Evaluating Smoking Cessation Interventions for PWH in South Africa
Tlogela
2 other identifiers
interventional
660
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2023
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 3, 2022
CompletedFirst Posted
Study publicly available on registry
June 9, 2022
CompletedStudy Start
First participant enrolled
November 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
June 9, 2026
June 1, 2026
3.8 years
June 3, 2022
June 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
7-day point prevalence tobacco abstinence at 52 weeks
Verified by exhaled breath CO \< 7ppm and a negative urine cotinine test.
52 weeks
Secondary Outcomes (2)
7-day point prevalence tobacco abstinence at 26 weeks
26 weeks
7-day point prevalence tobacco abstinence at 12 weeks
12 weeks
Study Arms (16)
Intensive Behavioral Counselling
EXPERIMENTALParticipants randomized to the Intensive Behavioural Counselling condition will receive in-person intensive (\~45 minutes) behavioural counselling in the clinic at enrolment/baseline and at weeks 2, 4, 8, and 12. Additionally, on non-clinic visit weeks participants will receive (1) one phone call each week from the clinic counsellor, and (2) two text messages each week providing encouragement and advice. \].
Peer Support
EXPERIMENTALParticipants randomized to receive Peer Support will be engaged by participants' own peer counsellor assigned from Day 0-12 weeks, with in-person visits at least at baseline, weeks 2, 4, 8 and 12. Peer counselling will follow a flexible framework for contact with participants, which will include in-person and phone-based check-ins, depending upon individual participant preference. Peer counsellors will visit the counsellors' assigned participant in-person at participants' home, workplace, or other setting based on participant preference at least during baseline, weeks 2, 4, 8 and 12; additional in-person contact will be provided upon participant request.
c-NRT
EXPERIMENTALA 12-week course of nicotine patches and nicotine gum will be dispensed to the participant by the counsellor according to randomization into the c-NRT condition. c-NRT will be provided per label instructions given number of cigarettes the participant smokes per day and will be provided in the commercially available package. Participants will be provided with education on its use, including where and how to place a patch, strength of patches to use and how to taper, not smoking while using the patch, and using gum ad hoc; the investigators will also discuss possible side effects. Participants will be given a number to call should the participants require assistance, and weekly calls will be made to participants to screen for adverse events and monitor adherence; calls will taper to every other week after four weeks.
Varenicline
EXPERIMENTALAt enrolment, a 12-week course of varenicline in the commercially available package will be dispensed by a study clinician according to randomization into the varenicline condition and participants will be provided with education on its use. Participants will be instructed to begin taking varenicline one week prior to participants' quit date and for 11 weeks following quit date. Participants will be given a number to call should the participants require assistance, and weekly calls will be made to participants to screen for adverse events and to monitor adherence; calls will taper to every other week after four weeks.
Control
NO INTERVENTIONNo intervention
Varenicline & c-NRT
EXPERIMENTALVarenicline \& c-NRT
Peer Support & Varenicline
EXPERIMENTALPeer Support \& Varenicline
c-NRT & Peer Support
EXPERIMENTALc-NRT \& Peer Support
c-NRT & Peer Support & Varenicline
EXPERIMENTALc-NRT \& Peer Support \& Varenicline
Intensive Behavioral Counseling & Varenicline
EXPERIMENTALIntensive Behavioral Counseling \& Varenicline
Intensive Behavioral Counseling & c-NRT
EXPERIMENTALIntensive Behavioral Counseling \& c-NRT
Intensive Behavioral Counseling & Varenicline & c-NRT
EXPERIMENTALIntensive Behavioral Counseling \& Varenicline \& c-NRT
Intensive Behavioral Counseling & Peer Support
EXPERIMENTALIntensive Behavioral Counseling \& Peer Support
Intensive Behavioral Counseling & Peer Support & Varenicline
EXPERIMENTALIntensive Behavioral Counseling \& Peer Support \& Varenicline
Intensive Behavioral Counseling & Peer Support & c-NRT
EXPERIMENTALIntensive Behavioral Counseling \& Peer Support \& c-NRT
Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline
EXPERIMENTALIntensive Behavioral Counseling \& Peer Support \& c-NRT \& Varenicline
Interventions
At enrolment, a 12-week course of varenicline in the commercially available package will be dispensed by a study clinician.
A 12-week course of nicotine patches and nicotine gum will be dispensed to the participant by the counsellor according to randomization into the c-NRT condition. c-NRT will be provided per label instructions given number of cigarettes the participant smokes per day and will be provided in the commercially available package.
A 12-week course of nicotine patches and nicotine gum will be dispensed to the participant by the counsellor according to randomization into the c-NRT condition. c-NRT will be provided per label instructions given number of cigarettes the participant smokes per day and will be provided in the commercially available package.
Participants randomized to the Peer Support condition will be engaged by a peer counsellor over weeks -2 to 12. Peer counselling will follow a flexible framework for contact with participants, which will include in-person and phone-based check-ins, depending upon individual participant preference. Peer counsellors will visit the counsellors' assigned participant in-person at participants' home, workplace, or other setting based on participant preference at least during weeks -2, 2, 4, 8 and 12; additional in-person contact will be provided upon participant request.
Participants randomized to the Intensive Behavioural Counselling condition will receive in-person intensive (\~45 minutes) behavioural counselling in the clinic at screening and at weeks 2, 4, 8, and 12. Additionally, on non-clinic visit weeks participants will receive (1) one phone call each week from the clinic counsellor, and (2) two text messages each week providing encouragement and advice.
Eligibility Criteria
You may qualify if:
- ≥18 years of age, and
- attend one of the selected study clinics, and
- 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
- have been taking ART for at least three consecutive months or evidence of taking ART for four of the past six months (to ensure engagement in care at the recruitment clinic), and
- are current tobacco smokers (smoked at least 100 cigarettes in the subject's lifetime, smoked at least one cigarette daily in the past 30 days, have exhaled breath carbon monoxide (CO) ≥ 7 parts per million (ppm), and have a positive urine cotinine test), and
- either own or have household access to a mobile phone, and
- provide written informed consent.
You may not qualify if:
- Currently (within the previous 14 days) receiving or using smoking cessation counselling or pharmacotherapy, or
- are unable to participate due to severity of medical illness, guided by a Karnofsky score of ≤ 40, or
- have a history of seizures, cancer, heart disease, stroke, myocardial infarction, stomach ulcers, kidney failure, or liver failure, or
- have generalized eczema or psoriasis, or
- have cognitive dysfunction or psychosis as defined by the Mini-International Neuropsychiatric Interview (M.I.N.I.), or
- have suicide risk as defined by the Columbia-Suicide Severity Rating Scale (C-SSRS), or
- are pregnant, planning to become pregnant in the next four months, lactating, or are unwilling to use effective birth control, or
- have a history of adverse reactions to varenicline or nicotine patch, or
- are not planning to continue to receive care at the clinic for the next 52 weeks, or
- are a household member of a currently enrolled participant in this trial, or
- In the opinion of the attending investigator are not a candidate for the clinical trail.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- Colorado State Universitycollaborator
- New York Universitycollaborator
- National Cancer Institute (NCI)collaborator
- Perinatal HIV Research Unit of the University of the Witswatersrandcollaborator
Study Sites (1)
Perinatal HIV Research Unit (PHRU)
Soweto, Gauteng, South Africa
Related Publications (1)
Genade LP, Steiner L, Nabeemeeah F, Niaura RS, Nonyane BAS, Hoffmann CJ, Sohn H, Kemp CG, Guastaferro K, Mlambo L, Chetty D, Waja Z, Martinson N, Golub JE, Elf JL. Evaluating smoking cessation interventions for people living with HIV in a factorial randomised clinical trial in South Africa using the Multiphase Optimization Strategy (MOST) framework: The Tlogela Trial protocol. Contemp Clin Trials. 2025 Aug;155:107985. doi: 10.1016/j.cct.2025.107985. Epub 2025 Jun 19.
PMID: 40543725DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neil Martison
Perinatal HIV Research Unit (PHRU)
- PRINCIPAL INVESTIGATOR
Jonathan E Golub, PhD MPH
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2022
First Posted
June 9, 2022
Study Start
November 27, 2023
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
June 9, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available for sharing following publication of primary findings from the study, indefinitely.
- Access Criteria
- Following publication of research findings, the final research database may be shared upon request with qualified individuals within the scientific community for research purposes in accordance with the policies of the partnering organizations. Data will be stripped of all personal identifiers and available as a tab delimited ASCII data file with an accompanying data dictionary. Data will be anonymized and maintained in a password-protected database.
Intellectual property and data generated under this project will be administered in accordance with policies of the Johns Hopkins University, the Perinatal HIV Research Unit (PHRU) at the University of the Witwatersrand, and NIH policies, including the most recent NIH Data Sharing Policy and Implementation Guidance. Materials generated under the project will be disseminated in accordance with University/Participating institutional and NIH policies. Access to data generated under the project will be available for educational, research and non-profit purposes. Publication of data shall occur during the project, as appropriate, or at the end of the project, consistent with normal scientific practices. Research data which documents, supports and validates research findings will be made available after the main findings from the final research data set have been accepted for publication. Such research data will be redacted to prevent the disclosure of personal identifiers.