NCT06169813CompletedPhase 1
E-cigarette Harm Reduction Among PLWHA in South Africa
Evaluating Smoking Cessation and Harm Reduction Approaches Among People Living With HIV/AIDS in South Africa
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 106 (actual)
- First submitted
- 4 Dec 2023
- Start date
- 15 Apr 2025
- Primary completion date
- 24 Oct 2025
- Lead sponsor
- NYU Langone Health
- Diseases
- HIV
- NCT number
- NCT06169813
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 106
- From 15 Apr 2025 to the primary completion date, 24 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- current major depressive or manic episode, current psychotic disorder, past-year suicide attempt, or current suicidal ideation with plan or intent. plan or intent.
Other
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| South African Medical Research Council (SAMRC) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.