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

Primary Purpose

HIV/AIDS

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mLTCR
LTCR
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV/AIDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Baltimore City Health Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mLTCR

LTC

Arm Description

The mLTCR intervention consists of two smartphone applications (app), one for patients and one for patient supporters, to help facilitate communication.

Existing linkage to care and retention (LTCR) services which are standard-of-care

Outcomes

Primary Outcome Measures

Proportion with HIV Viral Load Suppression (copies/cc)
Viral Suppression defined as a viral load < 200 copies/cc

Secondary Outcome Measures

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

Full Information

First Posted
April 29, 2019
Last Updated
March 9, 2023
Sponsor
Johns Hopkins University
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03934437
Brief Title
Leveraging mHealth and Peers to Engage African- Americans and Latinxs in HIV Care (LEAN)
Official Title
Leveraging mHealth and Peers to Engage African-Americans and Latinxs in HIV Care (LEAN)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Patient-Centered Outcomes Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mLTCR
Arm Type
Experimental
Arm Description
The mLTCR intervention consists of two smartphone applications (app), one for patients and one for patient supporters, to help facilitate communication.
Arm Title
LTC
Arm Type
Active Comparator
Arm Description
Existing linkage to care and retention (LTCR) services which are standard-of-care
Intervention Type
Behavioral
Intervention Name(s)
mLTCR
Intervention Description
mHealth-enhanced Linkage to Care and Retention
Intervention Type
Behavioral
Intervention Name(s)
LTCR
Intervention Description
Linkage and Retention Services (Standard-of-Care)
Primary Outcome Measure Information:
Title
Proportion with HIV Viral Load Suppression (copies/cc)
Description
Viral Suppression defined as a viral load < 200 copies/cc
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Proportion Retained in Care
Description
Retained in care based upon viral load, CD4, OR clinic visit reported in enhanced HIV/AIDS Reporting System (eHARS)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen W Page
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore City Health Department
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Requests for data sharing should be made to the PI.
IPD Sharing Time Frame
Within 1 year after study recruitment has begun.
IPD Sharing Access Criteria
All reasonable requests will be considered.

Learn more about this trial

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

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