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Completed

NCT Number: NCT06169813

E-cigarette Harm Reduction Among PLWHA in South Africa

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.

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Key information

Conditions

Tobacco Smoking Behavior Smoking Tobacco Use

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

South African Medical Research Council (SAMRC)

Cape Town, 7501, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

E-Cigarette (EC)

Other

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

Other names: Vuse Solo EC

Counseling

Behavioral

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

Primary outcomes

  1. Recruitment Rate

    Time frame: Up to Month 6

    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.

  2. Percent of Patients who Enroll in Counseling

    Time frame: Up to Month 6

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

  3. Follow-Up Rate at 3 Months

    Time frame: Month 3

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

  4. Follow-Up Rate at 6 Months

    Time frame: Month 6

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

  5. Client Satisfaction Questionnaire (CSQ-8) Score

    Time frame: Week 8

    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.

  6. Client Satisfaction Questionnaire (CSQ-8) Score

    Time frame: Month 3

    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.

Secondary outcomes

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

    Time frame: Month 3

    Abstinence will be verified by exhaled carbon monoxide and defined as no combustible cigarette use in the last 7 days.

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

    Time frame: Up to Month 6

    CPD will be self-reported.

  3. Change in American Thoracic Society Questionnaire Score

    Time frame: Baseline, Month 6

    Change in American Thoracic Questionnaire Score from Baseline to Week 12 8-item questionnaire assessing general thoracic pain. Items are rated on a Likert scale from 1 (never) to 5 (every day). The total score is the sum of responses and ranges from 8-40; higher scores indicate more severe impact of general thoracic pain.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Fogarty International Center of the National Institute of Health

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Dec 14, 2023
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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