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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

Brief Summary:
This study explores whether offering follow-up counseling and referral over the phone after using a home-based HIV test increases rates of ever and repeat testing, compared with home-based testing with no follow-up (HBST alone) or mailing reminders for clinic-based testing.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of Participants Who Received HIV Testing [ Time Frame: Up to 28 weeks ]
    Count of the number of participants who reported receiving HIV testing.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Sex with a partner met online in the past year
  • Anal sex (either insertive or receptive) with a casual male partner in the past 6 months without using condoms or pre-exposure prophylaxis
  • Own a smartphone (iOS or Android) with a service contract and data plan
  • Have a stable address where mail can be received
  • Speak English fluently

Exclusion Criteria:

  • Having tested for HIV in the last year

Information from the National Library of Medicine

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


Locations
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United States, Rhode Island
Brown University School of Public Health
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Brown University
  Study Documents (Full-Text)

Documents provided by Tyler Wray, Brown University:
Statistical Analysis Plan  [PDF] September 15, 2018
Study Protocol  [PDF] September 15, 2018


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Responsible Party: Tyler Wray, Assistant Professor (Research), Brown University
ClinicalTrials.gov Identifier: NCT02876926     History of Changes
Other Study ID Numbers: 1508001315
First Posted: August 24, 2016    Key Record Dates
Results First Posted: April 19, 2019
Last Update Posted: April 19, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tyler Wray, Brown University:
HIV testing
Self-testing
Counseling
Referral