Tobacco SmokingPhase 1NCT06169813
E-cigarette Harm Reduction Among PLWHA in South Africa
A Phase 1 study testing Nicotine Replacement Therapy (NRT), E-Cigarette (EC) and Counseling in people with Tobacco Smoking, run by NYU Langone Health at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Nicotine Replacement Therapy (NRT), E-Cigarette (EC) and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteSouth Africa
- Study dates
- 15 Apr 2025to 19 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Africa1 site
South African Medical Research Council (SAMRC)
Cape Town, 7501
About this study
Official title: Evaluating Smoking Cessation and Harm Reduction Approaches Among People Living With HIV/AIDS 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.
- Conditions
- Tobacco Smoking
- Being tested
- Nicotine Replacement Therapy (NRT), E-Cigarette (EC), Counseling
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called Vuse Solo EC
EC with single-use pods. Nicotine - 48 mg/ ml (4.8% nicotine) concentration.
CounselingBehavioural
Each participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: Other: E-Cigarette (EC); Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Month 6
Percent of Patients who Enroll in Counseling
Defined as the percentage of participants who start the intervention counseling sessions.
Measured: Up to Month 6
Follow-Up Rate at 3 Months
Defined as the percent of participants who completed the 3-month follow-up.
Measured: Month 3
Follow-Up Rate at 6 Months
Defined as the percent of participants who completed the 6-month follow-up.
Measured: 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.
Measured: 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.
Measured: Month 3
Secondary outcomes (3)
Percentage of Participants who Achieve 7-Day Point Prevalence Abstinence.
Abstinence will be verified by exhaled carbon monoxide and defined as no combustible cigarette use in the last 7 days.
Measured: Month 3
Percentage of Participants who achieve 50% Reduction in Cigarettes Per Day (CPD), compared with Baseline
CPD will be self-reported.
Measured: Up to Month 6
Change in American Thoracic Society Questionnaire Score
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.
Measured: Baseline, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start15 Apr 2025
- Primary completion24 Oct 2025
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Omar El-Shahawy, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169813
- Sponsor's protocol ID
- 22-00868
- Status last verified
- Jun 2026
- First submitted
- 4 Dec 2023
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request or for individual participant data meta-analysis beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data or the researchers who provide a methodologically sound proposal execute a data use agreement with NYU Langone Health. Requests may be directed to: Omar.ElShahawy@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Smoking Cessation and Harm Reduction Approaches Among People Living With HIV/AIDS in South Africa
- ClinicalTrials.gov ID
- NCT06169813
- Acronym / sponsor ID
- 22-00868
- Conditions
- Tobacco Smoking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control (Quit-Line Referral) | Active comparator | Behavioral: CounselingParticipants 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. |
| Nicotine Replacement Therapy (NRT) | Experimental | Other: Nicotine Replacement Therapy (NRT), Behavioral: CounselingIn addition to phone counseling + ecological momentary intervention (EMI) texting, participants will receive combination NRT (daily patches and lozenges). |
| Electronic Cigarette (EC) | Experimental | Other: E-Cigarette (EC), Behavioral: CounselingIn conjunction with phone counseling + EMI texting, participants will receive the VUSE "Solo" EC. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Nicotine Replacement Therapy (NRT) |
| E-Cigarette (EC)Also: Vuse Solo ECEC with single-use pods. Nicotine - 48 mg/ ml (4.8% nicotine) concentration. | Other | Electronic Cigarette (EC) |
| CounselingEach participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting. | Behavioural | Control (Quit-Line Referral), Electronic Cigarette (EC), Nicotine Replacement Therapy (NRT) |
Primary outcome
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.
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.
Follow-Up Rate at 3 Months
Time frame: Month 3
Defined as the percent of participants who completed the 3-month follow-up.
Follow-Up Rate at 6 Months
Time frame: Month 6
Defined as the percent of participants who completed the 6-month follow-up.
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.
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.
3 secondary outcomes
Percentage of Participants who Achieve 7-Day Point Prevalence Abstinence.
Time frame: Month 3
Percentage of Participants who achieve 50% Reduction in Cigarettes Per Day (CPD), compared with Baseline
Time frame: Up to Month 6
Change in American Thoracic Society Questionnaire Score
Time frame: Baseline, Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request or for individual participant data meta-analysis beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data or the researchers who provide a methodologically sound proposal execute a data use agreement with NYU Langone Health. Requests may be directed to: Omar.ElShahawy@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar El-Shahawy principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nicotine Replacement Therapy (NRT), E-Cigarette (EC) and Counseling in people with Tobacco Smoking, run by NYU Langone Health at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Up to Month 6). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.