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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Nicotine Replacement Therapy (NRT) | Experimental | In addition to phone counseling + ecological momentary intervention (EMI) texting, participants will receive combination NRT (daily patches and lozenges). |
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| Electronic Cigarette (EC) | Experimental | In conjunction with phone counseling + EMI texting, participants will receive the VUSE "Solo" EC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 3 |
| Percentage of Participants who achieve 50% Reduction in Cigarettes Per Day (CPD), compared with Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omar El-Shahawy | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South African Medical Research Council (SAMRC) | Cape Town | 7501 | South Africa |
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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2023 | Oct 30, 2025 | ICF_000.pdf |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| D066300 | Electronic Nicotine Delivery Systems |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000074602 | Smoking Devices |
| D008420 | Manufactured Materials |
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| E-Cigarette (EC) | Other | EC with single-use pods. Nicotine - 48 mg/ ml (4.8% nicotine) concentration. |
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| Counseling | Behavioral | Each participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting. |
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CPD will be self-reported. |
| 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. | Baseline, Month 6 |
| D013676 |
| Technology, Industry, and Agriculture |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |