E-cigarette Harm Reduction Among PLWHA in South Africa

Evaluating Smoking Cessation and Harm Reduction Approaches Among People Living With HIV/AIDS in South Africa

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 Overview

• Status: Active, not recruiting
• Conditions: Tobacco Smoking
• Intervention / Treatment: Behavioral: Counseling; Other: Nicotine Replacement Therapy (NRT); Other: E-Cigarette (EC)

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 1

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa, 7501
    • South African Medical Research Council (SAMRC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control (Quit-Line Referral); 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; Each participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting.
Experimental: Nicotine Replacement Therapy (NRT); In addition to phone counseling + ecological momentary intervention (EMI) texting, participants will receive combination NRT (daily patches and lozenges).	Behavioral: Counseling; Each participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting.; Other: Nicotine Replacement Therapy (NRT); 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
Experimental: Electronic Cigarette (EC); In conjunction with phone counseling + EMI texting, participants will receive the VUSE "Solo" EC.	Behavioral: Counseling; Each participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting.; Other: E-Cigarette (EC); EC with single-use pods. Nicotine - 48 mg/ ml (4.8% nicotine) concentration.; Other Names: Vuse Solo EC

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Fogarty International Center of the National Institute of Health
• Investigators: Principal Investigator: Omar El-Shahawy, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Actual): October 24, 2025
• Study Completion (Estimated): February 27, 2026

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 3, 2025
• Last Update Submitted That Met QC Criteria: October 30, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Smoking; Tobacco Use; Tobacco Smoking; Therapeutics; Drug Therapy; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Manufactured Materials; Technology, Industry, and Agriculture; Smoking Devices; Mental Health Services; Electronic Nicotine Delivery Systems; Nicotine Replacement Therapy; Counseling
• Other Study ID Numbers: 22-00868

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request or for individual participant data meta-analysis beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data or the researchers who provide a methodologically sound proposal execute a data use agreement with NYU Langone Health. Requests may be directed to: Omar.ElShahawy@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data or the researchers who provide a methodologically sound proposal will be granted access upon reasonable request or for individual participant data meta-analysis. Requests should be directed to Omar.ElShahawy@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No