The purpose of this pilot randomized controlled trial study aims to address the unmet need for feasible and efficacious strategies for reducing combustible cigarette (CC) use among people living with HIV/AIDS (PLWHA) in South Africa, which has the potential to significantly improve the health and long-term survival of PLWHA CC smokers. Using the proposed intervention, based on the Information-Motivation-Behavioral Skills (IMB), and a simultaneous embedded mixed methods approach, the investigators will evaluate a telehealth program targeting CC harm reduction, comparing E-cigarettes (EC) to nicotine replacement therapy (NRT) that is enhanced by integrating ecological momentary intervention (EMI) texting. As such, this proposal will significantly build research capacity in South Africa to conduct telehealth tobacco treatment interventions using innovative EMI approaches enhancing participants' engagement, as well as state-of-the art evaluation approaches.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
106
NRT (daily patches and lozenges). NRT strength will be according to the established dosing guidelines for tobacco treatment. NRT is the standard of care in tobacco treatment and helped reduce CPD in prior trials
EC with single-use pods. Nicotine - 48 mg/ ml (4.8% nicotine) concentration.
Each participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting.
South African Medical Research Council (SAMRC)
Cape Town, South Africa
Recruitment Rate
Defined as the total number of participants recruited divided by the maximum number of recruiting sites, then divided by the total number of months that the trial recruited for.
Time frame: Up to Month 6
Percent of Patients who Enroll in Counseling
Defined as the percentage of participants who start the intervention counseling sessions.
Time frame: Up to Month 6
Follow-Up Rate at 3 Months
Defined as the percent of participants who completed the 3-month follow-up.
Time frame: Month 3
Follow-Up Rate at 6 Months
Defined as the percent of participants who completed the 6-month follow-up.
Time frame: Month 6
Client Satisfaction Questionnaire (CSQ-8) Score
8-item assessment of satisfaction with the intervention. The total score is the sum of responses and ranges from 8 to 32, with higher numbers indicating greater satisfaction.
Time frame: Week 8
Client Satisfaction Questionnaire (CSQ-8) Score
8-item assessment of satisfaction with the intervention. The total score is the sum of responses and ranges from 8 to 32, with higher numbers indicating greater satisfaction.
Time frame: Month 3
Percentage of Participants who Achieve 7-Day Point Prevalence Abstinence.
Abstinence will be verified by exhaled carbon monoxide and defined as no combustible cigarette use in the last 7 days.
Time frame: Month 3
Percentage of Participants who achieve 50% Reduction in Cigarettes Per Day (CPD), compared with Baseline
CPD will be self-reported.
Time frame: Up to Month 6
Change in American Thoracic Society Questionnaire Score
Change in American Thoracic Questionnaire Score from Baseline to Week 12 8-item questionnaire assessing general thoracic pain. Items are rated on a Likert scale from 1 (never) to 5 (every day). The total score is the sum of responses and ranges from 8-40; higher scores indicate more severe impact of general thoracic pain.
Time frame: Baseline, Month 6
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