Leveraging mHealth and Peers to Engage African- Americans and Latinxs in HIV Care (LEAN)
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|ClinicalTrials.gov Identifier: NCT03934437|
Recruitment Status : Not yet recruiting
First Posted : May 1, 2019
Last Update Posted : February 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Behavioral: mLTCR Behavioral: LTC||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|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|
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)
- Proportion with HIV Viral Load Suppression (copies/cc) [ Time Frame: 12 months ]Viral Suppression defined as a viral load < 200 copies/cc
- 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)
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
|Contact: Kathleen Page, MD||(410) firstname.lastname@example.org|
|Principal Investigator:||Kathleen W Page||Johns Hopkins School of Medicine|