Human Immunodeficiency VirusPhase 3NCT05786547
V+PSF-M for Tobacco Cessation in HIV Care in India
A Phase 3 study testing Varenicline and Positively Smoke Free Mobile (PSF-M) in people with Human Immunodeficiency Virus and Smoking Cessation, run by University of Colorado, Denver at 2 sites in 2 countries.
Trial summary
The goal of this research study is to test an intervention to help quit tobacco use in participants with Human Immunodeficiency Virus (HIV). The study interventions used in this research study are: Positively Smoke Free - Mobile (PSF-M) (mobile behavioral program) Varenicline (or Chantix, apovarenicline, Champix or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, Smoking Cessation, Smoking, Tobacco
- What is being tested?
- Varenicline and Positively Smoke Free Mobile (PSF-M)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Jan 2024to 22 Jul 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥18 years)
- Confirmed HIV diagnosis
- Self-reported current smoking or dual tobacco use verified either by exhaled carbon monoxide ≥7 ppm, or by positive qualitative cotinine point-of-care test
- Able to read at 6th grade level or greater and speak Tamil, Telugu or English
- Able to use varenicline safely based on evaluation by primary provider at VHS
- Women of childbearing potential who consent to use a medically approved method of contraception or abstain from intercourse while taking study medication and for one month after.
- Ready to quit or interested in quitting
Who cannot join
- Pregnant or planning to become pregnant in the next 6 months
- Breastfeeding
- Myocardial infarction in past 30 days or unstable angina
- History of liver or kidney failure
- Alanine aminotransferase and Aspartate aminotransferase > 2 times upper limit of normal or creatinine clearance <50 in past 6 months
- History of suicide attempt
Show all 11Show fewer
- Current suicidal ideation
- Untreated or unstable major depressive disorder
- History of psychosis or on anti-psychotic medications
- Cognitive impairment limiting ability to consent
- Allergy to varenicline
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
Gina Kruse, MD, 303-724-4811, Gina.Kruse@cuanschutz.edu
Yamila L Sierra, MPH, 303-724-4549, yamila.sierra@cuanschutz.edu
India1 site, 1 recruiting
- Recruiting
VHS Infectious Disease Medical Centre, CART Clinical Research Site
Chennai, Tamil Nadu, 600113
N Kumarasammy, 09176912007, kumarasamy@cartcrs.org
Poongulali Selvamuthu, 09940560019, poongulali@cartcrs.org
About this study
Official title: Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India
The goal of this research study is to test an intervention to help quit tobacco use in participants with Human Immunodeficiency Virus (HIV).
The study interventions used in this research study are:
- Positively Smoke Free - Mobile (PSF-M) (mobile behavioral program)
- Varenicline (or Chantix, apovarenicline, Champix or Nocrav)
Read the detailed description
Open-label, practice-based randomized trial of varenicline + Positively Smoke Free-Mobile (PSF-M) for people living with Human Immunodeficiency Virus (PWH) who smoke or use both smoked and smokeless tobacco compared with a group that receives standard care including brief advice and quitline referral.
Positively Smoke Free (PSF) is a behavioral intervention which has been tested in multiple formats including a mobile version. Varenicline is the single most-effective pharmacotherapy agent for quitting tobacco with demonstrated efficacy for cessation of cigarettes, smokeless tobacco, and cessation among smokers with comorbidities
In this study, participants will be randomized to either Group 1: Varenicline + Positively Smoke Free-Mobile adapted for Chennai versus Group 2: Standard care with brief tobacco cessation advice and referral to the national quitline.
Research procedures include screening for eligibility, in-clinic visits, and completion of surveys and questionnaires.
Participation in this study is expected to last about 24 weeks.
It is expected about 400 people will take part in this research study.
This study is funded by the National Cancer Institute of the National Institute of Health (NIH).
- Being tested
- Varenicline, Positively Smoke Free Mobile (PSF-M), Standard Care
- Keywords
- Human Immunodeficiency Virus, Smoking Cessation, Smoking, Tobacco
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Smoking Cessation, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Champix, apovarenicline, Nocrav
Per package dosing, tablet taken orally
Positively Smoke Free Mobile (PSF-M)Behavioural
Behavioral tobacco cessation intervention for people living with HIV, delivered via mobile phone
Standard CareBehavioural
Brief cessation advice plus referral to local tobacco quitline
| Study group | Role | What they receive |
|---|---|---|
| Varenicline + Positively Smoke Free - Mobile | Experimental | Offer of varenicline per package dosing with dose escalation over week 1: 0.5 mg once daily on days 1 - 3, 0.5 mg twice daily on days 4 -7, followed by 1.0 mg twice daily on days 8 to 84.
Offer of Positively Smoke Free Mobile delivered by mobile phone including 42 days of content, tailored to individual quit date. Receives: Drug: Varenicline; Behavioral: Positively Smoke Free Mobile (PSF-M) |
| Standard Care | Active comparator | Brief advice to quit tobacco Offer of referral to the national tobacco quitline Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-Day Point Prevalent Abstinence Rate
Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding 24-week follow-up supported by a negative urine cotinine test of < 50 ng/ml
Measured: 24 weeks post-randomization
Secondary outcomes (2)
7-day self-reported Point Prevalent Abstinence Rate
Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding follow-up
Measured: 4 weeks post-randomization
7-day self-reported Point Prevalent Abstinence Rate
Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding 24-week follow-up supported by a negative urine cotinine test of < 50 ng/ml
Measured: 12 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start2 Jan 2024
- Primary completion22 Jul 2026 (estimated)
- Study completion22 Jul 2026 (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 Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gina Kruse, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786547
- Sponsor's protocol ID
- 23-1017
- Other IDs
- 1U01CA261614-01
- Status last verified
- Jun 2025
- First submitted
- 13 Mar 2023
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Principle Investigator. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Malpeddi T, Poongulali S, Shuter J, Rigotti NA, An LC, Kumarasamy N, Reddy KP, Shergina E, Colborn K, Faith B, Sierra YL, Kruse GR. Protocol for the Mobile behavioral support plus varenicline for tobacco cessation among people living with HIV in India (MoVIe): A hybrid implementation-effectiveness randomized trial. Contemp Clin Trials. 2026 Jan;160:108179. doi: 10.1016/j.cct.2025.108179. Epub 2025 Dec 4.
PubMed 41352530
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varenicline and Mobile Behavioral Assistance for Tobacco Cessation in HIV Care in India
- ClinicalTrials.gov ID
- NCT05786547
- Acronym / sponsor ID
- 23-1017
- Keywords
- Human Immunodeficiency Virus, Smoking Cessation, Smoking, Tobacco
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 22 Jul 2026 (estimated)
- Study completion
- 22 Jul 2026 (estimated)
- First posted
- 27 Mar 2023 (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 goal of this research study is to test an intervention to help quit tobacco use in participants with Human Immunodeficiency Virus (HIV).
The study interventions used in this research study are:
- Positively Smoke Free - Mobile (PSF-M) (mobile behavioral program)
- Varenicline (or Chantix, apovarenicline, Champix or Nocrav)
Detailed description
Open-label, practice-based randomized trial of varenicline + Positively Smoke Free-Mobile (PSF-M) for people living with Human Immunodeficiency Virus (PWH) who smoke or use both smoked and smokeless tobacco compared with a group that receives standard care including brief advice and quitline referral.
Positively Smoke Free (PSF) is a behavioral intervention which has been tested in multiple formats including a mobile version. Varenicline is the single most-effective pharmacotherapy agent for quitting tobacco with demonstrated efficacy for cessation of cigarettes, smokeless tobacco, and cessation among smokers with comorbidities
In this study, participants will be randomized to either Group 1: Varenicline + Positively Smoke Free-Mobile adapted for Chennai versus Group 2: Standard care with brief tobacco cessation advice and referral to the national quitline.
Research procedures include screening for eligibility, in-clinic visits, and completion of surveys and questionnaires.
Participation in this study is expected to last about 24 weeks.
It is expected about 400 people will take part in this research study.
This study is funded by the National Cancer Institute of the National Institute of Health (NIH).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline + Positively Smoke Free - Mobile | Experimental | Drug: Varenicline, Behavioral: Positively Smoke Free Mobile (PSF-M)Offer of varenicline per package dosing with dose escalation over week 1: 0.5 mg once daily on days 1 - 3, 0.5 mg twice daily on days 4 -7, followed by 1.0 mg twice daily on days 8 to 84. Offer of Positively Smoke Free Mobile delivered by mobile phone including 42 days of content, tailored to individual quit date. |
| Standard Care | Active comparator | Behavioral: Standard CareBrief advice to quit tobacco Offer of referral to the national tobacco quitline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (≥18 years)
- Confirmed HIV diagnosis
- Self-reported current smoking or dual tobacco use verified either by exhaled carbon monoxide ≥7 ppm, or by positive qualitative cotinine point-of-care test
- Able to read at 6th grade level or greater and speak Tamil, Telugu or English
- Able to use varenicline safely based on evaluation by primary provider at VHS
Key exclusion criteria (11 listed)
- Pregnant or planning to become pregnant in the next 6 months
- Breastfeeding
- Myocardial infarction in past 30 days or unstable angina
- History of liver or kidney failure
- Alanine aminotransferase and Aspartate aminotransferase > 2 times upper limit of normal or creatinine clearance <50 in past 6 months
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 |
|---|---|---|
| VareniclineAlso: Champix, apovarenicline, NocravPer package dosing, tablet taken orally | Drug | Varenicline + Positively Smoke Free - Mobile |
| Positively Smoke Free Mobile (PSF-M)Behavioral tobacco cessation intervention for people living with HIV, delivered via mobile phone | Behavioural | Varenicline + Positively Smoke Free - Mobile |
| Standard CareBrief cessation advice plus referral to local tobacco quitline | Behavioural | Standard Care |
Primary outcome
7-Day Point Prevalent Abstinence Rate
Time frame: 24 weeks post-randomization
Defined as abstinence from all combustible and smokeless tobacco products in the 7 days preceding 24-week follow-up supported by a negative urine cotinine test of < 50 ng/ml
2 secondary outcomes
7-day self-reported Point Prevalent Abstinence Rate
Time frame: 4 weeks post-randomization
7-day self-reported Point Prevalent Abstinence Rate
Time frame: 12 weeks post-randomization
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 15 Jun 2025.
- Derived from this study: PubMed 41352530Malpeddi T, Poongulali S, Shuter J, Rigotti NA, An LC, Kumarasamy N, Reddy KP, Shergina E, Colborn K, Faith B, Sierra YL, Kruse GR. Protocol for the Mobile behavioral support plus varenicline for tobacco cessation among people living with HIV in India (MoVIe): A hybrid implementation-effectiveness randomized trial. Contemp Clin Trials. 2026 Jan;160:108179. doi: 10.1016/j.cct.2025.108179. Epub 2025 Dec 4.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Principle Investigator. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Gina Kruse, MD principal investigator
University of Colorado, Denver
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Varenicline and Positively Smoke Free Mobile (PSF-M) in people with Human Immunodeficiency Virus and Smoking Cessation, run by University of Colorado, Denver at 2 sites in 2 countries.
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 15 Jun 2025. 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 United States, India. 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 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 Gina Kruse, MD (303-724-4811, gina.kruse@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-Day Point Prevalent Abstinence Rate (time frame: 24 weeks post-randomization). 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 NCT05786547, 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 15 Jun 2025.