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NCT04998019 · ClinicalTrials.gov registry record · NA
PositiveLinks: mHealth for DC Cohort
A NA study of HIV/AIDS, sponsored by George Washington University.
- Completed
- Registry status
- NA
- Development phase
- 682
- Enrollment target
- 13
- Study locations
NCT04998019 is a NA study of HIV/AIDS that has completed, run by George Washington University. The registered enrollment target is 682 participants, below the 33,169-participant average among 61 other HIV/AIDS trials with a reported enrollment target (98% lower). The trial reports 13 study locations across 1 state.
The verdict
NCT04998019, a NA study of HIV/AIDS, has completed, sponsored by George Washington University.
- COMPLETED
- Registry status
- NA
- Development phase
- 682 participants
- Enrollment target
- 13
- Study locations
Study Summary
To achieve the end of the HIV epidemic, concerted efforts will be needed to address the HIV care continuum, including improving retention in care (RIC) and viral suppression (VS) among persons with HIV (PWH). In the U.S., less than 50% of PWH are RIC and even fewer are VS. Studies have shown that these PWH have poorer clinical outcomes and are at risk of transmitting HIV to others, hence the need for innovative solutions to improve retention in care and subsequent viral suppression. Theory-based mHealth interventions have been shown to be promising in reaching these at-risk groups and improving HIV-related outcomes. PositiveLinks is a clinic-deployed mHealth platform that includes patient and provider smartphone apps, a web portal for clinic staff and providers to manage patient cohorts, an online implementation guide, and a learning management system to train and certify clinic staff. It has theory-based features including daily queries of adherence, mood, and stress, graphical feedback for self-monitoring, secure messaging with staff, appointment reminders, anonymized peer support, information resources, and document upload capability to support insurance re-enrollment. A 12-month prospective study in poorly retained PWH found that PL increased RIC and VS, with app use related to benefit as well as improved social support and stigma. PL is a promising existing mHealth tool for PWH, yet its efficacy has not been tested in a randomized trial, nor in urban populations. The investigators will test the efficacy of PositiveLinks to improve RIC and VS among a cohort of PWH in a high HIV prevalence city of Washington, DC. Participants will be identified from the DC Cohort, a longitudinal prospective cohort of PWH receiving HIV care at 15 clinics in DC. First, the investigators will conduct formative research to assess the feasibility, acceptability and usability of PositiveLinks among this urban cohort and conduct subsequent adaptations based on these findings. The invest
Conditions Studied
Interventions
- BEHAVIORAL PositiveLinks
Study Locations (13)
District of Columbia
- MetroHealth - Washington D.C.
- Unity Medical Center - Washington D.C.
- Georgetown University - Washington D.C.
- La Clinica Del Pueblo - Washington D.C.
- Children's National Medical Center Pediatric Clinic - Washington D.C.
- Medstar Washington Hospital Center - Washington D.C.
- Washington Health Institute - Washington D.C.
- Family and Medical Counseling Service - Washington D.C.
- Whitman-Walker Health - Washington D.C.
- George Washington Medical Faculty Associates - Washington D.C.
- Howard University Hospital Adult Clinic - Washington D.C.
- Howard University Hospital Pediatric Clinic - Washington D.C.
- Veterans Affairs Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 682 participants |
| Start Date | 2022-12-12 |
| Est. Completion | 2025-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04998019
The ClinicalTrials.gov registry entry for NCT04998019 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 682 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 33,169-participant average among 61 other HIV/AIDS trials with a reported enrollment target (98% lower). The listed sponsor is George Washington University, which has 133 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV/AIDS appearing as the primary indexed condition, and to 1 intervention - of which PositiveLinks is the first listed.
NCT04998019 reports 13 study locations spanning 1 distinct geographic area - top geographies include District of Columbia.
Frequently Asked Questions
What is clinical trial NCT04998019 about?
NCT04998019 is a clinical study titled "PositiveLinks: mHealth for DC Cohort". To achieve the end of the HIV epidemic, concerted efforts will be needed to address the HIV care continuum, including improving retention in care (RIC) and viral suppression (VS) among persons with HIV (PWH). In the U.S., less than 50% of PWH are RIC and even fewer are VS. Studies have shown that th...
What is the current status of trial NCT04998019?
This trial is currently completed. It is a NA study. The enrollment target is 682 participants. The study started on 2022-12-12. Estimated completion is 2025-06-30.
What conditions does trial NCT04998019 study?
This clinical trial studies the following conditions: HIV/AIDS.
What interventions are being tested in trial NCT04998019?
The interventions under investigation include: PositiveLinks (BEHAVIORAL).
Who is sponsoring clinical trial NCT04998019?
This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04998019 being conducted?
This trial has 13 study locations across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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