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

NCT ID: NCT03934437

Last Updated: 2024-11-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

451 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2024-03-30

Brief Summary

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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

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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.

Conditions

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HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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mLTCR

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

Group Type EXPERIMENTAL

mLTCR

Intervention Type BEHAVIORAL

mHealth-enhanced Linkage to Care and Retention

LTC

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

Group Type ACTIVE_COMPARATOR

LTCR

Intervention Type BEHAVIORAL

Linkage and Retention Services (Standard-of-Care)

Interventions

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mLTCR

mHealth-enhanced Linkage to Care and Retention

Intervention Type BEHAVIORAL

LTCR

Linkage and Retention Services (Standard-of-Care)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen W Page

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

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Baltimore City Health Department

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36787165 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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11244

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00195120

Identifier Type: -

Identifier Source: org_study_id

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