Trial Outcomes & Findings for Improving Health Outcomes in Young Cisgender Men and Transgender Women (mLab App) (NCT NCT03803683)
NCT ID: NCT03803683
Last Updated: 2024-11-26
Results Overview
Total number of youth tested for HIV at 6 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
525 participants
Primary outcome timeframe
6 months
Results posted on
2024-11-26
Participant Flow
525 participants enrolled, however 523 were randomized as two participants withdrew prior to randomization.
Participant milestones
| Measure |
mLab App Intervention
Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
mLab App: The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
Standard of Care HIV Information Control Arm
Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
|
HIV Home Tests
Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
|---|---|---|---|
|
Overall Study
STARTED
|
211
|
208
|
104
|
|
Overall Study
COMPLETED
|
161
|
189
|
88
|
|
Overall Study
NOT COMPLETED
|
50
|
19
|
16
|
Reasons for withdrawal
| Measure |
mLab App Intervention
Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
mLab App: The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
Standard of Care HIV Information Control Arm
Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
|
HIV Home Tests
Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
41
|
18
|
12
|
|
Overall Study
Withdrawal by Subject
|
9
|
1
|
4
|
Baseline Characteristics
Improving Health Outcomes in Young Cisgender Men and Transgender Women (mLab App)
Baseline characteristics by cohort
| Measure |
mLab App Intervention
n=211 Participants
Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
mLab App: The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
Standard of Care HIV Information Control Arm
n=208 Participants
Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
|
HIV Home Tests
n=104 Participants
Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
Total
n=523 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
24.3 years
STANDARD_DEVIATION 3.23 • n=5 Participants
|
23.9 years
STANDARD_DEVIATION 3.34 • n=7 Participants
|
24.3 years
STANDARD_DEVIATION 3.28 • n=5 Participants
|
24.1 years
STANDARD_DEVIATION 3.28 • n=4 Participants
|
|
Sex/Gender, Customized
Male
|
186 Participants
n=5 Participants
|
193 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
475 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Trans Feminine
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Genderqueer
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Non-binary
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
73 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
160 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
137 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
361 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian or Asian American
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino/Latinx
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
123 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
303 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Something else
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
211 participants
n=5 Participants
|
208 participants
n=7 Participants
|
104 participants
n=5 Participants
|
523 participants
n=4 Participants
|
|
Sexual Orientation
Bisexual
|
36 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Sexual Orientation
Gay/homosexual
|
142 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
380 Participants
n=4 Participants
|
|
Sexual Orientation
Queer
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Sexual Orientation
Straight/heterosexual
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sexual Orientation
Other
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Any HIV test in the past 6 months
|
74 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
156 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 175 in Arm1, 189 in Arm 2, and 94 in Arm 3 analyzed as this was the number of participants that completed the 6 month visit and from which data was collected.
Total number of youth tested for HIV at 6 months
Outcome measures
| Measure |
mLab App Intervention
n=175 Participants
Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
mLab App: The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
Standard of Care HIV Information Control Arm
n=189 Participants
Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
|
HIV Home Tests
n=94 Participants
Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
|---|---|---|---|
|
Total Number of Youth Tested for HIV
|
154 Participants
|
123 Participants
|
68 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 161 in Arm1, 189 in Arm 2, and 88 in Arm 3 analyzed as this was the number of participants that completed the 12 month visit and from which data was collected.
Total number of youth tested for HIV at 12 months
Outcome measures
| Measure |
mLab App Intervention
n=161 Participants
Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
mLab App: The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
Standard of Care HIV Information Control Arm
n=189 Participants
Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
|
HIV Home Tests
n=88 Participants
Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
|---|---|---|---|
|
Total Number of Youth Tested for HIV
|
145 Participants
|
109 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 154 in Arm 1, 123 in Arm 2, and 68 in Arm 3 analyzed as this was the number of participants that completed the HIV test and from which data was collected.
Total number of HIV negative/ positive results at 6 months
Outcome measures
| Measure |
mLab App Intervention
n=154 Participants
Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
mLab App: The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
Standard of Care HIV Information Control Arm
n=123 Participants
Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
|
HIV Home Tests
n=68 Participants
Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
|---|---|---|---|
|
Total Number of HIV Negative/ Positive Results
Negative
|
154 Participants
|
123 Participants
|
68 Participants
|
|
Total Number of HIV Negative/ Positive Results
Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 161 in Arm1, 189 in Arm 2, and 88 in Arm 3 analyzed as this was the number of participants that completed the 12 month visit and from which data was collected.
Total number of HIV negative/ positive results at 12 months
Outcome measures
| Measure |
mLab App Intervention
n=161 Participants
Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
mLab App: The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
Standard of Care HIV Information Control Arm
n=189 Participants
Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
|
HIV Home Tests
n=88 Participants
Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
|---|---|---|---|
|
Total Number of HIV Negative/ Positive Results
Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Total Number of HIV Negative/ Positive Results
Negative
|
161 Participants
|
189 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 175 in Arm1, 189 in Arm 2, and 94 in Arm 3 analyzed as this was the number of participants that completed the 6 month visit and from which data was collected.
Total number of youth who link to HIV care services at 6 months
Outcome measures
| Measure |
mLab App Intervention
n=175 Participants
Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
mLab App: The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
Standard of Care HIV Information Control Arm
n=189 Participants
Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
|
HIV Home Tests
n=94 Participants
Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
|---|---|---|---|
|
Total Number of Youth Who Link to HIV Care Services
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 161 in Arm1, 189 in Arm 2, and 88 in Arm 3 analyzed as this was the number of participants that completed the 12 month visit and from which data was collected.
Total number of youth who link to HIV care services at 12 months
Outcome measures
| Measure |
mLab App Intervention
n=161 Participants
Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
mLab App: The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
Standard of Care HIV Information Control Arm
n=189 Participants
Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
|
HIV Home Tests
n=88 Participants
Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
|---|---|---|---|
|
Total Number of Youth Who Link to HIV Care Services
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 175 in Arm1, 189 in Arm 2, and 94 in Arm 3 analyzed as this was the number of participants that completed the 6 month visit and from which data was collected.
Number of Sexual Partners in the past 3 months collected at the 6 month mark
Outcome measures
| Measure |
mLab App Intervention
n=175 Participants
Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
mLab App: The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
Standard of Care HIV Information Control Arm
n=189 Participants
Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
|
HIV Home Tests
n=94 Participants
Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
|---|---|---|---|
|
Number of Sexual Partners in the Past 3 Months
|
2.12 partners
Standard Deviation 3.98
|
1.69 partners
Standard Deviation 3.56
|
1.78 partners
Standard Deviation 1.90
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 161 in Arm1, 189 in Arm 2, and 88 in Arm 3 analyzed as this was the number of participants that completed the 12 month visit and from which data was collected.
Number of Sexual Partners in the past 3 months collected at the 12 month mark
Outcome measures
| Measure |
mLab App Intervention
n=161 Participants
Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
mLab App: The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
Standard of Care HIV Information Control Arm
n=189 Participants
Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
|
HIV Home Tests
n=88 Participants
Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
|---|---|---|---|
|
Number of Sexual Partners in the Past 3 Months
|
2.24 partners
Standard Deviation 4.80
|
2.11 partners
Standard Deviation 7.44
|
2.43 partners
Standard Deviation 3.57
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 175 in Arm1, 189 in Arm 2, and 94 in Arm 3 analyzed as this was the number of participants that completed the 6 month visit and from which data was collected.
Number of condomless anal sex acts in the past 3 months at 6 months
Outcome measures
| Measure |
mLab App Intervention
n=175 Participants
Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
mLab App: The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
Standard of Care HIV Information Control Arm
n=189 Participants
Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
|
HIV Home Tests
n=94 Participants
Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
|---|---|---|---|
|
Number of Condomless Anal Sex Acts
|
7.35 condomless anal sex acts
Standard Deviation 15.34
|
8.21 condomless anal sex acts
Standard Deviation 21.67
|
7.56 condomless anal sex acts
Standard Deviation 9.93
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 161 in Arm1, 189 in Arm 2, and 88 in Arm 3 analyzed as this was the number of participants that completed the 12 month visit and from which data was collected.
Number of condomless anal sex acts in the past 3 months at 12 months
Outcome measures
| Measure |
mLab App Intervention
n=161 Participants
Youth randomized to the intervention arm (arm 1) will be provided with the mLab App, 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at their 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
mLab App: The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
Standard of Care HIV Information Control Arm
n=189 Participants
Youth randomized to the Standard of Care HIV information control arm (arm 2) will receive standard-of-care HIV/STI testing-related risk reduction counseling, a box of condoms, PrEP assessment, and referral information for clinics that provide PrEP during their first visit. Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including pre-exposure prophylaxis (PrEP) and HIV testing information that is found on the CDC website.They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
|
HIV Home Tests
n=88 Participants
Youth randomized to the HIV home testing arm (arm 3) will be provided with the 2 OraQuick tests (including the package insert), and a box of condoms to take home at baseline. They will receive 2 more OraQuick tests at the 6 month visit. At their baseline appointment, youth will also be sent an email or text with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the CDC website. They will also receive a study information card listing the Columbia University School of Nursing / Lurie Children's study teams' contact information.
HIV Prevention Information: Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
HIV Home Tests: Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
|
|---|---|---|---|
|
Number of Condomless Anal Sex Acts
|
7.01 condomless anal sex acts
Standard Deviation 12.15
|
8.33 condomless anal sex acts
Standard Deviation 15.75
|
8.32 condomless anal sex acts
Standard Deviation 11.49
|
Adverse Events
mLab App Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care HIV Information Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Home Tests
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rebecca Schnall, PhD, MPH, RN-BC, FAAN, FACMI
Columbia University
Phone: 212-342-6886
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place