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| ID | Type | Description | Link |
|---|---|---|---|
| K24NR018621 | U.S. NIH Grant/Contract | View source | |
| R01MH118151 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| National Institute of Mental Health (NIMH) | NIH |
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Men who have sex with men (MSM), especially young men who have sex with men (YMSM), and transgender women (TGW) have some of the highest rates of HIV and syphilis diagnoses in the United States. The goal of this study is to pilot the mobile Lab (mLab) App Plus to assess YMSM's and YTGW's abilities to perform and interpret self-tests for HIV and syphilis and consequently increase the number of YMSM and young transgender woman (YTGW) who initiate self-testing for HIV and syphilis.
From 2018 to 2019, the rate of syphilis increased by 11.2%. It has increased steadily since 2000 especially among men, in which MSM bear a disproportionate majority of cases (47% of all cases were among MSM in 2019). HIV and syphilis rates continue to rise among YMSM. While MSM account for only about 2% of the US population, they are most affected by HIV, constituting 56% of people living with HIV (PLWH).
Moreover, the rate of syphilis among MSM is profoundly elevated, at least 100 times higher than that in men who have sex with women and even higher among YMSM. Importantly, syphilis makes it easier to both acquire and transmit HIV, and about half of MSM who have syphilis are co-infected with HIV. The risk of syphilis and HIV continues to rise in YMSM in New York City, the study site. Given these epidemiologic risk factors for HIV and syphilis, there is a strong scientific premise for this pilot study that proposes to test innovative and effective HIV and sexually transmitted infection (STI) testing, prevention, and treatment models. Given that approximately 17% of MSM living with HIV in the U.S. are unaware of their status and significant comorbid syphilis in that population, both pathogens may be simultaneously transmitted. The increasing number of syphilis diagnosed in MSM highlights the importance of STI control in this population, not just for the health of the patient, but also for prevention of HIV and syphilis in uninfected persons. YMSM and YTGW, and specifically Blacks and Latinos, are disproportionately infected with HIV.
In response to the need for interventions to increase HIV testing in youth, our study team developed the mLab App, which affords advantages over existing self-test options to support the potential for higher uptake of the HIV self-test. The app provides HIV prevention information, push notification reminders for testing, step-by-step instructions for using the OraQuick HIV tests (OraQuick), and an image upload function so individuals can send an image of their OraQuick HIV test to the study team. In response to the mLab App study and the scientific evidence of need for at-home syphilis point of care (POC) testing among YMSM and YTGW, we propose to implement the mLab App Plus to assess YMSM's and YTGW's abilities to perform and interpret self-tests for HIV and syphilis and consequently increase the number of YMSM and YTGW who initiate self-testing for HIV and syphilis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mLab App Plus | Experimental | Participants randomized to intervention will receive standard of care counseling, complete online surveys, be provided with the mLab App Plus, and a box of condoms. The intervention arm will also complete two HIV/Syphilis Ab Combo Rapid Tests (DPP® HIV-Syphilis Test) at their baseline (first test) and 3-month follow- up (second test) appointments. |
|
| Standard of Care | No Intervention | Participants randomized to standard care will receive standard of care counseling, complete online surveys and be sent an email with links to mobile-optimized online prevention information, including Pre-Exposure Prophylaxis(PrEP) and HIV/STI testing information found on the Centers for Disease Control (CDC) website, and a box of condoms. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mLab App Plus | Behavioral | Participants will use the mLab Plus app to test for Syphilis and HIV using the DPP HIV/Syphilis Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Are Able to Self-administer the DPP® HIV-Syphilis Test With mLab App Plus | A successful self-test is defined as having completed the DPP® HIV-Syphilis test by themselves and having accurately identified and interpreted their HIV and Syphilis statuses as determined by the supervising clinician. In the event that the clinician, rather than the participant administers the DPP® HIV-Syphilis test, the test is not recorded as a successful self-test. | 3-Month Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Negative/Positive Results | The number of participants who tested reactive (R) or positive and/or non-reactive (NR) or negative for syphilis and HIV using the DPP® HIV-Syphilis test with mLab App Plus. Test results appear in a single reading with the results of both HIV and syphilis. | 3-Month Follow-up |
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Inclusion Criteria:
Assigned male sex at birth and identify as (1) a man or (2) a trans woman
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Schnall, PhD, MPH | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States | ||
| Vanderbilt University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41468606 | Derived | Brin M, Scherr TF, Chaiyasit J, Liu J, Abbott M, Garofalo R, Kuhns LM, Sky T, Esliker I, Schnall R. Feasibility and Usability of an mHealth App (mLab+) to Guide Users Through HIV and Syphilis Self-Testing: Pilot Randomized Controlled Trial. JMIR Form Res. 2025 Dec 30;9:e72955. doi: 10.2196/72955. |
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| ID | Title | Description |
|---|---|---|
| FG000 | mLab App Plus | Participants randomized to intervention will receive standard of care counseling, complete online surveys, be provided with the mLab App Plus, and a box of condoms. The intervention arm will also complete two HIV/Syphilis Ab Combo Rapid Tests (DPP® HIV-Syphilis Test) at their baseline (first test) and 3-month follow- up (second test) appointments. mLab App Plus: Participants will use the mLab Plus app to test for Syphilis and HIV using the DPP HIV/Syphilis Test |
| FG001 | Standard of Care | Participants randomized to standard care will receive standard of care counseling, complete online surveys and be sent an email with links to mobile-optimized online prevention information, including Pre-Exposure Prophylaxis(PrEP) and HIV/sexually transmitted infection (STI) testing information found on the Centers for Disease Control (CDC) website, and a box of condoms. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | mLab App Plus | Participants randomized to intervention will receive standard of care counseling, complete online surveys, be provided with the mLab App Plus, and a box of condoms. The intervention arm will also complete two HIV/Syphilis Ab Combo Rapid Tests (DPP® HIV-Syphilis Test) at their baseline (first test) and 3-month follow- up (second test) appointments. mLab App Plus: Participants will use the mLab Plus app to test for Syphilis and HIV using the DPP HIV/Syphilis Test |
| 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 | The Number of Participants Who Are Able to Self-administer the DPP® HIV-Syphilis Test With mLab App Plus | A successful self-test is defined as having completed the DPP® HIV-Syphilis test by themselves and having accurately identified and interpreted their HIV and Syphilis statuses as determined by the supervising clinician. In the event that the clinician, rather than the participant administers the DPP® HIV-Syphilis test, the test is not recorded as a successful self-test. | The Standard of Care arm did not receive access to the mLab App Plus. | Posted | Count of Participants | Participants | 3-Month Follow-up |
|
3 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 | mLab App Plus | Participants randomized to intervention will receive standard of care counseling, complete online surveys, be provided with the mLab App Plus, and a box of condoms. The intervention arm will also complete two HIV/Syphilis Ab Combo Rapid Tests (DPP® HIV-Syphilis Test) at their baseline (first test) and 3-month follow- up (second test) appointments. mLab App Plus: Participants will use the mLab Plus app to test for Syphilis and HIV using the DPP HIV/Syphilis Test |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rebecca Schnall | Columbia University School of Nursing | 212-342-6886 | rb897@cumc.columbia.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 | Feb 14, 2024 | Dec 4, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 22, 2024 | Dec 9, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D013587 | Syphilis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D012749 | Sexually Transmitted Diseases |
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Participants will be randomly assigned to one of two trial arms using the randomization module in REDCap. We will use block randomization with randomly permutated blocks to reduce opportunities for selection bias
| Number of Participants Referred for HIV/STI Services (Participants With HIV and/or Syphilis Only) |
The number of Young Men who have sex with men/ Young transgender women referred for HIV/STI services (participants with HIV and/or syphilis only). Using count of referral for participants that tested positive (reactive) to HIV and/or syphilis using mLabApp Plus. |
| 3-Month Follow-up |
| Number of Participants Linked to (Attend One Appointment) HIV/STI Prevention or Care Services | The number of Young Men who have sex with men/ Young transgender women linked to (attend one appointment) HIV/STI prevention or care services. Using count of appointments attended. | 3-Month Follow-up |
| Nashville |
| Tennessee |
| 37235 |
| United States |
| BG001 | Standard of Care | Participants randomized to standard care will receive standard of care counseling, complete online surveys and be sent an email with links to mobile-optimized online prevention information, including Pre-Exposure Prophylaxis(PrEP) and HIV/STI testing information found on the Centers for Disease Control (CDC) website, and a box of condoms. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| The Number of Participants Who Are Able to Self-administer the DPP® HIV-Syphilis Test With mLab App | A successful self-test is defined as having completed the DPP® HIV-Syphilis test by themselves and having accurately identified and interpreted their HIV and Syphilis statuses as determined by the supervising clinician. In the event that the clinician, rather than the participant administers the DPP® HIV-Syphilis test, the test is not recorded as a successful self-test. | The Standard of Care Arm did not test with mLab App Plus | Count of Participants | Participants |
|
| The Number of Negative/Positive Results | The number of participants who tested reactive (R) or positive and/or non-reactive (NR) or negative for syphilis and HIV using the DPP® HIV-Syphilis test with mLab App Plus. Test results appear in a single reading with the results of both HIV and syphilis. | Zero analyzed in the Standard of Care (SOC) Arm, as the SOC Arm did not use the mLab Ap Plus. | Count of Participants | Participants |
|
| Number of Participants referred for HIV/STI Services | Using the count of referral for participants that tested positive (reactive) to HIV and/or syphilis using mLabApp Plus. | 5 analyzed as 5 participants tested positive for HIV/Syphilis. Zero analyzed in the Standard of Care (SOC) Arm, as the SOC Arm did not use the mLab App Plus. | Count of Participants | Participants |
|
| Number of Participants Linked to HIV/STI Prevention or Care Services | The number of participants linked to and that attend one appointment for HIV/STI services. | 5 analyzed as 5 participants tested positive for HIV/Syphilis. Zero analyzed in the Standard of Care (SOC) Arm, as the SOC Arm did not use the mLab App Plus. | Count of Participants | Participants |
|
|
|
| Secondary | The Number of Negative/Positive Results | The number of participants who tested reactive (R) or positive and/or non-reactive (NR) or negative for syphilis and HIV using the DPP® HIV-Syphilis test with mLab App Plus. Test results appear in a single reading with the results of both HIV and syphilis. | 15 participants analyzed in the mLab App Plus arm as data was collected from 15 out of 20 (n=4 did not complete the 3-month follow up and a sample was not collected for n=1). The Standard of Care arm did not receive access to the mLab App Plus. | Posted | Count of Participants | Participants | 3-Month Follow-up |
|
|
|
| Secondary | Number of Participants Referred for HIV/STI Services (Participants With HIV and/or Syphilis Only) | The number of Young Men who have sex with men/ Young transgender women referred for HIV/STI services (participants with HIV and/or syphilis only). Using count of referral for participants that tested positive (reactive) to HIV and/or syphilis using mLabApp Plus. | Three analyzed as three tested positive using the mLabApp Plus. The Standard of Care arm did not receive access to the mLab App Plus. | Posted | Count of Participants | Participants | 3-Month Follow-up |
|
|
|
| Secondary | Number of Participants Linked to (Attend One Appointment) HIV/STI Prevention or Care Services | The number of Young Men who have sex with men/ Young transgender women linked to (attend one appointment) HIV/STI prevention or care services. Using count of appointments attended. | Three analyzed as three participants tested positive at month 3 | Posted | Count of Participants | Participants | 3-Month Follow-up |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Standard of Care | Participants randomized to standard care will receive standard of care counseling, complete online surveys and be sent an email with links to mobile-optimized online prevention information, including Pre-Exposure Prophylaxis(PrEP) and HIV/STI testing information found on the Centers for Disease Control (CDC) website, and a box of condoms. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Unknown |
|
| Positive (HIV) /Positive (Syphilis) |
|