Quit4Life+: Adapting and Evaluating a Phone-Based Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia (Quit4Life+ )
Overview
- Phase
- Phase 1
- Intervention
- Nicotine patch
- Conditions
- Nicotine Dependence
- Sponsor
- University of Southern California
- Enrollment
- 800
- Locations
- 2
- Primary Endpoint
- Prolonged tobacco abstinence
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Heather Wipfli
Associate Professor
University of Southern California
Eligibility Criteria
Inclusion Criteria
- Not provided
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
Arms & Interventions
Nicotine Replacement
This group will receive the standard of care and be prescribed nicotine replacement therapy
Intervention: Nicotine patch
Text Messaging
This group will receive the standard of care and receive text message support
Intervention: text messaging
Nicotine replacement and text messaging
This group will receive the standard of care, be prescribed nicotine replacement therapy, and receive text message support
Intervention: Nicotine patch
Nicotine replacement and text messaging
This group will receive the standard of care, be prescribed nicotine replacement therapy, and receive text message support
Intervention: text messaging
Outcomes
Primary Outcomes
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
- Point Prevalence(4 weeks, 8 weeks, and 3 months post enrollment)