Clinical trial NCT04135937: Mobile Evidence-Based Smoking Cessation for Veterans Living With HIV (MESH)
Official title: A Personalized mHealth Approach to Smoking Cessation for Veterans Living With HIV (CDA 17-005)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Human Immunodeficiency Virus
Smoking
Keywords: Human Immunodeficiency Virus
Smoking
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-10-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Smoking is a significant cause of damage to health and quality of life specifically for Veterans with human immunodeficiency virus (HIV). Smoking cessation interventions for this population are lacking. The primary aim of this project is to explore smoking cessation treatment preferences among Veteran smokers living with HIV. The study team will refine the design and content of a smoking cessation treatment for Veteran smokers living with HIV. The intervention uses mobile health and telehealth technology to personalize smoking cessation counseling and medications and provide relapse prevention text messaging.

Detailed description: Although smoking is a significant cause of damage to health and quality of life specifically for Veterans with human immunodeficiency virus (HIV), smoking cessation interventions for this population are lacking. The primary aim of this project is to qualitatively explore smoking cessation treatment preferences among Veteran smokers living with HIV. The study team will refine the design and content of an intervention that uses mobile health and telehealth technology to a)individually personalize smoking cessation counseling and pharmacotherapy, and b) provide relapse prevention messaging support. It is a personalized, tailored, multi-component intervention for smoking cessation specifically designed for Veteran smokers living with HIV.

This project is highly significant given that: 1) smoking is prevalent among and particularly harmful for HIV-positive Veterans; 2) there is a dearth of research on smoking cessation for Veterans with HIV; 3) current approaches to smoking cessation in this population are not effective; 4) as the largest US provider of HIV health services, VHA is an ideal setting; and 5) the proposed intervention follows the VA Blueprint for Excellence, which prioritizes mobile health and treatment personalization to increase reach/efficacy.

Eligibility criteria: Inclusion Criteria:

* VHA patient
* HIV positive serostatus
* currently smoking 7 cigarettes per week
* willing to complete study procedures. Exclusion criteria are:

Exclusion Criteria:

* current hospitalization
* acute risk for suicide documented in the medical record
* inability to complete study procedures.

Primary outcomes:
measure: Number of Participants Who Participate in the Post-treatment Interview
timeFrame: Post-treatment follow-up visit (week 5)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Sarah M. Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
References: