Trial Outcomes & Findings for TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission (NCT NCT04000724)
NCT ID: NCT04000724
Last Updated: 2024-02-20
Results Overview
Participants will report the frequency of condomless sexual intercourse events they have engaged in for the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
254 participants
Primary outcome timeframe
9 Months
Results posted on
2024-02-20
Participant Flow
A confirmed negative HIV test was required to enroll in the study. Participants who used a remote enrollment option were offered at-home STI testing which included an HIV test. Participants who did not return at least the HIV test portion of the kit were subsequently and retroactively ineligible for the study, withdrawn, and not considered randomized.
Participant milestones
| Measure |
Information
The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
Information/No Step: Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
|
Text+Step
The TechStep Text+Step messaging intervention is a six-month technology-based culturally competent theory-based text messaging intervention that sends three automated text messages to participants daily to reduce HIV risk and increase PrEP uptake and adherence.
Text Messaging (Text+Step): Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
WebApp+Step
The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence.
WebApp (App+Step): Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
85
|
82
|
87
|
|
Overall Study
3-month Follow-up
|
73
|
78
|
77
|
|
Overall Study
6-month Follow-up
|
67
|
71
|
67
|
|
Overall Study
COMPLETED
|
69
|
72
|
70
|
|
Overall Study
NOT COMPLETED
|
16
|
10
|
17
|
Reasons for withdrawal
| Measure |
Information
The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
Information/No Step: Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
|
Text+Step
The TechStep Text+Step messaging intervention is a six-month technology-based culturally competent theory-based text messaging intervention that sends three automated text messages to participants daily to reduce HIV risk and increase PrEP uptake and adherence.
Text Messaging (Text+Step): Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
WebApp+Step
The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence.
WebApp (App+Step): Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
4
|
|
Overall Study
Lost to Follow-up
|
11
|
7
|
13
|
Baseline Characteristics
TechStep: Technology-based Stepped Care to Stem Transgender Adolescent Risk Transmission
Baseline characteristics by cohort
| Measure |
Text+Step
n=82 Participants
The TechStep Text+Step messaging intervention is a six-month technology-based culturally competent theory-based text messaging intervention that sends three automated text messages to participants daily to reduce HIV risk and increase PrEP uptake and adherence.
Text Messaging (Text+Step): Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
WebApp+Step
n=87 Participants
The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence.
WebApp (App+Step): Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
Information
n=85 Participants
The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
Information/No Step: Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
|
Total
n=254 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20.88 years
STANDARD_DEVIATION 2.08 • n=5 Participants
|
21.21 years
STANDARD_DEVIATION 1.87 • n=7 Participants
|
21.57 years
STANDARD_DEVIATION 1.83 • n=5 Participants
|
21.22 years
STANDARD_DEVIATION 1.94 • n=4 Participants
|
|
Sex/Gender, Customized
nonbinary (assigned female at birth)
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Sex/Gender, Customized
nonbinary (assigned male at birth)
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Sex/Gender, Customized
trans feminine
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex/Gender, Customized
trans masculine
|
25 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
189 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
144 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=5 Participants
|
87 participants
n=7 Participants
|
85 participants
n=5 Participants
|
254 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 9 MonthsParticipants will report the frequency of condomless sexual intercourse events they have engaged in for the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up.
Outcome measures
| Measure |
Text+Step
n=82 Participants
The TechStep Text+Step messaging intervention is a six-month technology-based culturally competent theory-based text messaging intervention that sends three automated text messages to participants daily to reduce HIV risk and increase PrEP uptake and adherence.
Text Messaging (Text+Step): Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
WebApp+Step
n=87 Participants
The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence.
WebApp (App+Step): Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
Information
n=85 Participants
The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
Information/No Step: Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
|
|---|---|---|---|
|
Condomless Intercourse Events
|
3.14 Expected events
Interval 2.45 to 3.82
|
3.17 Expected events
Interval 2.59 to 3.74
|
3.68 Expected events
Interval 3.16 to 4.2
|
PRIMARY outcome
Timeframe: 9 MonthsParticipants will report the number of condomless sexual intercourse events they have engaged in while high on drugs or alcohol during their three most recent sexual encounters in the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up.
Outcome measures
| Measure |
Text+Step
n=85 Participants
The TechStep Text+Step messaging intervention is a six-month technology-based culturally competent theory-based text messaging intervention that sends three automated text messages to participants daily to reduce HIV risk and increase PrEP uptake and adherence.
Text Messaging (Text+Step): Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
WebApp+Step
n=82 Participants
The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence.
WebApp (App+Step): Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
Information
n=87 Participants
The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
Information/No Step: Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
|
|---|---|---|---|
|
Condomless Intercourse Events While High on Drugs/Alcohol
|
1.04 Expected events
Interval 0.74 to 1.33
|
0.79 Expected events
Interval 0.55 to 1.04
|
1.02 Expected events
Interval 0.74 to 1.29
|
PRIMARY outcome
Timeframe: 9 MonthsPopulation: Participants who answered the relevant survey questions necessary to assess the 3-month step-up criteria were included in the analytical sample.
Participants will report the number of exchange partners in the past 3 months at baseline and at each follow-up. The value of interest is the cumulative number of events over follow-up.
Outcome measures
| Measure |
Text+Step
n=75 Participants
The TechStep Text+Step messaging intervention is a six-month technology-based culturally competent theory-based text messaging intervention that sends three automated text messages to participants daily to reduce HIV risk and increase PrEP uptake and adherence.
Text Messaging (Text+Step): Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
WebApp+Step
n=78 Participants
The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence.
WebApp (App+Step): Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
Information
n=77 Participants
The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
Information/No Step: Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
|
|---|---|---|---|
|
Condomless Intercourse Events During Sex Work
|
0 Expected events
Interval 0.0 to 0.0
|
0.03 Expected events
Interval 0.0 to 0.1
|
0 Expected events
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: 9 MonthsHIV tests will be collected at each time point. Incident infections will be recorded.
Outcome measures
| Measure |
Text+Step
n=85 Participants
The TechStep Text+Step messaging intervention is a six-month technology-based culturally competent theory-based text messaging intervention that sends three automated text messages to participants daily to reduce HIV risk and increase PrEP uptake and adherence.
Text Messaging (Text+Step): Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
WebApp+Step
n=82 Participants
The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence.
WebApp (App+Step): Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
Information
n=87 Participants
The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
Information/No Step: Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
|
|---|---|---|---|
|
HIV Seroconversion
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 9 MonthsPopulation: Participants who answered the relevant survey questions necessary to assess the 3-month step-up criteria were included in the analytical sample.
Participants will be tested for gonorrhea and chlamydia via throat, rectal, and urogenital swab specimen collection, as well as via urine samples at each time point. Incident STIs will be recorded.
Outcome measures
| Measure |
Text+Step
n=75 Participants
The TechStep Text+Step messaging intervention is a six-month technology-based culturally competent theory-based text messaging intervention that sends three automated text messages to participants daily to reduce HIV risk and increase PrEP uptake and adherence.
Text Messaging (Text+Step): Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
WebApp+Step
n=78 Participants
The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence.
WebApp (App+Step): Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
Information
n=77 Participants
The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
Information/No Step: Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
|
|---|---|---|---|
|
Incident STIs
|
0.06 Expected infections
Interval 0.0 to 0.16
|
0.02 Expected infections
Interval 0.0 to 0.07
|
0.04 Expected infections
Interval 0.0 to 0.14
|
Adverse Events
Information
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Text+Step
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
WebApp+Step
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Information
n=85 participants at risk
The Information/No Step intervention includes nothing more than access to a website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
Information/No Step: Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
|
Text+Step
n=82 participants at risk
The TechStep Text+Step messaging intervention is a six-month technology-based culturally competent theory-based text messaging intervention that sends three automated text messages to participants daily to reduce HIV risk and increase PrEP uptake and adherence.
Text Messaging (Text+Step): Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
WebApp+Step
n=87 participants at risk
The TechStep WebApp+Step website intervention is a six-month technology-based intervention that uses peer-to-peer interaction, daily self-monitoring, and tailored content to address barriers to HIV sexual risk reduction and PrEP uptake and adherence.
WebApp (App+Step): Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
|
|---|---|---|---|
|
Psychiatric disorders
Unrelated mental health issues
|
2.4%
2/85 • 9 months
|
0.00%
0/82 • 9 months
|
1.1%
1/87 • 9 months
|
|
Psychiatric disorders
Protocol related mental health concern
|
0.00%
0/85 • 9 months
|
0.00%
0/82 • 9 months
|
2.3%
2/87 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
COVID
|
0.00%
0/85 • 9 months
|
1.2%
1/82 • 9 months
|
0.00%
0/87 • 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place