NCT04998019

PositiveLinks: mHealth for DC Cohort

Completed NA Last updated 19 August 2025

What this trial tests

NA trial testing PositiveLinks in HIV/AIDS in 682 participants. Completed in 30 June 2025.

Timeline

12 December 2022

Primary endpoint
30 June 2025

30 June 2025

Quick facts

Lead sponsor	George Washington University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	682
Start date	12 December 2022
Primary completion	30 June 2025
Estimated completion	30 June 2025
Sites	13 locations across United States

Drugs / interventions tested

• PositiveLinks

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

George Washington University

Who can join

16 and older, any sex, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 investigators will then conduct an efficacy study through a cluster randomized controlled trial at 12 DC Cohort sites among 482 PWH. Clinics will be randomized to PL or usual care. Primary outcomes will include VS, RIC, and visit constancy at 12 months. Finally, the investigators will conduct mixed methods implementation science research guided by the Consolidated Framework for Implementation Research and RE-AIM to identify site, patient, provider, and system factors that characterize best practices in program implementation. If successful, this research will lead to the development of a novel and efficacious approach to improving RIC and VS among PWH which could lead to dissemination research that will contribute to HIV epidemic control. This project is responsive to NIH priorities, National HIV/AIDS Strategy, and Ending the HIV Epidemic goals as it is cross-cutting, seeks to reduce health inequities, and to improve health outcomes to achieve sustained viral suppression in a geographic hotspot for HIV.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluation of the Implementation and Effectiveness of a Mobile Health Intervention to Improve Outcomes for People With HIV in the Washington, DC Cohort: Study Protocol for a Cluster Randomized Controlled Trial.
   Hodges J, Caldwell S, Cohn W, Flickinger T, et al · · 2022 · cited 6× · PMID 35349466 · DOI 10.2196/37748
2. A Complex Digital Health Intervention to Support People With HIV: Organizational Readiness Survey Study and Preimplementation Planning for a Hybrid Effectiveness-Implementation Study.
   Hodges J, Cohn W, Castel A, Flickinger T, et al · · 2026 · PMID 41566411 · DOI 10.2196/76327
3. Operationalizing implementation science frameworks to plan a hybrid effectiveness-implementation study of a digital health intervention
   Hodges J, Cohn W, Castel AD, Flickinger T, et al · · 2024 · DOI 10.21203/rs.3.rs-5347341/v1