NonadherenceNCT02837250
Pilot RCT of Pos4Health for Nonadherent HIV+ Substance Users
A study testing Pos4Health and Patient Education in people with Nonadherence, run by University of Virginia at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonadherence
- What is being tested?
- Pos4Health and Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 5 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Behavioral Health and Technology
Charlottesville, Virginia, 22903
About this study
Official title: Pilot RCT of Patient Centered eHealth Intervention for Nonadherent HIV+ Substance Users
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.
Read the 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:
- 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.
- 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
- To pilot test the finalized intervention to determine whether it warrants a subsequent randomized clinical trial.
The pilot test will:
- 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
- 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
- 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.
- Conditions
- Nonadherence
- Being tested
- Pos4Health, Patient Education
- Keywords
- HIV, Substance Use
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pos4HealthBehavioural
This is a personalized, interactive, patient-centered Internet intervention targeting nonadherence to ART among substance users living with HIV.
Patient EducationBehavioural
This is a patient education website with content about nonadherence to ART pertinent to substance users living with HIV.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
Adherence by Pharmacy Refill Rate and Treatment Engagement by Missed Visit Proportion
There is 1 secondary research question: How do adherence and engagement in care measures perform as future primary outcomes? Unfortunately, the quantity and quality of adherence and engagement in care indicators (Pharmacy Refill Rate, Missed Visit Proportion) were not adequate to determine which ones are suitable as outcome measures in a future RCT. Our team had hoped to calculate effect sizes for a subsequent randomized trial.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startOct 2016
- Primary completion1 Jan 2018
- Study completion5 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NonadherenceStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Karen Ingersoll, University of Virginia
- Investigators
- Karen S Ingersoll, Ph.D., Principal investigator, University of VirginiaInterest Site, Study director, www.pos4health.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837250
- Sponsor's protocol ID
- 18938
- Other IDs
- R34DA039011-01
- Status last verified
- Nov 2022
- First submitted
- 15 Jul 2016
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27123688
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot RCT of Patient Centered eHealth Intervention for Nonadherent HIV+ Substance Users
- ClinicalTrials.gov ID
- NCT02837250
- Acronym / sponsor ID
- 18938
- Conditions
- Nonadherence
- Keywords
- HIV, Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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
- To pilot test the finalized intervention to determine whether it warrants a subsequent randomized clinical trial.
The pilot test will:
- 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
- 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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pos4Health | Experimental | Behavioral: Pos4HealthPos4Health 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. |
| Patient Education | Active comparator | Behavioral: Patient EducationPatient Education is a static (unchanging) website that presents accurate information about the same topics in Pos4Health, but without personalization, peer videos, or interactivity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- • Never missed an ART dose in past 90 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pos4HealthThis is a personalized, interactive, patient-centered Internet intervention targeting nonadherence to ART among substance users living with HIV. | Behavioural | Pos4Health |
| Patient EducationThis is a patient education website with content about nonadherence to ART pertinent to substance users living with HIV. | Behavioural | Patient Education |
Primary outcome
Feasibility
Time frame: 6 months
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%.
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.
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.
1 secondary outcome
Adherence by Pharmacy Refill Rate and Treatment Engagement by Missed Visit Proportion
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Background: PubMed 27123688Modipane 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen S Ingersoll, Ph.D. principal investigator
University of Virginia
Interest Site study director
www.pos4health.org
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pos4Health and Patient Education in people with Nonadherence, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02837250, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.