Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Enhancing Smoking Cessation for Black People with HIV

Official title: A National Test of a Culturally Tailored Smartphone-based Smoking Cessation and Mental Health Intervention for Black Adults With HIV

Run by University of Houston · NCT07024992 · Data updated 2026-11-12

A smartphone-based program plus nicotine replacement is tested to help Black people living with HIV quit smoking.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment300 (estimated)
SponsorUniversity of Houston
Academic / other
Locations1 site (Oklahoma City, Oklahoma)
StatusRecruiting
StartedJune 30, 2026
Main results expectedJune 30, 2029
Study endsJune 30, 2029
Registry record updatedJuly 13, 2026
Trial IDNCT07024992 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are Black adults with HIV who smoke, are motivated to quit, own an Android or iPhone, and have adequate English literacy.

Probably not a fit

Individuals not ready to quit within 14 days, without access to a compatible smartphone, or without willingness to use NRT may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial compares two mobile smoking cessation programs plus NRT against an assessment-only control among 300 Black adults living with HIV who smoke. Participants are randomly assigned to ESCAPE + NRT, quitSTART + NRT, or control + NRT, with remote assessments over 54 weeks and a subset completing qualitative interviews in week 6. The study uses ecological momentary assessments, regular follow-ups, and biomarker verification to measure quit rates and HIV care management outcomes. The aim is to determine whether culturally tailored mHealth support improves cessation and HIV-related health management more than standard mobile tools or no active intervention.

Why it matters

Potential benefit: If successful, participants may achieve higher quit rates and better HIV management with a culturally tailored mobile program.

How similar studies have gone: Prior mobile smoking cessation studies show benefits with app-based interventions, but this trial specifically tests a culturally tailored approach in Black people with HIV.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* At least 18 years of age
* Identify as Black/African American
* Living with HIV
* Biochemical verification of self-reported smoking status following minimum study specified smoking rate endorsement
* Motivated to quit smoking
* Must be ready to quit cigarettes within 14 days of full enrollment
* Moderate or higher anxiety sensitivity OR elevated anxiety OR depression
* Must be willing to download a mobile app onto their personal phone
* Must be willing to use NRT
* Possess an Android/Apple smartphone that is compatible with the mobile app
* Demonstrate 7th grade level proficiency in English (≥4 on the Rapid Estimate of Adult Literacy in Medicine-Short Form \[REALM-SF\])
* Valid proof of identification (photo of valid US ID)

Exclusion Criteria:

* Legal situations which may interfere with study participation
* Not being fluent in English
* High blood pressure that is not under control
* Having experienced a heart attack within the past 2 weeks
* Pregnant of planning to become pregnant within the next six months

Where it's running

  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma, United States
    Recruiting

Study contacts

  • Principal investigator: Michael S. Businelle, Ph.D. — University of Oklahoma Health Sciences
  • Study coordinator: Lorra Garey, Ph.D.
  • Email: llgarey@central.uh.edu
  • Phone: 713-743-8056

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.