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

January 17, 2019 updated by: Tyler Wray, Brown University

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Brown University School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Received HIV Testing
Time Frame: Up to 28 weeks
Count of the number of participants who reported receiving HIV testing.
Up to 28 weeks
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.
Up to 28 weeks
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.
Up to 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

February 15, 2018

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1508001315

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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