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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03934437
Recruitment Status : Not yet recruiting
First Posted : May 1, 2019
Last Update Posted : February 13, 2020
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This is a pragmatic randomized controlled study comparing the Baltimore City Health Department's (BCHD) existing linkage to care (LTC) service to an mHealth-enhanced linkage to care and retention (mLTCR) protocol.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: mLTCR Behavioral: LTC Not Applicable

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 hypothesis of this study is that a health department-driven mHealth-enhanced Linkage to Care and Retention (mLTCR) intervention can improve HIV outcomes among HIV-infected African Americans and Latinxs compared to standard Baltimore City Health Department linkage to care protocols. The mLTCR intervention consists of two smartphone applications (app), one for patients and one for linkage officers (who are members of the community), to help facilitate communication. Communication will focus on issues related to HIV care (e.g. appointment scheduling, medication reminders, refills, transportation), as well as patient-directed requests. Using HIV surveillance data (e.g. unsuppressed HIV viral load), linkage officers will be automatically alerted if a patient has a high viral load and prompted to contact the patient. In addition to appointment and medication reminders, patients will receive positive reinforcement behavioral text messages.

This is a pragmatic randomized controlled study comparing the Baltimore City Health Department's (BCHD) existing linkage to care (LTC) service to an mHealth-enhanced linkage to care and retention (mLTCR) protocol.

According to modelling studies, improvement in linkage and retention in care indicators is the single most important component to achieve the 2020 National HIV/AIDS Strategy targets and substantially reduce the burden of HIV in the United States. The results of this randomized study will contribute to the evidence on the effectiveness of mHealth-enhanced LTCR initiatives implemented by the local health department. Evidence supporting the feasibility and effectiveness of this intervention will be important for the BCHD and other health departments to allocate limited resources to address the HIV epidemic in the jurisdictions. The information will also be relevant to Ryan White officials responsible for allocating federal dollars to support clinical and ancillary services to improve HIV outcomes, particularly among patients who are uninsured or underinsured.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Leveraging mHealth and Peers to Engage African-Americans and Latinxs in HIV Care (LEAN)
Estimated Study Start Date : February 15, 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mLTCR
The mLTCR intervention consists of two smartphone applications (app), one for patients and one for linkage officers (who are members of the community), to help facilitate communication.
Behavioral: mLTCR
mHealth-enhanced Linkage to Care and Retention

Active Comparator: LTC
Existing linkage to care (LTC) service which is standard-of-care
Behavioral: LTC
Linkage-to-Care Officers (Standard-of-Care)




Primary Outcome Measures :
  1. Proportion with HIV Viral Load Suppression (copies/cc) [ Time Frame: 12 months ]
    Viral Suppression defined as a viral load < 200 copies/cc


Secondary Outcome Measures :
  1. Proportion Retained in Care [ Time Frame: 12 months ]
    Retained in care based upon viral load, CD4, OR clinic visit reported in enhanced HIV/AIDS Reporting System (eHARS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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"
  • Live in Baltimore City (within BCHD catchment area).

Exclusion Criteria:

  • Not able to provide consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934437


Contacts
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Contact: Kathleen Page, MD (410) 614-1814 kpage2@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Kathleen W Page Johns Hopkins School of Medicine

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03934437    
Other Study ID Numbers: IRB00195120
11244 ( Other Grant/Funding Number: PCORI )
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Requests for data sharing should be made to the PI.
Supporting Materials: Study Protocol
Time Frame: Within 1 year after study recruitment has begun.
Access Criteria: All reasonable requests will be considered.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No