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NCT Number: NCT05487807

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

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.

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Key information

Conditions

Nicotine Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Dependence Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Makerere University, Kampala, Uganda

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

-

Exclusion criteria

  • Females who are pregnant, planning to get pregnant, or breastfeeding
  • <18 years (underage of consent)
  • Visitor, not receiving continuous care at study site
  • Not a current daily tobacco user
  • Any physical, cognitive, or psychological disabilities that would prevent them from participating in the study
  • Illiterate in English and/or local languages
  • Does not consent

Treatment and study plan

Nicotine patch

Drug

Will be receiving nicotine therapy

Other names: NicoDerm

Text messaging

Behavioral

Will be enrolled in an texting app

Other names: Text2Quit

Primary outcomes

  1. Prolonged tobacco abstinence

    Time frame: 6 months post enrollment

    The primary outcome for this efficacy trial is the proportion of study participants that have prolonged abstinence (i.e., no tobacco use from the target quit date through follow-up) at 3 and 6 months post enrollment measured by self-report and biochemically-verified as recommended by the Society for Research on Nicotine and Tobacco, the biomarker being assessed is urinary cotinine (<12 ng/mL) at 6 months post enrollment

Secondary outcomes

  1. Point Prevalence

    Time frame: 4 weeks, 8 weeks, and 3 months post enrollment

    7 consecutive days of no tobacco use, biochemically-verified at 4 weeks, 8 weeks, and 3 months post enrollment, the biomarker being assessed is urinary cotinine (<12 ng/mL) at 6 months post enrollment, the measurement tool is urine cotinine dip sticks

Other outcomes

  1. Quit attempts

    Time frame: 4 weeks, 8 weeks, and 3 months post enrollment

    Self-reported quit attempts and changes in tobacco use, monitoring survey, health assessment form

  2. Nicotine patch adherence

    Time frame: 4 weeks, 8 weeks, and 3 months post enrollment

    Self-reported adherence to nicotine patch treatment, monitoring survey, health assessment form

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Quit4Life+: Adapting and Evaluating a Phone-Based Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia (Quit4Life+ )

Acronym: Quit4Life

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 4, 2022
Registry last updated
Nov 28, 2023

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

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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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