Trial Outcomes & Findings for PrEP iT! Mobile App Intervention (NCT NCT04509076)
NCT ID: NCT04509076
Last Updated: 2023-07-07
Results Overview
Adherence thresholds estimated through analysis of tenofovir diphosphate (TVF-DP) levels from dried blood spot (DBS) specimens were used to categorize each participant as having a high protective level (i.e., a high likelihood of protection from HIV) of PrEP (800 or greater of emtricitabine-tenofovir disoproxil fumarate \[FTC-TDF\] and 950 or greater of FTC-tenofovir alafenamide \[FTC-TAF\]) or not. Results reported here are for high protective levels of PrEP.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
6-month follow up assessment
Results posted on
2023-07-07
Participant Flow
Participant milestones
| Measure |
PrEP iT! (Plus Usual PrEP Care)
The PrEP iT! intervention is a mobile-optimized website with components tailored for young men who have sex with men on PrEP.
PrEP iT! (plus usual PrEP care): The PrEP iT! intervention is a mobile-optimized website, with the following components:
* PrEP Adherence, PrEP Appointment, and Sexual Activity Self-Monitoring
* Tailored feedback on PrEP adherence/non-adherence
* PrEP and sexual health information tailored for YMSM
* Text message reminders for PrEP adherence and healthcare appointments
* An "ask the expert" feature
|
Usual PrEP Care Only
Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing
Usual PrEP care: Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
38
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
PrEP iT! (Plus Usual PrEP Care)
The PrEP iT! intervention is a mobile-optimized website with components tailored for young men who have sex with men on PrEP.
PrEP iT! (plus usual PrEP care): The PrEP iT! intervention is a mobile-optimized website, with the following components:
* PrEP Adherence, PrEP Appointment, and Sexual Activity Self-Monitoring
* Tailored feedback on PrEP adherence/non-adherence
* PrEP and sexual health information tailored for YMSM
* Text message reminders for PrEP adherence and healthcare appointments
* An "ask the expert" feature
|
Usual PrEP Care Only
Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing
Usual PrEP care: Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
PrEP iT! Mobile App Intervention
Baseline characteristics by cohort
| Measure |
PrEP iT! (Plus Usual PrEP Care)
n=40 Participants
The PrEP iT! intervention is a mobile-optimized website with components tailored for young men who have sex with men on PrEP.
PrEP iT! (plus usual PrEP care): The PrEP iT! intervention is a mobile-optimized website, with the following components:
* PrEP Adherence, PrEP Appointment, and Sexual Activity Self-Monitoring
* Tailored feedback on PrEP adherence/non-adherence
* PrEP and sexual health information tailored for YMSM
* Text message reminders for PrEP adherence and healthcare appointments
* An "ask the expert" feature
|
Usual PrEP Care Only
n=40 Participants
Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing
Usual PrEP care: Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.9 years
STANDARD_DEVIATION 2.70 • n=99 Participants
|
25.3 years
STANDARD_DEVIATION 2.62 • n=107 Participants
|
25.1 years
STANDARD_DEVIATION 2.65 • n=206 Participants
|
|
Sex/Gender, Customized
Male
|
39 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Gender nonbinary
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
40 participants
n=107 Participants
|
80 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6-month follow up assessmentAdherence thresholds estimated through analysis of tenofovir diphosphate (TVF-DP) levels from dried blood spot (DBS) specimens were used to categorize each participant as having a high protective level (i.e., a high likelihood of protection from HIV) of PrEP (800 or greater of emtricitabine-tenofovir disoproxil fumarate \[FTC-TDF\] and 950 or greater of FTC-tenofovir alafenamide \[FTC-TAF\]) or not. Results reported here are for high protective levels of PrEP.
Outcome measures
| Measure |
PrEP iT! (Plus Usual PrEP Care)
n=27 Participants
The PrEP iT! intervention is a mobile-optimized website with components tailored for young men who have sex with men on PrEP.
PrEP iT! (plus usual PrEP care): The PrEP iT! intervention is a mobile-optimized website, with the following components:
* PrEP Adherence, PrEP Appointment, and Sexual Activity Self-Monitoring
* Tailored feedback on PrEP adherence/non-adherence
* PrEP and sexual health information tailored for YMSM
* Text message reminders for PrEP adherence and healthcare appointments
* An "ask the expert" feature
|
Usual PrEP Care Only
n=24 Participants
Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing
Usual PrEP care: Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing
|
|---|---|---|
|
High Protective Level of PrEP Adherence From Tenofovir Diphosphate (TVF-DP) Levels
|
13 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: 6-month follow up assessmentParticipants were asked at the month 6 survey to respond to the following item: "In the past 7 days, how many days did you take PrEP?" Response options ranging from 0 days to 7 days, with 1 day increments. Responses of 4, 5, 6, or 7 days were categorized as having a high protective level of PrEP (i.e., a high likelihood of protection from HIV). Results reported here are for high protective levels of PrEP.
Outcome measures
| Measure |
PrEP iT! (Plus Usual PrEP Care)
n=38 Participants
The PrEP iT! intervention is a mobile-optimized website with components tailored for young men who have sex with men on PrEP.
PrEP iT! (plus usual PrEP care): The PrEP iT! intervention is a mobile-optimized website, with the following components:
* PrEP Adherence, PrEP Appointment, and Sexual Activity Self-Monitoring
* Tailored feedback on PrEP adherence/non-adherence
* PrEP and sexual health information tailored for YMSM
* Text message reminders for PrEP adherence and healthcare appointments
* An "ask the expert" feature
|
Usual PrEP Care Only
n=35 Participants
Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing
Usual PrEP care: Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing
|
|---|---|---|
|
Proportion of Participants With High Self-reported PrEP Adherence in the Past 7 Days
|
27 Participants
|
22 Participants
|
Adverse Events
PrEP iT! (Plus Usual PrEP Care)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual PrEP Care Only
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
D. Keith Horvath, Professor of Psychology
San Diego State University
Phone: 619-594-3346
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place