Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06169813
Other study ID # 22-00868
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 27, 2024
Est. completion date June 30, 2024

Study information

Verified date April 2024
Source NYU Langone Health
Contact Omar El-Shahawy
Phone 646-501-3587
Email Omar.ElShahawy@nyulangone.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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
E-Cigarette (EC)
EC with single-use pods. Nicotine - 48 mg/ ml (4.8% nicotine) concentration.
Behavioral:
Counseling
Each participant will receive up to 5-motivational counseling sessions. The first session will also include orientation of EMA/EMI texting.

Locations

Country Name City State
South Africa South African Medical Research Council (SAMRC) Cape Town

Sponsors (2)

Lead Sponsor Collaborator
NYU Langone Health JOHN E FOGARTY INTERNATIONAL CENTER FOR ADVANCED STUDY IN THE HEALTH SCIENCES (FIC)

Country where clinical trial is conducted

South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Percent of Patients who Enroll in Counseling Defined as the percentage of participants who start the intervention counseling sessions. Up to Month 6
Primary Follow-Up Rate at 3 Months Defined as the percent of participants who completed the 3-month follow-up. Month 3
Primary Follow-Up Rate at 6 Months Defined as the percent of participants who completed the 6-month follow-up. Month 6
Primary 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
Primary 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
Secondary 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
Secondary Percentage of Participants who achieve 50% Reduction in Cigarettes Per Day (CPD), compared with Baseline CPD will be self-reported. Up to Month 6
Secondary 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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Recruiting NCT04038255 - Mindfulness Based Smoking Cessation Among Cancer Survivors Phase 4
Completed NCT04123041 - Characterize the Nicotine Uptake and Subjective Effects With Use of JUUL Electronic Nicotine Delivery Systems N/A
Completed NCT02735382 - EHR-Based and Fax-Based Referral to a Tobacco Quitline: A Comparative Study N/A
Completed NCT02139930 - Project 2: Strategies for Reducing Nicotine Content in Cigarettes N/A
Completed NCT04107779 - Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS N/A
Completed NCT05037656 - Testing a School-Based E-cigarette, Tobacco, and Betel (Areca) Nut Use Prevention Curriculum for Guam Youths N/A
Completed NCT04200157 - Testing the Decoy Effect to Increase Tobacco Treatment Uptake
Enrolling by invitation NCT06042361 - Enhancing Equity in Smoke-free Housing N/A
Completed NCT02841683 - Pragmatic Randomised Controlled Trial Evaluating Effectiveness of a Smoking Cessation e- Intervention " Tabac Info Service " N/A
Completed NCT03151421 - Air Quality Feedback to Reduce Second-hand Smoke (SHS) Exposure in the Home N/A
Completed NCT04104152 - CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting N/A
Recruiting NCT05306158 - Dual Use Approach Bias Training for Nicotine Addiction N/A
Completed NCT04143256 - Evaluating Selected Constituents in the Exhaled Breath Samples N/A
Completed NCT04094363 - CSD190202: Study to Assess Elements of Abuse Liability for Two Electronic Nicotine Delivery Systems N/A
Completed NCT03553992 - An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers N/A
Completed NCT05102786 - CSD210904: Study to Assess Actual Use of a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in Current Adult Smokers
Terminated NCT04396847 - Laboratory Screening of Lorcaserin for Alcohol Use Disorder Phase 2
Completed NCT03694327 - Innovative Digital Therapeutic for Smoking Cessation N/A
Completed NCT05030194 - Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study] N/A