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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03934437
Recruitment Status Recruiting
First Posted May 1, 2019
Last update posted March 4, 2020
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.
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.
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.
mHealth-enhanced Linkage to Care and Retention
|Active Comparator: LTC
Existing linkage to care (LTC) service which is standard-of-care
Linkage-to-Care Officers (Standard-of-Care)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
- ≥ 18 years of age
- Ability to provide consent
- Identified by BCHD Linkage protocol to be a new HIV diagnosis or HIV-infected and "out
- Live in Baltimore City (within BCHD catchment area).
- Not able to provide consent.
Contact: Kathleen Page, MD (410) 614-1814 email@example.com
United States, Maryland
Baltimore City Health Department
Johns Hopkins University
Patient-Centered Outcomes Research Institute
Principal Investigator: Kathleen W Page Johns Hopkins School of Medicine