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Evaluating a Real-Time, Remote Monitoring System for Home-Based HIV Testing ((eTEST))

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ClinicalTrials.gov Identifier: NCT02876926
Recruitment Status : Completed
First Posted : August 24, 2016
Results First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Tyler Wray, Brown University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition HIV
Interventions Behavioral: "Smart" home-based test for HIV
Behavioral: Home-based testing only
Behavioral: Reminder letters for clinic-based testing
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title "Enhanced" Home-based Testing Home-based Testing Alone Reminders for Clinic-based Testing
Hide Arm/Group Description

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.

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.

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

Period Title: Overall Study
Started 21 22 22
Completed 3 3 2
Not Completed 18 19 20
Arm/Group Title "Enhanced" Home-based Testing Home-based Testing Alone Reminders for Clinic-based Testing Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 21 22 22 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 22 participants 65 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
22
 100.0%
22
 100.0%
65
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 22 participants 22 participants 65 participants
34.1  (13.9) 35.8  (16.3) 35.5  (15.2) 35.2  (14.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 22 participants 65 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
21
 100.0%
22
 100.0%
22
 100.0%
65
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 22 participants 22 participants 65 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   9.5%
1
   4.5%
2
   9.1%
5
   7.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   9.5%
1
   4.5%
4
  18.2%
7
  10.8%
White
16
  76.2%
20
  90.9%
14
  63.6%
50
  76.9%
More than one race
1
   4.8%
0
   0.0%
2
   9.1%
3
   4.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 21 participants 22 participants 22 participants 65 participants
21
 100.0%
22
 100.0%
22
 100.0%
65
 100.0%
1.Primary Outcome
Title Number of Participants Who Received HIV Testing
Hide Description Count of the number of participants who reported receiving HIV testing.
Time Frame Up to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title "Enhanced" Home-based Testing Home-based Testing Alone Reminders for Clinic-based Testing
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 21 22 22
Measure Type: Count of Participants
Unit of Measure: Participants
21
 100.0%
22
 100.0%
16
  72.7%
2.Primary Outcome
Title Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis
Hide Description Count of the number of participants who reported receiving a referral for pre-exposure prophylaxis from a counselor or medical professional.
Time Frame Up to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title "Enhanced" Home-based Testing Home-based Testing Alone Reminders for Clinic-based Testing
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 21 22 22
Measure Type: Count of Participants
Unit of Measure: Participants
8
  38.1%
2
   9.1%
3
  13.6%
3.Primary Outcome
Title Number of Participants Who Reported Having Actually Received a Prescription for Pre-exposure Prophylaxis
Hide Description Count of the number of participants who reported actually having received a prescription for pre-exposure prophylaxis after having been referred by a medical professional.
Time Frame Up to 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title "Enhanced" Home-based Testing Home-based Testing Alone Reminders for Clinic-based Testing
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 21 22 22
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.8%
1
   4.5%
2
   9.1%
Time Frame Adverse event data was collected monthly over the course of the 7-month study period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title "Enhanced" Home-based Testing Home-based Testing Alone Reminders for Clinic-based Testing
Hide Arm/Group Description

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.

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.

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

All-Cause Mortality
"Enhanced" Home-based Testing Home-based Testing Alone Reminders for Clinic-based Testing
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/22 (0.00%)   0/22 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
"Enhanced" Home-based Testing Home-based Testing Alone Reminders for Clinic-based Testing
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/22 (0.00%)   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
"Enhanced" Home-based Testing Home-based Testing Alone Reminders for Clinic-based Testing
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/22 (0.00%)   0/22 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Tyler Wray
Organization: Brown University School of Public Health
Phone: 401-863-6659
EMail: tyler_wray@brown.edu
Layout table for additonal information
Responsible Party: Tyler Wray, Brown University
ClinicalTrials.gov Identifier: NCT02876926     History of Changes
Other Study ID Numbers: 1508001315
First Submitted: August 17, 2016
First Posted: August 24, 2016
Results First Submitted: February 15, 2018
Results First Posted: April 19, 2019
Last Update Posted: April 19, 2019