Smoking CessationPhase 2/3TlogelaNCT05413122
Evaluating Smoking Cessation Interventions for PWH in South Africa
A Phase 2/3 study testing Varenicline, Nicotine patch and Nicotine gum in people with Smoking Cessation and HIV, run by Johns Hopkins University at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, HIV, Comorbidities and Coexisting Conditions
- What is being tested?
- Varenicline, Nicotine patch and Nicotine gum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 660 participants
- Where
- 1 siteSouth Africa
- Study dates
- 27 Nov 2023to 31 Aug 2027
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Perinatal HIV Research Unit (PHRU)
Soweto, Gauteng
Neil Martinson, MD PHD, +27 11 989 9836, martinson@phru.co.za
Leisha Genade, MPH, 27 11 989 9714, genadel@phru.co.za
About this study
Official title: Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-effectiveness
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.
Read the 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.
- Being tested
- Varenicline, Nicotine patch, Nicotine gum, Intensive Behavioral Counselling, Peer Counselling
- Keywords
- Smoking Cessation, Combination NRT, Varenicline, Behavioral Counselling, Peer Counseling
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
At enrolment, a 12-week course of varenicline in the commercially available package will be dispensed by a study clinician.
Nicotine patchDrug
Also called combination nicotine replacement therapy
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.
Nicotine gumDrug
Also called nicotine replacement
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.
Intensive Behavioral CounsellingBehavioural
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.
Peer CounsellingBehavioural
Also called Peer Support
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.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Behavioral Counselling | Experimental | Participants 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. ]. Receives: Behavioral: Intensive Behavioral Counselling |
| Peer Support | Experimental | Participants 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. Receives: Behavioral: Peer Counselling |
| c-NRT | Experimental | 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 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. Receives: Drug: Nicotine patch; Drug: Nicotine gum |
| Varenicline | Experimental | At 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. Receives: Drug: Varenicline |
| Control | No intervention | No intervention |
| Varenicline & c-NRT | Experimental | Varenicline \& c-NRT Receives: Drug: Varenicline; Drug: Nicotine patch; Drug: Nicotine gum |
| Peer Support & Varenicline | Experimental | Peer Support \& Varenicline Receives: Drug: Varenicline; Behavioral: Peer Counselling |
| c-NRT & Peer Support | Experimental | c-NRT \& Peer Support Receives: Drug: Nicotine patch; Drug: Nicotine gum; Behavioral: Peer Counselling |
| c-NRT & Peer Support & Varenicline | Experimental | c-NRT \& Peer Support \& Varenicline Receives: Drug: Varenicline; Drug: Nicotine patch; Drug: Nicotine gum; Behavioral: Peer Counselling |
| Intensive Behavioral Counseling & Varenicline | Experimental | Intensive Behavioral Counseling \& Varenicline Receives: Drug: Varenicline; Behavioral: Intensive Behavioral Counselling |
| Intensive Behavioral Counseling & c-NRT | Experimental | Intensive Behavioral Counseling \& c-NRT Receives: Drug: Nicotine patch; Drug: Nicotine gum; Behavioral: Intensive Behavioral Counselling |
| Intensive Behavioral Counseling & Varenicline & c-NRT | Experimental | Intensive Behavioral Counseling \& Varenicline \& c-NRT Receives: Drug: Varenicline; Drug: Nicotine patch; Drug: Nicotine gum; Behavioral: Intensive Behavioral Counselling |
| Intensive Behavioral Counseling & Peer Support | Experimental | Intensive Behavioral Counseling \& Peer Support Receives: Behavioral: Intensive Behavioral Counselling; Behavioral: Peer Counselling |
| Intensive Behavioral Counseling & Peer Support & Varenicline | Experimental | Intensive Behavioral Counseling \& Peer Support \& Varenicline Receives: Drug: Varenicline; Behavioral: Intensive Behavioral Counselling; Behavioral: Peer Counselling |
| Intensive Behavioral Counseling & Peer Support & c-NRT | Experimental | Intensive Behavioral Counseling \& Peer Support \& c-NRT Receives: Drug: Nicotine patch; Drug: Nicotine gum; Behavioral: Intensive Behavioral Counselling; Behavioral: Peer Counselling |
| Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline | Experimental | Intensive Behavioral Counseling \& Peer Support \& c-NRT \& Varenicline Receives: Drug: Varenicline; Drug: Nicotine patch; Drug: Nicotine gum; Behavioral: Intensive Behavioral Counselling; Behavioral: Peer Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence tobacco abstinence at 52 weeks
Verified by exhaled breath CO < 7ppm and a negative urine cotinine test.
Measured: 52 weeks
Secondary outcomes (2)
7-day point prevalence tobacco abstinence at 26 weeks
Verified by exhaled breath CO < 7ppm and a negative urine cotinine test. Urine cotinine will be excluded as an indicator of abstinence for those self-reporting c-NRT use in the preceding week.
Measured: 26 weeks
7-day point prevalence tobacco abstinence at 12 weeks
Verified by exhaled breath CO < 7ppm and a negative urine cotinine test. Urine cotinine will be excluded as an indicator of abstinence for those self-reporting c-NRT use in the preceding week.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start27 Nov 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- None (open label)
- Enrolment
- 660 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University, New York University, Perinatal HIV Research Unit of the University of the Witswatersrand, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Neil Martison, Principal investigator, Perinatal HIV Research Unit (PHRU)Jonathan E Golub, PhD MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413122
- Sponsor's protocol ID
- IRB00335707
- Other IDs
- 1U01CA261626-01
- Acronym
- Tlogela
- Status last verified
- Oct 2026
- First submitted
- 3 Jun 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40543725