Skip to main content
OpenTrials
Completed

NCT Number: NCT03934437

Leveraging mHealth and Peers to Engage African- Americans and Latinxs in HIV Care (LEAN)

This is a pragmatic randomized controlled study comparing existing linkage to care and retention (LTCR) services to an mHealth-enhanced linkage to care and retention (mLTCR) protocol.

Completed

Looking for future studies?

Notify Me

Key information

About this study

Baltimore's HIV prevalence rate (586/100,000) is among the top 5 in metropolitan areas in the US, and disparities are profound. African Americans have an HIV prevalence that is 5 times higher than among whites, and account for 78% of all HIV cases. Latinxs also have a higher prevalence of HIV than whites and are at the highest risk for late HIV diagnosis among all racial/ethnic groups. In addition, HIV viral load suppression, which is the best predictor of long-term survival among HIV-infected patients, is substantially lower among minority populations in Baltimore.

The overall goal of this proposal is to evaluate whether mHealth-enhanced Linkage to Care and Retention (mLTCR) can improve HIV outcomes among HIV-infected African Americans and Latinos compared to standard Linkage to Care and Retention (LTCR) programs. The mHealth-enhancement consists of two smartphone applications (app), one for patients and one for patient supporters (e.g. linkage officers, patient navigators, nurses, etc.), to help facilitate communication. Communication will focus on issues related to HIV care (e.g. appointment scheduling, transportation), as well as patient-directed requests. Using HIV surveillance data (e.g. unsuppressed HIV viral load), patient supporters will be automatically alerted if a patient has a high viral load and prompted to contact the patient. In addition to appointment reminders, patients will receive positive reinforcement behavioral text messages.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years of age
  • Ability to provide consent
  • Identified by BCHD Linkage protocol to be a new HIV diagnosis or HIV-infected and "out of care"
  • Identified by participating clinics as needing patient support services

Exclusion criteria

  • Not able to provide consent.

Treatment and study plan

mLTCR

Behavioral

mHealth-enhanced Linkage to Care and Retention

LTCR

Behavioral

Linkage and Retention Services (Standard-of-Care)

Primary outcomes

  1. Participants With HIV Viral Load Suppression (Copies/cc)

    Time frame: 12 months

    Viral Suppression defined as a viral load < 200 copies/cc

Secondary outcomes

  1. Participants Retained in Care

    Time frame: 12 months

    Retained in care based upon viral load, CD4, OR clinic visit reported in enhanced HIV/AIDS Reporting System (eHARS)

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Leveraging mHealth and Peers to Engage African-Americans and Latinxs in HIV Care (LEAN)

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 1, 2019
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.