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

Not Applicable

Completed

• Conditions: HIV/AIDS
• Interventions: Behavioral: mLTCR; Behavioral: LTCR

• Registration Number: NCT03934437
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-05-01
• Study Start: 2020-02-10
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30
• Status Verified: 2024-10
• Results First Submitted: 2024-10-01
• Results First Submitted QC: 2024-10-02
• Last Update Submitted: 2024-10-02
• Results First Posted: 2024-11-22
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 451

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mLTCR	mLTCR	The mLTCR intervention consists of two smartphone applications (app), one for patients and one for patient supporters, to help facilitate communication.
LTC	LTCR	Existing linkage to care and retention (LTCR) services which are standard-of-care

Primary Outcome Measures

Name	Time	Method
Participants With HIV Viral Load Suppression (Copies/cc)	12 months	Viral Suppression defined as a viral load \< 200 copies/cc

Secondary Outcome Measures

Name	Time	Method
Participants Retained in Care	12 months	Retained in care based upon viral load, CD4, OR clinic visit reported in enhanced HIV/AIDS Reporting System (eHARS)

Trial Locations

Locations (1)

Baltimore City Health Department; 🇺🇸 Baltimore, Maryland, United States