Optimizing Tobacco Treatment Delivery for People Living With HIV
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 21 and older
Current diagnosis of HIV
Current smoker (defined as self-report of current smoking)
Willing to be randomized
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PrOMOTE
BehavioralThis 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.
Treatment groups
231 Participants
are divided into 2 treatment groupsGroup A: Treatment as UsualNo intervention 0 interventions
Group B: ProMOTEExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tobacco use abstinence
Self-reported and confirmed by breath carbon monoxide test
Time frame
7 daysSecondary outcomes
1
Reach
Percentage of current smokers engaged in an intervention
Time frame
24 weeks (study completion)2
Fidelity of intervention
The extent to which an intervention is implemented as intended. This will be collected via interviews with patients and providers.
Time frame
24 weeks (study completion)3
Fidelity of intervention
The extent to which an intervention is implemented as intended. This will be collected via surveys.
Time frame
24 weeks (study completion)4
Perceived barriers to the outcomes
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.
Time frame
24 weeks (study completion)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Medical University of South Carolina
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov