E-cigarette Harm Reduction Among PLWHA in South Africa

NCT ID: NCT06169813

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2026-02-27

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.

Conditions

Tobacco Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Counseling

Intervention Type: BEHAVIORAL

Each participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting.

Nicotine Replacement Therapy (NRT)

In addition to phone counseling + ecological momentary intervention (EMI) texting, participants will receive combination NRT (daily patches and lozenges).

Group Type: EXPERIMENTAL

Nicotine Replacement Therapy (NRT)

Intervention Type: OTHER

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

Counseling

Intervention Type: BEHAVIORAL

Each participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting.

Electronic Cigarette (EC)

In conjunction with phone counseling + EMI texting, participants will receive the VUSE "Solo" EC.

Group Type: EXPERIMENTAL

E-Cigarette (EC)

Intervention Type: OTHER

EC with single-use pods. Nicotine - 48 mg/ ml (4.8% nicotine) concentration.

Counseling

Intervention Type: BEHAVIORAL

Each participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting.

Interventions

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

Intervention Type: OTHER

E-Cigarette (EC)

EC with single-use pods. Nicotine - 48 mg/ ml (4.8% nicotine) concentration.

Intervention Type: OTHER

Counseling

Each participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting.

Intervention Type: BEHAVIORAL

Other Intervention Names

Vuse Solo EC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Omar El-Shahawy

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

South African Medical Research Council (SAMRC)

Cape Town, , South Africa

Countries

South Africa

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

22-00868

Identifier Type: -

Identifier Source: org_study_id