Clinical trial NCT05413122: Evaluating Smoking Cessation Interventions for PWH in South Africa
Official title: Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-effectiveness
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Smoking Cessation
HIV
Comorbidities and Coexisting Conditions
Keywords: Smoking Cessation
Combination NRT
Varenicline
Behavioral Counselling
Peer Counseling
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Colorado State University
name: New York University
name: Perinatal HIV Research Unit of the University of the Witswatersrand
name: National Cancer Institute (NCI)
First posted: 2022-06-09
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The investigators will conduct a 4-factor, balanced full factorial randomized controlled trial to evaluate the main and interaction effects of these 2-level interventions in one peri-urban and one urban setting in South Africa. The investigators will randomize adults with HIV who are current smokers into 1 of 16 possible combinations of the four intervention components.
Primary purpose: TREATMENT

Brief summary: The overall objective of the study is to optimize a smoking cessation treatment package for people with HIV (PWH) that can be integrated into existing HIV care in South Africa.

Detailed description: This project will evaluate the main and interaction effects of four evidence-based smoking cessation components integrated within HIV care in South Africa: (1) intensive behavioural counselling, (2) peer support, (3) combination nicotine replacement therapy (c-NRT), and (4) varenicline. The investigators will also evaluate the implementation and cost-effectiveness of these interventions. This study is a balanced full factorial randomised trial of 660 adults with HIV and will be implemented in two diverse sites in Gauteng, South Africa representing both peri-urban and urban settings.

Participants will be recruited via health care worker-referral or self-referral. Interested patients will be further screened for eligibility. Eligible participants will be administered written informed consent (see "Informed Consent and Assent" section below), and participants will be randomized into one of 16 study conditions for a 12-week intervention period. This will be an open-label trial; neither the participants nor study personnel will be blinded to treatment assignment post randomization, but randomization block assignment will be concealed from the study personnel who will be enrolling participants.

Eligibility criteria: Inclusion Criteria:

1. ≥18 years of age, and
2. attend one of the selected study clinics, and
3. have a confirmed diagnosis of HIV (evidenced by one of: clinic or hospital prescription for combination antiretroviral therapy (ART), or a current ART medication pack that has the patient's name documented thereon) and
4. have been taking ART for at least three consecutive months (to ensure engagement in care at the recruitment clinic), and
5. are current tobacco smokers (smoked at least 100 cigarettes in the subject's lifetime, have smoked daily for the past 30 days, have exhaled breath carbon monoxide (CO) ≥ 7 parts per million (ppm), and have a positive urine cotinine test), and
6. either own or have household access to a mobile phone, and
7. provide written informed consent.

Exclusion Criteria:

1. Currently (within the previous 14 days) receiving or using smoking cessation counselling or pharmacotherapy, or
2. are unable to participate due to severity of medical illness, guided by a Karnofsky score of ≤ 40, or
3. have a history of seizures, cancer, heart disease, stroke, myocardial infarction, stomach ulcers, kidney failure, or liver failure, or
4. have generalized eczema or psoriasis, or
5. have cognitive dysfunction or psychosis as defined by the Mini-International Neuropsychiatric Interview (M.I.N.I.), or
6. have suicide risk as defined by the Columbia-Suicide Severity Rating Scale (C-SSRS), or
7. are pregnant, planning to become pregnant in the next four months, lactating, or are unwilling to use effective birth control, or
8. have a history of adverse reactions to varenicline or nicotine patch, or
9. are not planning to continue to receive care at the clinic for the next 52 weeks.
10. In the opinion of the attending investigator are not a candidate for the clinical trail.

Primary outcomes:
measure: 7-day point prevalence tobacco abstinence at 52 weeks
timeFrame: 52 weeks
Secondary outcomes:
measure: 7-day point prevalence tobacco abstinence at 26 weeks
timeFrame: 26 weeks
measure: 7-day point prevalence tobacco abstinence at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Soweto
country: South Africa
facility: Perinatal HIV Research Unit (PHRU)
state: Gauteng
Study officials:
affiliation: Perinatal HIV Research Unit (PHRU)
name: Neil Martison
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Jonathan E Golub, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: