Evaluating a Real-Time, Remote Monitoring System for Home-Based HIV Testing ((eTEST))
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02876926|
Recruitment Status : Completed
First Posted : August 24, 2016
Results First Posted : April 19, 2019
Last Update Posted : April 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: "Smart" home-based test for HIV Behavioral: Home-based testing only Behavioral: Reminder letters for clinic-based testing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exploring Use of a Real-time, Remote Monitoring and Follow-up System for Home-based, HIV Self-testing Among High-risk Men Who Have Sex With Men (MSM)|
|Study Start Date :||July 2016|
|Actual Primary Completion Date :||February 15, 2018|
|Actual Study Completion Date :||February 15, 2018|
Experimental: "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.
Behavioral: "Smart" home-based test for HIV
A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring.
Active Comparator: 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.
Behavioral: Home-based testing only
A standard home-based HIV test kit.
Sham Comparator: 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.
Behavioral: Reminder letters for clinic-based testing
Letters reminding patients to get tested at a free clinic location
- Number of Participants Who Received HIV Testing [ Time Frame: Up to 28 weeks ]Count of the number of participants who reported receiving HIV testing.
- Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis [ Time Frame: Up to 28 weeks ]Count of the number of participants who reported receiving a referral for pre-exposure prophylaxis from a counselor or medical professional.
- Number of Participants Who Reported Having Actually Received a Prescription for Pre-exposure Prophylaxis [ Time Frame: Up to 28 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876926
|United States, Rhode Island|
|Brown University School of Public Health|
|Providence, Rhode Island, United States, 02906|