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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

Must not have

Unable to provide legal, independent consent to participate

Age below 16, or if patient is 16-17; parent is in charge of HIV care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12 from baseline

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot legally consent to participate on my own.

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I am under 16, or if 16-17, my parent manages my HIV care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12 from baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12 from baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 from baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Retention in Care

Viral Suppression

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

0 / 2Eligibility criteria met