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
- Are there results?
- Not yet: the study is under way
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
Show all 11Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Smoking Cessation Interventions for PWH in South Africa: Efficacy, Implementation, and Cost-effectiveness
- ClinicalTrials.gov ID
- NCT05413122
- Acronym / sponsor ID
- Tlogela / IRB00335707
- Keywords
- Smoking Cessation, Combination NRT, Varenicline, Behavioral Counselling, Peer Counseling
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 660 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Colorado State University, New York University, Perinatal HIV Research Unit of the University of the Witswatersrand, National Cancer Institute (NCI)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 16
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intensive Behavioral Counselling | Experimental | Behavioral: Intensive Behavioral CounsellingParticipants 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 | Experimental | Behavioral: Peer CounsellingParticipants 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 | Experimental | Drug: Nicotine patch, Drug: Nicotine gumA 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 | Experimental | Drug: VareniclineAt 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 intervention | –No intervention |
| Varenicline & c-NRT | Experimental | Drug: Varenicline, Drug: Nicotine patch, Drug: Nicotine gumVarenicline \& c-NRT |
| Peer Support & Varenicline | Experimental | Drug: Varenicline, Behavioral: Peer CounsellingPeer Support \& Varenicline |
| c-NRT & Peer Support | Experimental | Drug: Nicotine patch, Drug: Nicotine gum, Behavioral: Peer Counsellingc-NRT \& Peer Support |
| c-NRT & Peer Support & Varenicline | Experimental | Drug: Varenicline, Drug: Nicotine patch, Drug: Nicotine gum, Behavioral: Peer Counsellingc-NRT \& Peer Support \& Varenicline |
| Intensive Behavioral Counseling & Varenicline | Experimental | Drug: Varenicline, Behavioral: Intensive Behavioral CounsellingIntensive Behavioral Counseling \& Varenicline |
| Intensive Behavioral Counseling & c-NRT | Experimental | Drug: Nicotine patch, Drug: Nicotine gum, Behavioral: Intensive Behavioral CounsellingIntensive Behavioral Counseling \& c-NRT |
| Intensive Behavioral Counseling & Varenicline & c-NRT | Experimental | Drug: Varenicline, Drug: Nicotine patch, Drug: Nicotine gum, Behavioral: Intensive Behavioral CounsellingIntensive Behavioral Counseling \& Varenicline \& c-NRT |
| Intensive Behavioral Counseling & Peer Support | Experimental | Behavioral: Intensive Behavioral Counselling, Behavioral: Peer CounsellingIntensive Behavioral Counseling \& Peer Support |
| Intensive Behavioral Counseling & Peer Support & Varenicline | Experimental | Drug: Varenicline, Behavioral: Intensive Behavioral Counselling, Behavioral: Peer CounsellingIntensive Behavioral Counseling \& Peer Support \& Varenicline |
| Intensive Behavioral Counseling & Peer Support & c-NRT | Experimental | Drug: Nicotine patch, Drug: Nicotine gum, Behavioral: Intensive Behavioral Counselling, Behavioral: Peer CounsellingIntensive Behavioral Counseling \& Peer Support \& c-NRT |
| Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline | Experimental | Drug: Varenicline, Drug: Nicotine patch, Drug: Nicotine gum, Behavioral: Intensive Behavioral Counselling, Behavioral: Peer CounsellingIntensive Behavioral Counseling \& Peer Support \& c-NRT \& Varenicline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineAt enrolment, a 12-week course of varenicline in the commercially available package will be dispensed by a study clinician. | Drug | Intensive Behavioral Counseling & Peer Support & Varenicline, Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline, Intensive Behavioral Counseling & Varenicline, Intensive Behavioral Counseling & Varenicline & c-NRT, Peer Support & Varenicline, Varenicline, Varenicline & c-NRT, c-NRT & Peer Support & Varenicline |
| Nicotine patchAlso: combination nicotine replacement therapyA 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. | Drug | Intensive Behavioral Counseling & Peer Support & c-NRT, Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline, Intensive Behavioral Counseling & Varenicline & c-NRT, Intensive Behavioral Counseling & c-NRT, Varenicline & c-NRT, c-NRT, c-NRT & Peer Support, c-NRT & Peer Support & Varenicline |
| Nicotine gumAlso: nicotine replacementA 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. | Drug | Intensive Behavioral Counseling & Peer Support & c-NRT, Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline, Intensive Behavioral Counseling & Varenicline & c-NRT, Intensive Behavioral Counseling & c-NRT, Varenicline & c-NRT, c-NRT, c-NRT & Peer Support, c-NRT & Peer Support & Varenicline |
| Intensive Behavioral CounsellingParticipants 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. | Behavioural | Intensive Behavioral Counseling & Peer Support, Intensive Behavioral Counseling & Peer Support & Varenicline, Intensive Behavioral Counseling & Peer Support & c-NRT, Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline, Intensive Behavioral Counseling & Varenicline, Intensive Behavioral Counseling & Varenicline & c-NRT, Intensive Behavioral Counseling & c-NRT, Intensive Behavioral Counselling |
| Peer CounsellingAlso: Peer SupportParticipants 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. | Behavioural | Intensive Behavioral Counseling & Peer Support, Intensive Behavioral Counseling & Peer Support & Varenicline, Intensive Behavioral Counseling & Peer Support & c-NRT, Intensive Behavioral Counseling & Peer Support & c-NRT & Varenicline, Peer Support, Peer Support & Varenicline, c-NRT & Peer Support, c-NRT & Peer Support & Varenicline |
Primary outcome
7-day point prevalence tobacco abstinence at 52 weeks
Time frame: 52 weeks
Verified by exhaled breath CO < 7ppm and a negative urine cotinine test.
2 secondary outcomes
7-day point prevalence tobacco abstinence at 26 weeks
Time frame: 26 weeks
7-day point prevalence tobacco abstinence at 12 weeks
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 40543725Genade 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.
- Individual participant dataSharing planned: 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.
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neil Martison principal investigator
Perinatal HIV Research Unit (PHRU)
Jonathan E Golub, PhD MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan E Golub, PhD MPH (443-287-2969, jgolub@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence tobacco abstinence at 52 weeks (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05413122, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.