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Behavioral Intervention

PrOMOTE Program for Smoking Cessation in HIV

N/A
Recruiting
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21 and older
Current diagnosis of HIV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks (study completion)
Awards & highlights

Study Summary

This trial will compare 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.

Who is the study for?
This trial is for English-speaking adults aged 21 or older who are living with HIV and currently smoke cigarettes. Participants must be willing to be randomly assigned to different treatment groups. People cannot join if they're already in another tobacco treatment program, using cessation medications, pregnant, or incarcerated.Check my eligibility
What is being tested?
The study is testing a proactive approach called PrOMOTE that reaches out to patients directly for smoking cessation support versus the standard care which relies on traditional clinic visits. The goal is to find the best way to help people with HIV quit smoking.See study design
What are the potential side effects?
Since this trial focuses on behavioral intervention rather than medication, specific side effects are not detailed like drug trials. However, participants may experience stress or discomfort related to quitting smoking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or older.
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I am currently diagnosed with HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks (study completion)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks (study completion) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tobacco use abstinence
Secondary outcome measures
Acceptability of intervention
Fidelity of intervention
Perceived barriers to the outcomes
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ProMOTEExperimental Treatment1 Intervention
In the PrOMOTE group, the participants will be contacted by the clinical pharmacist on the tobacco treatment staff three times for medication prescriptions and refills. They will also receive brief counseling and motivational interviewing by the clinical pharmacist.
Group II: Treatment as UsualActive Control1 Intervention
Treatment as Usual (TAU) participants will follow traditional clinic pathways for receiving tobacco treatment in the Medical University of South Carolina Health Infectious Disease outpatient clinic. All patients randomized to TAU will have the opportunity to access smoking cessation pharmacotherapy from the Infectious Disease clinical pharmacist.

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,404 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,674 Total Patients Enrolled

Media Library

PrOMOTE (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05019495 — N/A
HIV (Human Immunodeficiency Virus) Research Study Groups: ProMOTE, Treatment as Usual
HIV (Human Immunodeficiency Virus) Clinical Trial 2023: PrOMOTE Highlights & Side Effects. Trial Name: NCT05019495 — N/A
PrOMOTE (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05019495 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant size of this clinical trial?

"Affirmative. Clinicaltrials.gov data shows that this clinical research, which was first announced on December 1st 2021, is ongoing and requires 231 patients to join from a single location."

Answered by AI

Is enrollment still open for this research project?

"This clinical trial, which was initially published on December 1st 2021, is currently accepting patients. The latest update to the study occurred on November 28th 2022 according to data hosted on clinicialtrials.gov."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Medical University of South Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Optimizing Tobacco Treatment Delivery for People Living With HIV
Alana Rojewski 2021. "Optimizing Tobacco Treatment Delivery for People Living With HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05019495.
~87 spots leftby Sep 2025
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