Pilot RCT of Pos4Health for Nonadherent HIV+ Substance Users

NCT02837250 | Completed

• 2 other identifiers: 18938R34DA039011-01
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonadherence

Keywords

HIV; Substance Use

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Adherence by Pharmacy Refill Rate and Treatment Engagement by Missed Visit Proportion

  6 months

Study Arms (2)

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.

Behavioral: Pos4Health

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.

Behavioral: Patient Education

Interventions

Pos4Health BEHAVIORAL

This is a personalized, interactive, patient-centered Internet intervention targeting nonadherence to ART among substance users living with HIV.

Pos4Health

Patient Education BEHAVIORAL

This is a patient education website with content about nonadherence to ART pertinent to substance users living with HIV.

Patient Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Virginia Center for Behavioral Health and Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• 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.

  PMID: 27123688 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Karen S Ingersoll, Ph.D.

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Interest Site

  www.pos4health.org

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: July 19, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: July 5, 2018
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)