Nicotine Dependence, Tobacco Dependence
Conditions
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.
Interventions
DRUGNicotine patch
Will be receiving nicotine therapy
BEHAVIORALtext messaging
Will be enrolled in an texting app
Sponsors
National Cancer Institute (NCI)
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized control trial with 4 arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quit attempts | 4 weeks, 8 weeks, and 3 months post enrollment | Self-reported quit attempts and changes in tobacco use, monitoring survey, health assessment form |
| Nicotine patch adherence | 4 weeks, 8 weeks, and 3 months post enrollment | Self-reported adherence to nicotine patch treatment, monitoring survey, health assessment form |
Countries
Uganda, Zambia
Outcome results
None listed