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PositiveLinks mHealth Platform for HIV/AIDS
N/A
Recruiting
Led By Amanda D Castel, MD, MPH
Research Sponsored by George Washington University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12 from baseline
Awards & highlights
Study Summary
This trial will test the efficacy of an mHealth platform, PositiveLinks, to improve retention in care and viral suppression among people with HIV in Washington, DC.
Who is the study for?
This trial is for people living with HIV in the DC area who can consent to participate, are at least 16 years old, and plan to stay local for the next year. Participants should speak English or Spanish at a basic level and be poorly retained in HIV care, which could mean having detectable virus levels or inconsistent clinic visits.Check my eligibility
What is being tested?
The PositiveLinks mobile health platform is being tested. It's designed to help people with HIV stay on track with their treatment by offering medication reminders, mood tracking, secure messaging with healthcare staff, peer support forums, and resources for managing their condition.See study design
What are the potential side effects?
Since PositiveLinks is a digital tool rather than a medication, it doesn't have physical side effects. However, users may experience issues related to privacy concerns or stress from constant health monitoring.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12 from baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12 from baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Retention in Care
Viral Suppression
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PositiveLinksExperimental Treatment1 Intervention
Participants from clinics randomized to PL will get the patient smartphone app; clinic staff will receive the provider portal and provider smartphone app, the provider online LMS (learning management system), and the research assistant will use the administrative website to enroll participants. Patients randomized to PL will use it for 12 months or more; they can opt to use it as long as it is available during the study(access depending on enrollment date).
Group II: Usual CareActive Control1 Intervention
Participants from clinics randomized to Usual Care (UC) will receive usual clinic retention and medication adherence support services for 12M. Based on site assessments, and descriptions from the clinics, the UC condition ranges from having no ancillary support to only case management, to Ryan White funding and comprehensive services (adherence support, patient navigation, mental health, substance abuse, dental services and food banks)
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Who is running the clinical trial?
George Washington UniversityLead Sponsor
243 Previous Clinical Trials
452,946 Total Patients Enrolled
University of VirginiaOTHER
753 Previous Clinical Trials
1,244,287 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,776 Previous Clinical Trials
2,673,007 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot legally consent to participate on my own.I am under 16, or if 16-17, my parent manages my HIV care.I am 16 or older, living with HIV, and eligible for or enrolled in the DC Cohort study.
Research Study Groups:
This trial has the following groups:- Group 1: PositiveLinks
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can persons still apply to participate in this trial?
"Reportedly, this specific clinical trial is not presently recruiting any new participants. Initially posted on November 28th 2022 and last updated on the 7th of November, 514 other trials are actively seeking out enrollees right now."
Answered by AI
Who else is applying?
What site did they apply to?
Veterans Affairs Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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