Clinical trial NCT02837250: Pilot RCT of Pos4Health for Nonadherent HIV+ Substance Users
Official title: Pilot RCT of Patient Centered eHealth Intervention for Nonadherent HIV+ Substance Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonadherence
Keywords: HIV
Substance Use
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-07-19
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

HIV positive and on ART

* Reports ART nonadherence in the past 30 days (Subject reports missed taking HIV medication at least 5/90 days on the 90 day TLFB at enrollment)
* Screens positive for substance use in the past 30 days (Subject reports using illicit drug at least once on the 90 day TLFB at enrollment) OR Screens positive for alcohol abuse in past 30 days (Subject reports binging or exceeding weekly drinking limit (for women 8 drinks/week; for men 15 drinks/week) at least twice on the 90 day TLFB at enrollment)
* At least 18 years old
* Speaks and reads English
* Can provide meaningful informed consent
* Willing to be followed for 4-5 months
* Has regular access to a phone, email, and computer connected to the Internet

Exclusion Criteria:

* • Never missed an ART dose in past 90 days

  * Reports no use of illicit drugs or risky drinking in past 90 days
  * Cognitive disorders including mental retardation and dementia that could impair ability to understand the intervention material or give informed consent, or psychotic disorder due to the same issues
  * A prisoner, hospitalized, or institutionalized
  * Illiterate
  * Does not have email or ability to access the internet

Primary outcomes:
measure: Feasibility
timeFrame: 6 months
measure: Acceptability
timeFrame: 6 months
measure: Knowledge and Usage of Coping Strategies
timeFrame: 6 months
Secondary outcomes:
measure: Adherence by Pharmacy Refill Rate and Treatment Engagement by Missed Visit Proportion
timeFrame: 6 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Center for Behavioral Health and Technology
state: Virginia
Study officials:
affiliation: University of Virginia
name: Karen S Ingersoll, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: www.pos4health.org
name: Interest Site
role: STUDY_DIRECTOR
References:
citation: 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.