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| ID | Type | Description | Link |
|---|---|---|---|
| 11244 | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mLTCR | Experimental | The mLTCR intervention consists of two smartphone applications (app), one for patients and one for patient supporters, to help facilitate communication. |
|
| LTC | Active Comparator | Existing linkage to care and retention (LTCR) services which are standard-of-care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mLTCR | Behavioral | mHealth-enhanced Linkage to Care and Retention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With HIV Viral Load Suppression (Copies/cc) | Viral Suppression defined as a viral load < 200 copies/cc | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Retained in Care | Retained in care based upon viral load, CD4, OR clinic visit reported in enhanced HIV/AIDS Reporting System (eHARS) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen W Page | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore City Health Department | Baltimore | Maryland | 21202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36787165 | Derived | Jones J, McKenzie-White J, Saxton R, Grieb SM, Nonyane B, Graham C, Cano A, Johnson S, Childs L, Greenbaum A, Flynn C, Pearlowitz M, Celano S, Chang LW, Page KR. Leveraging mHealth and Patient Supporters for African Americans' and Latinxs' Engagement in HIV Care (LEAN): Protocol for a Randomized, Controlled, Effectiveness-Implementation Trial. JMIR Res Protoc. 2023 Feb 14;12:e42691. doi: 10.2196/42691. |
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Requests for data sharing should be made to the PI.
Within 1 year after study recruitment has begun.
All reasonable requests will be considered.
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| ID | Title | Description |
|---|---|---|
| FG000 | mLTCR | The mLTCR intervention consists of two smartphone applications (app), one for patients and one for patient supporters, to help facilitate communication. mLTCR: mHealth-enhanced Linkage to Care and Retention |
| FG001 | LTCR | Existing linkage to care and retention (LTCR) services which are standard-of-care LTCR: Linkage and Retention Services (Standard-of-Care) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
3 participants withdrew.
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| ID | Title | Description |
|---|---|---|
| BG000 | mLTCR | The mLTCR intervention consists of two smartphone applications (app), one for patients and one for patient supporters, to help facilitate communication. mLTCR: mHealth-enhanced Linkage to Care and Retention |
| BG001 | LTCR |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants With HIV Viral Load Suppression (Copies/cc) | Viral Suppression defined as a viral load < 200 copies/cc | Two participants withdrew from mLTCR; one participant withdrew from LTCR. | Posted | Count of Participants | Participants | 12 months |
|
Up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | mLTCR | The mLTCR intervention consists of two smartphone applications (app), one for patients and one for patient supporters, to help facilitate communication. mLTCR: mHealth-enhanced Linkage to Care and Retention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larry Chang | Johns Hopkins University | 4109551725 | lchang8@jh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2023 | Oct 1, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| LTCR |
| Behavioral |
Linkage and Retention Services (Standard-of-Care) |
|
Existing linkage to care and retention (LTCR) services which are standard-of-care
LTCR: Linkage and Retention Services (Standard-of-Care)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| HIV Viral Load Suppression (Copies/cc) | Viral Suppression defined as a viral load < 200 copies/cc | Count of Participants | Participants |
|
|
|
| Secondary | Participants Retained in Care | Retained in care based upon viral load, CD4, OR clinic visit reported in enhanced HIV/AIDS Reporting System (eHARS) | Two participants withdrew from mLTCR; one participant withdrew from LTCR. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 9 |
| 225 |
| 0 |
| 225 |
| 0 |
| 225 |
| EG001 | Linkage to Care | Existing linkage to care and retention (LTCR) services which are standard-of-care LTCR: Linkage and Retention Services (Standard-of-Care) | 11 | 226 | 0 | 226 | 0 | 226 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |