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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

Tracking Information
First Submitted Date  ICMJE August 17, 2016
First Posted Date  ICMJE August 24, 2016
Results First Submitted Date  ICMJE February 15, 2018
Results First Posted Date  ICMJE April 19, 2019
Last Update Posted Date April 19, 2019
Study Start Date  ICMJE July 2016
Actual Primary Completion Date February 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 19, 2016)
  • Receipt of HIV testing [ Time Frame: Up to 28 weeks ]
  • Receipt of referrals [ Time Frame: Up to 28 weeks ]
    Whether or not participants receive referrals for HIV risk reduction counseling, testing for other sexually transmitted infections, pre-exposure prophylaxis, safe sex supplies, and other resources.
  • Rates of follow-up with referrals [ Time Frame: Up to 28 weeks ]
    Whether or not participants actually follow-up with referrals for HIV risk reduction counseling, testing for other sexually transmitted infections, pre-exposure prophylaxis, safe sex supplies, and other resources.
Change History Complete list of historical versions of study NCT02876926 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating a Real-Time, Remote Monitoring System for Home-Based HIV Testing
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE HIV
Intervention  ICMJE
  • 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.
  • Behavioral: Home-based testing only
    A standard home-based HIV test kit.
  • Behavioral: Reminder letters for clinic-based testing
    Letters reminding patients to get tested at a free clinic location
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: "Smart" home-based test for HIV
  • 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.
    Intervention: Behavioral: Home-based testing only
  • 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.
    Intervention: Behavioral: Reminder letters for clinic-based testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2019)
65
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2016)
60
Actual Study Completion Date  ICMJE February 15, 2018
Actual Primary Completion Date February 15, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02876926
Other Study ID Numbers  ICMJE 1508001315
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tyler Wray, Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Brown University
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP