E-cigarette Harm Reduction Among PLWHA in South Africa

NCT06169813 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: 22-00868
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Recruitment Rate

  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.

  Up to Month 6

• Percent of Patients who Enroll in Counseling

  Defined as the percentage of participants who start the intervention counseling sessions.

  Up to Month 6

• Follow-Up Rate at 3 Months

  Defined as the percent of participants who completed the 3-month follow-up.

  Month 3

• Follow-Up Rate at 6 Months

  Defined as the percent of participants who completed the 6-month follow-up.

  Month 6

• Client Satisfaction Questionnaire (CSQ-8) Score

  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.

  Week 8

• Client Satisfaction Questionnaire (CSQ-8) Score

  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.

  Month 3

Secondary Outcomes (3)

• Percentage of Participants who Achieve 7-Day Point Prevalence Abstinence.

  Month 3

• Percentage of Participants who achieve 50% Reduction in Cigarettes Per Day (CPD), compared with Baseline

  Up to Month 6

• Change in American Thoracic Society Questionnaire Score

  Baseline, Month 6

Study Arms (3)

Control (Quit-Line Referral)

ACTIVE COMPARATOR

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.

Behavioral: Counseling

Nicotine Replacement Therapy (NRT)

EXPERIMENTAL

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

Other: Nicotine Replacement Therapy (NRT); Behavioral: Counseling

Electronic Cigarette (EC)

EXPERIMENTAL

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

Other: E-Cigarette (EC); Behavioral: Counseling

Interventions

Nicotine Replacement Therapy (NRT) 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

Nicotine Replacement Therapy (NRT)

E-Cigarette (EC) OTHER

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

Also known as: Vuse Solo EC

Electronic Cigarette (EC)

Counseling BEHAVIORAL

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

Control (Quit-Line Referral); Electronic Cigarette (EC); Nicotine Replacement Therapy (NRT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

South African Medical Research Council (SAMRC)

Cape Town, 7501, South Africa

Location

MeSH Terms

Conditions

Tobacco Smoking

Interventions

Nicotine Replacement Therapy; Electronic Nicotine Delivery Systems; Counseling

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Omar El-Shahawy

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 14, 2023
• Study Start: April 15, 2025
• Primary Completion: October 24, 2025
• Study Completion: February 27, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data or the researchers who provide a methodologically sound proposal will be granted access upon reasonable request or for individual participant data meta-analysis. Requests should be directed to Omar.ElShahawy@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

ZA (1)