Adapting & Evaluating a Tobacco Use Cessation Program for People Living

Status Recruiting

Clinical Trial Summary

This proposal tests the efficacy of a phone-based tobacco cessation intervention for people living with HIV (PLWH) in comparison to the standard of care (brief advice to quit) and nicotine replacement therapy (nicotine patches) in Uganda and Zambia. This study will provide insight into the efficacy, feasibility, applicability, and affordability of delivering tobacco cessation interventions through health care professionals at HIV treatment centers in two countries with different tobacco use patterns, policy environments, and health care resources. The previously tested SMS-platform to be used in this study is uniquely positioned to be scaled in low- and middle-income countries worldwide, in which case rigorous research showing even modest success in reducing the prevalence of tobacco consumption among PLWH could confer substantial health and economic benefits.

Clinical Trial Description

While there is substantial evidence supporting interventions to help tobacco users in the general population quit, little is available relevant to the challenges facing HIV+ tobacco users, especially those living in low-income African countries. This study approaches this gap with the first randomized control trial (RCT) to test the efficacy of a tailored short message service (SMS) based tobacco use cessation intervention on prolonged tobacco use abstinence at 6 months post program initiation in comparison to the standard of care (brief advice to quit) and nicotine replacement therapy (nicotine patches) among PLWH in Uganda and Zambia. This study will provide insight into the efficacy, feasibility, applicability, and affordability of delivering tobacco cessation interventions through health care professionals at HIV treatment centers in two countries with different tobacco use patterns, policy environments, and health care resources and provide needed information to providers and policymakers looking for cost-effective tobacco cessation interventions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05487807
Study type	Interventional
Source	University of Southern California
Contact
Status	Recruiting
Phase	Phase 1
Start date	September 13, 2023
Completion date	August 31, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05176418` - IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate	Early Phase 1
Completed	`NCT04084210` - Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use	Phase 2
Completed	`NCT04043728` - Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study	N/A
Withdrawn	`NCT03707600` - State and Trait Mediated Response to TMS in Substance Use Disorder	N/A
Recruiting	`NCT03999099` - Targeting Orexin to Treat Nicotine Dependence	Phase 1
Completed	`NCT03847155` - Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery	N/A
Completed	`NCT02840435` - Study on Sit to Quit Phone Intervention	N/A
Completed	`NCT02139930` - Project 2: Strategies for Reducing Nicotine Content in Cigarettes	N/A
Completed	`NCT01982110` - A Mindfulness Based Application for Smoking Cessation	N/A
Completed	`NCT01926626` - Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers	Phase 2
Withdrawn	`NCT01569477` - Striving to Quit-Wisconsin Tobacco Quit Line	N/A
Completed	`NCT01569490` - Striving to Quit: First Breath	N/A
Completed	`NCT01685996` - Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation	Phase 1/Phase 2
Completed	`NCT01632189` - The Effect of Varenicline on D2/D3 Receptor Binding in Smokers	N/A
Active, not recruiting	`NCT01182766` - New Treatment for Alcohol and Nicotine Dependence	Phase 2/Phase 3
Completed	`NCT00996034` - Nicotine Vaccination and Nicotinic Receptor Occupancy	Phase 2
Completed	`NCT01061528` - Coping Skills Treatment for Smoking Cessation	N/A
Suspended	`NCT01636336` - Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects	N/A
Completed	`NCT01943994` - Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study	N/A
Withdrawn	`NCT01589081` - Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Adapting and Evaluating a Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia — Quit4Life

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms