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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Smart home-based test for HIV
* Behavioral: Home-based testing only
* Behavioral: Reminder letters for clinic-based testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced home-based testing<br>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<br>* A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring.<br>|
| Active Comparator: Home-based testing alone<br>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<br>* A standard home-based HIV test kit.<br>|
| Sham Comparator: Reminders for clinic-based testing<br>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<br>* Letters reminding patients to get tested at a free clinic location<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Received HIV Testing | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV testing, Self-testing, Counseling, Referral