Optimizing tobacco treatment delivery for people with HIV: trial protocol for a randomized controlled trial
Abstract Background With advances in antiretroviral therapy, people with HIV (PWH) are living longer and are less likely to die from AIDS-related complications. Yet, prior research has shown that smoking is often not addressed in the context of HIV care, and few individuals are offered cessation tre...
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| Format: | Article |
| Language: | English |
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BMC
2022-11-01
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| Series: | Addiction Science & Clinical Practice |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13722-022-00341-2 |
| _version_ | 1798044342153117696 |
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| author | Brandon T. Sanford Benjamin A. Toll Allison Ross Eckard Katherine R. Sterba K. Michael Cummings Nathaniel L. Baker Alana M. Rojewski |
| author_facet | Brandon T. Sanford Benjamin A. Toll Allison Ross Eckard Katherine R. Sterba K. Michael Cummings Nathaniel L. Baker Alana M. Rojewski |
| author_sort | Brandon T. Sanford |
| collection | DOAJ |
| description | Abstract Background With advances in antiretroviral therapy, people with HIV (PWH) are living longer and are less likely to die from AIDS-related complications. Yet, prior research has shown that smoking is often not addressed in the context of HIV care, and few individuals are offered cessation treatment. Optimizing tobacco treatment delivery for PWH may increase engagement with evidence-based treatments and successful quit attempts. Methods The current study is a type 1 hybrid effectiveness-implementation trial to evaluate the impact of a proactive, opt-out tobacco treatment intervention on cessation outcomes and advance understanding of key barriers and facilitators of implementation processes. A total of 230 PWH who smoke will be recruited from an infectious diseases clinic at an academic medical center and will be randomized to receive (1) treatment as usual (TAU) or (2) Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement (PrOMOTE). Primary outcomes include: biochemically verified 7-day point prevalence abstinence (PPA) rates, continuous abstinence (Weeks 9–12), and the number of 24-hour quit attempts at the end of study treatment (Week 12). Secondary outcomes include: participant reach (proportion reached out of contact attempts), implementation fidelity (including number of prescriptions written), participant adherence to prescribed pharmacotherapy, acceptability (participant and provider satisfaction with intervention delivery and content), and perceived barriers. Discussion This study will examine a novel approach to optimizing tobacco treatment delivery for PWH. Integrating effectiveness and implementation results will help define best practices for engaging PWH with evidence-based tobacco treatment interventions. The intervention is low-cost, has the potential to be highly scalable, and could be translatable to other ambulatory HIV clinic settings. Trial Registration ClinicalTrials.gov: NCT05019495 (August 24, 2021). |
| first_indexed | 2024-04-11T23:02:16Z |
| format | Article |
| id | doaj.art-f918796cb9694339a966cd7485b69bcf |
| institution | Directory Open Access Journal |
| issn | 1940-0640 |
| language | English |
| last_indexed | 2024-04-11T23:02:16Z |
| publishDate | 2022-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Addiction Science & Clinical Practice |
| spelling | doaj.art-f918796cb9694339a966cd7485b69bcf2022-12-22T03:58:07ZengBMCAddiction Science & Clinical Practice1940-06402022-11-0117111010.1186/s13722-022-00341-2Optimizing tobacco treatment delivery for people with HIV: trial protocol for a randomized controlled trialBrandon T. Sanford0Benjamin A. Toll1Allison Ross Eckard2Katherine R. Sterba3K. Michael Cummings4Nathaniel L. Baker5Alana M. Rojewski6Department of Public Health Sciences, Medical University of South CarolinaDepartment of Public Health Sciences, Medical University of South CarolinaDepartment of Public Health Sciences, Medical University of South CarolinaDepartment of Public Health Sciences, Medical University of South CarolinaDepartment of Public Health Sciences, Medical University of South CarolinaDepartment of Public Health Sciences, Medical University of South CarolinaDepartment of Public Health Sciences, Medical University of South CarolinaAbstract Background With advances in antiretroviral therapy, people with HIV (PWH) are living longer and are less likely to die from AIDS-related complications. Yet, prior research has shown that smoking is often not addressed in the context of HIV care, and few individuals are offered cessation treatment. Optimizing tobacco treatment delivery for PWH may increase engagement with evidence-based treatments and successful quit attempts. Methods The current study is a type 1 hybrid effectiveness-implementation trial to evaluate the impact of a proactive, opt-out tobacco treatment intervention on cessation outcomes and advance understanding of key barriers and facilitators of implementation processes. A total of 230 PWH who smoke will be recruited from an infectious diseases clinic at an academic medical center and will be randomized to receive (1) treatment as usual (TAU) or (2) Proactive Outreach with Medication Opt-out for Tobacco Treatment Engagement (PrOMOTE). Primary outcomes include: biochemically verified 7-day point prevalence abstinence (PPA) rates, continuous abstinence (Weeks 9–12), and the number of 24-hour quit attempts at the end of study treatment (Week 12). Secondary outcomes include: participant reach (proportion reached out of contact attempts), implementation fidelity (including number of prescriptions written), participant adherence to prescribed pharmacotherapy, acceptability (participant and provider satisfaction with intervention delivery and content), and perceived barriers. Discussion This study will examine a novel approach to optimizing tobacco treatment delivery for PWH. Integrating effectiveness and implementation results will help define best practices for engaging PWH with evidence-based tobacco treatment interventions. The intervention is low-cost, has the potential to be highly scalable, and could be translatable to other ambulatory HIV clinic settings. Trial Registration ClinicalTrials.gov: NCT05019495 (August 24, 2021).https://doi.org/10.1186/s13722-022-00341-2Implementation scienceTobacco treatmentHIVSpecial populationsOpt-outSmoking cessation |
| spellingShingle | Brandon T. Sanford Benjamin A. Toll Allison Ross Eckard Katherine R. Sterba K. Michael Cummings Nathaniel L. Baker Alana M. Rojewski Optimizing tobacco treatment delivery for people with HIV: trial protocol for a randomized controlled trial Addiction Science & Clinical Practice Implementation science Tobacco treatment HIV Special populations Opt-out Smoking cessation |
| title | Optimizing tobacco treatment delivery for people with HIV: trial protocol for a randomized controlled trial |
| title_full | Optimizing tobacco treatment delivery for people with HIV: trial protocol for a randomized controlled trial |
| title_fullStr | Optimizing tobacco treatment delivery for people with HIV: trial protocol for a randomized controlled trial |
| title_full_unstemmed | Optimizing tobacco treatment delivery for people with HIV: trial protocol for a randomized controlled trial |
| title_short | Optimizing tobacco treatment delivery for people with HIV: trial protocol for a randomized controlled trial |
| title_sort | optimizing tobacco treatment delivery for people with hiv trial protocol for a randomized controlled trial |
| topic | Implementation science Tobacco treatment HIV Special populations Opt-out Smoking cessation |
| url | https://doi.org/10.1186/s13722-022-00341-2 |
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