HIVPhase 3NCT06790342
Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya
A Phase 3 study testing Cystine and Positively Smoke Free in people with HIV and Tobacco Use, run by University of Chicago at 2 sites in Kenya.
Trial summary
People with HIV (PWH) smoke tobacco cigarettes and drink alcohol at higher rates than the general population, both in the US and internationally, including low- and middle-income countries. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV, Tobacco Use, Alcohol Use Disorder
- What is being tested?
- Cystine and Positively Smoke Free
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 2 sitesKenya
- Study dates
- 31 Jul 2026to 1 Jun 2029
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed chart diagnosis of HIV
- At least 18 years or age
- Currently self-reports smoking (has smoked a cigarette within the past 7 days) and has expired air Carbon Monoxide (CO) 6ppm. Expired air CO provides an accurate indirect measure of carboxyhemoglobin (COHb) level and is a standard biochemical method for assessing a smoker's level of intake.
- Motivation to quit smoking within the next 6 months (score 6-8 on the Abrams and Biener Readiness to Quit Ladder)
- Meets criteria for heavy drinking: National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines suggest gender-based criteria for heavy drinking but note that lower thresholds may be needed for people with a medical condition. PWH show increased physiologic injury and decreased survival at lower levels of alcohol consumption than those without HIV. Thus, we will use the lower limit for alcohol misuse/heavy drinking from the NIAAA guidelines for all study candidates, i.e. drinking 4+ drinks on a given day or >7 drinks/week over the past 30 days
- Able to speak English (in Nairobi spoken English is near universal as English is an official language of Kenya)
- Willingness to accept behavioral and/or pharmacologic tobacco and alcohol treatment
- Willingness and ability to provide informed consent to participate.
Who cannot join
- Current receipt of any tobacco or alcohol use behavioral or pharmacologic treatment
- Previous allergic reaction or hypersensitivity to cytosine (CYT) (unlikely since CYT is not available in Kenya)
- History of severe alcohol withdrawal symptoms in the past 12 months, including seizure or hallucinations
- Pregnant, nursing, or becoming pregnant during the study
- Current use of any medication that would interfere with the protocol in the opinion of the Medically Accountable Physician
- Meets criteria for possible dementia by scoring below 10 on the Hopkins HIV Dementia Scale
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- Unstable psychiatric illness
- Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period
- Expected survival of less than 6 months.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya2 sites
Mathari National Teaching and Referral Hospital
Nairobi
Riruta Health Centre
Nairobi
About this study
People with HIV (PWH) smoke tobacco cigarettes and drink alcohol at higher rates than the general population, both in the US and internationally, including low- and middle-income countries. Now that effective antiretroviral therapy is available throughout most of the world, PWH are surviving long enough to manifest the lethal consequences of both their smoking and drinking. In this project, the investigational team aims to advance the knowledge and understanding of treatment strategies (i.e. individual intensive counseling ± pharmacotherapy with cytisine) that target both tobacco and alcohol use among PWH in Kenya, a resource constrained environment, and to generate outcome data that may benefit co-users of tobacco and alcohol throughout the world.
Read the detailed description
This study was reviewed and approved for data analysis by the University of Chicago.
The research portion of this study was also submitted to and is pending approval from:
Board Name: AMREF ETHICAL AND SCIENTIFIC REVIEW COMMITTEE (ESRC) Board Affiliation: The AMREF ESRC is affiliated with AMREF Health Africa and accredited by National Commission for Science, Technology and Innovation (NACOSTI) since 200 Phone: +254 20 699 4000 Email: esrc.kenya@amref.org
Address:
Langata Road PO Box 27691-00506 Nairobi, Kenya
- Conditions
- HIV, Tobacco Use, Alcohol Use Disorder
- Being tested
- Cystine, Positively Smoke Free, Placebo, Standard of Care
- Keywords
- HIV, Tobacco Cessation, Alcohol Reduction
- Medical subject headings
- Tobacco Use, Alcoholism, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CystineDrug
Used for smoking cessation and alcohol reduction
Positively Smoke FreeBehavioural
An 8 session tailored behavioral treatment for smoking cessation and alcohol reduction
PlaceboOther
Matched to cystine
Standard of CareOther
Standardized brief advice to quit smoking (standard of care)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Cystine (CYT) + Positively Smoke Free | Experimental | Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction
Cystine--used for smoking cessation and alcohol reduction Receives: Drug: Cystine; Behavioral: Positively Smoke Free |
| Experimental: Cystine + Standard of Care | Experimental | Cystine--used for smoking cessation and alcohol reduction
Standard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation Receives: Drug: Cystine; Other: Standard of Care |
| Experimental: Placebo + Positively Smoke Free | Experimental | Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction
Placebo--matched to bupropion Receives: Behavioral: Positively Smoke Free; Other: Placebo |
| Placebo Comparator: Placebo + Standard of Care. | Placebo comparator | Placebo--matched to bupropion
Standard of Care--brief advice to quit provided in a standardized format Receives: Other: Placebo; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence abstinence (PPA)
Defined as self-reported no smoking in the past 7 days + Carbon Monoxide (CO)<7 ppm
Measured: 36 months
Dried blood spot phosphatidylethanol (PEth)
PEth level of less than 50ng/dl for cessation from heavy drinking linked (P30D)
Measured: 36 months
Timeline Follow-Back (TLFB)
denial of self-reported heavy drinking days (denying any prior 7-day period with >7 drinks or any single day with 4 drinks) for the past 30 days
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start31 Jul 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Maryland
- Responsible party
- Sponsor
- Investigators
- Seth Himelhoch, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790342
- Sponsor's protocol ID
- IRB24-1626
- Other IDs
- 1R01CA288235-01A1
- Status last verified
- Jun 2026
- First submitted
- 17 Jan 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rigotti NA, Benowitz NL, Prochaska J, Leischow S, Nides M, Blumenstein B, Clarke A, Cain D, Jacobs C. Cytisinicline for Smoking Cessation: A Randomized Clinical Trial. JAMA. 2023 Jul 11;330(2):152-160. doi: 10.1001/jama.2023.10042.
PubMed 37432430Himelhoch SS, Koech E, Omanya AA, Oduor P, Mchembere W, Masai TW, Bennett ME, Li L, Potts W, Ojoo S, Shuter J. Efficacy of Smoking Cessation Interventions among People with HIV in Kenya. NEJM Evid. 2024 Nov;3(11):EVIDoa2400090. doi: 10.1056/EVIDoa2400090. Epub 2024 Oct 22.
PubMed 39437141
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Treatment of Co-occurring Smoking and Unhealthy Alcohol Use Among PWH in Nairobi, Kenya
- ClinicalTrials.gov ID
- NCT06790342
- Acronym / sponsor ID
- IRB24-1626
- Conditions
- HIV, Tobacco Use, Alcohol Use Disorder
- Keywords
- HIV, Tobacco Cessation, Alcohol Reduction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Maryland
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 24 Jan 2025 (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.
People with HIV (PWH) smoke tobacco cigarettes and drink alcohol at higher rates than the general population, both in the US and internationally, including low- and middle-income countries. Now that effective antiretroviral therapy is available throughout most of the world, PWH are surviving long enough to manifest the lethal consequences of both their smoking and drinking. In this project, the investigational team aims to advance the knowledge and understanding of treatment strategies (i.e. individual intensive counseling ± pharmacotherapy with cytisine) that target both tobacco and alcohol use among PWH in Kenya, a resource constrained environment, and to generate outcome data that may benefit co-users of tobacco and alcohol throughout the world.
Detailed description
This study was reviewed and approved for data analysis by the University of Chicago.
The research portion of this study was also submitted to and is pending approval from:
Board Name: AMREF ETHICAL AND SCIENTIFIC REVIEW COMMITTEE (ESRC) Board Affiliation: The AMREF ESRC is affiliated with AMREF Health Africa and accredited by National Commission for Science, Technology and Innovation (NACOSTI) since 200 Phone: +254 20 699 4000 Email: esrc.kenya@amref.org
Address:
Langata Road PO Box 27691-00506 Nairobi, Kenya
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Experimental: Cystine (CYT) + Positively Smoke Free | Experimental | Drug: Cystine, Behavioral: Positively Smoke FreePositively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction Cystine--used for smoking cessation and alcohol reduction |
| Experimental: Cystine + Standard of Care | Experimental | Drug: Cystine, Other: Standard of CareCystine--used for smoking cessation and alcohol reduction Standard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation |
| Experimental: Placebo + Positively Smoke Free | Experimental | Behavioral: Positively Smoke Free, Other: PlaceboPositively smoke free-- an 8 session tailored behavioral treatment for smoking cessation and alcohol reduction Placebo--matched to bupropion |
| Placebo Comparator: Placebo + Standard of Care. | Placebo comparator | Other: Placebo, Other: Standard of CarePlacebo--matched to bupropion Standard of Care--brief advice to quit provided in a standardized format |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed chart diagnosis of HIV
- At least 18 years or age
- Currently self-reports smoking (has smoked a cigarette within the past 7 days) and has expired air Carbon Monoxide (CO) 6ppm. Expired air CO provides an accurate indirect measure of carboxyhemoglobin (COHb) level and is a standard biochemical method for assessing a smoker's level of intake.
- Motivation to quit smoking within the next 6 months (score 6-8 on the Abrams and Biener Readiness to Quit Ladder)
- Meets criteria for heavy drinking: National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines suggest gender-based criteria for heavy drinking but note that lower thresholds may be needed for people with a medical condition. PWH show increased physiologic injury and decreased survival at lower levels of alcohol consumption than those without HIV. Thus, we will use the lower limit for alcohol misuse/heavy drinking from the NIAAA guidelines for all study candidates, i.e. drinking 4+ drinks on a given day or >7 drinks/week over the past 30 days
Key exclusion criteria (9 listed)
- Current receipt of any tobacco or alcohol use behavioral or pharmacologic treatment
- Previous allergic reaction or hypersensitivity to cytosine (CYT) (unlikely since CYT is not available in Kenya)
- History of severe alcohol withdrawal symptoms in the past 12 months, including seizure or hallucinations
- Pregnant, nursing, or becoming pregnant during the study
- Current use of any medication that would interfere with the protocol in the opinion of the Medically Accountable Physician
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 |
|---|---|---|
| CystineUsed for smoking cessation and alcohol reduction | Drug | Experimental: Cystine (CYT) + Positively Smoke Free, Experimental: Cystine + Standard of Care |
| Positively Smoke FreeAn 8 session tailored behavioral treatment for smoking cessation and alcohol reduction | Behavioural | Experimental: Cystine (CYT) + Positively Smoke Free, Experimental: Placebo + Positively Smoke Free |
| PlaceboMatched to cystine | Other | Experimental: Placebo + Positively Smoke Free, Placebo Comparator: Placebo + Standard of Care. |
| Standard of CareStandardized brief advice to quit smoking (standard of care) | Other | Experimental: Cystine + Standard of Care, Placebo Comparator: Placebo + Standard of Care. |
Primary outcome
7-day point prevalence abstinence (PPA)
Time frame: 36 months
Defined as self-reported no smoking in the past 7 days + Carbon Monoxide (CO)<7 ppm
Dried blood spot phosphatidylethanol (PEth)
Time frame: 36 months
PEth level of less than 50ng/dl for cessation from heavy drinking linked (P30D)
Timeline Follow-Back (TLFB)
Time frame: 36 months
denial of self-reported heavy drinking days (denying any prior 7-day period with >7 drinks or any single day with 4 drinks) for the past 30 days
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 30 Jul 2026.
- Background: PubMed 37432430Rigotti NA, Benowitz NL, Prochaska J, Leischow S, Nides M, Blumenstein B, Clarke A, Cain D, Jacobs C. Cytisinicline for Smoking Cessation: A Randomized Clinical Trial. JAMA. 2023 Jul 11;330(2):152-160. doi: 10.1001/jama.2023.10042.
- Background: PubMed 39437141Himelhoch SS, Koech E, Omanya AA, Oduor P, Mchembere W, Masai TW, Bennett ME, Li L, Potts W, Ojoo S, Shuter J. Efficacy of Smoking Cessation Interventions among People with HIV in Kenya. NEJM Evid. 2024 Nov;3(11):EVIDoa2400090. doi: 10.1056/EVIDoa2400090. Epub 2024 Oct 22.
- Individual participant dataSharing planned: No
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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.
Seth Himelhoch principal investigator
University of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cystine and Positively Smoke Free in people with HIV and Tobacco Use, run by University of Chicago at 2 sites in Kenya.
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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 Walter Mchembere (+254 20 3908219, wmchembere@cihebkenya.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day point prevalence abstinence (PPA) (time frame: 36 months). The study lists 3 primary outcomes in all. 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 NCT06790342, which also lists 2 linked publications.
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 30 Jul 2026.