HIV Infections Clinical Trial
Official title:
Development, Implementation, and Evaluation of a Tobacco Cessation Intervention Tailored to Patients Living With HIV (PLWH) in Brazil: A Feasibility Study
| Verified date | September 2023 |
| Source | University of Alabama at Birmingham |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | August 31, 2023 |
| Est. primary completion date | August 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - PLWH (that is, patients with a confirmed HIV diagnosis) receiving care at the reference center in Londrina - 18 years of age and older; (c) smoke at least 5 cigarettes (industrialized or hand-rolled) per day Smoked within the past seven days. - No intent to move from the area served by reference center in Londrina within the next 12 months. Exclusion Criteria: - History of hypertension - History of angina - History of asthma - On medication for depression. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | Universidade Estadual de Londrina | Londrina | Paraná |
| Lead Sponsor | Collaborator |
|---|---|
| University of Alabama at Birmingham | Universidade Estadual de Londrina |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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