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

NCT03654690 | Completed Results FDA Device

• 2 other identifiers: 18040020211R01MH114891-01A1
• Study Type: interventional
• Target: 811
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (3)

• Model Adjusted Probability of Any HIV Testing

  We used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. A dummy-coded covariate indicating whether participants reported testing fewer than three times in the 3 years prior to enrolling was included in all models of HIV testing. We fit longitudinal mixed effects models for two outcomes, HIV testing and high-risk CAS events within a given follow-up period, given that these outcomes varied within participants across the study period. We specified distributions appropriate for each outcome (logistic for HIV testing and negative binomial for high-risk CAS events) with suitable link functions, unstructured covariance structures and robust standard errors. Time was included as a continuous covariate. A covariate reflecting pre-enrolment HIV testing and baseline CAS events were included in these models. We used an intent-to-treat approach for all analyses. Missing data were considered missing at random.

  12 month study period

• Model Adjusted Probabilities of Repeat HIV Testing (>1)

  We used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. A dummy-coded covariate indicating whether participants reported testing fewer than three times in the 3 years prior to enrolling was included in all models of HIV testing. We fit longitudinal mixed effects models for two outcomes, HIV testing and high-risk CAS events within a given follow-up period, given that these outcomes varied within participants across the study period. We specified distributions appropriate for each outcome (logistic for HIV testing and negative binomial for high-risk CAS events) with suitable link functions, unstructured covariance structures and robust standard errors. Time was included as a continuous covariate. A covariate reflecting pre-enrolment HIV testing and baseline CAS events were included in these models. We used an intent-to-treat approach for all analyses. Missing data were considered missing at random.

  12 months

• HIV Diagnoses

  count of participants who were ultimately diagnosed with HIV during the course of the study

  12 months

Secondary Outcomes (2)

• Model Predicted Probability of Receipt of a Prescription for Pre-exposure Prophylaxis (PrEP)

  12 month study period

• Model Predicted Probability of Receipt of Testing for Other Sexually-transmitted Infections

  12 months

Other Outcomes (1)

• Average Predicted Number of High-risk Casual Anal Sex (CAS) Events With Partners of Unknown HIV and PrEP Status

  12 months

Study Arms (3)

Control

NO INTERVENTION

Participants will receive SMS text message reminders to get tested for HIV in a clinic.

Standard Self-Testing

ACTIVE COMPARATOR

Participants will receive an HIV self-test kit in the mail with no standardized follow-up from counselors.

Diagnostic Test: HIV self-test

Enhanced Self-Testing

EXPERIMENTAL

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; Behavioral: Counseling

Interventions

HIV self-test DIAGNOSTIC_TEST

Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)

Enhanced Self-Testing; Standard Self-Testing

Counseling BEHAVIORAL

Post-Test HIV Risk ReductionCounseling

Enhanced Self-Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• currently on PrEP

Sponsors & Collaborators

• Brown University: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Southern California: collaborator
• The Miriam Hospital: collaborator
• University of Mississippi Medical Center: collaborator

Study Sites (1)

Brown University School of Public Health

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

• Wray TB, Chan PA, Klausner JD, Mena LA, Brock JB, Simpanen EM, Ward LM, Chrysovalantis S. eTest: a limited-interaction, longitudinal randomized controlled trial of a mobile health platform that enables real-time phone counseling after HIV self-testing among high-risk men who have sex with men. Trials. 2020 Jul 16;21(1):654. doi: 10.1186/s13063-020-04554-1.

  PMID: 32677999 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Counseling

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Tyler Wray
• Organization: Brown University

tyler_wray@brown.edu

4018636659

Study Officials

• Tyler B Wray, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are not informed of their condition assignment, but may infer it via the procedures they are provided. Both investigators and staff assessing outcomes are blinded to participants' group assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: August 31, 2018
• Study Start: January 23, 2019
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available after the publication of primary analyses. Data will be available for as long as requests are made.
• Access Criteria: De-identified individual participant data will be available to outside investigators after the primary analyses have been conducted and are published.

Locations

US (1)