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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934437
• Other study ID #: IRB00195120
• Secondary ID: 11244
• Status: Completed
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: March 30, 2024

Study information

• Verified date: April 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• mLTCR
mHealth-enhanced Linkage to Care and Retention
• LTCR
Linkage and Retention Services (Standard-of-Care)

Locations

Country	Name	City	State
United States	Baltimore City Health Department	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion with HIV Viral Load Suppression (copies/cc)	Viral Suppression defined as a viral load < 200 copies/cc	12 months
Secondary	Proportion Retained in Care	Retained in care based upon viral load, CD4, OR clinic visit reported in enhanced HIV/AIDS Reporting System (eHARS)	12 months