eTest: Real-time, Remote Monitoring System for Home-based HIV Testing Among High-risk Men Who Have Sex With Men

Study Overview
=================
Brief Summary
-----------------
The proposed research will conduct a fully-powered efficacy trial of this approach in areas with large populations of AA and H/L MSM and high HIV incidence: Jackson, MS, Los Angeles, CA, and Boston, MA. High-risk MSM who have not tested for HIV in the last year will be recruited from MSM-oriented hook-up mobile apps, and assigned to receive either (1) HBST with post-test phone counseling/referral (eTEST condition), (2) standard HBST without active follow-up, or (3) reminders to get tested for HIV at a local clinic (control condition) at three month intervals over the course of 12 months. The investigators will explore the impact of the eTEST system on key outcomes, including rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation, compared with standard HBST or clinic-based testing reminders alone. The investigators will also explore the cost effectiveness of the eTEST system under various scenarios compared with relying on traditional, clinic-based testing alone.

Detailed Description
-----------------
HIV disproportionately affects men who have sex with men (MSM) in the United States, and new infections continue to increase particularly among African American (AA) and Hispanic/Latino (H/L) MSM. Past studies estimate that up to 50% of these new infections originate from the approximately 20% of MSM who are unaware of their status. Expanded HIV testing can produce reductions in incidence when implemented on a broad scale by facilitating earlier diagnosis and treatment. Rates of HIV testing are particularly low among AA and H/L MSM, and innovative approaches to encourage testing may help address high incidence in these men. Home-based, self-testing (HBST) for HIV offers considerable promise for increasing the number of MSM who are aware of their status by overcoming key barriers to clinic-based testing, such as inconvenience and confidentiality concerns. HBST may also be particularly well-suited for AA and H/L MSM, given that stigma and mistrust of medical care contribute to low testing rates. Despite its promise, however, many are concerned that HBST does not sufficiently connect users with critical post-testing resources, such as confirmatory testing and care among those who test positive, and that these limitations may result in delayed linkage to care. Existing, FDA-approved HBST kits provide a free, 24-hour helpline that offers these services to those who seek it, but few users do, and this passive approach may miss critical opportunities to engage with MSM for further prevention services. To address these challenges, the investigators developed a mobile health platform (eTEST) that uses internet-of-things (IoT) technologies to monitor when HBST users open their tests in real time, allowing the investigators to provide timely, active follow-up counseling and referral over the phone after they do so. In a pilot study, the investigators show that providing HBST by mail at regular intervals boosted rates of any/repeat HIV testing among high-risk MSM compared with clinic-based testing reminders. Moreover, those who received follow-up phone counseling after HBST were more likely to receive risk reduction counseling, to consult with a medical provider about PrEP, and to initiate PrEP. Given these promising results, the proposed research will conduct a fully-powered efficacy trial of this approach in areas with large populations of AA and H/L MSM and high HIV incidence: Jackson, MS, Los Angeles, CA, and Boston, MA. High-risk MSM who have not tested for HIV in the last year will be recruited from MSM-oriented hook-up mobile apps, and assigned to receive either (1) HBST with post-test phone counseling/referral (eTEST condition), (2) standard HBST without active follow-up, or (3) reminders to get tested for HIV at a local clinic (control condition) at three month intervals over the course of 12 months. The investigators will explore the impact of the eTEST system on key outcomes, including rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation, compared with standard HBST or clinic-based testing reminders alone. The investigators will also explore the cost effectiveness of the eTEST system under various scenarios compared with relying on traditional, clinic-based testing alone.

Official Title
-----------------
eTest: Real-time, Remote Monitoring System for Home-based HIV Testing Among High-risk Men Who Have Sex With Men

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Diagnostic Test: HIV self-test
* Behavioral: Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: report any of the following in the past six months: anal sex without condoms outside of a monogamous partnership with a recently tested, HIV-negative male, having been diagnosed with an STI, or being in an ongoing sexual partnership with an HIV-positive male not tested for HIV in the last 12 months have a stable residence in one of the site metros where they can securely receive packages use an iOS/Android smartphone with a data plan or home wifi fluent in either English or Spanish Exclusion Criteria: currently on PrEP

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Participants will receive SMS text message reminders to get tested for HIV in a clinic. | |
| Active Comparator: Standard Self-Testing<br>Participants will receive an HIV self-test kit in the mail with no standardized follow-up from counselors. | Diagnostic Test: HIV self-test<br>* Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)<br>|
| Experimental: Enhanced Self-Testing<br>Participants will receive an HIV self-test kit and will be contacted via telephone for counseling within 24 hours of opening their test. | Diagnostic Test: HIV self-test<br>* Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)<br>Behavioral: Counseling<br>* Post-Test HIV Risk ReductionCounseling<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV testing | Whether participants were tested for HIV, either at a clinic or via self-test | In 3-month intervals over a 12 month study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of a prescription for pre-exposure prophylaxis (PrEP) | Whether participants received a prescription for PrEP, assessed via self-report and medical record verification | Over a 12 month period | 
| Receipt of consultation about pre-exposure prophylaxis (PrEP) | Whether participants sought consultation with a medical provider about beginning a PrEP regimen, as assessed via self-report and medical records review | Over a 12 month period | 
| Receipt of testing for other sexually-transmitted infections | Whether participants were tested for other STIs, as assessed via self-report and medical record review | In 6-month intervals over a 12 months study period | 
| Receipt of counseling to reduce HIV-risk behavior | Whether participants received counseling about ways to reduce their risk for HIV, as assessed via self-report | In 3-month intervals over a 12 month period |