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

Phase 1

Recruiting

• Conditions: Tobacco Dependence; Nicotine Dependence
• Interventions: Drug: Nicotine patch; Behavioral: text messaging

• Registration Number: NCT05487807
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-08-01
• Study First Posted: 2022-08-04
• Study Start: 2023-09-13
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine Replacement	Nicotine patch	This group will receive the standard of care and be prescribed nicotine replacement therapy
Nicotine replacement and text messaging	Nicotine patch	This group will receive the standard of care, be prescribed nicotine replacement therapy, and receive text message support
Text Messaging	text messaging	This group will receive the standard of care and receive text message support
Nicotine replacement and text messaging	text messaging	This group will receive the standard of care, be prescribed nicotine replacement therapy, and receive text message support

Primary Outcome Measures

Name	Time	Method
Prolonged tobacco abstinence	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 Outcome Measures

Name	Time	Method
Point Prevalence	4 weeks, 8 weeks, and 3 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

Trial Locations

Locations (2)

Makerere University; 🇺🇬 Kampala, Uganda

University of Zambia; 🇿🇲 Lusaka, Zambia