Clinical trial NCT04594109: Development of a Tailored Smoking Cessation Program for Individuals With HIV Infection in Washington, D.C.
Official title: Development of a Tailored Smoking Cessation Program for Individuals With HIV Infection in Washington, D.C.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Smoking
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Morbidity and mortality from smoking-related diseases among people living with HIV (PLWH) in the U.S. surpasses that due to HIV itself. Conventional smoking cessation treatments have not demonstrated strong efficacy among PLWH. The investigators conducted a pilot randomized controlled trial (RCT) to evaluate a tailored smoking cessation intervention based on the minority stress model, hypothesizing that behavioral counseling through this lens would enhance cessation. The investigators compared standard of care counseling (SOC) to a tailored intervention (TI) including one face-to-face counseling session incorporating cognitive behavioral therapy to build resilience, and 30 days of 2-way text messaging.


Eligibility criteria: Inclusion Criteria:

* ≥18 years of age
* report being HIV-infected
* be a resident of the Washington, D.C. area
* current, daily smokers of tobacco
* have a confirmed smoking status of 6 parts per million (ppm) or more by using an exhaled carbon monoxide breath monitor
* agree to participate
* be willing to set a quit date within 7 days of baseline assessment.

Exclusion Criteria:

* are currently using smokeless tobacco or electronic cigarettes at least every day
* are currently using nicotine replacement therapy or other smoking cessation treatment
* report being HIV-uninfected
* report having heart disease or high blood pressure not controlled by medication
* are currently in an alcohol treatment program
* are pregnant (exclusion items 4-6 are contraindications of nicotine replacement therapy, which will be provided)
* do not have a primary care provider or HIV care provider to refer to in the event of an adverse reaction to nicotine replacement therapy.

Primary outcomes:
measure: Smoking Abstinence
timeFrame: 30 day follow-up
Secondary outcomes:
measure: Cigarettes per day
timeFrame: 30 day follow-up
measure: Exhaled breath carbon monoxide
timeFrame: 30 day follow-up
measure: Self-efficacy
timeFrame: 30 day follow-up
Other outcomes:
Locations:
city: Washington
country: United States
facility: Truth Initiative
state: District of Columbia
Study officials:
affiliation: Colorado State University
name: Jessica Elf, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kierstead EC, Harvey E, Sanchez D, Horn K, Abroms LC, Spielberg F, Stanton CA, Debnam C, Cohn AM, Gray T, Magnus M, Patel M, Niaura R, Elf JL. A pilot randomized controlled trial of a tailored smoking cessation program for people living with HIV in the Washington, D.C. metropolitan area. BMC Res Notes. 2021 Jan 6;14(1):2. doi: 10.1186/s13104-020-05417-3.