Trial Outcomes & Findings for Evaluating a Real-Time, Remote Monitoring System for Home-Based HIV Testing (NCT NCT02876926)
NCT ID: NCT02876926
Last Updated: 2019-04-19
Results Overview
Count of the number of participants who reported receiving HIV testing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
Up to 28 weeks
Results posted on
2019-04-19
Participant Flow
Participant milestones
| Measure |
"Enhanced" Home-based Testing
These participants will download a study-specific smartphone app ("eTEST"), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care.
"Smart" home-based test for HIV: A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring.
|
Home-based Testing Alone
These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided.
Home-based testing only: A standard home-based HIV test kit.
|
Reminders for Clinic-based Testing
Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free.
Reminder letters for clinic-based testing: Letters reminding patients to get tested at a free clinic location
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
22
|
|
Overall Study
COMPLETED
|
3
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
18
|
19
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating a Real-Time, Remote Monitoring System for Home-Based HIV Testing
Baseline characteristics by cohort
| Measure |
"Enhanced" Home-based Testing
n=21 Participants
These participants will download a study-specific smartphone app ("eTEST"), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care.
"Smart" home-based test for HIV: A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring.
|
Home-based Testing Alone
n=22 Participants
These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided.
Home-based testing only: A standard home-based HIV test kit.
|
Reminders for Clinic-based Testing
n=22 Participants
Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free.
Reminder letters for clinic-based testing: Letters reminding patients to get tested at a free clinic location
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
65 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 13.9 • n=99 Participants
|
35.8 years
STANDARD_DEVIATION 16.3 • n=107 Participants
|
35.5 years
STANDARD_DEVIATION 15.2 • n=206 Participants
|
35.2 years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
65 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 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
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
65 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 28 weeksCount of the number of participants who reported receiving HIV testing.
Outcome measures
| Measure |
"Enhanced" Home-based Testing
n=21 Participants
These participants will download a study-specific smartphone app ("eTEST"), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care.
"Smart" home-based test for HIV: A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring.
|
Home-based Testing Alone
n=22 Participants
These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided.
Home-based testing only: A standard home-based HIV test kit.
|
Reminders for Clinic-based Testing
n=22 Participants
Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free.
Reminder letters for clinic-based testing: Letters reminding patients to get tested at a free clinic location
|
|---|---|---|---|
|
Number of Participants Who Received HIV Testing
|
21 Participants
|
22 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Up to 28 weeksCount of the number of participants who reported receiving a referral for pre-exposure prophylaxis from a counselor or medical professional.
Outcome measures
| Measure |
"Enhanced" Home-based Testing
n=21 Participants
These participants will download a study-specific smartphone app ("eTEST"), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care.
"Smart" home-based test for HIV: A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring.
|
Home-based Testing Alone
n=22 Participants
These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided.
Home-based testing only: A standard home-based HIV test kit.
|
Reminders for Clinic-based Testing
n=22 Participants
Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free.
Reminder letters for clinic-based testing: Letters reminding patients to get tested at a free clinic location
|
|---|---|---|---|
|
Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis
|
8 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 28 weeksCount of the number of participants who reported actually having received a prescription for pre-exposure prophylaxis after having been referred by a medical professional.
Outcome measures
| Measure |
"Enhanced" Home-based Testing
n=21 Participants
These participants will download a study-specific smartphone app ("eTEST"), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care.
"Smart" home-based test for HIV: A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring.
|
Home-based Testing Alone
n=22 Participants
These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided.
Home-based testing only: A standard home-based HIV test kit.
|
Reminders for Clinic-based Testing
n=22 Participants
Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free.
Reminder letters for clinic-based testing: Letters reminding patients to get tested at a free clinic location
|
|---|---|---|---|
|
Number of Participants Who Reported Having Actually Received a Prescription for Pre-exposure Prophylaxis
|
1 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
"Enhanced" Home-based Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home-based Testing Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reminders for Clinic-based Testing
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. Tyler Wray
Brown University School of Public Health
Phone: 401-863-6659
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place