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

University of Southern California

Status and phase: Enrolling; Phase 1

Conditions: Tobacco Dependence; Nicotine Dependence

Treatments: Behavioral: text messaging; Drug: Nicotine patch

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05487807

1U01CA261624 (U.S. NIH Grant/Contract)

00006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 4 patient groups

Standard of Care

No Intervention group

Description:

This is the baseline group receiving advice to quit.

Nicotine Replacement

Active Comparator group

Description:

This group will receive the standard of care and be prescribed nicotine replacement therapy

Treatment:

Drug: Nicotine patch

Text Messaging

Active Comparator group

Description:

This group will receive the standard of care and receive text message support

Treatment:

Behavioral: text messaging

Nicotine replacement and text messaging

Active Comparator group

Description:

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

Treatment:

Drug: Nicotine patch

Behavioral: text messaging