Clinical Trials Directory

Trials / Completed

CompletedNCT04594109

Development of a Tailored Smoking Cessation Program for Individuals With HIV Infection in Washington, D.C.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
25 (actual)
Sponsor
Colorado State University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTailored behavioral counselingParticipants in the intervention arm were provided a one-time tailored cognitive-behavioral therapy in-person cessation counseling intervention lasting approximately one hour, a 30-day supply of nicotine replacement therapy (consisting of nicotine patches and nicotine gum; dosage according to current smoking intensity according to manufacturers instructions), and a tailored bi-directional text messaging program delivering two messages per day for four weeks. The TI session was adapted from the clinical practice guidelines to include behavioral elements rooted in the minority stress model. The intervention used addressed issues of stress related to HIV stigma, minority status and socioeconomic condition.
BEHAVIORALStandard of CareOne-time standard of care in-person behavioral counseling lasting approximately one hour, plus a 30-day supply of nicotine replacement therapy consisting of nicotine patches and nicotine gum (dosage according to current smoking intensity according to manufacturers instructions). The standard of care behavioral counseling was adapted from the current U.S. clinical practice guidelines.

Timeline

Start date
2017-06-30
Primary completion
2018-01-29
Completion
2018-01-30
First posted
2020-10-20
Last updated
2023-04-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04594109. Inclusion in this directory is not an endorsement.