HIVPhase 3NCT03342027
Smoking Cessation Interventions for People Living With HIV in Nairobi, Kenya
A Phase 3 study testing Bupropion, Positively smoke free and Brief advice to quit smoking in people with HIV and Smoking Cessation, run by University of Maryland, Baltimore at 1 site in Kenya.
Trial summary
The proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV who smoke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HIV, Smoking Cessation
- What is being tested?
- Bupropion, Positively smoke free and Brief advice to quit smoking
- 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
- 1 siteKenya
- Study dates
- 1 Aug 2020to 25 Jul 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Chart diagnosis of HIV at recruitment clinic.
- Age 18 years and older
- Currently self-report smoking approximately 1 cigarette per day.
- Motivation to quit (score 6-8 on the Abrams and Briener Readiness to Quit Ladder)
- Able to read and speak English or Swahili
- Willingness and ability to provide informed consent to participate
Who cannot join
- Has a history of seizure disorder or bulimia nervosa
- Recent use of Bupropion (by participant report in the past 3 months)
- Previous allergic reaction/hypersensitivity to Bupropion (by participant report ever in lifetime)
- Pregnant, nursing, or becoming pregnant during the study (pregnancy test)
- Current use of any medication that would interfere with the protocol in the opinion of a medically accountable Physician
- Known plans to re-locate or travel away from the study site for more than two consecutive months during the study period.
Show all 10Show fewer
- Expected survival of less than 6 months
- Meets criteria for dementia by scoring below 10 on the Hopkins HIV Dementia Scale.
- The study physician believes that the individual is not medially stable enough to participate in the study. This exclusion will be based on a review of the individual's past medical history and current medical status.
- Based on screening, not meeting criteria for moderate or severe substance disorder as established by the MINI International Neuropsychiatric Interview.
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Center for International Health, Education, and Biosecurity (CIHEB)
Kilimani, Nairobi County
About this study
Official title: Optimizing Smoking Cessation Interventions for People Living With HIV in Nairobi, Kenya
The proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV who smoke. The study will randomize 300 participants people living with HIV , who smoke and who are receiving care in HIV clinics affiliated with the Center for International Health, Education, and Biosecurity in Nairobi, Kenya to one of the following 4 conditions: (1) bupropion + Positively Smoke Free (an 8 session tailored behavioral intervention for people living with HIV smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care.
Read the detailed description
The proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV who smoke. The will randomize 300 participants people living with HIV, who smoke and who are receiving care at HIV clinics affiliated with the Center for International Health, Education, and Biosecurity in Nairobi, Kenya to one of the following 4 conditions: (1) bupropion + Positively Smoke Free (an 8 session tailored behavioral intervention for people living with HIV smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care. The study will use a factorial design as it is a highly efficient method of assessing multiple treatments in a single trial with the possibility of saving both time and resources. All participants will be assessed at baseline,12 weeks and 36 weeks with the main outcome being 7-day abstinence (defined as self-reported no smoking in the past 7 days + CO<7 ppm).
- Conditions
- HIV, Smoking Cessation
- Being tested
- Bupropion, Positively smoke free, Brief advice to quit smoking
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Zyban
medication for smoking cessation
Positively smoke freeBehavioural
an 8 session, tailored behavioral intervention for treating tobacco dependence
Brief advice to quit smokingOther
Standardized brief advice to quit smoking (standard of care)
| Study group | Role | What they receive |
|---|---|---|
| Bupropion + Positively Smoke Free | Experimental | Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation bupropion--used for smoking cessation Receives: Drug: Bupropion; Behavioral: Positively smoke free |
| Bupropion + Standard of Care | Experimental | Standard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation Receives: Drug: Bupropion; Other: Brief advice to quit smoking |
| Placebo + Positively Smoke Free | Experimental | Placebo--matched to bupropion Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation Receives: Behavioral: Positively smoke free |
| Placebo + Standard of Care. | Placebo comparator | Placebo--matched to bupropion Standard of Care--brief advice to quit provided in a standardized format Receives: Other: Brief advice to quit smoking |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day Abstinence
defined as self-reported no smoking in the past 7 days + CO<7 ppm
Measured: Up to 36 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start1 Aug 2020
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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 Maryland, BaltimoreThe 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
- Model description
- 4 conditions: (1) bupropion + Positively Smoke Free (an 8 session tailored behavioral intervention for PLWH smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seth Himelhoch, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342027
- Sponsor's protocol ID
- HP-00077523
- Status last verified
- Feb 2025
- First submitted
- 9 Nov 2017
- Last updated
- 5 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Keith A, Dong Y, Shuter J, Himelhoch S. Behavioral Interventions for Tobacco Use in HIV-Infected Smokers: A Meta-Analysis. J Acquir Immune Defic Syndr. 2016 Aug 15;72(5):527-33. doi: 10.1097/QAI.0000000000001007.
PubMed 27028502
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Smoking Cessation Interventions for People Living With HIV in Nairobi, Kenya
- ClinicalTrials.gov ID
- NCT03342027
- Acronym / sponsor ID
- HP-00077523
- Conditions
- HIV, Smoking Cessation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 14 Nov 2017 (actual)
- Results
- Posted 5 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV who smoke. The study will randomize 300 participants people living with HIV , who smoke and who are receiving care in HIV clinics affiliated with the Center for International Health, Education, and Biosecurity in Nairobi, Kenya to one of the following 4 conditions: (1) bupropion + Positively Smoke Free (an 8 session tailored behavioral intervention for people living with HIV smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care.
Detailed description
The proposed study will use a factorial design to evaluate the most promising and accessible behavioral and pharmacologic treatments aimed at achieving maximal efficacy for smoking cessation among people living with HIV who smoke. The will randomize 300 participants people living with HIV, who smoke and who are receiving care at HIV clinics affiliated with the Center for International Health, Education, and Biosecurity in Nairobi, Kenya to one of the following 4 conditions: (1) bupropion + Positively Smoke Free (an 8 session tailored behavioral intervention for people living with HIV smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care. The study will use a factorial design as it is a highly efficient method of assessing multiple treatments in a single trial with the possibility of saving both time and resources. All participants will be assessed at baseline,12 weeks and 36 weeks with the main outcome being 7-day abstinence (defined as self-reported no smoking in the past 7 days + CO<7 ppm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4 conditions: (1) bupropion + Positively Smoke Free (an 8 session tailored behavioral intervention for PLWH smokers); (2) bupropion + Standard of Care (brief advice to quit); (3) Placebo + Positively Smoke Free; and (4) Placebo + Standard of Care.
| Arm | Type | Receives |
|---|---|---|
| Bupropion + Positively Smoke Free | Experimental | Drug: Bupropion, Behavioral: Positively smoke freePositively smoke free-- an 8 session tailored behavioral treatment for smoking cessation bupropion--used for smoking cessation |
| Bupropion + Standard of Care | Experimental | Drug: Bupropion, Other: Brief advice to quit smokingStandard of Care--brief advice to quit provided in a standardized format bupropion--used for smoking cessation |
| Placebo + Positively Smoke Free | Experimental | Behavioral: Positively smoke freePlacebo--matched to bupropion Positively smoke free-- an 8 session tailored behavioral treatment for smoking cessation |
| Placebo + Standard of Care. | Placebo comparator | Other: Brief advice to quit smokingPlacebo--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 (6 listed)
- Chart diagnosis of HIV at recruitment clinic.
- Age 18 years and older
- Currently self-report smoking approximately 1 cigarette per day.
- Motivation to quit (score 6-8 on the Abrams and Briener Readiness to Quit Ladder)
- Able to read and speak English or Swahili
Key exclusion criteria (10 listed)
- Has a history of seizure disorder or bulimia nervosa
- Recent use of Bupropion (by participant report in the past 3 months)
- Previous allergic reaction/hypersensitivity to Bupropion (by participant report ever in lifetime)
- Pregnant, nursing, or becoming pregnant during the study (pregnancy test)
- Current use of any medication that would interfere with the protocol in the opinion of a 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 |
|---|---|---|
| BupropionAlso: Zybanmedication for smoking cessation | Drug | Bupropion + Positively Smoke Free, Bupropion + Standard of Care |
| Positively smoke freean 8 session, tailored behavioral intervention for treating tobacco dependence | Behavioural | Bupropion + Positively Smoke Free, Placebo + Positively Smoke Free |
| Brief advice to quit smokingStandardized brief advice to quit smoking (standard of care) | Other | Bupropion + Standard of Care, Placebo + Standard of Care. |
Primary outcome
7-day Abstinence
Time frame: Up to 36 Weeks
defined as self-reported no smoking in the past 7 days + CO<7 ppm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27028502Keith A, Dong Y, Shuter J, Himelhoch S. Behavioral Interventions for Tobacco Use in HIV-Infected Smokers: A Meta-Analysis. J Acquir Immune Defic Syndr. 2016 Aug 15;72(5):527-33. doi: 10.1097/QAI.0000000000001007.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupropion, Positively smoke free and Brief advice to quit smoking in people with HIV and Smoking Cessation, run by University of Maryland, Baltimore at 1 site 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 6 inclusion and 10 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: finished, as of the sponsor's last update on 5 Feb 2025. 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 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?
Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day Abstinence (time frame: Up to 36 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 NCT03342027, 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 5 Feb 2025.