E-cigarette Harm Reduction Among PLWHA in South Africa (NCT06169813) | Clinical Trial Compass
CompletedPhase 1
E-cigarette Harm Reduction Among PLWHA in South Africa
South Africa106 participantsStarted 2025-04-15
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This was a Phase 1 feasibility study of e-cigarettes as a harm reduction approach for people living with HIV in South Africa — since the trial is already completed, can you tell me whether any results have been published and what they showed about whether this approach was practical and acceptable to participants?
2Because this was an early-phase study focused on things like enrollment rates and participant satisfaction rather than long-term health outcomes, does that mean there's still a lot we don't know about whether switching to e-cigarettes is actually safer for someone in my situation?
3The trial specifically involved people living with HIV who smoke — given my own health profile, do you think an e-cigarette harm reduction approach is even something worth considering for me, or are there better-supported options I should try first?
4Since this study tracked participants at 3 months and 6 months, is there any data yet on whether people were actually smoking less or quitting by those points, and how does that compare to other cessation methods you'd recommend?
5Given that this trial was conducted in South Africa and is now completed, would you be able to find out if there are any follow-up or larger trials building on these results that might be available to me closer to home?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.