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| ID | Type | Description | Link |
|---|---|---|---|
| R34DA039011-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This project has developed a patient-centered eHealth intervention; specifically, an Internet intervention, targeting multiple issues and nonadherence in HIV. The intervention, Pos4Health, includes peer role model videos and evidence-based interactions to promote understanding, coping with, and managing risk factors for nonadherence to ART, and to improve nonadherence itself. In this Pilot Trial, investigators will test the eHealth intervention Pos4Health with PLWH who reside outside urban centers. The pilot trial will determine the acceptability and feasibility of Pos4Health and explore data on HIV clinical outcomes.
Improving treatment adherence among active substance users requires addressing many health barriers beyond substance use alone.(Dr N. Zaller Ph. D, Gillani, & Rich, 2007; Simoni, Amico, Pearson, & Malow, 2008; Willenbring, 2005) Behaviors like smoking and drug use, and experiences like poverty, poor social support, stigma, fear of HIV disclosure, depression, and anxiety, all reduce antiretroviral (ART) adherence and engagement in care, while accelerating disease progression.(Atkinson & Petrozzino, 2009; Bouhnik et al., 2002; Hendershot, Stoner, Pantalone, & Simoni, 2009; Mugavero et al., 2009; Shuter & Bernstein, 2008; Simoni, Frick, & Huang, 2006; Tucker, Burnam, Sherbourne, Kung, & Gifford, 2003; Villes et al., 2007) Improving multiple health behaviors that are related to nonadherence is a promising approach that will be used in the current project. Emerging evidence supports simultaneously targeting multiple health behaviors.(Prochaska et al., 2008) Unfortunately, few interventions address the range of issues that undermine adherence to HIV care.
Extending a program of research by the investigative team, this project will develop a patient-centered eHealth intervention; specifically, an Internet intervention, targeting multiple issues and nonadherence in HIV.
The specific aims are:
The pilot test will:
If the pilot test of the new patient-centered eHealth intervention shows an impact on knowledge and use of strategies, and it proves to be feasible and acceptable, it will be tested in a subsequent RCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pos4Health | Experimental | Pos4Health is a 6 Core Internet intervention focusing on improving adherence to ART among nonadherent substance users living with HIV in non urban areas. Pos4Health Cores each present a topic, show videos of HIV+ peers discussing that topic, and how they have coped with it, and use interactions to teach about the topic and to develop knowledge and skills. Each core ends with tips to try that include tips mentioned by peers or from expert material. Content is personalized to the user and users receive tailored feedback. Cores are metered out weekly after each Core is completed. |
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| Patient Education | Active Comparator | Patient Education is a static (unchanging) website that presents accurate information about the same topics in Pos4Health, but without personalization, peer videos, or interactivity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pos4Health | Behavioral | This is a personalized, interactive, patient-centered Internet intervention targeting nonadherence to ART among substance users living with HIV. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Study Acceptance will be determined by consents obtained divided by patients approached for the study. The trial will be considered feasible if the acceptance rate among eligible patients is equal to or greater than 56%. | 6 months |
| Acceptability | Is the intervention acceptable? Acceptability will be judged by participant ratings, and by actual program usage data. Participants will rate the Intervention at follow-up. The range of items on this scale is from 1 to 7. An item mean of 3.5 would be mid-range. Basic descriptive information will be gathered from the tracking system about whether participants logged in, how many times, and for how long. Time spent in each Core will be tracked and summarized. Pos4Health will be judged acceptable if if the average score on the evaluation was > 5.6, which is 80% of the highest score (range 1-7), and if 75% of participants completed at least half of the Cores and provide 4 of 7daily diaries of adherence on at least 4 weeks. | 6 months |
| Knowledge and Usage of Coping Strategies | The study will compare the Pos4Health and PtEd groups are knowledge and usage of evidence-based coping strategies for the problems targeted by each Core. Linear models will compare change between groups from baseline to post-treatment follow-up. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence by Pharmacy Refill Rate and Treatment Engagement by Missed Visit Proportion | There is 1 secondary research question: How do adherence and engagement in care measures perform as future primary outcomes? Unfortunately, the quantity and quality of adherence and engagement in care indicators (Pharmacy Refill Rate, Missed Visit Proportion) were not adequate to determine which ones are suitable as outcome measures in a future RCT. Our team had hoped to calculate effect sizes for a subsequent randomized trial. |
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Inclusion Criteria:
HIV positive and on ART
Exclusion Criteria:
• Never missed an ART dose in past 90 days
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| Name | Affiliation | Role |
|---|---|---|
| Karen S Ingersoll, Ph.D. | University of Virginia | Principal Investigator |
| Interest Site | www.pos4health.org | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Behavioral Health and Technology | Charlottesville | Virginia | 22903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27123688 | Background | Modipane MB, Waldman AL, Ritterband L, Dillingham R, Bullock L, Ingersoll KS. Technology Use Among Patients in a Nonurban Southern U.S. HIV Clinic in 2015. Telemed J E Health. 2016 Nov;22(11):965-968. doi: 10.1089/tmj.2015.0242. Epub 2016 Apr 28. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2022 | Nov 7, 2022 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 11, 2017 | Feb 14, 2018 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Patient Education | Behavioral | This is a patient education website with content about nonadherence to ART pertinent to substance users living with HIV. |
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| 6 months |