Ignite Creation Date:
2024-05-06 @ 8:51 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02837250
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2016-07-15
Brief Title:
Pilot RCT of Pos4Health for Nonadherent HIV Substance Users
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Pilot RCT of Patient Centered eHealth Intervention for Nonadherent HIV Substance Users
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Improving treatment adherence among active substance users requires addressing many health barriers beyond substance use aloneDr 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 progressionAtkinson 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 behaviorsProchaska 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
1 To develop a prototype of a patient-centered eHealth Internet intervention targeting adherence and a set of behaviors and experiences known to undermine adherence among non-urban PLWH
2 To evaluate the prototype for usability feasibility and acceptability among PLWH and HIV care clinicians modify it using PLWH and clinician feedback and finalize it for pilot testing
3 To pilot test the finalized intervention to determine whether it warrants a subsequent randomized clinical trial
The pilot test will
1 evaluate the feasibility of the eHealth intervention by examining access usage refusal vs enrollment retention vs dropout etc using both web-tracked process data and interviews
2 provide preliminary data on the impact of the eHealth intervention on knowledge and usage of strategies of adherence and each targeted experience and behavior that undermines ART adherence
3 test variables likely to be used as primary outcome markers in a subsequent RCT for their variance in this population ie adherence by pharmacy refill rate rate of missed HIV care visits rate of drug-using days and rate of risky drinking days
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
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
1 To develop a prototype of a patient-centered eHealth Internet intervention targeting adherence and a set of behaviors and experiences known to undermine adherence among non-urban PLWH
2 To evaluate the prototype for usability feasibility and acceptability among PLWH and HIV care clinicians modify it using PLWH and clinician feedback and finalize it for pilot testing
3 To pilot test the finalized intervention to determine whether it warrants a subsequent randomized clinical trial
The pilot test will
1 evaluate the feasibility of the eHealth intervention by examining access usage refusal vs enrollment retention vs dropout etc using both web-tracked process data and interviews
2 provide preliminary data on the impact of the eHealth intervention on knowledge and usage of strategies of adherence and each targeted experience and behavior that undermines ART adherence
3 test variables likely to be used as primary outcome markers in a subsequent RCT for their variance in this population ie adherence by pharmacy refill rate rate of missed HIV care visits rate of drug-using days and rate of risky drinking days
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34DA039011-01 | NIH | None | httpsreporternihgovquickSearchR34DA039011-01 |