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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nicotine Dependence, Tobacco Dependence

Intervention / Treatment
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* Drug: Nicotine patch
* Behavioral: text messaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized control trial with 4 arms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>This is the baseline group receiving advice to quit. | |
| Active Comparator: Nicotine Replacement<br>This group will receive the standard of care and be prescribed nicotine replacement therapy | Drug: Nicotine patch<br>* Will be receiving nicotine therapy<br>* Other names: NicoDerm;|
| Active Comparator: Text Messaging<br>This group will receive the standard of care and receive text message support | Behavioral: text messaging<br>* Will be enrolled in an texting app<br>* Other names: Text2Quit;|
| Active Comparator: Nicotine replacement and text messaging<br>This group will receive the standard of care, be prescribed nicotine replacement therapy, and receive text message support | Drug: Nicotine patch<br>* Will be receiving nicotine therapy<br>* Other names: NicoDerm;Behavioral: text messaging<br>* Will be enrolled in an texting app<br>* Other names: Text2Quit;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolonged tobacco abstinence | 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 | 6 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point Prevalence | 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 | 4 weeks, 8 weeks, and 3 months post enrollment |