E-cigarette Harm Reduction Among PLWHA in South Africa

Not Applicable

Not yet recruiting

• Conditions: Tobacco Smoking
• Interventions: Other: Nicotine Replacement Therapy (NRT); Other: E-Cigarette (EC); Behavioral: Counseling

• Registration Number: NCT06169813
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Study First Posted: 2023-12-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11
• Study Start: 2025-04-15
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nicotine Replacement Therapy (NRT)	Counseling	In addition to phone counseling + ecological momentary intervention (EMI) texting, participants will receive combination NRT (daily patches and lozenges).
Electronic Cigarette (EC)	Counseling	In conjunction with phone counseling + EMI texting, participants will receive the VUSE "Solo" EC.
Control (Quit-Line Referral)	Counseling	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.
Nicotine Replacement Therapy (NRT)	Nicotine Replacement Therapy (NRT)	In addition to phone counseling + ecological momentary intervention (EMI) texting, participants will receive combination NRT (daily patches and lozenges).
Electronic Cigarette (EC)	E-Cigarette (EC)	In conjunction with phone counseling + EMI texting, participants will receive the VUSE "Solo" EC.

Primary Outcome Measures

Name	Time	Method
Follow-Up Rate at 6 Months	Month 6	Defined as the percent of participants who completed the 6-month follow-up.
Percent of Patients who Enroll in Counseling	Up to Month 6	Defined as the percentage of participants who start the intervention counseling sessions.
Recruitment Rate	Up to Month 6	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.
Follow-Up Rate at 3 Months	Month 3	Defined as the percent of participants who completed the 3-month follow-up.
Client Satisfaction Questionnaire (CSQ-8) Score	Month 3	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants who Achieve 7-Day Point Prevalence Abstinence.	Month 3	Abstinence will be verified by exhaled carbon monoxide and defined as no combustible cigarette use in the last 7 days.
Change in American Thoracic Society Questionnaire Score	Baseline, Month 6	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.
Percentage of Participants who achieve 50% Reduction in Cigarettes Per Day (CPD), compared with Baseline	Up to Month 6	CPD will be self-reported.

Trial Locations

Locations (1)

South African Medical Research Council (SAMRC); 🇿🇦 Cape Town, South Africa