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N/A N=811 Randomized Triple-blind Prevention

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

HIV Infections

Enrolled (actual)
811
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Model Adjusted Probability of Any HIV Testing — 57.0; 91.0; 89.4 percent probability

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
HIV self-test (Diagnostic_test); Counseling (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
Male
Sponsor
Brown University
Primary completion
May 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Model Adjusted Probability of Any HIV Testing
57.0; 91.0; 89.4
PRIMARY
Model Adjusted Probabilities of Repeat HIV Testing (>1)
31.3; 79.4; 80.4
PRIMARY
HIV Diagnoses
0; 4; 4
SECONDARY
Model Predicted Probability of Receipt of a Prescription for Pre-exposure Prophylaxis (PrEP)
20; 15; 15
SECONDARY
Model Predicted Probability of Receipt of Testing for Other Sexually-transmitted Infections
46; 49; 50

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03654690). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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