Hiv, Smoking, Cigarette
Conditions
Keywords
Smoking
Brief summary
The purpose of this study is to conduct a randomized trial to evaluate a proactive, opt-out model of provider contact to deliver smoking cessation support for people living with HIV compared to standard care support delivered through traditional clinic pathways. Investigators will also evaluate implementation outcomes to identify barriers and facilitators towards future implementation. Investigators hope to define best practices and optimize the delivery of smoking cessation interventions for people living with HIV.
Detailed description
This hybrid effectiveness-implementation trial presents on opportunity to optimize tobacco treatment delivery for people living with HIV (PLWH), and identify barriers and facilitators towards future implementation. We are proposing a comparison of Treatment As Usual (TAU; reactive, opt-in tobacco treatment using standard clinical pathways) vs Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement (PrOMOTE). Participants will be randomized in a 1:1 allocation. The primary aim is to compare rates of cessation and quit attempts at the Week 12 follow-up between participants who received TAU versus PrOMOTE. As a secondary aim we will characterize key determinants of PrOMOTE reach, implementation fidelity, adherence, and acceptability. We hypothesize that the PrOMOTE intervention will increase cessation rates and number of quit attempts, and that it will result in greater reach and pharmacotherapy delivery compared to TAU. Key determinants of PrOMOTE implementation outcomes will also be characterized. An exploratory assessment of CD4 cell count and HIV viral load, in addition to durability of smoking cessation outcomes, will also be assessed. By optimizing the delivery of effective tobacco treatments for PLWH, we hope to increase the number of people receiving tobacco treatment, increase tobacco cessation rates, and reduce the risk of morbidity and mortality from smoking-related causes.
Interventions
BEHAVIORALPrOMOTE
This is an opt-out, proactive approach to tobacco treatment by a clinical pharmacy specialist. The pharmacist will call patients and offer an individualized pharmacotherapy prescription. The patient must opt-out for it not to be sent to their pharmacy. The patient will also receive brief motivational interviewing and behavioral counseling from the pharmacist.
Sponsors
National Cancer Institute (NCI)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 21 and older * Current diagnosis of HIV * Current smoker (defined as self-report of current smoking) * Willing to be randomized * English speaking
Exclusion criteria
* Currently taking part in any other tobacco treatment program or using cessation medication (i.e., taking nicotine replacement therapy or other cessation medications, enrolled in the Quitline, or in another study) * Currently imprisoned * Pregnant women * Non-English speaking persons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tobacco use abstinence | 7 days | Self-reported and confirmed by breath carbon monoxide test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reach | 24 weeks (study completion) | Percentage of current smokers engaged in an intervention |
| Fidelity of intervention | 24 weeks (study completion) | The extent to which an intervention is implemented as intended. This will be collected via interviews with patients and providers. |
| Perceived barriers to the outcomes | 24 weeks (study completion) | Using the implementation tracking checklist, provider perceptions of barriers faced in completion of intervention steps will be monitored. These will be collected via interviews with patients. |
| Acceptability of intervention | 24 weeks (study completion) | The perception among stakeholders that the treatment is agreeable or satisfactory. This will be collected via interviews with patients and providers. |
Countries
United States
Contacts
Primary ContactChloe Morone
Backup ContactAlana Rojewski
Outcome results
None listed