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

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

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

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.

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.

This group will receive the standard of care, be prescribed nicotine replacement therapy, and receive text message support

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

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

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

Our dissemination strategy will target tobacco and HIV stakeholders including Ministry of Health and other government officials, health care organizations, health facility managers, HIV health care providers, tobacco control professionals, non-governmental organizations engaged in HIV and tobacco control, and PLWH. Our investigators will publish study results through peer-reviewed journals and scientific conferences; generate fact sheets and policy briefs; and disseminate our results through websites, social media, television and radio. We will share the study results in the participating Districts and the Cancer Treatments Centers of America will host a workshop in the final year with regional stakeholders to share the study results and promote tobacco use cessation programming for PLWH throughout Sub-saharan Africa. World Health Organization will assist in disseminating the study findings to other low/middle income countries.

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