Tobacco UseVquitNCT05162911
Implementing Tobacco Use Treatment in HIV Clinics Vietnam
A study testing Ask, advise, Assist and refer to the Quitline, Ask, advise, Assist and referral to onsite counselor and Ask, advise, Assist and referral to onsite counselor and NRT in people with Tobacco Use, run by New York University at 1 site in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Ask, advise, Assist and refer to the Quitline, Ask, advise, Assist and referral to onsite counselor and Ask, advise, Assist and referral to onsite counselor and NRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 672 participants
- Where
- 1 siteVietnam
- Study dates
- 23 Nov 2021to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients in the HIV OPCs
- current tobacco users
- patients who live in Hanoi
- patients reachable by phone
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Ask, advise, Assist and refer to the Quitline, Ask, advise, Assist and referral to onsite counselor, Ask, advise, Assist and referral to onsite counselor and NRT
- Keywords
- Tobacco Use, Implementation Science
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ask, advise, Assist and refer to the QuitlineBehavioural
A nurse will ask, advise, assist and refer patient to the Quitline
Ask, advise, Assist and referral to onsite counselorBehavioural
A nurse will ask, advise, assist and refer patient to a counselor
Ask, advise, Assist and referral to onsite counselor and NRTBehavioural
A nurse will ask, advise, assist and refer patient to a counselor and provide nicotine replacement therapy in the form of gum
| Study group | Role | What they receive |
|---|---|---|
| Ask, Advise, Assist (AAA) and Refer. | Active comparator | Patients will receive Ask, Advise, Assist (AAA) and refer to the quitline as the intervention. Receives: Behavioral: Ask, advise, Assist and refer to the Quitline |
| AAA plus referral to onsite counselor (Counsel). | Active comparator | Patients will receive Ask, Advise, Assist plus referral to onsite counselor. Receives: Behavioral: Ask, advise, Assist and referral to onsite counselor |
| AAA+Counsel+N (Nicotine gum). | Active comparator | Patients will receive Ask, Advise, Assist, plus referral to onsite counselor and nicotine gum. Receives: Behavioral: Ask, advise, Assist and referral to onsite counselor and NRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-months smoking abstinence
Secondary outcomes (1)
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start23 Nov 2021
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- randomized control trial
- Masking
- None (open label)
- Enrolment
- 672 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05162911
- Sponsor's protocol ID
- i19-01783
- Acronym
- Vquit
- Status last verified
- May 2026
- First submitted
- 10 Nov 2021
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shelley D, Armstrong-Hough M, Nguyen T, Alvarez GG, Kapur R, Shuter J, Goldsamt L, Tozan Y, Van Minh H, Van Vu G, Phan PT, Cleland CM, Nguyen N. Effectiveness of behavioural tobacco cessation interventions with and without pharmacotherapy among people living with HIV in Viet Nam: a three-arm pragmatic randomised controlled trial. Lancet Glob Health. 2026 Mar;14(3):e407-e416. doi: 10.1016/S2214-109X(25)00451-6.
PubMed 41713442Hoang TH, Nguyen CVT, Alvarez GG, Nguyen T, Nguyen N, Adermark L, Ng N, Shelley D, Armstrong-Hough M. Multilevel barriers and facilitators to smoking cessation among men living with HIV in Vietnam: a qualitative study of male patients and healthcare providers. BMC Health Serv Res. 2026 Jan 29;26(1):312. doi: 10.1186/s12913-026-14087-z.
PubMed 41612291Shelley 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.
PubMed 36253834
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Tobacco Use Treatment in HIV Clinics in Vietnam
- ClinicalTrials.gov ID
- NCT05162911
- Acronym / sponsor ID
- Vquit / i19-01783
- Conditions
- Tobacco Use
- Keywords
- Tobacco Use, Implementation Science
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 672 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Ask, Advise, Assist (AAA) and Refer. | Active comparator | Behavioral: Ask, advise, Assist and refer to the QuitlinePatients will receive Ask, Advise, Assist (AAA) and refer to the quitline as the intervention. |
| AAA plus referral to onsite counselor (Counsel). | Active comparator | Behavioral: Ask, advise, Assist and referral to onsite counselorPatients will receive Ask, Advise, Assist plus referral to onsite counselor. |
| AAA+Counsel+N (Nicotine gum). | Active comparator | Behavioral: Ask, advise, Assist and referral to onsite counselor and NRTPatients will receive Ask, Advise, Assist, plus referral to onsite counselor and nicotine gum. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients in the HIV OPCs
- current tobacco users
- patients who live in Hanoi
- patients reachable by phone
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ask, advise, Assist and refer to the QuitlineA nurse will ask, advise, assist and refer patient to the Quitline | Behavioural | Ask, Advise, Assist (AAA) and Refer. |
| Ask, advise, Assist and referral to onsite counselorA nurse will ask, advise, assist and refer patient to a counselor | Behavioural | AAA plus referral to onsite counselor (Counsel). |
| Ask, advise, Assist and referral to onsite counselor and NRTA nurse will ask, advise, assist and refer patient to a counselor and provide nicotine replacement therapy in the form of gum | Behavioural | AAA+Counsel+N (Nicotine gum). |
Primary outcome
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.
1 secondary outcome
Factors that may influence tobacco cessation, and sustainability of the interventions tested
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Derived from this study: PubMed 41713442Shelley D, Armstrong-Hough M, Nguyen T, Alvarez GG, Kapur R, Shuter J, Goldsamt L, Tozan Y, Van Minh H, Van Vu G, Phan PT, Cleland CM, Nguyen N. Effectiveness of behavioural tobacco cessation interventions with and without pharmacotherapy among people living with HIV in Viet Nam: a three-arm pragmatic randomised controlled trial. Lancet Glob Health. 2026 Mar;14(3):e407-e416. doi: 10.1016/S2214-109X(25)00451-6.
- Derived from this study: PubMed 41612291Hoang TH, Nguyen CVT, Alvarez GG, Nguyen T, Nguyen N, Adermark L, Ng N, Shelley D, Armstrong-Hough M. Multilevel barriers and facilitators to smoking cessation among men living with HIV in Vietnam: a qualitative study of male patients and healthcare providers. BMC Health Serv Res. 2026 Jan 29;26(1):312. doi: 10.1186/s12913-026-14087-z.
- Derived from this study: PubMed 36253834Shelley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ask, advise, Assist and refer to the Quitline, Ask, advise, Assist and referral to onsite counselor and Ask, advise, Assist and referral to onsite counselor and NRT in people with Tobacco Use, run by New York University at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carbon test at 6-months of smoking abstinence (time frame: 6-months smoking abstinence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05162911, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.