HIV/AIDS
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALmLTCR
mHealth-enhanced Linkage to Care and Retention
BEHAVIORALLTCR
Linkage and Retention Services (Standard-of-Care)
Sponsors
Patient-Centered Outcomes Research Institute
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With HIV Viral Load Suppression (Copies/cc) | 12 months | Viral Suppression defined as a viral load \< 200 copies/cc |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants Retained in Care | 12 months | Retained in care based upon viral load, CD4, OR clinic visit reported in enhanced HIV/AIDS Reporting System (eHARS) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 223 |
| LTCR Existing linkage to care and retention (LTCR) services which are standard-of-care
LTCR: Linkage and Retention Services (Standard-of-Care) | 225 |
| Total | 448 |
Baseline characteristics
| Characteristic | mLTCR | LTCR | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 18 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 210 Participants | 207 Participants | 417 Participants |
| Age, Continuous | 45.1 years | 45.0 years | 45.1 years |
| HIV Viral Load Suppression (Copies/cc) Detectable (>=200 copies/cc, poorly controlled) | 93 Participants | 82 Participants | 175 Participants |
| HIV Viral Load Suppression (Copies/cc) No VL (presumed poorly controlled) | 18 Participants | 15 Participants | 33 Participants |
| HIV Viral Load Suppression (Copies/cc) Undetectable (<200 copies/cc, well controlled) | 112 Participants | 128 Participants | 240 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 173 Participants | 172 Participants | 345 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 5 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 22 Participants | 25 Participants | 47 Participants |
| Race (NIH/OMB) White | 20 Participants | 17 Participants | 37 Participants |
| Region of Enrollment United States | 223 participants | 225 participants | 448 participants |
| Sex: Female, Male Female | 87 Participants | 73 Participants | 160 Participants |
| Sex: Female, Male Male | 136 Participants | 152 Participants | 288 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 225 | 11 / 226 |
| other Total, other adverse events | 0 / 225 | 0 / 226 |
| serious Total, serious adverse events | 0 / 225 | 0 / 226 |
Outcome results
Primary
Participants With HIV Viral Load Suppression (Copies/cc)
Viral Suppression defined as a viral load \< 200 copies/cc
Time frame: 12 months
Population: Two participants withdrew from mLTCR; one participant withdrew from LTCR.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mLTCR | Participants With HIV Viral Load Suppression (Copies/cc) | Undetectable (<200 copies/cc, well controlled) | 114 Participants |
| mLTCR | Participants With HIV Viral Load Suppression (Copies/cc) | Detectable (>=200 copies/cc, poorly controlled) | 38 Participants |
| mLTCR | Participants With HIV Viral Load Suppression (Copies/cc) | No VL (presumed poorly controlled) | 71 Participants |
| LTCR | Participants With HIV Viral Load Suppression (Copies/cc) | Undetectable (<200 copies/cc, well controlled) | 128 Participants |
| LTCR | Participants With HIV Viral Load Suppression (Copies/cc) | Detectable (>=200 copies/cc, poorly controlled) | 32 Participants |
| LTCR | Participants With HIV Viral Load Suppression (Copies/cc) | No VL (presumed poorly controlled) | 65 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)
Time frame: 12 months
Population: Two participants withdrew from mLTCR; one participant withdrew from LTCR.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mLTCR | Participants Retained in Care | 152 Participants |
| LTCR | Participants Retained in Care | 160 Participants |