Trial Outcomes & Findings for mLab App Plus: A Randomized Controlled Trial of a Mobile Health (mHealth) Intervention (NCT NCT06059443)

Last Updated: 2025-03-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

3-Month Follow-up

Results posted on

2025-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	20	20
Overall Study COMPLETED	16	18
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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.
Overall Study Withdrawal by Subject	2	0
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

The Standard of Care Arm did not test with mLab App Plus

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 3-Month Follow-up

Population: The Standard of Care arm did not receive access to the mLab App Plus.

Outcome measures

Outcome measures
Measure	mLab App Plus n=20 Participants 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
The Number of Participants Who Are Able to Self-administer the DPP® HIV-Syphilis Test With mLab App Plus	12 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	mLab App Plus n=15 Participants 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
The Number of Negative/Positive Results Negative (HIV) / Negative (Syphilis)	12 Participants
The Number of Negative/Positive Results Negative (HIV) / Positive (Syphilis)	3 Participants
The Number of Negative/Positive Results Positive (HIV) / Negative (Syphilis)	0 Participants
The Number of Negative/Positive Results Positive (HIV) /Positive (Syphilis)	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	mLab App Plus n=3 Participants 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
Number of Participants Referred for HIV/STI Services (Participants With HIV and/or Syphilis Only)	3 Participants

SECONDARY outcome

Timeframe: 3-Month Follow-up

Population: Three analyzed as three participants tested positive at month 3

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.

Outcome measures

Outcome measures
Measure	mLab App Plus n=3 Participants 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
Number of Participants Linked to (Attend One Appointment) HIV/STI Prevention or Care Services	0 Participants

Adverse Events

mLab App Plus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care

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

Dr. Rebecca Schnall

Columbia University School of Nursing

Phone: 212-342-6886

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	mLab App Plus n=20 Participants 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	Standard of Care n=20 Participants 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.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants	20 Participants n=20 Participants	40 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Continuous	28.33 years STANDARD_DEVIATION 3.94 • n=20 Participants	28.71 years STANDARD_DEVIATION 4.99 • n=20 Participants	28.52 years STANDARD_DEVIATION 4.45 • n=40 Participants
Sex: Female, Male Female	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Sex: Female, Male Male	20 Participants n=20 Participants	20 Participants n=20 Participants	40 Participants n=40 Participants
Race/Ethnicity, Customized Race · Black or African American	5 Participants n=20 Participants	4 Participants n=20 Participants	9 Participants n=40 Participants
Race/Ethnicity, Customized Race · White	8 Participants n=20 Participants	8 Participants n=20 Participants	16 Participants n=40 Participants
Race/Ethnicity, Customized Race · Asian	5 Participants n=20 Participants	2 Participants n=20 Participants	7 Participants n=40 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants	2 Participants n=20 Participants	2 Participants n=40 Participants
Race/Ethnicity, Customized Race · Unknown	2 Participants n=20 Participants	4 Participants n=20 Participants	6 Participants n=40 Participants
Region of Enrollment United States	20 participants n=20 Participants	20 participants n=20 Participants	40 participants n=40 Participants
The Number of Participants Who Are Able to Self-administer the DPP® HIV-Syphilis Test With mLab App	16 Participants n=20 Participants • The Standard of Care Arm did not test with mLab App Plus	—	16 Participants n=20 Participants • The Standard of Care Arm did not test with mLab App Plus
The Number of Negative/Positive Results Negative (HIV)/ Negative (Syphilis)	15 Participants n=20 Participants • Zero analyzed in the Standard of Care (SOC) Arm, as the SOC Arm did not use the mLab Ap Plus.	—	15 Participants n=20 Participants • Zero analyzed in the Standard of Care (SOC) Arm, as the SOC Arm did not use the mLab Ap Plus.
The Number of Negative/Positive Results Negative (HIV)/ Positive (Syphilis)	3 Participants n=20 Participants • Zero analyzed in the Standard of Care (SOC) Arm, as the SOC Arm did not use the mLab Ap Plus.	—	3 Participants n=20 Participants • Zero analyzed in the Standard of Care (SOC) Arm, as the SOC Arm did not use the mLab Ap Plus.
The Number of Negative/Positive Results Positive (HIV)/ Negative (Syphilis)	1 Participants n=20 Participants • Zero analyzed in the Standard of Care (SOC) Arm, as the SOC Arm did not use the mLab Ap Plus.	—	1 Participants n=20 Participants • Zero analyzed in the Standard of Care (SOC) Arm, as the SOC Arm did not use the mLab Ap Plus.
The Number of Negative/Positive Results Positive (HIV)/ Positive (Syphilis)	1 Participants n=20 Participants • Zero analyzed in the Standard of Care (SOC) Arm, as the SOC Arm did not use the mLab Ap Plus.	—	1 Participants n=20 Participants • Zero analyzed in the Standard of Care (SOC) Arm, as the SOC Arm did not use the mLab Ap Plus.
Number of Participants referred for HIV/STI Services	5 Participants n=5 Participants • 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.	—	5 Participants n=5 Participants • 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.
Number of Participants Linked to HIV/STI Prevention or Care Services	2 Participants n=5 Participants • 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.	—	2 Participants n=5 Participants • 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.