About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

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

Clinicaltrials.gov identifier NCT03934437

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted March 4, 2020

Study Description

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:HIV/AIDS
  • Intervention/Treatment: Behavioral: mLTCR
    Behavioral: LTC
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • 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)
  • Actual Study Start Date: February 2020
  • Estimated Primary Completion Date: September 2023
  • Estimated Study Completion Date: September 2023
Arms and interventions
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)
Outcome Measures
  • 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)
Eligibility Criteria
  • 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.

Contacts and Locations
Contacts

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

Locations

United States, Maryland
Baltimore City Health Department
Baltimore

Sponsors and Collaborators

Johns Hopkins University

Patient-Centered Outcomes Research Institute

Investigators

Principal Investigator: Kathleen W Page Johns Hopkins School of Medicine

More Information
  • Responsible Party: Johns Hopkins University
  • ClinicalTrials.gov Identifier: NCT03934437 History of Changes
  • Other Study ID Numbers: IRB00195120, 11244
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: March 4, 2020
  • Last Verified: March 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.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No