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Pilot RCT of Pos4Health for Nonadherent HIV+ Substance Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837250
Recruitment Status : Unknown
Verified February 2018 by Karen Ingersoll, University of Virginia.
Recruitment status was:  Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Karen Ingersoll, University of Virginia

Brief Summary:

RECRUITING NOW AT www.pos4health.org

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.


Condition or disease Intervention/treatment Phase
Nonadherence Behavioral: Pos4Health Behavioral: Patient Education Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pilot RCT of Patient Centered eHealth Intervention for Nonadherent HIV+ Substance Users
Actual Study Start Date : October 2016
Actual Primary Completion Date : January 1, 2018
Estimated Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse HIV/AIDS

Arm Intervention/treatment
Experimental: Pos4Health
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.
Behavioral: Pos4Health
This is a personalized, interactive, patient-centered Internet intervention targeting nonadherence to ART among substance users living with HIV.

Active Comparator: Patient Education
Patient Education is a static (unchanging) website that presents accurate information about the same topics in Pos4Health, but without personalization, peer videos, or interactivity.
Behavioral: Patient Education
This is a patient education website with content about nonadherence to ART pertinent to substance users living with HIV.




Primary Outcome Measures :
  1. Feasibility [ Time Frame: 6 months ]
    Feasibility will be judged by the rates of study acceptance and completion of the trial. 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%.

  2. Acceptability [ Time Frame: 6 months ]
    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.

  3. Knowledge and Usage of Coping Strategies [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Impact on adherence and engagement in care [ Time Frame: 6 months ]
    There is 1 secondary research question: How do adherence and engagement in care measures perform as future primary outcomes? At this stage, investigators will examine the data quality of adherence and engagement in care indicators (Pharmacy Refill Rate, Missed Visit Proportion) to determine which ones are suitable as outcome measures in a future RCT. The purpose is to calculate effect sizes for the planned randomized trial.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837250


Locations
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United States, Virginia
University of Virginia Center for Behavioral Health and Technology
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Karen S Ingersoll, Ph.D. University of Virginia
Study Director: Interest Site RECRUITING NOW at www.pos4health.org
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Responsible Party: Karen Ingersoll, PI, University of Virginia
ClinicalTrials.gov Identifier: NCT02837250    
Other Study ID Numbers: 18938
R34DA039011-01 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Karen Ingersoll, University of Virginia:
HIV
Substance Use