Clinical trial NCT06169813: E-cigarette Harm Reduction Among PLWHA in South Africa
Official title: Evaluating Smoking Cessation and Harm Reduction Approaches Among People Living With HIV/AIDS (PLWHA ) in South Africa
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tobacco Smoking
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: JOHN E FOGARTY INTERNATIONAL CENTER FOR ADVANCED STUDY IN THE HEALTH SCIENCES (FIC)
First posted: 2023-12-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment Rate
timeFrame: Up to Month 6
measure: Percent of Patients who Enroll in Counseling
timeFrame: Up to Month 6
measure: Follow-Up Rate at 3 Months
timeFrame: Month 3
measure: Follow-Up Rate at 6 Months
timeFrame: Month 6
measure: Client Satisfaction Questionnaire (CSQ-8) Score
timeFrame: Week 8
measure: Client Satisfaction Questionnaire (CSQ-8) Score
timeFrame: Month 3
Secondary outcomes:
measure: Percentage of Participants who Achieve 7-Day Point Prevalence Abstinence.
timeFrame: Month 3
measure: Percentage of Participants who achieve 50% Reduction in Cigarettes Per Day (CPD), compared with Baseline
timeFrame: Up to Month 6
measure: Change in American Thoracic Society Questionnaire Score
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: South African Medical Research Council (SAMRC)
Study officials:
affiliation: NYU Langone Health
name: Omar El-Shahawy
role: PRINCIPAL_INVESTIGATOR
References: