E-cigarette Harm Reduction Among PLWHA in South Africa

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating Smoking Cessation and Harm Reduction Approaches Among People Living With HIV/AIDS (PLWHA ) in South Africa

Conditions
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Tobacco Smoking

Intervention / Treatment
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* Other: Nicotine Replacement Therapy (NRT)
* Other: E-Cigarette (EC)
* Behavioral: Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult PLWHA CC smokers; Speaks Afrikaans, or Xhosa, or English; reports daily CC smoking (≥ 5 CPD); Owns any type of mobile phone; interested in reducing CC smoking but not necessarily trying to quit; Receives HIV/AIDS care in one of the eight selected clinics follow-up rates. Exclusion Criteria: are pregnant or breastfeeding; unable to provide consent; used tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo); currently engaged in an attempt to quit CC smoking; current major depressive or manic episode, current psychotic disorder, past-year suicide attempt, or current suicidal ideation with plan or intent. plan or intent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control (Quit-Line Referral)<br>Participants will receive referral to the existing South African Quitline. Participants will receive information to contact the Quitline if participants so choose, in addition to ecological momentary assessment (EMA) texting orientation. | Behavioral: Counseling<br>* Each participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting.<br>|
| Experimental: Nicotine Replacement Therapy (NRT)<br>In addition to phone counseling + ecological momentary intervention (EMI) texting, participants will receive combination NRT (daily patches and lozenges). | Other: Nicotine Replacement Therapy (NRT)<br>* 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<br>Behavioral: Counseling<br>* Each participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting.<br>|
| Experimental: Electronic Cigarette (EC)<br>In conjunction with phone counseling + EMI texting, participants will receive the VUSE Solo EC. | Other: E-Cigarette (EC)<br>* EC with single-use pods. Nicotine - 48 mg/ ml (4.8% nicotine) concentration.<br>* Other names: Vuse Solo EC;Behavioral: Counseling<br>* Each participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to Month 6 | 
| Percent of Patients who Enroll in Counseling | Defined as the percentage of participants who start the intervention counseling sessions. | Up to Month 6 | 
| Follow-Up Rate at 3 Months | Defined as the percent of participants who completed the 3-month follow-up. | Month 3 | 
| Follow-Up Rate at 6 Months | Defined as the percent of participants who completed the 6-month follow-up. | 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. | 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. | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Month 3 | 
| Percentage of Participants who achieve 50% Reduction in Cigarettes Per Day (CPD), compared with Baseline | CPD will be self-reported. | 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. | Baseline, Month 6 |