Pilot RCT of Pos4Health for Nonadherent HIV+ Substance Users

Nonadherence Clinical Trial

Official title: Pilot RCT of Patient Centered eHealth Intervention for Nonadherent HIV+ Substance Users

Status Completed

Clinical Trial 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.

Clinical Trial Description

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:

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 (i.e., 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. ;

Related Conditions & MeSH terms

• Nonadherence

• NCT number: NCT02837250
• Study type: Interventional
• Source: University of Virginia
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Completion date: July 5, 2018