MedTrace Logo

E-cigarette Harm Reduction Among PLWHA in South Africa

NCT06169813 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2025-11-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Omar El-Shahawy · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2025-10-24
Completion
2026-02-27

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06169813 on ClinicalTrials.gov