HIV Infections, Sexually Transmitted Diseases, Viral, Syphilis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALmLab App Plus
Participants will use the mLab Plus app to test for Syphilis and HIV using the DPP HIV/Syphilis Test
Sponsors
National Institute of Nursing Research (NINR)
National Institute of Mental Health (NIMH)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
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
Eligibility
Sex/Gender
MALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-39 years of age * Assigned male sex at birth and identify as (1) a man or (2) a trans woman * Understand and read English * Self-identify as any race or ethnicity * Substantial risk for acquiring HIV infection per CDC (Centers for Disease Control) guidance * All participants must report having sex with a man/men * Smart phone ownership * Self-report being HIV-negative or unknown status * Self-report being negative for syphilis or unknown status * Not having been tested for HIV or syphilis in the past 3 months * Understand the limitations of the duplex lateral flow test and the mLab App Plus (e.g., a confirmatory test is needed and self-test must be performed in the presence of a qualified clinician)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants Who Are Able to Self-administer the DPP® HIV-Syphilis Test With mLab App Plus | 3-Month Follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Negative/Positive Results | 3-Month Follow-up | 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. |
| Number of Participants Referred for HIV/STI Services (Participants With HIV and/or Syphilis Only) | 3-Month Follow-up | 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. |
| Number of Participants Linked to (Attend One Appointment) HIV/STI Prevention or Care Services | 3-Month Follow-up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | mLab App Plus | Total | Standard of Care |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 40 Participants | 20 Participants |
| Age, Continuous | 28.33 years STANDARD_DEVIATION 3.94 | 28.52 years STANDARD_DEVIATION 4.45 | 28.71 years STANDARD_DEVIATION 4.99 |
| Number of Participants Linked to HIV/STI Prevention or Care Services | 2 Participants | 2 Participants | — |
| Number of Participants referred for HIV/STI Services | 5 Participants | 5 Participants | — |
| Race/Ethnicity, Customized Race Asian | 5 Participants | 7 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Black or African American | 5 Participants | 9 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Unknown | 2 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized Race White | 8 Participants | 16 Participants | 8 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 20 Participants | 40 Participants | 20 Participants |
| The Number of Negative/Positive Results Negative (HIV)/ Negative (Syphilis) | 15 Participants | 15 Participants | — |
| The Number of Negative/Positive Results Negative (HIV)/ Positive (Syphilis) | 3 Participants | 3 Participants | — |
| The Number of Negative/Positive Results Positive (HIV)/ Negative (Syphilis) | 1 Participants | 1 Participants | — |
| The Number of Negative/Positive Results Positive (HIV)/ Positive (Syphilis) | 1 Participants | 1 Participants | — |
| The Number of Participants Who Are Able to Self-administer the DPP® HIV-Syphilis Test With mLab App | 16 Participants | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: 3-Month Follow-up
Population: The Standard of Care arm did not receive access to the mLab App Plus.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mLab App Plus | The Number of Participants Who Are Able to Self-administer the DPP® HIV-Syphilis Test With mLab App Plus | 12 Participants |
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.
Time frame: 3-Month Follow-up
Population: Three analyzed as three participants tested positive at month 3
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mLab App Plus | Number of Participants Linked to (Attend One Appointment) HIV/STI Prevention or Care Services | 0 Participants |
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.
Time frame: 3-Month Follow-up
Population: Three analyzed as three tested positive using the mLabApp Plus. The Standard of Care arm did not receive access to the mLab App Plus.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| mLab App Plus | Number of Participants Referred for HIV/STI Services (Participants With HIV and/or Syphilis Only) | 3 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.
Time frame: 3-Month Follow-up
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| mLab App Plus | The Number of Negative/Positive Results | Negative (HIV) / Negative (Syphilis) | 12 Participants |
| mLab App Plus | The Number of Negative/Positive Results | Negative (HIV) / Positive (Syphilis) | 3 Participants |
| mLab App Plus | The Number of Negative/Positive Results | Positive (HIV) / Negative (Syphilis) | 0 Participants |
| mLab App Plus | The Number of Negative/Positive Results | Positive (HIV) /Positive (Syphilis) | 0 Participants |