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| Name | Class |
|---|---|
| Universidade Estadual de Londrina | OTHER |
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The overall goal of this feasibility study is to make adaptations to these evidence-based approaches in collaboration with PLWH and health care providers working with this population, and develop, implement, and evaluate the feasibility and scalability of a theory-based, culturally relevant tobacco cessation intervention for PLWH receiving care through the public health system in a southern town in Brazil (Londrina). This proposal will focus on the intervention development, pretesting, and feasibility testing. The primary outcome will be a 7-day point prevalence abstinence (defined as no tobacco use in the past 7 days and verified through measurement of salivary cotinine and exhaled carbon monoxide levels) at 6-month follow-up. We will also conduct detailed treatment fidelity and scalability assessments (acceptability, feasibility, potential reach and adoption, alignment with the strategic context) to inform a full-scale efficacy trial.
This study aims at developing and examining feasibility and scalability of a theory-based, culturally relevant tobacco cessation intervention for PLWH receiving care through the public health system in a southern town in Brazil. It consists of three phases: formative assessments with patients and health care providers to inform relevant components of the intervention, pretesting of the intervention components, and pilot testing of the intervention (feasibility).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients will receive a tobacco cessation intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tobacco cessation | Behavioral | Tobacco cessation program consisting of cognitive-therapy sessions and pharmacological management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a 7-day Prevalence Abstinence of Tobacco Use | 7-day point prevalence abstinence (defined as no tobacco use in the past 7 days and verified through measurement of salivary cotinine and exhaled carbon monoxide (CO) levels) at 6-month follow-up. | 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Tobacco Use Abstinence Based on Salivary Cotinine at 7-month Follow-up. | Tobacco use abstinence based on salivary cotinine was assessed at 7-month follow-up | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabel C Scarinci, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Estadual de Londrina | Londrina | Paraná | 86057 | Brazil |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Patients will receive a tobacco cessation intervention Tobacco cessation: Tobacco cessation program consisting of cognitive-therapy sessions and pharmacological management |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Patients will receive a tobacco cessation intervention Tobacco cessation: Tobacco cessation program consisting of cognitive-therapy sessions and pharmacological management |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a 7-day Prevalence Abstinence of Tobacco Use | 7-day point prevalence abstinence (defined as no tobacco use in the past 7 days and verified through measurement of salivary cotinine and exhaled carbon monoxide (CO) levels) at 6-month follow-up. | Posted | Number | participants | 6-month follow-up |
|
|
12 months
Adverse events were monitored but none reported
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Patients will receive a tobacco cessation intervention Tobacco cessation: Tobacco cessation program consisting of cognitive-therapy sessions and pharmacological management |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Isabel Scarinci, Principal Investigator | University of Alabama at Birmingham | 2059757177 | scarinci@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2023 | Sep 4, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Feasibility of a tobacco cessation program tailored to patients living with HIV
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Educational attainment - completed at least high school | Number | participants |
|
| Number of cigarettes/day | Mean | Standard Deviation | cigarettes/day |
|
| Fagerstrom Score - moderate to very high | Fagerstrom Test for Nicotine Dependence assesses the intensity of physical addiction to nicotine. It contains six items and final score ranges from 0 to 10. Scores between 5 and 10 are considered moderate to very high physical addiction and if of clinical significance. | Number | participants |
|
| Depressive symptomatology (CES-D) | The Center for Epidemiological Studies Depression Scale (CES-D) assesses self-report depressive symptomatology in the general population. It is a screening test for depressive symptomatology and not a diagnostic test. Scores range from 0 to 60. Scores of 16 and higher are indicative of depressive symptomatology and it requires further assessments. This questionnaire does not have sub-scales. | Mean | Standard Deviation | units on a scale |
|
| Social Support | The Multidimensional Scale of Perceived Social Support assesses the adequacy of social support participants receive. Final scores between 1 and 2.9 indicate low social support, 3-5 moderate social support, and 5-7 high social support. | Mean | Standard Deviation | units on a scale |
|
|
| Secondary | Participants With Tobacco Use Abstinence Based on Salivary Cotinine at 7-month Follow-up. | Tobacco use abstinence based on salivary cotinine was assessed at 7-month follow-up | Posted | Number | participants | 7 months |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |