Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06169813
PHASE1

E-cigarette Harm Reduction Among PLWHA in South Africa

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2025-04-15

Completion Date

2026-02-27

Last Updated

2025-11-03

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

South African Medical Research Council (SAMRC)

Cape Town, South Africa