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

Johns Hopkins University

Status: Completed

Conditions: HIV/AIDS

Treatments: Behavioral: mLTCR; Behavioral: LTCR

Study type: Interventional

Funder types: Other

Identifiers

NCT03934437

11244 (Registry Identifier)

IRB00195120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 451 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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451 participants in 2 patient groups

mLTCR

Experimental group

Description:

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

Treatment:

Behavioral: mLTCR

LTC

Active Comparator group

Description:

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

Treatment:

Behavioral: LTCR