobacco Use Treatment in HIV Clinics Vietnam (Vquit)

Implementing Tobacco Use Treatment in HIV Clinics in 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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Use
• Intervention / Treatment: Behavioral: Ask, advise, Assist and refer to the Quitline; Behavioral: Ask, advise, Assist and referral to onsite counselor; Behavioral: Ask, advise, Assist and referral to onsite counselor and NRT

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.

• Study Type: Interventional
• Enrollment (Estimated): 672
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nam Nguyen, MD DrPH; Phone Number: +84-4-35558288; Email: ntnam@isms.org.vn
• Study Contact Backup: Name: Donna Shelley, MD MPH; Phone Number: 917-494-4210; Email: ds186@nyu.edu

Study Locations

• Vietnam
  • Nam Tu Liem
    • Hanoi, Nam Tu Liem, Vietnam, 2QJG+94
      • Recruiting
      • Nam Nguyen
      • Contact: Nam Nguyen, PhD; Phone Number: +84-4-35558288; Email: ntnam@isms.org.vn
      • Principal Investigator: Nam Nguyen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ask, Advise, Assist (AAA) and Refer.; Patients will receive Ask, Advise, Assist (AAA) and refer to the quitline as the intervention.	Behavioral: Ask, advise, Assist and refer to the Quitline; A nurse will ask, advise, assist and refer patient to the Quitline
Active Comparator: AAA plus referral to onsite counselor (Counsel).; Patients will receive Ask, Advise, Assist plus referral to onsite counselor.	Behavioral: Ask, advise, Assist and referral to onsite counselor; A nurse will ask, advise, assist and refer patient to a counselor
Active Comparator: AAA+Counsel+N (Nicotine gum).; 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; A nurse will ask, advise, assist and refer patient to a counselor and provide nicotine replacement therapy in the form of gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
factors that may influence tobacco cessation, and sustainability of the interventions tested	using questionnaires measure health care setting, provider, and patient level factors that may influence tobacco cessation, and sustainability of the interventions tested.	18 months

Collaborators and Investigators

• Sponsor: New York University
• Investigators: Principal Investigator: Donna Shelley, MD MPH, New York University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: December 15, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Tobacco Use; Implementation Science
• Other Study ID Numbers: i19-01783

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No