Contingency Management Smoking Cessation Intervention for HIV Infections

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Miami, Miami, FL
HIV Infections+2 More
Contingency Management Smoking Cessation Intervention - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a smoking cessation intervention is feasible and acceptable for Hispanic HIV patients.

See full description

Eligible Conditions

  • HIV Infections
  • Smoking, Cessation
  • Smoking

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

This trial is evaluating whether Contingency Management Smoking Cessation Intervention will improve 1 primary outcome and 4 secondary outcomes in patients with HIV Infections. Measurement will happen over the course of Up to 22 weeks.

Baseline
Average enrollment time
Number of enrolled participants
Up to 22 weeks
Number of completed study measures
Number of participants reporting 7-day point-prevalence abstinence
Retention rate

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

4 Treatment Groups

CM plus NRT with additional MT Group
1 of 4
CM plus NRT Group
1 of 4
MT plus NRT with additional CM Group
1 of 4
MT plus NRT Group
1 of 4
Experimental Treatment

This trial requires 50 total participants across 4 different treatment groups

This trial involves 4 different treatments. Contingency Management Smoking Cessation Intervention is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

CM plus NRT with additional MT GroupParticipants who received the CM intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional MT intervention for another 4 weeks.
CM plus NRT GroupParticipants who receive the Contingency Management (CM) intervention for 4 weeks in addition to 6 weeks of NRT. These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.
MT plus NRT with additional CM GroupParticipants who received the MT intervention for 4 weeks with 6 weeks of NRT and are non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive an additional CM intervention for another 4 weeks.
MT plus NRT GroupParticipants who receive the Mindfulness Training (MT) intervention for 4 weeks in addition to 6 weeks of Nicotine Replacement Therapy (NRT).These participants are responders (have quit smoking at the 1 month follow up) or non-responders (those who have not quit smoking at the 1 month follow up) and randomized to receive no additional intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 22 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 22 weeks for reporting.

Who is running the study

Principal Investigator
T. A.
Prof. Taghrid Asfar, Research Assistant Professor
University of Miami

Closest Location

University of Miami - Miami, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diagnosed with HIV (based on self-report).
Be 18 years and older
Have smoked ≥ 5 cigarettes/day in the past year
Be interested in making a quit attempt in the next 30 days
Own a smartphone (apple/android), and plan to keep it active for the next 6 months
Able to consent
Have no plans to move in the next 6 months
Are not pregnant or planning to be pregnant in the following 6 months
Have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements

Patient Q&A Section

What are common treatments for hiv infections?

"Antiviral medications are the most commonly used treatments for hiv infections, but treatment effectiveness has yet to be well determined. The number of treatments used varies depending on the stage of HIV infection. A greater number of newer antiretroviral therapies become available each year. New antiretroviral therapies may be more efficacious in the treatment of HIV, and therefore may be beneficial in the long-term treatment of HIV infection. Targeted therapy and the possibility of cure await more clarification of the treatment's efficacy and toxicity profiles, but they may become part of future HIV treatment plans." - Anonymous Online Contributor

Unverified Answer

What causes hiv infections?

"A significant percentage of hiv disease cases may be avoided if patients who test positive for HIV are aware of the risks. As of this publication, no effective HIV vaccine has been developed. Effective prevention may be achieved by expanding access to HIV testing and treatment, and by ensuring good counseling from clinicians and peer educators." - Anonymous Online Contributor

Unverified Answer

Can hiv infections be cured?

"The HIV can and may be cured, depending on the nature and timing of the treatment and if the organism is a helper or non-helper. It is of particular concern that the treatment is not administered and is not complete until the AIDS related symptoms are present. Therefore, the disease is not completely cured but it can be cured, if the organism is a helper virus, but not if it is a non-helper virus." - Anonymous Online Contributor

Unverified Answer

What is hiv infections?

"HIV is an infection that is transmitted through blood and sexual contact. HIV in the USA is spread through heterosexual sex. People who are most likely to contract HIV are those who have multiple sexual partners. HIV can infect the nervous system and cause a variety of health complications that change over time. HIV and AIDS present with many different signs and symptoms. People infected with HIV typically develop symptoms such as fever, joint pain, swollen lymph glands, skin ulcers, diarrhea, weight loss, and swelling. People with HIV and AIDS typically develop AIDS symptoms like abnormal cell growth, difficulty breathing, and shortness of breath. The mainstay treatment of HIV infections is highly active antiretroviral therapy." - Anonymous Online Contributor

Unverified Answer

What are the signs of hiv infections?

"Symptoms of HIV include swollen lymph nodes, fever, chest pains, and a non-painful or non-blocked lung. It can also present in other ways, such as feeling tired or feeling sick. Some people may not notice any of these symptoms." - Anonymous Online Contributor

Unverified Answer

How many people get hiv infections a year in the United States?

"hiv is a public-health concern, and people living with and at risk of infection make a major contribution to its transmission. It is estimated that 1.5–2 million people in the United States are living with hiv as of 1994 and that 1.7–2.4 million people were living with hiv by 1998. Approximately 25% of HIV infection are acquired through sexual contact, 25% are transmitted through intravenous drug use, and 25% result from exposure to an HIV-infected person through the exchange of contaminated blood products, medical procedures, or a needle stick accident. People from all groups are susceptible to HIV infection, but men who have sex with men are at highest risk." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving contingency management smoking cessation intervention?

"While there are other clinical trials pertaining to cessation interventions among HIV-infected smokers, research into the efficacy of CI as a smoking cessation tool among HIV-infected patients is limited. For this reason, the results of any one CI trial is only applicable to the subgroup of HIV-infected smokers participating." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hiv infections?

"The majority of HIV infections worldwide are acquired from heterosexual contact. Therefore, prevention messages need to be directed to individuals at risk for genital HIV transmission who have not had a history of unprotected sex. Efforts to modify sexual behavior would appear necessary to reduce the prevalence and incidence of HIV infection." - Anonymous Online Contributor

Unverified Answer

Does contingency management smoking cessation intervention improve quality of life for those with hiv infections?

"The use of a contingency management model may make little to no impact on general health status, but may result in improvements in other aspects of health such as the perceived quality of life." - Anonymous Online Contributor

Unverified Answer

Is contingency management smoking cessation intervention safe for people?

"CMM shows good safety among this sample as evidenced by our findings that no participants were hospitalized, experienced a major adverse event, or were lost to follow-up. It shows promise as a smoking cessation tool as it does not appear to be an obstacle to those who have tried and failed other forms of smoking cessation strategies. The CMM group demonstrated similar abstinence rates to those of a previous clinical trial, although with an overall higher rate due to the differences in treatment intensity. Given the good safety and efficacy found in this clinical trial, this model provides an intriguing alternative treatment for this population that is less challenging." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating hiv infections?

"While [most commercially available treatments cannot cure hiv/AIDS infections(http://www.withpower.com/clinical-trials/hiv-treatment-is-a-clinical-trial-right-for-you-2019032216100)], HIV clinical trials can help improve the individual outcomes of hiv patients by helping with the development of anti-HIV drugs that may be better tolerated and/or more effective against HIV than existing medicines. If you are looking to join a hiv clinical trial(http://www.withpower." - Anonymous Online Contributor

Unverified Answer

How serious can hiv infections be?

"HIV infections can spread to and from other parts of your body. Some common symptoms of HIV infections include fever, muscle pains, trouble moving, headache, swollen lymph nodes, and shortness of breath. Symptoms generally go away without treatment during the incubation phase unless other opportunistic infections are present. In cases when other infections are present, treatments can slow viral replication and reduce or prevent a fever or symptoms from becoming severe. Other preventive measures to help prevent infections include regular hand-washing. If you are living with HIV and you have not used a condom or other type of birth control or have not been tested for sexually transmitted diseases, make sure that your sexual partner is not infected with any serious diseases." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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