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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: mLTCR
* Behavioral: LTCR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mLTCR<br>The mLTCR intervention consists of two smartphone applications (app), one for patients and one for patient supporters, to help facilitate communication. | Behavioral: mLTCR<br>* mHealth-enhanced Linkage to Care and Retention<br>|
| Active Comparator: LTC<br>Existing linkage to care and retention (LTCR) services which are standard-of-care | Behavioral: LTCR<br>* Linkage and Retention Services (Standard-of-Care)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion with HIV Viral Load Suppression (copies/cc) | Viral Suppression defined as a viral load < 200 copies/cc | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |