NCT06169813

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tobacco Smoking

Interventions

Type	Name	Description
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
OTHER	E-Cigarette (EC)	EC with single-use pods. Nicotine - 48 mg/ ml (4.8% nicotine) concentration.
BEHAVIORAL	Counseling	Each participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting.

Timeline

• Start date: 2025-04-15
• Primary completion: 2025-10-24
• Completion: 2026-02-27
• First posted: 2023-12-14
• Last updated: 2025-11-03

Locations

1 site across 1 country: South Africa