E-cigarette Harm Reduction Among PLWHA in South Africa

NYU Langone Health

Status: Not yet enrolling

Conditions: Tobacco Smoking

Treatments: Behavioral: Counseling; Other: Nicotine Replacement Therapy (NRT); Other: E-Cigarette (EC)

Study type: Interventional

Funder types: Other

Identifiers

NCT06169813

22-00868

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Control (Quit-Line Referral)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Counseling

Nicotine Replacement Therapy (NRT)

Experimental group

Description:

In addition to phone counseling + ecological momentary intervention (EMI) texting, participants will receive combination NRT (daily patches and lozenges).

Treatment:

Behavioral: Counseling

Other: Nicotine Replacement Therapy (NRT)

Electronic Cigarette (EC)

Experimental group

Description:

In conjunction with phone counseling + EMI texting, participants will receive the VUSE "Solo" EC.

Treatment:

Other: E-Cigarette (EC)

Behavioral: Counseling