Adapting and Evaluating a Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern California
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Nicotine patch
DrugWill be receiving nicotine therapy
text messaging
BehavioralWill be enrolled in an texting app
Treatment groups
800 Participants
are divided into 4 treatment groupsGroup A: Standard of CareNo intervention 0 interventions
Group B: Nicotine ReplacementActive comparator 1 intervention
Group C: Text MessagingActive comparator 1 intervention
Group D: Nicotine replacement and text messagingActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
6 months post enrollmentSecondary outcomes
1
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
Time frame
4 weeks, 8 weeks, and 3 months post enrollmentOther outcomes
1
Quit attempts
Self-reported quit attempts and changes in tobacco use, monitoring survey, health assessment form
Time frame
4 weeks, 8 weeks, and 3 months post enrollment2
Nicotine patch adherence
Self-reported adherence to nicotine patch treatment, monitoring survey, health assessment form
Time frame
4 weeks, 8 weeks, and 3 months post enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Southern California
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov