E-cigarette Harm Reduction Among PLWHA in South Africa

Tobacco Smoking Clinical Trial

Official title:

Evaluating Smoking Cessation and Harm Reduction Approaches Among People Living With HIV/AIDS (PLWHA ) in South Africa

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06169813
• Other study ID #: 22-00868
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Tobacco Smoking

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