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 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.
Conditions:
🦠 HIV/AIDS
🗓️ Study Start (Actual) 12 December 2022
🗓️ Primary Completion (Estimated) 30 April 2025
✅ Study Completion (Estimated) 30 June 2025
👥 Enrollment (Estimated) 753
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Washington, District of Columbia, United States
📍 Washington, District of Columbia, United States
📍 Washington, District of Columbia, United States
📍 Washington, District of Columbia, United States
📍 Washington, District of Columbia, United States
📍 Washington, District of Columbia, United States
📍 Washington, District of Columbia, United States
📍 Washington, District of Columbia, United States
📍 Washington, District of Columbia, United States
📍 Washington, District of Columbia, United States
📍 Washington, District of Columbia, United States
📍 Washington, District of Columbia, United States
📍 Washington, District of Columbia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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%).

    Exclusion Criteria:

    • * 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
Ages Eligible for Study: 16 Years to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 July 2021
  • First Submitted that Met QC Criteria 6 August 2021
  • First Posted 10 August 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 February 2024
  • Last Update Posted 20 February 2024
  • Last Verified February 2024