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

  • identifier


  • Recruitment Status


  • First Posted

    May 1, 2019

  • Last update posted

    March 10, 2021

Study Description

Brief summary:

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.

  • Condition or Disease:HIV/AIDS
  • Intervention/Treatment: Behavioral: mLTCR
    Behavioral: LTCR
  • Phase: N/A

Detailed Description

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.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 500 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Supportive Care
  • Official Title: Leveraging mHealth and Peers to Engage African-Americans and Latinxs in HIV Care (LEAN)
  • Actual Study Start Date: February 2020
  • Estimated Primary Completion Date: September 2023
  • Estimated Study Completion Date: September 2023

Arms and interventions

Arm Intervention/treatment
Experimental: mLTCR
The mLTCR intervention consists of two smartphone applications (app), one for patients and one for patient supporters, to help facilitate communication.
Behavioral: mLTCR
mHealth-enhanced Linkage to Care and Retention
Active Comparator: LTC
Existing linkage to care and retention (LTCR) services which are standard-of-care
Behavioral: LTCR
Linkage and Retention Services (Standard-of-Care)

Outcome Measures

  • Primary Outcome Measures: 1. Proportion with HIV Viral Load Suppression (copies/cc) [ Time Frame: 12 months ]
    Viral Suppression defined as a viral load < 200 copies/cc
  • Secondary Outcome Measures: 1. Proportion 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)

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No


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.

Contacts and Locations


Contact: Kathleen Page, MD (410) 614-1814


United States, Maryland
Baltimore City Health Department

Sponsors and Collaborators

Johns Hopkins University

Patient-Centered Outcomes Research Institute


Principal Investigator: Kathleen W Page Johns Hopkins School of Medicine

More Information

  • Responsible Party: Johns Hopkins University
  • Identifier: NCT03934437 History of Changes
  • Other Study ID Numbers: IRB00195120, 11244
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: March 10, 2021
  • Last Verified: March 2021
  • Individual Participant
    Data (IPD) Sharing

  • Plan to Share IPD: Yes
  • Plan Description: Requests for data sharing should be made to the PI.
  • Supporting Materials: Study Protocol
  • Time Frame: Within 1 year after study recruitment has begun.
  • Access Criteria: All reasonable requests will be considered.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: HIV Infections Acquired Immunodeficiency Syndrome