Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05863923
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-10
First Post:
2023-03-31
Brief Title:
Tobacco Cessation Texting Intervention for People Living With HIV Who Smoke in Vietnam
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
mHealth Messaging to Motivate Quitline Use and Quitting Among Persons Living With HIV PLWH in Vietnam M2Q2-HIV
Status:
ENROLLING_BY_INVITATION
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:
M2Q2-HIV
Brief Summary:
The intersection of smoking and HIVAIDS poses a serious public health threat in Vietnam Vietnam is dealing with these two challenges with parallel rather than integrated plans Using a computer-tailored texting intervention study investigators seek to promote the use of an underused available government-funded resource the Quitline and Nicotine Replacement Therapy NRT that the quitline provides thus promoting cessation among PLWH
Detailed Description:
M2Q2-HIV mHealth Messaging to Motivate Quitline Use and Quitting among Persons Living with HIV PLWH in Vietnam M2Q2-HIV is an adaptation of a current computer-tailored smoking cessation intervention in Vietnam Study investigators seek to promote underused government resources for public health the Quitline and Nicotine Replacement Therapy NRT among PLWH in a sustainable manner
Investigators will test M2Q2-HIV by conducting a randomized control trial with 600 PLWH smokers in two provinces in Northern Vietnam 26 clinics 9877 HIV patients
In Aim 1 study investigators will conduct formative work to prepare the M2Q2-HIV system for PLWH smokers
In Aim 2 the study team will randomize and follow smokers for six months The studys effectiveness hypothesis will evaluate carbon monoxide CO verified six-month seven-day point prevalence cessation Process hypotheses will evaluate self-efficacy Quitline and NRT use and test our hypothesized model that specific measured processes will partially mediate observed intervention effectiveness
Using qualitative interviews with key stakeholders and PLWH smokers Aim 3 will support nationwide M2Q2-HIV dissemination assessing acceptability and contextual factors guided by the Practical Robust Implementation and Sustainability Model PRISM
This project builds upon a long-standing successful collaboration between institutions in Vietnam Ministry of Health Bach Mai Quitline Institute of Population Health and Development Hanoi Medical University and UMass Chan Medical School The study team has expertise in smoking cessation HIV intervention including stigma related to concomitant substance use and implementation of complex interventions If proven effective the Vietnam Ministry of Health is committed to incorporating M2Q2-HIV as a permanent part of the national infrastructure
Investigators will test M2Q2-HIV by conducting a randomized control trial with 600 PLWH smokers in two provinces in Northern Vietnam 26 clinics 9877 HIV patients
In Aim 1 study investigators will conduct formative work to prepare the M2Q2-HIV system for PLWH smokers
In Aim 2 the study team will randomize and follow smokers for six months The studys effectiveness hypothesis will evaluate carbon monoxide CO verified six-month seven-day point prevalence cessation Process hypotheses will evaluate self-efficacy Quitline and NRT use and test our hypothesized model that specific measured processes will partially mediate observed intervention effectiveness
Using qualitative interviews with key stakeholders and PLWH smokers Aim 3 will support nationwide M2Q2-HIV dissemination assessing acceptability and contextual factors guided by the Practical Robust Implementation and Sustainability Model PRISM
This project builds upon a long-standing successful collaboration between institutions in Vietnam Ministry of Health Bach Mai Quitline Institute of Population Health and Development Hanoi Medical University and UMass Chan Medical School The study team has expertise in smoking cessation HIV intervention including stigma related to concomitant substance use and implementation of complex interventions If proven effective the Vietnam Ministry of Health is committed to incorporating M2Q2-HIV as a permanent part of the national infrastructure
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA261604 | NIH | None | httpsreporternihgovquickSearchU01CA261604 |