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

NCT03934437 | Completed Results DMC

• 2 other identifiers: IRB0019512011244
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• Participants With HIV Viral Load Suppression (Copies/cc)

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

  12 months

Secondary Outcomes (1)

• Participants Retained in Care

  12 months

Study Arms (2)

mLTCR

EXPERIMENTAL

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

Behavioral: mLTCR

LTC

ACTIVE COMPARATOR

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

Behavioral: LTCR

Interventions

mLTCR BEHAVIORAL

mHealth-enhanced Linkage to Care and Retention

mLTCR

LTCR BEHAVIORAL

Linkage and Retention Services (Standard-of-Care)

LTC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• Not able to provide consent.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Baltimore City Health Department

Baltimore, Maryland, 21202, United States

Location

Related Publications (1)

• Jones J, McKenzie-White J, Saxton R, Grieb SM, Nonyane B, Graham C, Cano A, Johnson S, Childs L, Greenbaum A, Flynn C, Pearlowitz M, Celano S, Chang LW, Page KR. Leveraging mHealth and Patient Supporters for African Americans' and Latinxs' Engagement in HIV Care (LEAN): Protocol for a Randomized, Controlled, Effectiveness-Implementation Trial. JMIR Res Protoc. 2023 Feb 14;12:e42691. doi: 10.2196/42691.

  PMID: 36787165 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Larry Chang
• Organization: Johns Hopkins University

lchang8@jh.edu

4109551725

Study Officials

• Kathleen W Page

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 1, 2019
• Study Start: February 10, 2020
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: November 22, 2024
• Results First Posted: November 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 1 year after study recruitment has begun.
• Access Criteria: All reasonable requests will be considered.

Locations

US (1)