NCT05019495

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
231

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
10mo left

Started Dec 2021

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Dec 2021Feb 2027

First Submitted

Initial submission to the registry

May 4, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

5.2 years

First QC Date

May 4, 2021

Last Update Submit

January 2, 2026

Conditions

HivSmoking, Cigarette

Keywords

Smoking

Outcome Measures

Primary Outcomes (1)

  • Tobacco use abstinence

    Self-reported and confirmed by breath carbon monoxide test

    7 days

Secondary Outcomes (7)

  • Reach

    24 weeks (study completion)

  • Fidelity of intervention

    24 weeks (study completion)

  • Fidelity of intervention

    24 weeks (study completion)

  • Perceived barriers to the outcomes

    24 weeks (study completion)

  • Perceived barriers to the outcomes

    24 weeks (study completion)

  • +2 more secondary outcomes

Study Arms (2)

Treatment as Usual

NO 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.

ProMOTE

EXPERIMENTAL

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.

Behavioral: PrOMOTE

Interventions

PrOMOTEBEHAVIORAL

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.

Also known as: Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement
ProMOTE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 21 and older
  • Current diagnosis of HIV
  • Current smoker (defined as self-report of current smoking)
  • Willing to be randomized
  • English speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Related Publications (1)

  • 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: 36335376DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeCigarette SmokingSmoking

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesTobacco SmokingBehaviorTobacco Use

Central Study Contacts

Chloe Morone

CONTACT

843-637-0734morone@musc.edu

Alana Rojewski

CONTACT

8438761593rojewski@musc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 4, 2021

First Posted

August 24, 2021

Study Start

December 1, 2021

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)