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NCT Number: NCT05019495

Optimizing Tobacco Treatment Delivery for People Living With HIV

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Cigarette Smoking Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Smoking Smoking, Cigarette Tobacco Smoking Tobacco Use Urogenital Diseases Virus Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Chloe Morone

CONTACT

843-637-0734

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PROMOTE

Behavioral

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.

Other names: Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement

Primary outcomes

  1. Tobacco use abstinence

    Time frame: 7 days

    Self-reported and confirmed by breath carbon monoxide test

Secondary outcomes

  1. Reach

    Time frame: 24 weeks (study completion)

    Percentage of current smokers engaged in an intervention

  2. Fidelity of intervention

    Time frame: 24 weeks (study completion)

    The extent to which an intervention is implemented as intended. This will be collected via interviews with patients and providers.

  3. Fidelity of intervention

    Time frame: 24 weeks (study completion)

    The extent to which an intervention is implemented as intended. This will be collected via surveys.

  4. Perceived barriers to the outcomes

    Time frame: 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.

  5. Perceived barriers to the outcomes

    Time frame: 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 providers.

  6. Acceptability of intervention

    Time frame: 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.

  7. Acceptability of intervention

    Time frame: 24 weeks (study completion)

    The perception among stakeholders that the treatment is agreeable or satisfactory. This will be collected via surveys.

Study contacts

Contact information is provided by the study sponsor or research team.

Alana Rojewski

CONTACT

[email protected]

8438761593

Chloe Morone

CONTACT

[email protected]

843-637-0734

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2021
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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