Optimizing Tobacco Treatment Delivery for People Living With HIV
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PrOMOTE.
- Who it may be relevant to
- Registry conditions: Hiv, Smoking, Cigarette. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral PrOMOTE
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.
Primary outcome measures
- Tobacco use abstinence [Time frame: 7 days]
Secondary outcome measures (7)
- Reach [Time frame: 24 weeks (study completion)]
- Fidelity of intervention [Time frame: 24 weeks (study completion)]
- Fidelity of intervention [Time frame: 24 weeks (study completion)]
- Perceived barriers to the outcomes [Time frame: 24 weeks (study completion)]
- Perceived barriers to the outcomes [Time frame: 24 weeks (study completion)]
- Acceptability of intervention [Time frame: 24 weeks (study completion)]
- Acceptability of intervention [Time frame: 24 weeks (study completion)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Publications
- Sanford BT, Toll BA, Eckard AR, Sterba KR, Cummings KM, Baker NL, Rojewski AM. Optimizing tobacco treatment delivery for people with HIV: trial protocol for a randomized controlled trial. Addict Sci Clin Pract. 2022 Nov 5;17(1):61. doi: 10.1186/s13722-022-00341-2. PMID 36335376
Identifiers
NCT: NCT05019495 · 00107332 · R01CA261232