NCT03654690: eTest

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

Completed NA Results posted Last updated 10 April 2025

What this trial tests

NA trial testing HIV self-test in HIV Infections in 811 participants. Completed in 1 May 2023.

Timeline

23 January 2019

Primary endpoint
1 May 2023

1 May 2023

Quick facts

Lead sponsor	Brown University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	811
Start date	23 January 2019
Primary completion	1 May 2023
Estimated completion	1 May 2023
Sites	1 location across United States

Drugs / interventions tested

• HIV self-test
• Counseling

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

Brown University

Who can join

18 and older, male only, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Model Adjusted Probability of Any HIV Testing Primary · 12 month study period

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

Group	Value	95% CI
Control	57.0	51.0 – 62.9
Standard Self-Testing	91.0	87.9 – 94.6
Enhanced Self-Testing	89.4	86.2 – 93.3

Model Adjusted Probabilities of Repeat HIV Testing (>1) Primary · 12 months

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

Group	Value	95% CI
Control	31.3	25.7 – 36.9
Standard Self-Testing	79.4	74.5 – 84.3
Enhanced Self-Testing	80.4	75.7 – 85.1

HIV Diagnoses Primary · 12 months

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

Group	Value	95% CI
Control	0
Standard Self-Testing	4
Enhanced Self-Testing	4

Model Predicted Probability of Receipt of a Prescription for Pre-exposure Prophylaxis (PrEP) Secondary · 12 month study period

We used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. A binary variable reflecting whether participants had ever had a PrEP prescription in the past was included for the PrEP prescription model. We specified two-way interactions between these covariates and condition assignment in all models, but none were significant and were excluded.

Group	Value	95% CI
Control	20	15 – 25
Standard Self-Testing	15	10 – 19
Enhanced Self-Testing	15	10 – 19

Model Predicted Probability of Receipt of Testing for Other Sexually-transmitted Infections Secondary · 12 months

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. A similar covariate for STI testing was included in the STI testing model. We specified two-way interactions between these covariates and condition assignment in all models, but none were significant and were excluded.

Group	Value	95% CI
Control	46	40 – 52
Standard Self-Testing	49	43 – 55
Enhanced Self-Testing	50	44 – 56

Average Predicted Number of High-risk Casual Anal Sex (CAS) Events With Partners of Unknown HIV and PrEP Status Secondary · 12 months

We used logistic regression with dummy-coded condition assignment as a predictor to test differences in outcomes across experimental conditions. We specified two-way interactions between these covariates and condition assignment in all models, but none were significant and were excluded. 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

Group	Value	95% CI
Control	2.03	0.5 – 3.6
Standard Self-Testing	2.01	0.5 – 3.5
Enhanced Self-Testing	1.46	.3 – 2.6

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.