PositiveLinks: mHealth for DC Cohort

Completed · Not applicable

Conditions studied: HIV/AIDS

In brief

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.

Key facts

Study ID: NCT04998019
Run by: George Washington University
People needed: 682
Starts: 2022-12-12
Expected to finish: 2025-06-30
Last updated by the study team: 2025-08-19

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

PLWH and eligible for/enrolled in DC Cohort study age 16 or older
speaks and reads English or Spanish at 4th grade level or above
can provide informed consent; if a minor, is in charge of own HIV care
plans to reside in the DC metro area for the next 12M
has at least one of the following indicators of poor retention (in order of priority):
detectable virus,
not retained in care,
returning to care after a gap of ≥6 months, d) no visit constancy
newly diagnosed or initiating HIV care
recently transferred from a different HIV care site
evidence of HIV care receipt at a DC Cohort site and a non-DC Cohort site based on the DOH (Department of Health) linkage(\~9%).

You may not qualify if…

age below 16, or if patient is 16-17; parent is in charge of HIV care
unable to provide legal, independent consent to participate
PLWH receiving care at two DC Cohort sites (\~10%) will be excluded

Where it is running

MetroHealth — Washington D.C., District of Columbia, United States
Unity Medical Center — Washington D.C., District of Columbia, United States
Georgetown University — Washington D.C., District of Columbia, United States
La Clinica Del Pueblo — Washington D.C., District of Columbia, United States
Children's National Medical Center Pediatric Clinic — Washington D.C., District of Columbia, United States
Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
Washington Health Institute — Washington D.C., District of Columbia, United States
Family and Medical Counseling Service — Washington D.C., District of Columbia, United States
Whitman-Walker Health — Washington D.C., District of Columbia, United States
George Washington Medical Faculty Associates — Washington D.C., District of Columbia, United States
Howard University Hospital Adult Clinic — Washington D.C., District of Columbia, United States
Howard University Hospital Pediatric Clinic — Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.