HIV/AIDSNCT03934437
Leveraging mHealth and Peers to Engage African- Americans and Latinxs in HIV Care (LEAN)
A study testing mLTCR and LTCR in people with HIV/AIDS, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- mLTCR and LTCR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 451 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- Not able to provide consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore City Health Department
Baltimore, Maryland, 21202
About this study
Official title: Leveraging mHealth and Peers to Engage African-Americans and Latinxs in HIV Care (LEAN)
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- mLTCR, LTCR
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mLTCRBehavioural
mHealth-enhanced Linkage to Care and Retention
LTCRBehavioural
Linkage and Retention Services (Standard-of-Care)
| Study group | Role | What they receive |
|---|---|---|
| mLTCR | Experimental | The mLTCR intervention consists of two smartphone applications (app), one for patients and one for patient supporters, to help facilitate communication. Receives: Behavioral: mLTCR |
| LTC | Active comparator | Existing linkage to care and retention (LTCR) services which are standard-of-care Receives: Behavioral: LTCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With HIV Viral Load Suppression (Copies/cc)
Viral Suppression defined as a viral load < 200 copies/cc
Measured: 12 months
Secondary outcomes (1)
Participants Retained in Care
Retained in care based upon viral load, CD4, OR clinic visit reported in enhanced HIV/AIDS Reporting System (eHARS)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start10 Feb 2020
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Kathleen W Page, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934437
- Sponsor's protocol ID
- IRB00195120
- Other IDs
- 11244
- Status last verified
- Oct 2024
- First submitted
- 29 Apr 2019
- Last updated
- 22 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for data sharing should be made to the PI.
Publications
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.
PubMed 36787165
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging mHealth and Peers to Engage African-Americans and Latinxs in HIV Care (LEAN)
- ClinicalTrials.gov ID
- NCT03934437
- Acronym / sponsor ID
- IRB00195120
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Posted 22 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mLTCR | Experimental | Behavioral: mLTCRThe mLTCR intervention consists of two smartphone applications (app), one for patients and one for patient supporters, to help facilitate communication. |
| LTC | Active comparator | Behavioral: LTCRExisting linkage to care and retention (LTCR) services which are standard-of-care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (1 listed)
- Not able to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mLTCRmHealth-enhanced Linkage to Care and Retention | Behavioural | mLTCR |
| LTCRLinkage and Retention Services (Standard-of-Care) | Behavioural | LTC |
Primary outcome
Participants With HIV Viral Load Suppression (Copies/cc)
Time frame: 12 months
Viral Suppression defined as a viral load < 200 copies/cc
1 secondary outcome
Participants Retained in Care
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36787165Jones 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.
- Individual participant dataSharing planned: Yes. Requests for data sharing should be made to the PI.
Related trials for HIV/AIDS
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen W Page principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mLTCR and LTCR in people with HIV/AIDS, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants With HIV Viral Load Suppression (Copies/cc) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03934437, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.