Clinical trial NCT05487807: Adapting and Evaluating a Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia
Official title: Quit4Life+: Adapting and Evaluating a Phone-Based Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia (Quit4Life+ )
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Nicotine Dependence
Tobacco Dependence
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-08-04
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial with 4 arms
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prolonged tobacco abstinence
timeFrame: 6 months post enrollment
Secondary outcomes:
measure: Point Prevalence
timeFrame: 4 weeks, 8 weeks, and 3 months post enrollment
Other outcomes:
measure: Quit attempts
timeFrame: 4 weeks, 8 weeks, and 3 months post enrollment
measure: Nicotine patch adherence
timeFrame: 4 weeks, 8 weeks, and 3 months post enrollment
Locations:
city: Kampala
country: Uganda
facility: Makerere University
city: Lusaka
country: Zambia
facility: University of Zambia
Study officials:
References:
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