Ignite Creation Date:
2024-05-06 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05162911
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2021-11-10
Brief Title:
Implementing Tobacco Use Treatment in HIV Clinics Vietnam
Sponsor:
New York University
Organization:
New York University
Study Overview
Official Title:
Implementing Tobacco Use Treatment in HIV Clinics in Vietnam
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Vquit
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 13AsReferral to the national quitline Ask about tobacco use Advise to quit Assist with brief counseling and Refer to Viet Nams national Quitline 2 AAA Counsel Counsel6-session cessation counseling intervention adapted for patients living with HIVAIDS PLWH and delivered by a trained onsite nurse and 3 AAACounselN Nnicotine 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 n24 The investigators will conduct key informant interviews with health care providers from 3 OPCs n28 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 HIVAIDS PLWH Patients n672 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 n98 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 n98 For Aim 4 the investigators will enroll 75 more patients who are non-smokers for a total of n747 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None