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New treatment option for Hiv
Official title Trial of a Harm Reduction Strategy for People With HIV Who Smoke Cigarettes
ClinicalTrials.gov ID: NCT05642715
What this study is testing
What is Varenicline?
Varenicline is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for hiv.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Cigarette smoking is now the leading killer of people with HIV (PWH) in the US, and most cessation strategies tried to date have failed to increase long-term quit rates. An "all or none" approach to smoking cessation in PWH offers little benefit to the large majority of PWH who are unable or unwilling to quit.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 79. Healthy volunteers may be eligible.
You may be able to join if
- Age 40-79 (the ACC/AHA PCEs risk score is only valid in this age range).
- Current cigarette smoking ("Yes" to: "Have you smoked more than 100 cigarettes in your lifetime?" AND "Have you smoked a cigarette, even a puff, in...
- Lab-confirmed HIV infection
- Willingness to participate in a web-based tobacco treatment (EX+) AND offer of varenicline
- Access to internet at least weekly and ability to read at ≥7th grade level (necessary to participate fully in EX+ program).
You likely can't join if
- Pregnancy
- Lack of insurance for specialty referral (we expect this exclusion to be rare because the great majority of people with HIV (PWH) at the Montefiore...
- Contraindication to varenicline
- Concurrent receipt of other cessation treatments
- Evaluation in Cardiometabolic Clinic within the 12 months prior to enrollment
- To minimize study contamination, eligible individuals who are spouses, partners, or roommates of participants will be excluded
See the full eligibility criteria
- Age 40-79 (the ACC/AHA PCEs risk score is only valid in this age range).
- Current cigarette smoking ("Yes" to: "Have you smoked more than 100 cigarettes in your lifetime?" AND "Have you smoked a cigarette, even a puff, in the past 7 days?"
- Lab-confirmed HIV infection
- Willingness to participate in a web-based tobacco treatment (EX+) AND offer of varenicline
- Access to internet at least weekly and ability to read at ≥7th grade level (necessary to participate fully in EX+ program).
- Willingness to be assigned by chance to one of the two study conditions
- Pregnancy
- Lack of insurance for specialty referral (we expect this exclusion to be rare because the great majority of people with HIV (PWH) at the Montefiore Medical Center have Medicaid or AIDS Drug Assistance Program (ADAP)
- Contraindication to varenicline
- Concurrent receipt of other cessation treatments
- Evaluation in Cardiometabolic Clinic within the 12 months prior to enrollment
- To minimize study contamination, eligible individuals who are spouses, partners, or roommates of participants will be excluded
The study team makes the final eligibility decision.
Where it's taking place
- The Bronx, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 79 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.